Dosing & Uses
Dosage Forms & Strengths
tablet (Adcirca, Alyq, generic)
- 20mg
tablet (Cialis, generic)
- 2.5mg
- 5mg
- 10mg
- 20mg
Erectile Dysfunction
Indicated for treatment of erectile dysfunction (ED)
Cialis or generic equivalent only
PRN use: 10 mg PO initially before sexual activity, with or without food; may be increased to 20 mg or reduced to 5 mg on basis of efficacy and tolerability; in most patients, maximum dosing frequency is once daily
Once-daily use: 2.5 mg/day PO in single daily dose, without regard to timing of sexual activity, with or without food; may be increased to 5 mg/day on basis of efficacy and tolerability
Dosing considerations
- PRN use: Decrease dose with concomitant use of potent CYP3A4 inhibitor (eg, ritonavir, ketoconazole, itraconazole); not to exceed 10 mg/72 hr
- Once-daily use: Decrease dose with concomitant use of potent CYP3A4 inhibitor (eg, ritonavir, ketoconazole, itraconazole); not to exceed 2.5 mg/day
Benign Prostatic Hyperplasia
Indicated for treatment of signs and symptoms of benign prostatic hyperplasia (BPH); daily use also indicated for treatment of patients with both BPH and erectile dysfunction
Cialis or generic equivalent only
BPH: 5 mg PO once daily
BPH with ED: 5 mg PO once daily, taken at approximately same time each day without regard to timing of sexual activity
Coadministration with finasteride for BPH: Tadalafil 5 mg plus finasteride 5 mg PO once daily for ≤26 weeks; incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and the benefit beyond 26 weeks is unknown
Pulmonary Arterial Hypertension
Indicated for pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability; studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%)
Adcirca, Alyq, or generic equivalent only
40 mg PO once daily; dividing dose for more frequent dosing is not recommended
Patients also taking ritonavir: 20 mg PO once daily initially for ≥1 week; may be increased to 40 mg/day on basis of tolerability
Dosing considerations
- If possible, avoid coadministration with CYP3A4 inhibitors; if coadministration is essential, long-term therapy is indicated, or strong CYP3A4 inhibitors are required, modify or hold dose
- Patients already taking strong CYP3A4 inhibitor who require tadalafil: 20 mg PO once daily; may be increased to 40 mg/day on basis of tolerability
- Patients already taking tadalafil who require strong CYP3A4 inhibitor: Avoid using tadalafil while starting strong CYP3A4 inhibitor; stop tadalafil ≥24 hours before starting strong CYP3A4 inhibitor; after 1 week, resume tadalafil at 20 mg PO once daily; may be increased to 40 mg/day on basis of tolerability
Dosing Modifications
Renal impairment (ED)
Cialis (PRN use)
- Mild (CrCl ≥51 mL/min): No dosage adjustment needed
- Moderate (CrCl 30-50 mL/min): Not to exceed 5 mg PO once daily initially; maximum dosage, 10 mg PO q48hr
- Severe (CrCl <30 mL/min and on hemodialysis): Not to exceed 5 mg PO q72hr
Cialis (once daily use)
- ED (CrCl ≥30 mL/min): No dosage adjustment needed
- BPH or BPH/ED (CrCl 30-50 mL/min): 2.5 mg/day starting dose recommended; may increase to 5 mg according to individual response
- ED or BPH (CrCl <30 mL/min:) Not recommended
Renal impairment (PAH)
Adcirca or Alyq
- Mild-to-moderate (CrCl 31-80 mL/min): 20 mg PO once daily initially; may be increased to 40 mg once daily on basis of tolerability
- Severe (CrCl <30 mL/min and on hemodialysis): Avoid use
Hepatic impairment (ED)
Cialis (PRN use)
- Mild-to-moderate (Child-Pugh class A or B): Not to exceed 10 mg PO once daily
- Severe (Child-Pugh class C): Not recommended
Cialis (once daily use)
- Mild-to-moderate (Child-Pugh class A or B): Data limited; caution advised
- Severe (Child-Pugh class C): Not recommended
Hepatic impairment (PAH)
Adcirca or Alyq
- Mild-to-moderate (Child-Pugh class A or B): Consider starting dosage of 20 mg PO once daily
- Severe (Child-Pugh class C): Avoid use
Muscular Dystrophy (Orphan)
Orphan designation for Duchenne muscular dystrophy (DMD)
Sponsor
- Eli Lilly and Company; Lilly Corporate Center; Indianapolis, IN 46285
Pulmonary Arterial Hypertension (Orphan)
Orphan designation of a fixed dose combination of macitentan and tadalafil for treatment of pulmonary arterial hypertension
Sponsor
- Actelion Clinical Research, Inc; 1820 Chapel Avenue West, Suite 300; Cherry Hill, New Jersey 08002
Safety and efficacy not established
Erectile Dysfunction
Indicated for treatment of erectile dysfunction (ED)
Cialis or generic equivalent only: No dosage adjustment is warranted solely on basis of age; however, greater sensitivity to medications in some older individuals should be considered
Pulmonary Arterial Hypertension
Indicated for pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability; studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%)
Adcirca, Alyq, or generic equivalent only: Lower dose or reduced dosing frequency may be required in elderly because of decreased renal or hepatic clearance
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (11)
- isosorbide dinitrate
isosorbide dinitrate, tadalafil. Mechanism: additive vasodilation. Contraindicated. Contraindicated. Potentially fatal hypotension. Allow 48h after last tadalafil dose before nitrate administration.
