Dosing & Uses
Dosage Forms & Strengths
packet
- 2.5mg
- 10mg
suspension
- 2mg/mL
tablet, delayed release
- 20mg (Prilosec OTC, OmepraCare)
capsule, delayed release
- 10mg (generic)
- 20mg (OmepraCare DR, generic)
- 40mg (generic)
oral disintegrating tablets
- 20mg
Duodenal Ulcer
20 mg PO qDay for 4-8 weeks
Safety and efficacy of omeprazole for maintenance treatment past 1 year not established
Helicobacter Pylori Infection
Various regimens exist of PPIs combined with antibiotics, an example is listed below
20 mg PO q12hr for 10 days, WITH
Amoxicillin 1000 mg PO q12hr, AND
Clarithromycin 500 mg PO q12hr for 10-14 days
Dosing considerations
- This regimen is available as a prepackaged 10-day supply of omeprazole, amoxicillin, and clarithromycin from Dava Pharms Inc, for eradication of H pylori
Gastric Ulcer
40 mg PO qDay for 4-8 weeks
GERD
20 mg PO qDay for 4 weeks
Erosive Esophagitis
20 mg PO qDay for 4-8 weeks
Maintenance: 20 mg PO qDay for up to 1 year
Hypersecretory Conditions (eg, Zollinger-Ellison Syndrome)
60 mg PO qDay (initial) up to 360 mg/day divided q8hr PO
If dose >80 mg, divide it
Dosage Modifications
Hepatic impairment: Not studied; expert analysis recommends a reduction in dose, especially for maintenance of healing of erosive esophagitis
Renal impairment: Dose adjustments not necessary
Dosage Forms & Strengths
packet
- 2.5mg
- 10mg
suspension
- 2 mg/mL
tablet/capsule
- 10mg (generic)
- 20mg (OmepraCare DR, generic)
- 40mg (generic)
oral disintegrating tablets
- 20mg
GERD
Indicated for treatment of GERD
<1 year: Safety and efficacy not established
5-10 kg: 5 mg PO qDay
10-20 kg: 10 mg PO qDay
>20 kg: 20 mg PO qDay
Erosive Esophagitis
Indicated for treatment and to maintain healing of erosive esophagitis caused by acid-mediated GERD
Treatment
- <1 month: Safety and efficacy not established
Aged 1 month to <1 year
- 3 to <5 kg: 2.5 mg qDay
- 5 to <10 kg: 5 mg qDay
- ≥10 kg: 10 mg qDay
- May treat for up to 6 weeks
Aged 1-16 years
- 5 to <10 kg: 5 mg PO qDay
- 10 to <20 kg: 10 mg PO qDay
- ≥20 kg: 20 mg PO qDay
- May treat for 4-8 weeks
Maintenance of healing
- <1 year: Safety and efficacy not established
- ≥1 year: Controlled trials for maintenance do not extend beyond 12 months
Neonates (Off-label)
Refractory duodenal ulcer or reflux esophagitis: 0.5-1.5 mg/kg PO qDay for up to 8 weeks
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (3)
- erlotinib
omeprazole decreases levels of erlotinib by Other (see comment). Contraindicated. Comment: Concomitant use of proton pump inhibitors with erlotinib should be avoided if possible. Drugs that alter pH of upper GI tract may alter the solubility of erlotinib and reduce its bioavailability. .
- nelfinavir
omeprazole decreases levels of nelfinavir by unspecified interaction mechanism. Contraindicated. Coadministration may lead to loss of nelfinavir virologic response and development of resistance; mechanism may be CYP2C19 inhibition of nelfinavir conversion to active M8 metabolite, and also PPIs decreasing gastric pH resulting in decreased nelfinavir absorption.
- rilpivirine
omeprazole decreases levels of rilpivirine by increasing gastric pH. Applies only to oral form of both agents. Contraindicated. Concurrent use may cause treatment failure and/or the development of rilpivirine or NNRTI resistance owing to decreased levels.
Serious - Use Alternative (42)
- abametapir
abametapir will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.
- acalabrutinib
omeprazole decreases levels of acalabrutinib by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Acalabrutinib solubility decreases with increasing gastric pH. Due to the long-lasting effect of PPIs, separation of doses may not eliminate the interaction.
- apalutamide
apalutamide will decrease the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP2C19 inducer, with drugs that are CYP2C19 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered.
apalutamide will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed. - atazanavir
omeprazole will decrease the level or effect of atazanavir by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Atazanavir solubility decreases as pH increases. Substantially reduced plasma concentrations of atazanavir are expected if PPIs are coadministered. PPI dose should not exceed a dose comparable to omeprazole 20 mg and must be taken ~12 h before atazanavir/ritonavir in treatment naive-patients. PPIs are not recommended in treatment-experienced taking atazanavir.
- carbamazepine
carbamazepine will decrease the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Avoid or Use Alternate Drug.
- ceritinib
omeprazole decreases effects of ceritinib by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- cilostazol
omeprazole will increase the level or effect of cilostazol by affecting hepatic enzyme CYP2C19 metabolism. Avoid or Use Alternate Drug.
- clopidogrel
omeprazole decreases effects of clopidogrel by affecting hepatic enzyme CYP2C19 metabolism. Avoid or Use Alternate Drug. Clopidogrel efficacy may be reduced by drugs that inhibit CYP2C19. Inhibition of platelet aggregation by clopidogrel is entirely due to an active metabolite. Clopidogrel is metabolized to this active metabolite in part by CYP2C19. .
