Dosing & Uses
Dosage Forms & Strengths
tablet (Fibricor)
- 35mg
- 105mg
capsule, delayed-release (Trilipix)
- 45mg
- 135mg
Hypertriglyceridemia
Indicated as adjunct to diet for severe hypertriglyceridemia (>500 mg/dL)
Fibricor: 35-105 mg PO qDay
Trilipix: 45-135 mg PO qDay
Primary Hypercholesterolemia or Mixed Lipidemia
Indicated as adjunct to diet to reduce elevated LDL-C, Total-C, TG, and Apo B, and to increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia
Fibricor: 105 mg PO qDay
Trilipix: 135 mg PO qDay
Dosage Modifications
Renal impairment
- Mild-to-moderate (CrCl 30-80 mL/min): Initiate at lowest available dose and increase only after evaluating effects on renal function and lipid levels
- Severe (CrCl <30 mL/min): Contraindicated
Dosing Considerations
Hypertriglyceridemia: Improving glycemic control in diabetic patients with fasting chylomicronemia will usually obviate the need for pharmacological intervention
Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus
Indication for use with statins withdrawn by FDA
- April 15, 2016: Based on several large cardiovascular outcome trials including AIM-HIGH, ACCORD, and HPS2-THRIVE, the FDA decided that "scientific evidence no longer supports the conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDL-cholesterol levels in statin-treated patients results in a reduction in the risk of cardiovascular events"
- Consistent with this conclusion, the FDA has determined that the benefits of fenofibric-acid (delayed-release) capsules (eg, Trilipix) for coadministration with statins no longer outweigh the risks, and the approval for this indication should be withdrawn
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (13)
- abametapir
abametapir will increase the level or effect of fenofibric acid 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.
- atorvastatin
fenofibric acid, atorvastatin. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Fenofibrate may further increase risk for rhabdomyolysis when added to optimal statin regimen to further decrease TG and increase HDLs.
- colchicine
colchicine, fenofibric acid. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased risk of rhabdomyolysis (incl a fatality).
- fexinidazole
fexinidazole will increase the level or effect of fenofibric acid 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.
- fluvastatin
fenofibric acid, fluvastatin. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Fenofibrate may further increase risk for rhabdomyolysis when added to optimal statin regimen to further decrease TG and increase HDLs.
- idelalisib
idelalisib will increase the level or effect of fenofibric acid by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates
- lovastatin
fenofibric acid, lovastatin. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Fenofibrate may further increase risk for rhabdomyolysis when added to optimal statin regimen to further decrease TG and increase HDLs. Do not exceed 20 mg/day of lovastatin.
- pitavastatin
fenofibric acid, pitavastatin. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Fenofibrate may further increase risk for rhabdomyolysis when added to optimal statin regimen to further decrease TG and increase HDLs.
- pravastatin
fenofibric acid, pravastatin. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Fenofibrate may further increase risk for rhabdomyolysis when added to optimal statin regimen to further decrease TG and increase HDLs.
- rosuvastatin
fenofibric acid, rosuvastatin. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Fenofibrate may further increase risk for rhabdomyolysis when added to optimal statin regimen to further decrease TG and increase HDLs.
- simvastatin
fenofibric acid, simvastatin. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Fenofibrate may further increase risk for rhabdomyolysis when added to optimal statin regimen to further decrease TG and increase HDLs.
- tucatinib
tucatinib will increase the level or effect of fenofibric acid 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 fenofibric acid 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 (37)
- belzutifan
belzutifan will decrease the level or effect of fenofibric acid by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. If unable to avoid coadministration of belzutifan with sensitive CYP3A4 substrates, consider increasing the sensitive CYP3A4 substrate dose in accordance with its prescribing information.
- cenobamate
cenobamate will decrease the level or effect of fenofibric acid by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.
- chlorpropamide
fenofibric acid increases effects of chlorpropamide by plasma protein binding competition. Use Caution/Monitor. Hypoglycemia; increased risk in hypoalbuminemia.
- cholestyramine
cholestyramine decreases levels of fenofibric acid by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
- cholic acid
fenofibric acid increases toxicity of cholic acid by decreasing elimination. Modify Therapy/Monitor Closely. Avoid concomitant use of inhibitors of the bile salt efflux pump (BSEP). May exacerbate accumulation of conjugated bile salts in the liver and result in clinical symptoms. If concomitant use is necessary, monitor serum transaminases and bilirubin.
- dabrafenib
dabrafenib will decrease the level or effect of fenofibric acid by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.
- elagolix
elagolix decreases levels of fenofibric acid 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.
- elvitegravir/cobicistat/emtricitabine/tenofovir DF
elvitegravir/cobicistat/emtricitabine/tenofovir DF increases levels of fenofibric acid by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Cobicistat is a CYP3A4 inhibitor; contraindicated with CYP3A4 substrates for which elevated plasma concentrations are associated with serious and/or life-threatening events.