- isosorbide mononitrate
isosorbide mononitrate, tadalafil. Mechanism: additive vasodilation. Contraindicated. Contraindicated. Potentially fatal hypotension. Allow 48h after last tadalafil dose before nitrate administration.
- nitroglycerin IV
nitroglycerin IV, tadalafil. Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.
- nitroglycerin PO
nitroglycerin PO, tadalafil. Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.
- nitroglycerin rectal
tadalafil increases effects of nitroglycerin rectal by additive vasodilation. Contraindicated. Use of nitroglycerin within a few days of PDE5 inhibitors is contraindicated. PDE5 inhibitors have been shown to potentiate the hypotensive effects of organic nitrates.
- nitroglycerin sublingual
nitroglycerin sublingual, tadalafil. Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.
- nitroglycerin topical
nitroglycerin topical, tadalafil. Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.
- nitroglycerin transdermal
nitroglycerin transdermal, tadalafil. Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.
- nitroglycerin translingual
nitroglycerin translingual, tadalafil. Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.
- riociguat
tadalafil, riociguat. Either increases effects of the other by additive vasodilation. Contraindicated. Coadministration of PDE-5 inhibitors (eg, avanafil, sildenafil, tadalafil, vardenafil) and guanylate cyclase stimulators (eg, riociguat) is contraindicated due to risk of additive hypotension; do not administer 24 hr before or within 48hr of each other.
- vericiguat
tadalafil, vericiguat. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Coadministration of vericiguat with PDE-5 inhibitors may result in additive hypotensive effects.
Serious - Use Alternative (26)
- abametapir
abametapir will increase the level or effect of tadalafil 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.
- amyl nitrite
amyl nitrite, tadalafil. Mechanism: additive vasodilation. Avoid or Use Alternate Drug. Contraindicated. Potentially fatal hypotension. Allow 48h after last tadalafil dose before nitrate administration.
- apalutamide
apalutamide will decrease the level or effect of tadalafil 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
atazanavir will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Stop tadalafil >24 hours prior to protease inhibitor (PI) initiation, restart 7 days after PI initiation at 20 mg once daily, and increase to 40 mg once daily based on tolerability.
- clarithromycin
clarithromycin will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For ED limit tadalafil to max of 2.5 mg/day (for daily use) or 10 mg dose every 72 hr (for use as needed). Avoid concurrent use of tadalafil for pulmonary HTN in patients taking strong CYP3A4 inhibitors.
- cobicistat
cobicistat will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Adjust tadalafil dose for PAH; if on cobicistat, start tadalafil 20 mg/day and may increase up to 40 mg/day; avoid tadalafil when starting cobicistat; for ED, may take a single dose of tadalafil not exceeding 10 mg in 72 hr.
- darunavir
darunavir will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Adjust tadalafil dose for PAH; if on cobicistat, start tadalafil 20 mg/day and may increase up to 40 mg/day; avoid tadalafil when starting cobicistat; for ED, may take a single dose of tadalafil not exceeding 10 mg in 72 hr.
- enzalutamide
enzalutamide will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- erythromycin base
erythromycin base will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For ED limit tadalafil to max of 2.5 mg/day (for daily use) or 10 mg dose every 72 hr (for use as needed). Avoid concurrent use of tadalafil for pulmonary HTN in patients taking strong CYP3A4 inhibitors.
- erythromycin ethylsuccinate
erythromycin ethylsuccinate will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For ED limit tadalafil to max of 2.5 mg/day (for daily use) or 10 mg dose every 72 hr (for use as needed). Avoid concurrent use of tadalafil for pulmonary HTN in patients taking strong CYP3A4 inhibitors.
- erythromycin lactobionate
erythromycin lactobionate will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For ED limit tadalafil to max of 2.5 mg/day (for daily use) or 10 mg dose every 72 hr (for use as needed). Avoid concurrent use of tadalafil for pulmonary HTN in patients taking strong CYP3A4 inhibitors.
- erythromycin stearate
erythromycin stearate will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For ED limit tadalafil to max of 2.5 mg/day (for daily use) or 10 mg dose every 72 hr (for use as needed). Avoid concurrent use of tadalafil for pulmonary HTN in patients taking strong CYP3A4 inhibitors.
- fexinidazole
fexinidazole will increase the level or effect of tadalafil 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.