- dacomitinib
omeprazole will increase the level or effect of dacomitinib by unspecified interaction mechanism. Avoid or Use Alternate Drug. Concomitant use with a PPI decreases dacomitinib concentrations, which may reduce dacomitinib efficacy. Avoid use of PPIs with dacomitinib. As an alternative to PPIs, use locally-acting antacids or an H2-receptor antagonist. Administer at least 6 hours before or 10 hours after taking an H2-receptor antagonist.
- dasatinib
omeprazole will decrease the level or effect of dasatinib by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- digoxin
omeprazole will increase the level or effect of digoxin by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- duloxetine
omeprazole will decrease the level or effect of duloxetine by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug.
- enzalutamide
enzalutamide will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- erdafitinib
omeprazole will increase the level or effect of erdafitinib by affecting hepatic enzyme CYP2C9/10 metabolism. Avoid or Use Alternate Drug. If coadministration of a strong CYP2C9 inhibitors is unavoidable, closely monitor adverse reactions and modify dose of erdafitinib accordingly. If strong CYP2C9 inhibitor is discontinued, consider increasing erdafitinib dose in the absence of any drug-related toxicities.
- fedratinib
omeprazole will increase the level or effect of fedratinib by Other (see comment). Avoid or Use Alternate Drug. Avoid coadministration of fedratinib (a CYP3A4 and CYP2C19 substrate) with dual CYP3A4 and CYP2C19 inhibitor. Effect of coadministration of a dual CYP3A4 and CYP2C19 inhibitor with fedratinib has not been studied.
- fexinidazole
fexinidazole will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.
- fluvoxamine
fluvoxamine will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Avoid or Use Alternate Drug.
- idelalisib
idelalisib will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates
- indinavir
omeprazole will decrease the level or effect of indinavir by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- infigratinib
omeprazole will decrease the level or effect of infigratinib by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- isoniazid
isoniazid will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Avoid or Use Alternate Drug.
- itraconazole
omeprazole will decrease the level or effect of itraconazole by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- ivosidenib
ivosidenib will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternative therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs.
- ketoconazole
omeprazole will decrease the level or effect of ketoconazole by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- lonafarnib
omeprazole will increase the level or effect of lonafarnib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration of lonafarnib (a sensitive CYP3A substrate) with weak CYP3A inhibitors is unavoidable, reduce to, or continue lonafarnib at starting dose. Closely monitor for arrhythmias and events (eg, syncope, heart palpitations) since lonafarnib effect on QT interval is unknown.
lonafarnib will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Avoid or Use Alternate Drug. Lonafarnib may increase the AUC and peak concentration of CYP2C19 substrates. If coadministration unavoidable, monitor for adverse reactions and reduce the CYP2C19 substrate dose in accordance with its approved product labeling. - mesalamine
omeprazole decreases effects of mesalamine by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Applies only to sustained release dosage form.
- neratinib
omeprazole will decrease the level or effect of neratinib by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- nilotinib
omeprazole will decrease the level or effect of nilotinib by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Nilotinib has a pH-dependent solubility and solubility is decreased at higher pH; separating doses may not eliminate this effect because of PPI extended duration of action
- nisoldipine
omeprazole will increase the level or effect of nisoldipine by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- pazopanib
omeprazole will decrease the level or effect of pazopanib by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Avoid coadministration of pazopanib with drugs that raise gastric pH; consider short-acting antacids in place of PPIs and H2 antagonists; separate antacid and pazopanib dosing by several hours
- pexidartinib
omeprazole will decrease the level or effect of pexidartinib by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Avoid coadministration of proton pump inhibitors (PPIs) with pexidartinib. Use H2-receptor antagonists or antacids if needed. When using alternatives to PPIs, administer pexidartinib 2 hr before or after taking locally-acting antacids OR administer pexidartinib at least 2 hr before or 10 hr after taking an H2-receptor antagonist.
- phenobarbital
phenobarbital will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- ponatinib
omeprazole decreases levels of ponatinib by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- rifampin
rifampin will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- rifapentine
rifapentine will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- secobarbital
secobarbital will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- secretin
omeprazole, secretin. Other (see comment). Avoid or Use Alternate Drug. Comment: Concomitant use of PPIs may cause a hyperresponse in gastrin secretion in response to stimulation testing with secretin, falsely suggesting gastrinoma. The time it takes for serum gastrin concentrations to return to baseline following discontinuation of PPIs is specific to the individual PPI. Temporarily stop omeprazole treatment at least 14 days before assessing to allow gastrin levels to return to baseline.
- siponimod
omeprazole will increase the level or effect of siponimod by affecting hepatic enzyme CYP2C9/10 metabolism. Avoid or Use Alternate Drug. Coadministration of siponimod with drugs that cause moderate CYP2C9 AND a moderate or strong CYP3A4 inhibition is not recommended. Caution if siponimod coadministered with moderate CYP2C9 inhibitors alone.
- sofosbuvir/velpatasvir
omeprazole will decrease the level or effect of sofosbuvir/velpatasvir by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Velpatasvir solubility decreases as gastric pH increases (practically insoluble at pH >5). Coadministration of sofosbuvir/velpatasvir with omeprazole or other PPIs is not recommended. If considered medically necessary, give sofosbuvir/velpatasvir with food 4 hr before omeprazole 20 mg. Use with other PPIs has not been studied.