- fedratinib
fedratinib will increase the level or effect of fenofibric acid by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.
- fosphenytoin
fosphenytoin will decrease the level or effect of fenofibric acid by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- furosemide
fenofibric acid, furosemide. Either increases levels of the other by plasma protein binding competition. Use Caution/Monitor. Increased risk in hypoalbuminemia.
- glimepiride
fenofibric acid increases effects of glimepiride by plasma protein binding competition. Use Caution/Monitor. Hypoglycemia; increased risk in hypoalbuminemia.
- glipizide
fenofibric acid increases effects of glipizide by plasma protein binding competition. Use Caution/Monitor. Hypoglycemia; increased risk in hypoalbuminemia.
- glyburide
fenofibric acid increases effects of glyburide by plasma protein binding competition. Use Caution/Monitor. Hypoglycemia; increased risk in hypoalbuminemia.
- iloperidone
iloperidone increases levels of fenofibric acid by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Iloperidone is a time-dependent CYP3A inhibitor and may lead to increased plasma levels of drugs predominantly eliminated by CYP3A4.
- insulin aspart
fenofibric acid increases effects of insulin aspart by unspecified interaction mechanism. Use Caution/Monitor. Hypoglycemia; increased risk in hypoalbuminemia.
- insulin degludec
fenofibric acid, insulin degludec. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs decrease blood glucose.
- insulin degludec/insulin aspart
fenofibric acid, insulin degludec/insulin aspart. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs decrease blood glucose.
- insulin detemir
fenofibric acid increases effects of insulin detemir by unspecified interaction mechanism. Use Caution/Monitor. Hypoglycemia; increased risk in hypoalbuminemia.
- insulin glargine
fenofibric acid increases effects of insulin glargine by unspecified interaction mechanism. Use Caution/Monitor. Hypoglycemia; increased risk in hypoalbuminemia.
- insulin glulisine
fenofibric acid increases effects of insulin glulisine by unspecified interaction mechanism. Use Caution/Monitor. Hypoglycemia; increased risk in hypoalbuminemia.
- insulin inhaled
fenofibric acid, insulin inhaled. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs decrease blood glucose.
- insulin lispro
fenofibric acid increases effects of insulin lispro by unspecified interaction mechanism. Use Caution/Monitor. Hypoglycemia; increased risk in hypoalbuminemia.
- insulin NPH
fenofibric acid increases effects of insulin NPH by unspecified interaction mechanism. Use Caution/Monitor. Hypoglycemia; increased risk in hypoalbuminemia.
- insulin regular human
fenofibric acid increases effects of insulin regular human by unspecified interaction mechanism. Use Caution/Monitor. Hypoglycemia; increased risk in hypoalbuminemia.
- istradefylline
istradefylline will increase the level or effect of fenofibric acid 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.
- lenacapavir
lenacapavir will increase the level or effect of fenofibric acid by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lencapavir (a moderate CYP3A4 inhibitor) may increase CYP3A4 substrates initiated within 9 months after last SC dose of lenacapavir, which may increase potential risk of adverse reactions of CYP3A4 substrates.
- mavacamten
fenofibric acid will increase the level or effect of mavacamten by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely. Inititiation of weak CYP2C19 inhibitors may require decreased mavacamten dose.
- mitotane
mitotane decreases levels of fenofibric acid by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments.
- rucaparib
rucaparib will increase the level or effect of fenofibric acid by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.
- stiripentol
stiripentol, fenofibric acid. 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.
- tazemetostat
tazemetostat will decrease the level or effect of fenofibric acid by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- tecovirimat
tecovirimat will decrease the level or effect of fenofibric acid by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.
- tenofovir DF
fenofibric acid increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. Increased risk of myopathy.
- tolazamide
fenofibric acid increases effects of tolazamide by plasma protein binding competition. Use Caution/Monitor. Hypoglycemia; increased risk in hypoalbuminemia.
- tolbutamide
fenofibric acid increases effects of tolbutamide by plasma protein binding competition. Use Caution/Monitor. Hypoglycemia; increased risk in hypoalbuminemia.
- warfarin
fenofibric acid will increase the level or effect of warfarin by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Mechanism of interaction may be caused by CYP2C9 inhibition and protein-binding displacement.
Minor (11)
- acetazolamide
acetazolamide will increase the level or effect of fenofibric acid by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- anastrozole
anastrozole will increase the level or effect of fenofibric acid by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- colestipol
colestipol decreases levels of fenofibric acid by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.
- cyclophosphamide
cyclophosphamide will increase the level or effect of fenofibric acid by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- cyclosporine
fenofibric acid increases levels of cyclosporine by unspecified interaction mechanism. Minor/Significance Unknown.