- fosamprenavir
fosamprenavir will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Stop tadalafil >24 hours prior to protease inhibitor (PI) initiation, restart 7 days after PI initiation at 20 mg once daily, and increase to 40 mg once daily based on tolerability.
- idelalisib
idelalisib will increase the level or effect of tadalafil 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
indinavir will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Stop tadalafil >24 hours prior to protease inhibitor (PI) initiation, restart 7 days after PI initiation at 20 mg once daily, and increase to 40 mg once daily based on tolerability.
- itraconazole
itraconazole will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For ED limit tadalafil to max of 2.5 mg/day (for daily use) or 10 mg dose every 72 hr (for use as needed). Avoid concurrent use of tadalafil for pulmonary HTN in patients taking strong CYP3A4 inhibitors.
- ketoconazole
ketoconazole will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. CYP3A4 inhibitors may reduce tadalafil clearance increasing systemic exposure to tadalafil; significantly increased levels may result in significant adverse events including severe hypotension, syncope, visual changes, and priapism.
- levoketoconazole
levoketoconazole will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. CYP3A4 inhibitors may reduce tadalafil clearance increasing systemic exposure to tadalafil; significantly increased levels may result in significant adverse events including severe hypotension, syncope, visual changes, and priapism.
- lonafarnib
lonafarnib will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration with sensitive CYP3A substrates. If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling.
- lopinavir
lopinavir will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. CYP3A4 inhibitors may reduce tadalafil clearance increasing systemic exposure to tadalafil; significantly increased levels may result in significant adverse events including severe hypotension, syncope, visual changes, and priapism.
- nelfinavir
nelfinavir will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Stop tadalafil >24 hours prior to protease inhibitor (PI) initiation, restart 7 days after PI initiation at 20 mg once daily, and increase to 40 mg once daily based on tolerability.
- nicardipine
nicardipine will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. CYP3A4 inhibitors may reduce tadalafil clearance increasing systemic exposure to tadalafil; significantly increased levels may result in significant adverse events including severe hypotension, syncope, visual changes, and priapism.
- ritonavir
ritonavir will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Stop tadalafil >24 hours prior to protease inhibitor (PI) initiation, restart 7 days after PI initiation at 20 mg once daily, and increase to 40 mg once daily based on tolerability.
- tucatinib
tucatinib will increase the level or effect of tadalafil 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 tadalafil 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 (154)
- acebutolol
tadalafil increases effects of acebutolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- acetazolamide
tadalafil increases effects of acetazolamide by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- alfuzosin
tadalafil increases effects of alfuzosin by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- aliskiren
tadalafil increases effects of aliskiren by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- amifostine
amifostine, tadalafil. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Monitor blood pressure response to phosphodiesterase type 5 (PDE5) inhibitors in patients receiving concurrent blood pressure lowering therapy.
- amiloride
tadalafil increases effects of amiloride by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- amiodarone
amiodarone will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. CYP3A4 inhibitors may reduce tadalafil clearance increasing systemic exposure to tadalafil; increased levels may result in increased associated adverse events.
- amlodipine
tadalafil increases effects of amlodipine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- amobarbital
amobarbital will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- aprepitant
aprepitant will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- armodafinil
armodafinil will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- artemether/lumefantrine
artemether/lumefantrine will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- asenapine
tadalafil increases effects of asenapine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- atazanavir
atazanavir increases levels of tadalafil by decreasing metabolism. Use Caution/Monitor. Stop tadalafil >24 hours prior to protease inhibitor (PI) initiation, restart 7 days after PI initiation at 20 mg once daily, and increase to 40 mg once daily based on tolerability.
- atenolol
tadalafil increases effects of atenolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- azilsartan
tadalafil increases effects of azilsartan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- benazepril
tadalafil increases effects of benazepril by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- betaxolol
tadalafil increases effects of betaxolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- bicalutamide
bicalutamide will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce tadalafil clearance increasing systemic exposure to tadalafil; increased levels may result in increased associated adverse events.
- bisoprolol
tadalafil increases effects of bisoprolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- bosentan
bosentan will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- budesonide
budesonide will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- bumetanide
tadalafil increases effects of bumetanide by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- butabarbital
butabarbital will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid combination in pulmonary HTN patients. For patients with ED, monitor response to tadalafil carefully because of potential for decreased effectiveness.
- butalbital
butalbital will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- candesartan
tadalafil increases effects of candesartan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- captopril
tadalafil increases effects of captopril by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- carbamazepine
carbamazepine will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid combination in pulmonary HTN patients. For patients with ED, monitor response to tadalafil carefully because of potential for decreased effectiveness.
- carvedilol
tadalafil increases effects of carvedilol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- cenobamate
cenobamate will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.
- chlorthalidone
tadalafil increases effects of chlorthalidone by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- cimetidine
cimetidine will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- clevidipine
tadalafil increases effects of clevidipine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- clonidine
tadalafil increases effects of clonidine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- clotrimazole
clotrimazole will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce tadalafil clearance increasing systemic exposure to tadalafil; increased levels may result in increased associated adverse events.