- sotorasib
omeprazole will decrease the level or effect of sotorasib by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. If use with an acid-reducing agent cannot be avoided, administer sotorasib 4 hr before or 10 hr after administration of a locally-acting antacid.
- tucatinib
tucatinib will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.
- voxelotor
voxelotor will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.
Monitor Closely (97)
- amobarbital
amobarbital will decrease the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.
- ampicillin
omeprazole will decrease the level or effect of ampicillin by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- armodafinil
armodafinil will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.
- avapritinib
omeprazole will increase the level or effect of avapritinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- axitinib
omeprazole increases levels of axitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- belumosudil
omeprazole will decrease the level or effect of belumosudil by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Increase belumosudil dosage to 200 mg PO BID when coadministered with proton pump inhibitors.
- belzutifan
omeprazole will increase the level or effect of belzutifan by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. Belzutifan is a CYP2C19 substrate. Coadministration with CYP2C19 inhibitors may increase incidence or severity of adverse effects. Monitor for anemia and hypoxia and reduce belzutifan dose as recommended.
- bendamustine
omeprazole decreases levels of bendamustine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Concentrations of active metabolites may be increased.
- bortezomib
bortezomib will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.
- bosutinib
omeprazole decreases levels of bosutinib by Other (see comment). Use Caution/Monitor. Comment: PPIs may decrease bosutinib concentration by ~45%; bosutinib displays pH-dependent solubility.
- budesonide
omeprazole decreases effects of budesonide by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Enteric-coated budesonide dissolves at pH >5.5. Also, dissolution of extended-release budesonide tablets is pH dependent. Coadministration with drugs that increase gastric pH may cause these budesonide products to prematurely dissolve, and possibly affect release properties and absorption of the drug in the duodenum.
- butabarbital
butabarbital will decrease the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.
- butalbital
butalbital will decrease the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.
- cannabidiol
omeprazole will increase the level or effect of cannabidiol by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. Consider reducing the cannabidiol dose when coadministered with a strong CYP2C19 inhibitor.
cannabidiol will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. Consider reducing the dose of sensitive CYP2C19 substrates, as clinically appropriate, when coadministered with cannabidiol. - carbamazepine
carbamazepine will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- carbonyl iron
omeprazole will decrease the level or effect of carbonyl iron by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- cefpodoxime
omeprazole decreases effects of cefpodoxime by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- cefuroxime
omeprazole decreases effects of cefuroxime by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- cenobamate
cenobamate will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.
cenobamate will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. Consider a dose reduction of CYP2C19 substrates, as clinically appropriate, when used concomitantly with cenobamate. - ciprofloxacin
omeprazole will decrease the level or effect of ciprofloxacin by unknown mechanism. Use Caution/Monitor. Absorption of the ciprofloxacin ER tablet was slightly diminished (20%) when coadministered with omeprazole.
- citalopram
omeprazole will increase the level or effect of citalopram by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. Citalopram 20 mg/day is the maximum recommended dose for patients taking CYP2C19 inhibitors because of the risk of QT prolongation.
- clobazam
omeprazole will increase the level or effect of clobazam by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. Dosage adjustment may be required; CYP2C19 inhibitors may result in increased exposure to N-desmethylclobazam (active metabolite).
- clozapine
omeprazole will decrease the level or effect of clozapine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- cobicistat
cobicistat will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- conivaptan
conivaptan will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- crizotinib
omeprazole will decrease the level or effect of crizotinib by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Drugs that elevate the gastric pH may decrease the solubility of crizotinib and subsequently reduce its bioavailability. However, no formal studies have been conducted.
- cyclosporine
omeprazole, cyclosporine. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Long-term use of PPIs may cause hypomagnesemia and increase this risk when coadministered with drugs that may also decrease magnesium levels.
- dabrafenib
omeprazole will decrease the level or effect of dabrafenib by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Drugs that alter upper GI tract pH (eg, PPIs, H2-blockers, antacids) may decrease dabrafenib solubility and reduce its bioavailability
dabrafenib will decrease the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. Use alternative if available - dextroamphetamine
omeprazole, dextroamphetamine. Other (see comment). Use Caution/Monitor. Comment: Reduced gastric acidity caused by proton pump inhibitors decreases time to Tmax for amphetamine and dextroamphetamine. AUC was unaffected. .
- diazepam intranasal
omeprazole will increase the level or effect of diazepam intranasal by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. Strong or moderate CYP2C19 inhibitors may decrease rate of diazepam elimination, thereby increasing adverse reactions to diazepam.
- dichlorphenamide
dichlorphenamide and omeprazole both decrease serum potassium. Use Caution/Monitor.
- digoxin
omeprazole increases toxicity of digoxin by Other (see comment). Use Caution/Monitor. Comment: Prolonged use of PPIs may cause hypomagnesemia and increase risk for digoxin toxicity.
- efavirenz
efavirenz will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.
efavirenz will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. - elagolix
elagolix will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak inhibitor of CYP2C19. No dose adjustments are needed for omeprazole with 40 mg/day or less. Consider omeprazole dose reduction with higher omeprazole doses (eg, dose for Zollinger-Ellison) if coadministered with elagolix.
elagolix decreases levels of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed. - eltrombopag
omeprazole will decrease the level or effect of eltrombopag by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.
- eluxadoline
omeprazole increases levels of eluxadoline by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. As a precautionary measure due to incomplete information on the metabolism of eluxadoline, use caution when coadministered with strong CYP2C19 inhibitors.
- encorafenib
encorafenib, omeprazole. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. Coadministration of encorafenib with sensitive CYP3A4 substrates may result in increased toxicity or decreased efficacy of these agents.