- ezetimibe
fenofibric acid increases levels of ezetimibe by unspecified interaction mechanism. Minor/Significance Unknown.
- larotrectinib
larotrectinib will increase the level or effect of fenofibric acid by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- levoketoconazole
levoketoconazole will increase the level or effect of fenofibric acid by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- octacosanol
octacosanol increases effects of fenofibric acid by pharmacodynamic synergism. Minor/Significance Unknown.
- orlistat
orlistat increases effects of fenofibric acid by pharmacodynamic synergism. Minor/Significance Unknown.
- ribociclib
ribociclib will increase the level or effect of fenofibric acid by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
Adverse Effects
>10%
Headache (11.9-13.1%)
1-10%
Back pain (4.1-6.3%)
Nausea (3.5-5.5%)
Upper respiratory tract infection (3.7-5.3%)
Nasopharyngitis (3.5-4.7%)
Diarrhea (3.1-3.7%)
Myalgia (3.1-3.5%)
Increased AST (3.4%)
Increased ALT (3%)
Increased CPK (3%)
Postmarketing Reports
Myalgia, rhabdomyolysis, muscle spasms, arthralgia
Pancreatitis
Renal failure
Hepatitis, cirrhosis
Anemia
Severely depressed HDL levels
Photosensitivity reactions (may occur days to months after initiating therapy)
Interstitial lung disease
Increase total bilirubin
Asthenia
Decreases in hematocrit
White blood cell decreases
Warnings
Contraindications
Hypersensitivity
Severe renal impairment (including dialysis)
Active liver disease, including primary biliary cirrhosis and unexplained persistent liver function abnormalities
Pre-existing gallbladder disease
Breastfeeding women
Cautions
Effect on coronary heart disease morbidity and mortality not established
Increases risk of myositis or myopathy, and has been associated with rhabdomyolysis; risk may increase when coadministered with statins
Higher doses or coadministration with statins associated with increased serum transaminases
May increase serum creatinine
May increase cholesterol excretion in bile, potentially leading to cholelithiasis
Coadministration with warfarin may increase anticoagulant effects resulting in PT/INR prolongation
Pancreatitis reported; may be a failure of efficacy with severe hypertriglyceridemia, a direct drug effect, or secondary effect via biliary stone or sludge formation
May decrease hemoglobin, hematocrit, and leukocytes; thrombocytopenia and agranulocytosis reported; monitoring of blood counts recommended during first year of therapy
Anaphylaxis and angioedema reported; if patient develops signs or symptoms of acute hypersensitivity reaction, advise them to seek immediate medical attention and discontinue therapy
Acute hypersensitivity reactions (eg, Stevens-Johnson syndrome, toxic necrolysis) reported PE and DVT reported; use caution in patients with risk factors for VTE
Severe cutaneous adverse drug reactions (SCAR), including Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported postmarketing, occurring days to weeks after initiation of fenofibrate; cases of DRESS associated with cutaneous reactions (such as rash exfoliative dermatitis) and a combination of eosinophilia, fever, systemic organ involvement (renal, hepatic, or respiratory); discontinue therapy and treat patients appropriately if SCAR is suspected
Paradoxical decreases in HDL cholesterol reported; monitor HDL-C within few months of initiating therapy; discontinue of HDL-C becomes severely depressed; do not restart therapy
Hepatotoxicity
- Serious drug-induced liver injury (DILI), including liver transplantation and death, reported; DILI reported within first few weeks of treatment or after several months of therapy and in some cases has reversed with discontinuation of treatment
- Patients with DILI have experienced signs and symptoms including dark urine, abnormal stool, jaundice, malaise, abdominal pain, myalgia, weight loss, pruritus, and nausea
- Many patients had concurrent elevations of total bilirubin, serum alanine transaminase (ALT), and aspartate transaminase (AST)
- DILI has been characterized as hepatocellular, chronic active, and cholestatic hepatitis, and cirrhosis has occurred in association with chronic active hepatitis
- In clinical trials, fenofibrate at doses equivalent to 90 mg daily associated with increases in serum AST or ALT; the incidence of increases in transaminases may be dose-related
- Monitor patient’s liver function, including serum ALT, AST, and total bilirubin, at baseline and periodically for duration of therapy
- Discontinue therapy if signs or symptoms of liver injury develop or if elevated enzyme levels persist (ALT or AST > 3 times the upper limit of normal, or if accompanied by elevation of bilirubin); do not restart therapy in these patients if there is no alternative explanation for the liver injury
Pregnancy & Lactation
Pregnancy
Limited available data in pregnant women are insufficient to determine drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes
Animal data
- In animal reproduction studies, no evidence of embryo-fetal toxicity observed with oral administration in rats and rabbits during organogenesis at doses less than or equivalent to maximum recommended clinical dose of 135 mg daily, based on body surface area (mg/m2); adverse reproductive outcomes occurred at higher doses in presence of maternal toxicity; therapy should be used during pregnancy only if potential benefit justifies potential risk to fetus
Lactation
There is no available information on presence of drug in human milk, effects on breastfed infant, or on milk production; drug is present in milk of rats, and is therefore likely to be present in human milk; because of potential for serious adverse reactions in breastfed infants, such as disruption of infant lipid metabolism, women should not breastfeed during treatment and for 5 days after final dose