- conivaptan
conivaptan will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. For ED limit tadalafil to max of 2.5 mg/day (for daily use) or 10 mg dose every 72 hr (for use as needed). Avoid concurrent use of tadalafil for pulmonary HTN in patients taking strong CYP3A4 inhibitors.
- crizotinib
crizotinib increases levels of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dose reduction may be needed for coadministered drugs that are predominantly metabolized by CYP3A.
- crofelemer
crofelemer increases levels of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Crofelemer has the potential to inhibit CYP3A4 at concentrations expected in the gut; unlikely to inhibit systemically because minimally absorbed.
- cyclosporine
cyclosporine will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- dabrafenib
dabrafenib will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.
- dasatinib
dasatinib will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- deferasirox
deferasirox will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- desipramine
desipramine will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce tadalafil clearance increasing systemic exposure to tadalafil; increased levels may result in increased associated adverse events.
- dexamethasone
dexamethasone will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid combination in pulmonary HTN patients. For patients with ED, monitor response to tadalafil carefully because of potential for decreased effectiveness.
- diltiazem
diltiazem will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Risk of hypotension.
- doxazosin
tadalafil increases effects of doxazosin by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- dronedarone
dronedarone will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- duvelisib
duvelisib will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Coadministration with duvelisib increases AUC of a sensitive CYP3A4 substrate which may increase the risk of toxicities of these drugs. Consider reducing the dose of the sensitive CYP3A4 substrate and monitor for signs of toxicities of the coadministered sensitive CYP3A substrate.
- efavirenz
efavirenz will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid combination in pulmonary HTN patients. For patients with ED, monitor response to tadalafil carefully because of potential for decreased effectiveness.
- elagolix
elagolix decreases levels of tadalafil 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 tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust tadalafil dose for PAH; if on Stribild, start tadalafil 20 mg/day; avoid tadalafil when starting Stribild; for ED, a single dose of tadalafil not exceeding 10 mg in 72 hr.
- enalapril
tadalafil increases effects of enalapril by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- encorafenib
encorafenib, tadalafil. 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.
- eplerenone
tadalafil increases effects of eplerenone by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- eprosartan
tadalafil increases effects of eprosartan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- eslicarbazepine acetate
eslicarbazepine acetate will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid combination in pulmonary HTN patients. For patients with ED, monitor response to tadalafil carefully because of potential for decreased effectiveness.
- esmolol
tadalafil increases effects of esmolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- ethacrynic acid
tadalafil increases effects of ethacrynic acid by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- ethanol
ethanol, tadalafil. Either increases effects of the other by additive vasodilation. Use Caution/Monitor. Combination may increase risk of orthostatic hypotension, tachycardia, dizziness and headache.
- etravirine
etravirine will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- fedratinib
fedratinib will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.
- felodipine
tadalafil increases effects of felodipine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- fluconazole
fluconazole will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- fluvoxamine
fluvoxamine will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- fosinopril
tadalafil increases effects of fosinopril by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- fosphenytoin
fosphenytoin will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid combination in pulmonary HTN patients. For patients with ED, monitor response to tadalafil carefully because of potential for decreased effectiveness.
- furosemide
tadalafil increases effects of furosemide by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- grapefruit
grapefruit will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- griseofulvin
griseofulvin will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- guanfacine
tadalafil increases effects of guanfacine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- haloperidol
haloperidol will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce tadalafil clearance increasing systemic exposure to tadalafil; increased levels may result in increased associated adverse events.
- hydralazine
tadalafil increases effects of hydralazine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- hydrochlorothiazide
tadalafil increases effects of hydrochlorothiazide by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- iloperidone
iloperidone increases levels of tadalafil 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.
- imatinib
imatinib will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. For ED limit tadalafil to max of 2.5 mg/day (for daily use) or 10 mg dose every 72 hr (for use as needed). Avoid concurrent use of tadalafil for pulmonary HTN in patients taking strong CYP3A4 inhibitors.
- indapamide
tadalafil increases effects of indapamide by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- irbesartan
tadalafil increases effects of irbesartan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- isoniazid
isoniazid will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. For ED limit tadalafil to max of 2.5 mg/day (for daily use) or 10 mg dose every 72 hr (for use as needed). Avoid concurrent use of tadalafil for pulmonary HTN in patients taking strong CYP3A4 inhibitors.
- isradipine
tadalafil increases effects of isradipine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- istradefylline
istradefylline will increase the level or effect of tadalafil 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.
- labetalol
tadalafil increases effects of labetalol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- lapatinib
lapatinib will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- letermovir
letermovir increases levels of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- lisinopril
tadalafil increases effects of lisinopril by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- losartan
tadalafil increases effects of losartan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- lumefantrine
lumefantrine will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- maraviroc
maraviroc, tadalafil. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of orthostatic hypotension.