- escitalopram
omeprazole will increase the level or effect of escitalopram by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.
- eslicarbazepine acetate
eslicarbazepine acetate will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.
- etravirine
etravirine will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.
- fedratinib
fedratinib will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.
- ferric gluconate
omeprazole will decrease the level or effect of ferric gluconate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- ferric maltol
omeprazole will decrease the level or effect of ferric maltol by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- ferrous fumarate
omeprazole will decrease the level or effect of ferrous fumarate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- ferrous gluconate
omeprazole will decrease the level or effect of ferrous gluconate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- ferrous sulfate
omeprazole will decrease the level or effect of ferrous sulfate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- fexinidazole
fexinidazole will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.
- finerenone
omeprazole will increase the level or effect of finerenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Monitor serum potassium during initiation and dosage adjustment of either finererone or weak CYP3A4 inhibitors. Adjust finererone dosage as needed.
- flibanserin
omeprazole will increase the level or effect of flibanserin by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. Coadministration of flibanserin with strong CYP2C19 inhibitors may increase flibanserin exposure and increase the risk of hypotension, syncope, and CNS depression.
omeprazole will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Increased flibanserin adverse effects may occur if coadministered with multiple weak CYP3A4 inhibitors. - fluconazole
fluconazole will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.
- fosamprenavir
omeprazole will decrease the level or effect of fosamprenavir by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- fosphenytoin
omeprazole will increase the level or effect of fosphenytoin by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.
fosphenytoin will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. - gefitinib
omeprazole decreases levels of gefitinib by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Avoid coadministration of gefitinib with PPIs if possible. If treatment with a PPI is required, separate gefitinib and PPI doses by 12 hr.
- glyburide
omeprazole will increase the level or effect of glyburide by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.
- iloperidone
iloperidone increases levels of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Iloperidone is a time-dependent CYP3A inhibitor and may lead to increased plasma levels of drugs predominantly eliminated by CYP3A4.
- imipramine
omeprazole will increase the level or effect of imipramine by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.
- iron dextran complex
omeprazole will decrease the level or effect of iron dextran complex by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- iron sucrose
omeprazole will decrease the level or effect of iron sucrose by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- isavuconazonium sulfate
omeprazole will increase the level or effect of isavuconazonium sulfate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- istradefylline
istradefylline will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.
- ledipasvir/sofosbuvir
omeprazole decreases levels of ledipasvir/sofosbuvir by Other (see comment). Use Caution/Monitor. Comment: Ledipasvir solubility decreases as pH increases; drugs that increase gastric pH are expected to decrease levels of ledipasvir; proton-pump inhibitor doses comparable to omeprazole <20 mg can be administered simultaneously with ledipasvir/sofosbuvir under fasted conditions.
- lemborexant
omeprazole will increase the level or effect of lemborexant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Lower nightly dose of lemborexant recommended if coadministered with weak CYP3A4 inhibitors. See drug monograph for specific dosage modification.
- letermovir
letermovir increases levels of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor and dose adjustment may be necessary.
- lomitapide
omeprazole increases levels of lomitapide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lomitapide dose should not exceed 30 mg/day.
- losartan
omeprazole will increase the level or effect of losartan by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. May inhibit the conversion of losartan to its active metabolite E-3174. Importance of interaction not established; monitor individual therapeutic response to determine losartan dosage.
- lumacaftor/ivacaftor
lumacaftor/ivacaftor, omeprazole. affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. In vitro studies suggest that lumacaftor may induce and ivacaftor may inhibit CYP2C19 substrates. .
lumacaftor/ivacaftor will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lumacaftor/ivacaftor is a strong CYP3A4 inhibitor and also has the potential to induce CYP2C19 and both induce and inhibitor P-gp. - methotrexate
omeprazole increases levels of methotrexate by decreasing renal clearance. Use Caution/Monitor. Temporary withdrawal of PPI may be considered in some patients.
- methylphenidate
omeprazole decreases effects of methylphenidate by enhancing GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Since the characteristics of methylphenidate extended release capsules (Ritalin LA) are pH dependent, coadministration of antacids or acid suppressants could alter the release of methylphenidate. Consider separating the administration of the antacid and the methylphenidate extended-release capsules may be avoided.
- midazolam intranasal
omeprazole will increase the level or effect of midazolam intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of mild CYP3A4 inhibitors with midazolam intranasal may cause higher midazolam systemic exposure, which may prolong sedation.
- modafinil
modafinil will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.
- mycophenolate
omeprazole will decrease the level or effect of mycophenolate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Potential interaction applies to mycophenolate mofetil. Enteric coated mycophenolate sodium formulation is less sensitive to this interaction. Clinical significance unclear.
- nateglinide
omeprazole will increase the level or effect of nateglinide by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.
- ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC)
ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC) will decrease the level or effect of omeprazole by unspecified interaction mechanism. Use Caution/Monitor. Monitor for decreased omeprazole efficacy; consider increasing omeprazole dose in patients whose symptoms are not well controlled (not to exceed 40 mg/day)
- oxcarbazepine
oxcarbazepine will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.
- pentobarbital
pentobarbital will decrease the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.
- phenobarbital
phenobarbital will decrease the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.
- phenytoin
omeprazole will increase the level or effect of phenytoin by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.
phenytoin will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. - polysaccharide iron
omeprazole will decrease the level or effect of polysaccharide iron by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- posaconazole
omeprazole will decrease the level or effect of posaconazole by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
posaconazole will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. - primidone
primidone will decrease the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.
primidone will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. - rifampin
rifampin will decrease the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.