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
Fenofibric acid is the active metabolite of fenofibrate
Activates peroxisome proliferator activated receptor-alpha (PPAR-alpha); increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reduces Apo CIII production (lipoprotein lipase inhibitor)
Reduces TC, LDL-C, Apo B, TG, and VLDL; increases HDL-C, Apo AI, and Apo AII
Absorption
Bioavailability: 81% (Trilipix)
Peak Plasma Time: 4-5 hr (Trilipix); 2.5 hr (Fibricor)
Distribution
Time to steady-state: 8 days (Trilipix); 9 days (Fibricor)
Protein Bound: 99%
Metabolism
Primarily conjugated with glucuronic acid; a small amount is reduced at the carbonyl moiety to a benzhydrol metabolite which is, in turn, conjugated with glucuronic acid
Elimination
Half-life: 20 hr
Excretion: Primarily in urine as fenofibric acid and fenofibric acid glucuronide
Pharmacogenomics
Genotyping patients with atherogenic dyslipidemia might establish who will benefit most from therapy with fenofibric to increase HDL-C
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| fenofibric acid oral - | 105 mg tablet |  | |
| fenofibric acid oral - | 35 mg tablet |  | |
| Fibricor oral - | 105 mg tablet | | |
| Fibricor oral - | 35 mg tablet | |
Copyright © 2010 First DataBank, Inc.
Patient Handout
fenofibric acid oral
FENOFIBRIC ACID - ORAL
(FEN-oh-FYE-brick AS-id)
COMMON BRAND NAME(S): Fibricor
USES: Fenofibric acid is used along with a proper diet to help lower "bad" cholesterol and fats (such as LDL, triglycerides) and raise "good" cholesterol (HDL) in the blood. It works by increasing the natural substance (enzyme) that breaks down fats in the blood. Fenofibric acid belongs to a group of drugs known as "fibrates." Lowering triglycerides in people with very high triglyceride blood levels may decrease the risk of pancreas disease (pancreatitis). However, fenofibric acid might not lower your risk of a heart attack or stroke. Talk to your doctor about the risks and benefits of fenofibric acid.In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details.
HOW TO USE: Take this medication by mouth with or without food as directed by your doctor, usually once daily.The manufacturer directs not to crush or chew the tablet before taking it. However, many similar drugs (immediate-release tablets) can be crushed or chewed. Follow your doctor's directions on how to take this medication.The dosage is based on your medical condition and response to treatment.If you are also taking certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take fenofibric acid at least 1 hour before or at least 4 to 6 hours after taking these medications. These medications can bind to fenofibric acid, preventing your body from fully absorbing the drug.Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your cholesterol/triglycerides level will not lower faster, and your risk of side effects will increase. Keep taking this medication even if you feel well. Most people with high cholesterol/triglycerides do not feel sick.It is very important to continue to follow your doctor's advice about diet and exercise. It may take up to 2 months before you get the full benefit of this medication.
SIDE EFFECTS: Remember that this medication has been prescribed because 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.This medication may rarely cause gallstones and liver problems. If you notice any of the following unlikely but serious side effects, tell your doctor right away: nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.This drug may rarely cause muscle problems (which can rarely lead to a very serious condition called rhabdomyolysis). Tell your doctor right away if you develop any of these symptoms: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), signs of kidney problems (such as change in the amount of urine).Rarely, this medication has caused severe lowering of HDL ("good" cholesterol) levels. This is the opposite of what should happen to your HDL levels (paradoxical reaction). Your HDL cholesterol levels should be checked regularly. Keep all of your laboratory appointments.Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, unusual tiredness.Get medical help right away if you have any very serious side effects, including: chest pain, sudden pain/redness/swelling usually in the leg, signs of infection (such as sore throat that doesn't go away, fever, swollen lymph nodes, chills, cough).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.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 fenofibric acid, tell your doctor or pharmacist if you are allergic to it; or to other "fibrates" (such as fenofibrate); 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: kidney disease, liver disease (such as biliary cholangitis, hepatitis), gallbladder disease, alcohol use.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for 5 days after stopping the drug. 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: "blood thinners" (such as warfarin).Fenofibric acid is very similar to fenofibrate. Do not use medications containing fenofibrate while using fenofibric acid.
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.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as cholesterol/triglyceride levels, kidney/liver function, complete blood count) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details. (See also Side Effects section.)
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 December 2022. Copyright(c) 2023 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
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