- marijuana
marijuana will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- metolazone
tadalafil increases effects of metolazone by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- metoprolol
tadalafil increases effects of metoprolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- metronidazole
metronidazole will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- mifepristone
mifepristone will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- minoxidil
tadalafil increases effects of minoxidil by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- mitotane
mitotane decreases levels of tadalafil 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.
- nadolol
tadalafil increases effects of nadolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- nafcillin
nafcillin will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- nebivolol
tadalafil increases effects of nebivolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- nefazodone
nefazodone will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. For ED limit tadalafil to max of 2.5 mg/day (for daily use) or 10 mg dose every 72 hr (for use as needed). Avoid concurrent use of tadalafil for pulmonary HTN in patients taking strong CYP3A4 inhibitors.
- nevirapine
nevirapine will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid combination in pulmonary HTN patients. For patients with ED, monitor response to tadalafil carefully because of potential for decreased effectiveness.
- nifedipine
nifedipine will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Risk of hypotension.
tadalafil increases effects of nifedipine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension. - nilotinib
nilotinib will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- nimodipine
tadalafil increases effects of nimodipine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- nisoldipine
tadalafil increases effects of nisoldipine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- nitroprusside sodium
nitroprusside sodium, tadalafil. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Additive hypotensive effects.
- olmesartan
tadalafil increases effects of olmesartan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- oxcarbazepine
oxcarbazepine will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid combination in pulmonary HTN patients. For patients with ED, monitor response to tadalafil carefully because of potential for decreased effectiveness.
- pazopanib
pazopanib will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- penbutolol
tadalafil increases effects of penbutolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- pentobarbital
pentobarbital will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid combination in pulmonary HTN patients. For patients with ED, monitor response to tadalafil carefully because of potential for decreased effectiveness.
- phenobarbital
phenobarbital will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid combination in pulmonary HTN patients. For patients with ED, monitor response to tadalafil carefully because of potential for decreased effectiveness.
- phenoxybenzamine
tadalafil increases effects of phenoxybenzamine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- phentolamine
tadalafil increases effects of phentolamine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- phenytoin
phenytoin will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid combination in pulmonary HTN patients. For patients with ED, monitor response to tadalafil carefully because of potential for decreased effectiveness.
- posaconazole
posaconazole will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- prazosin
tadalafil increases effects of prazosin by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- primidone
primidone will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid combination in pulmonary HTN patients. For patients with ED, monitor response to tadalafil carefully because of potential for decreased effectiveness.
- propranolol
tadalafil increases effects of propranolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- quinapril
tadalafil increases effects of quinapril by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- quinupristin/dalfopristin
quinupristin/dalfopristin will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- ramipril
tadalafil increases effects of ramipril by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- ribociclib
ribociclib will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- rifabutin
rifabutin will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid combination in pulmonary HTN patients. For patients with ED, monitor response to tadalafil carefully because of potential for decreased effectiveness.
- rifampin
rifampin will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid combination in pulmonary HTN patients. For patients with ED, monitor response to tadalafil carefully because of potential for decreased effectiveness.
- rifapentine
rifapentine will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid combination in pulmonary HTN patients. For patients with ED, monitor response to tadalafil carefully because of potential for decreased effectiveness.
- rucaparib
rucaparib will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.
- rufinamide
rufinamide will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- sacubitril/valsartan
tadalafil increases effects of sacubitril/valsartan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- sapropterin
sapropterin, tadalafil. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Possible additive vasorelaxation, leading to low blood pressure.
- saquinavir
saquinavir increases levels of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Potential for increased toxicity. .
- secobarbital
secobarbital will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid combination in pulmonary HTN patients. For patients with ED, monitor response to tadalafil carefully because of potential for decreased effectiveness.
- sertraline
sertraline will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce tadalafil clearance increasing systemic exposure to tadalafil; increased levels may result in increased associated adverse events.
- silodosin
tadalafil increases effects of silodosin by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- sotalol
tadalafil increases effects of sotalol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- spironolactone
tadalafil increases effects of spironolactone by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- St John's Wort
St John's Wort will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid combination in pulmonary HTN patients. For patients with ED, monitor response to tadalafil carefully because of potential for decreased effectiveness.
- stiripentol
stiripentol, tadalafil. 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.
- tamsulosin
tadalafil, tamsulosin. Either increases effects of the other by additive vasodilation. Use Caution/Monitor. Risk of hypotension.
- tazemetostat
tazemetostat will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- tecovirimat
tecovirimat will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.
- telmisartan
tadalafil increases effects of telmisartan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- terazosin
tadalafil increases effects of terazosin by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- tetracycline
tetracycline will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inhibitors may reduce tadalafil clearance increasing systemic exposure to tadalafil; increased levels may result in increased associated adverse events.