- riociguat
omeprazole will decrease the level or effect of riociguat by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- ritonavir
ritonavir will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- roflumilast
omeprazole will decrease the level or effect of roflumilast by affecting hepatic enzyme CYP1A2 metabolism. Modify Therapy/Monitor Closely. Concomitant therapy may reduce therapeutic effectiveness.
- rose hips
omeprazole will decrease the level or effect of rose hips by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- secobarbital
secobarbital will decrease the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.
- St John's Wort
St John's Wort will decrease the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.
- stiripentol
stiripentol, omeprazole. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.
stiripentol will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. Consider reducing the dose of CYP2C19 substrates, if adverse reactions are experienced when administered concomitantly with stiripentol. - tacrolimus
omeprazole will increase the level or effect of tacrolimus by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. Concomitant administration may increase tacrolimus whole blood concentrations, particularly in intermediate or poor metabolizers of CYP2C19
- tamoxifen
omeprazole will increase the level or effect of tamoxifen by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.
- tazemetostat
tazemetostat will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
omeprazole will increase the level or effect of tazemetostat by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. - tinidazole
omeprazole will increase the level or effect of tinidazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- tofacitinib
omeprazole increases levels of tofacitinib by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. No specific dose adjustment recommended when tofacitinib coadministered with potent CYP2C19 inhibitors; decrease tofacitinib dose if coadministered with both moderate CYP3A4 and potent CYP2C19 inhibitors .
- triclabendazole
triclabendazole will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.
- vismodegib
omeprazole will decrease the level or effect of vismodegib by Other (see comment). Use Caution/Monitor. Drugs that increase gastric pH alter vismodegib solubility and therefore reduce bioavailability; effect on efficacy unknown
- voriconazole
voriconazole will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.
voriconazole will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. - warfarin
omeprazole will increase the level or effect of warfarin by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.
Minor (54)
- alosetron
omeprazole will decrease the level or effect of alosetron by affecting hepatic enzyme CYP1A2 metabolism. Minor/Significance Unknown.
- alprazolam
omeprazole increases levels of alprazolam by decreasing metabolism. Minor/Significance Unknown.
- ambrisentan
omeprazole will increase the level or effect of ambrisentan by affecting hepatic enzyme CYP2C19 metabolism. Minor/Significance Unknown.
- bismuth subsalicylate
omeprazole increases levels of bismuth subsalicylate by enhancing GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.
- blessed thistle
blessed thistle decreases effects of omeprazole by pharmacodynamic antagonism. Minor/Significance Unknown. Theoretical interaction.
- bosentan
omeprazole will increase the level or effect of bosentan by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.
bosentan will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. - carbamazepine
omeprazole increases levels of carbamazepine by decreasing metabolism. Minor/Significance Unknown. Monitor plasma levels when used concomitantly.
- carvedilol
omeprazole will increase the level or effect of carvedilol by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.
- chlordiazepoxide
omeprazole increases levels of chlordiazepoxide by decreasing metabolism. Minor/Significance Unknown.
- clomipramine
omeprazole will increase the level or effect of clomipramine by affecting hepatic enzyme CYP2C19 metabolism. Minor/Significance Unknown.
- clonazepam
omeprazole increases levels of clonazepam by decreasing metabolism. Minor/Significance Unknown.
- clorazepate
omeprazole increases levels of clorazepate by decreasing metabolism. Minor/Significance Unknown.
- cyanocobalamin
omeprazole decreases levels of cyanocobalamin by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.
- darifenacin
darifenacin will decrease the level or effect of omeprazole by Other (see comment). Minor/Significance Unknown. Effectiveness of proton pump inhibitors may be decreased theoretically if administered with other antisecretory agents
- devil's claw
devil's claw decreases effects of omeprazole by pharmacodynamic antagonism. Minor/Significance Unknown.
- dexamethasone
dexamethasone will decrease the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- diazepam
omeprazole will increase the level or effect of diazepam by affecting hepatic enzyme CYP2C19 metabolism. Minor/Significance Unknown.
- dronedarone
dronedarone will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- elvitegravir/cobicistat/emtricitabine/tenofovir DF
elvitegravir/cobicistat/emtricitabine/tenofovir DF, omeprazole. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Based on drug interaction studies conducted with the components of Stribild, no clinically significant drug interactions have been either observed or are expected when coadministered with PPIs.
- eslicarbazepine acetate
eslicarbazepine acetate decreases effects of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Monitor for GI symptoms; net increased or decreased effect on PPI action unclear due to opposing CYP450 actions.
- estazolam
omeprazole increases levels of estazolam by decreasing metabolism. Minor/Significance Unknown.
- etravirine
omeprazole will increase the level or effect of etravirine by affecting hepatic enzyme CYP2C19 metabolism. Minor/Significance Unknown.
omeprazole will increase the level or effect of etravirine by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown. - ferric carboxymaltose
omeprazole will decrease the level or effect of ferric carboxymaltose by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown.
- fluoxetine
fluoxetine will increase the level or effect of omeprazole by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.
- flurazepam
omeprazole increases levels of flurazepam by decreasing metabolism. Minor/Significance Unknown.
- fluvastatin
omeprazole will increase the level or effect of fluvastatin by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.
- glipizide
omeprazole will increase the level or effect of glipizide by affecting hepatic enzyme CYP2C19 metabolism. Minor/Significance Unknown.