- timolol
tadalafil increases effects of timolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- tipranavir
tipranavir will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. For ED limit tadalafil to max of 2.5 mg/day (for daily use) or 10 mg dose every 72 hr (for use as needed). Avoid concurrent use of tadalafil for pulmonary HTN in patients taking strong CYP3A4 inhibitors.
- tobramycin inhaled
tobramycin inhaled and tadalafil both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- topiramate
topiramate will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- torsemide
tadalafil increases effects of torsemide by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- trandolapril
tadalafil increases effects of trandolapril by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- triamterene
tadalafil increases effects of triamterene by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- valsartan
tadalafil increases effects of valsartan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- vardenafil
vardenafil, tadalafil. Other (see comment). Use Caution/Monitor. Comment: Avoid combination; duplicate therapy is not recommended.
- verapamil
verapamil will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Risk of hypotension.
- voriconazole
voriconazole will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- zafirlukast
zafirlukast will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
Minor (1)
- ranolazine
ranolazine will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Ranolazine may theoretically increase plasma concentrations of CYP3A4 substrates, such as tadalafil.
Adverse Effects
>10%
Headache (11-42%)
Myalgia (1-14%)
Respiratory tract infection (3-13%)
Nasopharyngitis (2-13%)
Dyspepsia (1-13%)
Flushing (1-13%)
Back pain (2-12%)
Nausea (10-11%)
1-10%
Nasal congestion (≤9%)
Gastroesophageal reflux disease (1-3%)
Hypertension (1-3%)
Bronchitis (≤2%)
Genitourinary tract infection (≤2%)
<1%
Amnesia
Angina pectoris
Arthralgia
Change in color vision
Conjunctival hyperemia
Dyspnea
Epistaxis
Postmarketing reports
Hypotension
Visual field defect, retinal vein occlusion, retinal artery occlusion, and non–arteritic anterior ischemic optic neuropathy (NAION)
Hearing loss
Priapism
Warnings
Contraindications
Hypersensitivity, including Stevens-Johnson syndrome and exfoliative dermatitis
Soluble guanylate cyclase (sGC) stimulators (eg, riociguat); concomitant use can cause hypotension
Coadministration with nitrates
- Coadministration with nitrates (either regularly and/or intermittently) and nitric oxide donors
- Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors may potentiate the hypotensive effects of nitrates
- A suitable time interval following PDE5 dosing for the safe administration of nitrates or nitric oxide donors has not been determined
Cautions
Use caution in patients with anatomic deformation of penis, cardiovascular disease, left ventricular outflow obstruction, myocardial infarction in preceding 90 days, unstable angina, angina occurring during sexual intercourse, NYHA class 2 or greater heart failure in preceding 6 months, uncontrolled arrhythmias, hypotension, uncontrolled hypertension, cerebrovascular accident in preceding 6 months, bleeding disorders, active peptic ulcer disease, liver disease, renal impairment, conditions predisposing to priapism, concomitant use of CYP3A4 inhibitors
May cause dose-related impairment of color discrimination; use caution in patients with retinitis pigmentosa
Evaluate underlying causes of erectile dysfunction or BPH before initiating therapy
Do not use nitrates within 48 hours of last dose of tadalafil
Drug has vasodilatory properties that may result in transient decreases in blood pressure; prior to prescribing, carefully consider whether patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects; patients with preexisting hypotension, with autonomic dysfunction, with left ventricular outflow obstruction, may be particularly sensitive to actions of vasodilators
When used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, reported postmarketing; if vision problems arise, discontinue, and contact physician
Risk of sudden hearing loss
CYP3A4 inhibitors (eg, erythromycin, ketoconazole, itraconazole, indinavir, ritonavir) may significantly increase tadalafil serum levels
CYP3A4 inducers (eg, rifampin, St John’s wort) may decrease tadalafil serum levels
Potentiates hypotensive effect of nitrates (see Contraindications)
Concomitant use with alpha blockers (other than tamsulosin 0.4 mg/day) should be stabilized before initiation of phosphodiesterase (PDE)-5 inhibitors; patients with instability on alpha-blocker therapy alone are at increased risk for symptomatic hypotension with concurrent PDE-5 inhibitor therapy
Not to be taken with other PDE-5 inhibitors (eg, sildenafil, vardenafil)
Not recommended in patients with pulmonary veno-occlusive disease
Advise patients to seek emergency treatment if an erection lasts >4 hr
Pregnancy & Lactation
Pregnancy
Limited data from case series with use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes
Pregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death
Animal data