- ibuprofen IV
omeprazole will increase the level or effect of ibuprofen IV by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.
- levothyroxine
omeprazole decreases levels of levothyroxine by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown. Conflicting evidence regarding this interaction exists.
- lidocaine
omeprazole will decrease the level or effect of lidocaine by affecting hepatic enzyme CYP1A2 metabolism. Minor/Significance Unknown.
- liothyronine
omeprazole decreases levels of liothyronine by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown. Conflicting evidence regarding this interaction exists.
- liotrix
omeprazole decreases levels of liotrix by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown. Conflicting evidence regarding this interaction exists.
- lisdexamfetamine
omeprazole, lisdexamfetamine. Other (see comment). Minor/Significance Unknown. Comment: Reduced gastric acidity caused by proton pump inhibitors decreases time to Tmax for amphetamine and dextroamphetamine. AUC was unaffected. .
- lorazepam
omeprazole increases levels of lorazepam by decreasing metabolism. Minor/Significance Unknown.
- methamphetamine
omeprazole decreases levels of methamphetamine by Other (see comment). Minor/Significance Unknown. Comment: Time to maximum concentration (Tmax) of amphetamine is decreased compared to when administered alone; monitor patients for changes in clinical effect and adjust therapy based on clinical response.
- mexiletine
omeprazole will decrease the level or effect of mexiletine by affecting hepatic enzyme CYP1A2 metabolism. Minor/Significance Unknown.
- midazolam
omeprazole increases levels of midazolam by decreasing metabolism. Minor/Significance Unknown.
- mitotane
mitotane decreases levels of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments.
- olanzapine
omeprazole will decrease the level or effect of olanzapine by affecting hepatic enzyme CYP1A2 metabolism. Minor/Significance Unknown.
- ospemifene
omeprazole increases levels of ospemifene by affecting hepatic enzyme CYP2C19 metabolism. Minor/Significance Unknown.
- phytoestrogens
omeprazole decreases levels of phytoestrogens by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.
- quazepam
omeprazole increases levels of quazepam by decreasing metabolism. Minor/Significance Unknown.
- ribociclib
ribociclib will increase the level or effect of omeprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- riluzole
omeprazole will decrease the level or effect of riluzole by affecting hepatic enzyme CYP1A2 metabolism. Minor/Significance Unknown.
- ruxolitinib
omeprazole will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- ruxolitinib topical
omeprazole will increase the level or effect of ruxolitinib topical by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- sulfamethoxazole
omeprazole will increase the level or effect of sulfamethoxazole by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.
- theophylline
omeprazole will decrease the level or effect of theophylline by affecting hepatic enzyme CYP1A2 metabolism. Minor/Significance Unknown.
omeprazole increases toxicity of theophylline by Other (see comment). Minor/Significance Unknown. Comment: Prolonged use of proton pump inhibitors can cause hypochlorhydria, which in turn causes peristalsis in small intestine to increase and peristalsis in the proximal colon to decrease; monitor for toxicity. - thyroid desiccated
omeprazole decreases levels of thyroid desiccated by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown. Conflicting evidence regarding this interaction exists.
- tizanidine
omeprazole will decrease the level or effect of tizanidine by affecting hepatic enzyme CYP1A2 metabolism. Minor/Significance Unknown.
- tolbutamide
omeprazole will increase the level or effect of tolbutamide by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.
- triazolam
omeprazole increases levels of triazolam by decreasing metabolism. Minor/Significance Unknown.
- voriconazole
omeprazole will increase the level or effect of voriconazole by affecting hepatic enzyme CYP2C19 metabolism. Minor/Significance Unknown.
- warfarin
omeprazole will increase the level or effect of warfarin by affecting hepatic enzyme CYP2C19 metabolism. Minor/Significance Unknown.
Adverse Effects
1-10%
Headache (7%)
Abdominal pain (5%)
Diarrhea (4%)
Nausea (4%)
Vomiting (3%)
Flatulence (3%)
Dizziness (2%)
Upper respiratory infection (2%)
Acid regurgitation (2%)
Constipation (2%)
Rash (2%)
Cough (1%)
Frequency Not Defined
Fracture of bone, osteoporosis-related
Hepatotoxicity (rare)
Agranulocytosis
Anorexia
Gastric polyps
Hip fracture
Alopecia
Atrophic gastritis
Interstitial nephritis (rare)
Pancreatitis (rare)
Rhabdomyolysis
Taste perversion
Abnormal dreams
Toxic epidermal necrolysis (rare)
Postmarketing Reports
Bone fracture
Fundic gland polyps
Acute tubulointerstitial nephritis
Warnings
Contraindications
Hypersensitivity to omeprazole or other proton pump inhibitors (PPIs)
Cautions
PPIs are possibly associated with increased incidence of Clostridium difficile-associated diarrhea (CDAD); consider diagnosis of CDAD for patients taking PPIs who have diarrhea that does not improve
May require dosage reduction with liver disease
Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) reported with PPIs; avoid using for longer than medically indicated; discontinue if signs or symptoms consistent with CLE or SLE are observed and refer patient to specialist
Shown to cause gastric carcinoid tumors in rats with increased doses, but risk in humans unconfirmed
Published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine, particularly with prolonged (>1 yr), high-dose therapy
Hypomagnesemia may occur with prolonged use (>1 year); adverse effects may result and include tetany, arrhythmias, and seizures; in 25% of cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued
Decreased gastric acidity increases serum chromogranin A (CgA) levels and may cause false-positive diagnostic results for neuroendocrine tumors; temporarily discontinue PPIs before assessing CgA levels
Inhibits hepatic isoenzyme CYP2C19 and may alter metabolism of drugs that are CYP2C19 substrates
PPIs may decrease the efficacy of clopidogrel by reducing the formation of the active metabolite
Stop use and inform a healthcare professional if rash or joint pain develops
Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin
Acute interstitial nephritis has been observed in patients taking PPIs
Relief of symptoms does not eliminate the possibility of a gastric malignancy
Therapy increases risk of Salmonella, Campylobacter, and other infections
May elevate and/or prolong serum concentrations of methotrexate and/or its metabolite when administered concomitantly with PPIs, possibly leading to toxicity; consider a temporary withdrawal of PPI therapy therapy with high dose methotrexate administration
PPI therapy is associated with increased risk of fundic gland polyp; risk increases with long-term use >1 year; patient may be asymptomatic; problem usually identified incidentally on endoscopy; use shortest duration of therapy appropriate to condition being treated
If patient taking a prescription drug, the patient should ask a doctor or a pharmacist whether acid reducers can be taken concomitantly with it
Acute tubulointerstitial nephritis (TIN) reported in patients taking PPIs; may occur at any point during PPI therapy; patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (eg, malaise, nausea, anorexia); in reported case series, some patients were diagnosed on biopsy and in absence of extra-renal manifestations (eg, fever, rash or arthralgia); discontinue therapy and evaluate patients with suspected acute TIN
Pregnancy & Lactation
Pregnancy
There are no adequate and well-controlled studies in pregnant women; available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use; reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.4 to 34 times an oral human dose of 40 mg (based on a body surface area for a 60 kg person)
Teratogenicity was not observed in animal reproduction studies with administration of oral esomeprazole (an enantiomer of omeprazole) magnesium in rats and rabbits during organogenesis with doses about 68 times and 42 times, respectively, an oral human dose of 40 mg esomeprazole or 40 mg omeprazole (based on body surface area for a 60 kg person); changes in bone morphology were observed in offspring of rats dosed through most of pregnancy and lactation at doses equal to or greater than approximately 34 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole; when maternal administration was confined to gestation only, there were no effects on bone physeal morphology in offspring at any age
Lactation
Limited data suggest omeprazole may be present in human milk; there are no clinical data on effects of omeprazole on breastfed infant or on milk production; developmental and health benefits of breastfeeding should be considered along with mother's clinical need for therapy and any potential adverse effects on breastfed infant from treatment or from underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
PPI; binds to H+/K+-exchanging ATPase (proton pump) in gastric parietal cells, resulting in suppression of basal and stimulated acid secretion
Absorption
Bioavailability: 30-40%
Onset of action: 1 hr (antisecretory effect)
Duration: 73 hr
Peak plasma time: 0.5-3.5 hr
Peak response (PUD): 2 hr (initial); 5 days (peak)
Distribution
Protein bound: 95-96%
Vd: 0.39 L/kg
Metabolism
Metabolized extensively by hepatic CYP2C19; slow metabolizers are deficient in CYP2C19 enzyme system; plasma concentration can increase by 5-fold or higher in comparison with that found in persons with the enzyme
Metabolites: Hydroxyomeprazole, omeprazole sulfone, omeprazole sulfide (inactive)
Enzymes inhibited: CYP2C19
Elimination
Half-life: 0.5-1 hr; increases to 3 hr with hepatic impairment
Dialyzable: No
Total body clearance: 500-600 mL/min
Excretion: Urine (77%); feces (16-19%; mainly in bile)
Pharmacogenomics
CYP2C19 poor metabolizers
- Asians have ~4-fold higher exposure to omeprazole than whites
- CYP2C19, a polymorphic enzyme, is involved in the metabolism of omeprazole
- ~15-20% of Asians are CYP2C19 poor metabolizers
- Tests are available to identify a patient’s CYP2C19 genotype
- Avoid use in Asian patients with unknown CYP2C19 genotype or those who are known to be poor metabolizers
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| omeprazole oral - | 40 mg capsule |  | |
| omeprazole oral - | 20 mg capsule |  | |
| omeprazole oral - | 20 mg capsule |  | |
| omeprazole oral - | 40 mg capsule |  | |
| omeprazole oral - | 20 mg capsule |  | |
| omeprazole oral - | 10 mg capsule |  | |
| omeprazole oral - | 40 mg capsule |  | |
| omeprazole oral - | 20 mg capsule |  | |
| omeprazole oral - | 20 mg capsule |  | |
| omeprazole oral - | 20 mg capsule |  | |
| omeprazole oral - | 20 mg capsule |  | |
| omeprazole oral - | 40 mg capsule |  | |
| omeprazole oral - | 10 mg capsule |  | |
| omeprazole oral - | 20 mg capsule |  | |
| omeprazole oral - | 40 mg capsule |  | |
| omeprazole oral - | 40 mg capsule |  | |
| omeprazole oral - | 40 mg capsule |  | |
| omeprazole oral - | 10 mg capsule |  | |
| omeprazole oral - | 40 mg capsule |  | |
| omeprazole oral - | 40 mg capsule |  | |
| omeprazole oral - | 40 mg capsule |  | |
| omeprazole oral - | 20 mg capsule |  | |
| omeprazole oral - | 20 mg tablet |  | |
| omeprazole oral - | 20 mg tablet |  | |
| omeprazole oral - | 40 mg capsule |  | |
| omeprazole oral - | 10 mg capsule |  | |
| omeprazole oral - | 10 mg capsule |  | |
| omeprazole oral - | 10 mg capsule |  | |
| omeprazole oral - | 20 mg tablet |  | |
| omeprazole oral - | 20 mg tablet |  | |
| omeprazole oral - | 40 mg capsule |  | |
| omeprazole oral - | 10 mg capsule |  | |
| omeprazole oral - | 10 mg capsule |  | |
| omeprazole oral - | 20 mg tablet |  | |
| omeprazole oral - | 20 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
omeprazole oral
OMEPRAZOLE DELAYED RELEASE TABLET - ORAL
(oh-MEH-pruh-zole)
COMMON BRAND NAME(S): Prilosec OTC
USES: Omeprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Omeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs).If you are self-treating with this medication, over-the-counter omeprazole products are used to treat frequent heartburn (occurring 2 or more days a week). Since it may take 1 to 4 days to have full effect, these products do not relieve heartburn right away.For over-the-counter products, carefully read the package instructions to make sure the product is right for you. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar brand names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.