- In animal reproduction studies, no adverse developmental effects were observed with oral administration to pregnant rats or mice during organogenesis at exposures 7 times the exposure at maximum recommended human dose (MRHD) of 40 mg/day based on AUC
Lactation
There are no data on presence of drug and/or its metabolites in human milk, effects on breastfed child, or on milk production; drug and/or its metabolites are present in milk of lactating rats at concentrations approximately 2.4-times that found in the plasma; when a drug is present in animal milk, it is likely that the drug will be present in human milk
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
Erectile dysfunction: Inhibits PDE-5, increasing cyclic guanosine monophosphate (cGMP) to allow smooth-muscle relaxation and inflow of blood into corpus cavernosum
Pulmonary arterial hypertension (PAH): Inhibits PDE-5, increasing cGMP to allow relaxation of pulmonary vascular smooth-muscle cells and vasodilation of pulmonary vasculature
Absorption
Duration: ≤36 hr
Peak plasma time: Erectile dysfunction, 0.5-6 hr; PAH, 2-8 hr
Distribution
Protein bound: 94%
Vd: Erectile dysfunction, 63 L; PAH, 77 L
Metabolism
Metabolized in liver by CYP3A4
Elimination
Half-life: Erectile dysfunction, 15-17.5 hr; PAH (not on bosentan), 35 hr
Total body clearance: Erectile dysfunction, 2.5 L/hr; PAH (not on bosentan), 1.6 L/hr
Excretion: Feces (61%), urine (36%)
Administration
Oral Administration
Erectile dysfunction (PRN use): Take before anticipated sexual activity
Erectile dysfunction (once-daily use): Take at approximately same time each day without regard to timing of sexual activity
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Cialis oral - | 20 mg tablet |  | |
| Cialis oral - | 5 mg tablet |  | |
| Cialis oral - | 10 mg tablet |  | |
| Cialis oral - | 2.5 mg tablet |  | |
| tadalafil oral - | 5 mg tablet |  | |
| tadalafil oral - | 5 mg tablet | | |
| tadalafil oral - | 20 mg tablet |  | |
| tadalafil oral - | 10 mg tablet |  | |
| tadalafil oral - | 5 mg tablet |  | |
| tadalafil oral - | 2.5 mg tablet |  | |
| tadalafil oral - | 10 mg tablet |  | |
| tadalafil oral - | 5 mg tablet |  | |
| tadalafil oral - | 2.5 mg tablet |  | |
| tadalafil oral - | 20 mg tablet |  | |
| tadalafil oral - | 10 mg tablet |  | |
| tadalafil oral - | 2.5 mg tablet |  | |
| tadalafil oral - | 5 mg tablet |  | |
| tadalafil oral - | 5 mg tablet |  | |
| tadalafil oral - | 20 mg tablet |  | |
| tadalafil oral - | 2.5 mg tablet |  | |
| tadalafil oral - | 20 mg tablet | | |
| tadalafil oral - | 2.5 mg tablet |  | |
| tadalafil oral - | 20 mg tablet |  | |
| tadalafil oral - | 2.5 mg tablet |  | |
| tadalafil oral - | 20 mg tablet |  | |
| tadalafil oral - | 2.5 mg tablet |  | |
| tadalafil oral - | 10 mg tablet |  | |
| tadalafil oral - | 10 mg tablet |  | |
| tadalafil oral - | 20 mg tablet |  | |
| tadalafil oral - | 20 mg tablet |  | |
| tadalafil oral - | 5 mg tablet |  | |
| tadalafil oral - | 5 mg tablet |  | |
| tadalafil oral - | 2.5 mg tablet |  | |
| tadalafil oral - | 20 mg tablet |  | |
| tadalafil oral - | 20 mg tablet |  | |
| tadalafil oral - | 10 mg tablet |  | |
| tadalafil oral - | 2.5 mg tablet |  | |
| tadalafil oral - | 5 mg tablet |  | |
| tadalafil oral - | 5 mg tablet |  | |
| tadalafil oral - | 20 mg tablet |  | |
| tadalafil oral - | 10 mg tablet |  | |
| tadalafil oral - | 20 mg tablet |  | |
| tadalafil oral - | 5 mg tablet |  | |
| tadalafil oral - | 5 mg tablet |  | |
| tadalafil oral - | 10 mg tablet |  | |
| tadalafil oral - | 20 mg tablet |  | |
| tadalafil oral - | 10 mg tablet |  | |
| tadalafil oral - | 5 mg tablet |  | |
| tadalafil oral - | 20 mg tablet |  | |
| tadalafil oral - | 20 mg tablet |  | |
| tadalafil oral - | 10 mg tablet |  | |
| tadalafil oral - | 5 mg tablet |  | |
| tadalafil oral - | 2.5 mg tablet |  | |
| tadalafil oral - | 10 mg tablet | | |
| tadalafil oral - | 2.5 mg tablet | | |
| tadalafil oral - | 20 mg tablet |  | |
| tadalafil oral - | 20 mg tablet |  | |
| tadalafil oral - | 10 mg tablet |  | |
| tadalafil oral - | 5 mg tablet |  | |
| tadalafil oral - | 5 mg tablet |  | |
| tadalafil oral - | 2.5 mg tablet |  | |
| tadalafil oral - | 10 mg tablet |  | |
| tadalafil oral - | 2.5 mg tablet |  | |
| tadalafil oral - | 10 mg tablet |  | |
| tadalafil oral - | 2.5 mg tablet |  | |
| tadalafil oral - | 2.5 mg tablet |  | |
| tadalafil oral - | 10 mg tablet |  | |
| tadalafil oral - | 5 mg tablet |  | |
| tadalafil oral - | 2.5 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
tadalafil oral
TADALAFIL (ERECTILE DYSFUNCTION) - ORAL
(tah-DA-la-fil)
COMMON BRAND NAME(S): Cialis
USES: Tadalafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED). In combination with sexual stimulation, tadalafil works by increasing blood flow to the penis to help a man get and keep an erection.Tadalafil is also used to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). It helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate frequently or urgently (including during the middle of the night). Tadalafil is thought to work by relaxing the smooth muscle in the prostate and bladder.This drug does not protect against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Practice "safe sex" such as using latex condoms. Consult your doctor or pharmacist for more details.
HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start taking tadalafil and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth, with or without food, as directed by your doctor. Do not take tadalafil more often than once daily.The manufacturer directs to swallow this medication whole. However, many similar drugs (immediate-release tablets) can be split/crushed. Follow your doctor's directions on how to take this medication.The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).To treat the symptoms of BPH, take this medication as directed by your doctor, usually once a day. If you are also taking finasteride with this medication to treat symptoms of BPH, talk with your doctor about how long you should continue taking this medication.To treat erectile dysfunction-ED, there are 2 ways that tadalafil may be prescribed. Your doctor will determine which is the best way for you to take tadalafil. Follow your doctor's directions exactly since your dosage depends on how you are taking it. The first way is to take it as needed, usually at least 30 minutes before sexual activity. Tadalafil's effect on sexual ability may last up to 36 hours.The second way to treat ED is to take tadalafil regularly, once a day every day. If you take it this way, you may attempt sexual activity at any time between your doses.If you are taking tadalafil to treat both ED and BPH, take it as directed by your doctor, usually once a day. You may attempt sexual activity at any time between your doses.If you are taking tadalafil once daily for BPH, or for ED, or for both, take it regularly to get the most benefit from it. To help you remember, take it at the same time each day.Tell your doctor if your condition does not improve or if it worsens.
SIDE EFFECTS: Headache, stomach upset, back pain, muscle pain, stuffy nose, flushing, or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.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.Sexual activity may put extra strain on your heart, especially if you have heart problems. If you have heart problems and experience any of these serious side effects while having sex, stop and get medical help right away: severe dizziness, fainting, chest/jaw/left arm pain, nausea.Rarely, sudden decreased vision, including permanent blindness, in one or both eyes (NAION) may occur. If this serious problem occurs, stop taking tadalafil and get medical help right away. You have a slightly greater chance of developing NAION if you have heart disease, diabetes, high cholesterol, certain other eye problems ("crowded disk"), high blood pressure, if you are over 50, or if you smoke.Rarely, a sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness, may occur. Stop taking tadalafil and get medical help right away if these effects occur.In the rare event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and get medical help right away, or permanent problems could occur.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 tadalafil, tell your doctor or pharmacist if you are allergic to it; 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: heart problems (such as heart attack or life-threatening irregular heartbeat in the past 6 months, chest pain/angina, heart failure), stroke in the past 6 months, kidney disease, liver disease, high or low blood pressure, dehydration, penis conditions (such as angulation, fibrosis/scarring, Peyronie's disease), history of painful/prolonged erection (priapism), conditions that may increase the risk of priapism (such as sickle cell anemia, leukemia, multiple myeloma), eye problems (such as retinitis pigmentosa, sudden decreased vision, NAION), bleeding disorders, active stomach ulcers.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This brand of the drug is not usually used in women. During pregnancy, tadalafil 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. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: 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.A product that may interact with this drug is: riociguat.Tadalafil can cause a serious drop in your blood pressure when used with nitrates, which can lead to dizziness, fainting, and rarely heart attack or stroke. Do not use any of the following with tadalafil or within 48 hours of your last dose of tadalafil: certain drugs used to treat chest pain/angina (nitrates such as nitroglycerin, isosorbide), recreational drugs called "poppers" containing amyl or butyl nitrite.If you are also taking an alpha blocker medication (such as doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high blood pressure, your blood pressure may get too low which can lead to dizziness or fainting. Your doctor may start treatment with a lower dose of tadalafil or adjust your alpha blocker medication to minimize your risk of low blood pressure.Other medications can affect the removal of tadalafil from your body, which may affect how tadalafil works. Examples include azole antifungals (such as itraconazole, ketoconazole), macrolide antibiotics (such as clarithromycin, erythromycin), HIV protease inhibitors (such as fosamprenavir, ritonavir), rifampin, among others.Do not take this medication with any other product that contains tadalafil or other similar medications used to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, vardenafil).
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.
MISSED DOSE: If you are taking this medication on a regular schedule and 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 April 2022. Copyright(c) 2022 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.