HOW TO USE: If your doctor has prescribed this medication for you, read the Patient Information Leaflet if available from your pharmacist before you start taking omeprazole and each time you get a refill. If you are taking the over-the-counter product to self-treat, read and follow all directions on the product package before taking this medication.Take this medication by mouth as directed, usually once daily before a meal. The dosage and length of treatment are based on your medical condition and response to treatment. In children, the dosage is also based on weight. Do not increase your dose or take this drug more often than directed. If you have any questions, ask your doctor or pharmacist.Do not crush, break, or chew delayed release tablets. Doing so can release all of the drug at once, increasing the risk of side effects.If you are using the disintegrating delayed release tablets, use dry hands to handle the tablets. Place the tablet on your tongue and let it dissolve. After the tablet has dissolved, it can be swallowed with or without water. The tablets can also be swallowed whole with water.If needed, antacids may be taken along with this medication. If you are also taking sucralfate, take omeprazole at least 30 minutes before sucralfate.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Continue to take this medication for the prescribed length of treatment even if you are feeling better. If you are self-treating with the over-the-counter product, do not take it for more than 14 days unless directed by your doctor.Tell your doctor if your condition lasts or gets worse. If you are self-treating, tell your doctor if your heartburn lasts after 14 days or if you need to use this medication more than once every 4 months. The risk of side effects goes up over time. Ask your doctor how long you should take this medication. If you think you may have a serious medical problem, get medical help right away.
SIDE EFFECTS: See also Precautions section.Headache or abdominal pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.If your doctor has directed you to use this product, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: symptoms of a low magnesium blood level (such as unusually fast/slow/irregular heartbeat, persistent muscle spasms, seizures), signs of lupus (such as rash on nose and cheeks, new or worsening joint pain).This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn't stop, abdominal or stomach pain/cramping, fever, blood/mucus in your stool.If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse.Rarely, proton pump inhibitors (such as omeprazole) have caused vitamin B-12 deficiency. The risk is increased if they are taken every day for a long time (3 years or longer). Tell your doctor right away if you develop symptoms of vitamin B-12 deficiency (such as unusual weakness, sore tongue, or numbness/tingling of the hands/feet).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, signs of kidney problems (such as change in the amount of urine).This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking omeprazole, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (such as esomeprazole, lansoprazole, pantoprazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, lupus.Some symptoms may actually be signs of a more serious condition. Get medical help right away if you have: heartburn with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder pain (especially with shortness of breath, unusual sweating), unexplained weight loss.In addition, before you self-treat with this medication, get medical help right away if you have any of these signs of a serious condition: trouble/pain swallowing food, bloody vomit, vomit that looks like coffee grounds, bloody/black stools, heartburn for over 3 months, frequent chest pain, frequent wheezing (especially with heartburn), nausea/vomiting, stomach pain.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Proton pump inhibitors (such as omeprazole) may increase your risk for bone fractures, especially with longer use, higher doses, and in older adults. Talk with your doctor or pharmacist about ways to prevent bone loss/fracture, such as by taking calcium (such as calcium citrate) and vitamin D supplements.Older adults may be more sensitive to the side effects of this drug, especially bone loss and fractures (see above), and C. difficile infection (see Side Effects section).Children may be more sensitive to the side effects of this drug, especially fever, cough, and infections of the nose/throat/airways.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This medication passes into breast milk. The effects on a nursing infant are unknown. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: See also How to Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: cilostazol, clopidogrel, methotrexate (especially high-dose treatment), rifampin, St John's wort.Some products need stomach acid so that the body can absorb them properly. Omeprazole decreases stomach acid, so it may change how well these products work. Some affected products include atazanavir, erlotinib, nelfinavir, pazopanib, rilpivirine, certain azole antifungals (itraconazole, ketoconazole, posaconazole), among others.Omeprazole is very similar to esomeprazole. Do not use any medications containing esomeprazole while using omeprazole.This medication may interfere with certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: confusion, unusual sweating, blurred vision, unusually fast heartbeat.
NOTES: If your doctor has prescribed this medication for you, do not share it with others.If your doctor instructs you to use this medication regularly for a long time, laboratory and medical tests (such as a magnesium blood test, vitamin B-12 levels) may be performed periodically to monitor your progress or check for side effects. Keep all regular medical and laboratory appointments.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised July 2021. Copyright(c) 2021 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
