Dosing & Uses
Dosage Forms & Strengths
finasteride/tadalafil
capsule
- 5mg/5mg
Benign Prostatic Hyperplasia
Indicated to initiate treatment for signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate for up to 26 weeks
1 capsule (5 mg/5 mg) PO qDay
Dosage Modifications
Renal impairment
- CrCl <50 mL/min or on hemodialysis: Not recommended; increased tadalafil exposure (AUC), limited clinical experience, and inability of dialysis to influence clearance
Hepatic impairment
- Mild-to-moderate (Child-Pugh A or B): Caution; finasteride extensively metabolized in liver
- Severe: (Child-Pugh C): Not recommended; insufficient data
Dosing Considerations
Limitations of use: Not recommended for >26 weeks; incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and incremental benefit >26 weeks is unknown
Not indicated
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 (29)
- 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.
- ceritinib
ceritinib will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- 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.
- lenacapavir
lenacapavir will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Refer to the prescribing information of PDE5 inhibitors for dose recommendations.
- 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.
- nirmatrelvir/ritonavir
nirmatrelvir/ritonavir will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration if tadalafil used for pulmonary arterial hpertension. Reduce tadalafil dose if used for erectile dysfunction.
- 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 (135)
- 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.
carbamazepine will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. - carvedilol
tadalafil increases effects of carvedilol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.
- clarithromycin
clarithromycin will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- 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.
- 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.
- erythromycin base
erythromycin base will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- erythromycin ethylsuccinate
erythromycin ethylsuccinate will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- erythromycin lactobionate
erythromycin lactobionate will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- erythromycin stearate
erythromycin stearate will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- 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.
- fosaprepitant
fosaprepitant 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 finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
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.
- itraconazole
itraconazole will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- 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.
- ketoconazole
ketoconazole will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- 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 finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
letermovir increases levels of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. - levoketoconazole
levoketoconazole will increase the level or effect of finasteride 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 finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
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.
nevirapine will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. - 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. - rifabutin
rifabutin will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- 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.
rifampin will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. - St John's Wort
St John's Wort will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- 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.
Minor (52)
- acetazolamide
acetazolamide will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- amobarbital
amobarbital will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- anastrozole
anastrozole will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- aprepitant
aprepitant will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- armodafinil
armodafinil will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- artemether/lumefantrine
artemether/lumefantrine will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- atazanavir
atazanavir will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- bosentan
bosentan will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- budesonide
budesonide will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- butabarbital
butabarbital will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- butalbital
butalbital will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- conivaptan
conivaptan will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- cortisone
cortisone will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- cyclophosphamide
cyclophosphamide will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- darifenacin
darifenacin will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- darunavir
darunavir will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- dasatinib
dasatinib will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- dexamethasone
dexamethasone will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- DHEA, herbal
DHEA, herbal will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- dronedarone
dronedarone will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- efavirenz
efavirenz will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- eslicarbazepine acetate
eslicarbazepine acetate will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- etravirine
etravirine will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- fluconazole
fluconazole will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- fludrocortisone
fludrocortisone will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- fosamprenavir
fosamprenavir will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- fosaprepitant
fosaprepitant will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- fosphenytoin
fosphenytoin will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- grapefruit
grapefruit will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- griseofulvin
griseofulvin will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- hydrocortisone
hydrocortisone will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- indinavir
indinavir will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- lapatinib
lapatinib will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- larotrectinib
larotrectinib will increase the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- lumefantrine
lumefantrine will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- marijuana
marijuana will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- methylprednisolone
methylprednisolone will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- metronidazole
metronidazole will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- miconazole vaginal
miconazole vaginal will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- nelfinavir
nelfinavir will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- nifedipine
nifedipine will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- nilotinib
nilotinib will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- oxcarbazepine
oxcarbazepine will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- pentobarbital
pentobarbital will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- phenobarbital
phenobarbital will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- phenytoin
phenytoin will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- posaconazole
posaconazole will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- prednisone
prednisone will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- primidone
primidone will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- quinupristin/dalfopristin
quinupristin/dalfopristin will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- 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.
- rifapentine
rifapentine will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
Adverse Effects
>10%
Finasteride
- Impotence (5.1-18.5%)
1-10%
Finasteride
- Decreased libido (2.6-10%)
- Postural hypotension (9.1%)
- Dizziness (7.4%)
- Abnormal ejaculation (7.2%)
- Asthenia (5.3%)
- Decreased ejaculate volume (1.5-3.7%)
- Sexual function abnormal (2.5%)
- Gynecomastia (2.2%)
- Headache (2%)
- Breast enlargement (0.5-1.8%)
- Somnolence (1.7%)
- Peripheral edema (1.3%)
- Hypotension (1.2%)
- Rhinitis (1%)
Tadalafil
- Headache (4.1%)
- Dyspepsia (2.4%)
- Back pain (2.4%)
- Nasopharyngitis (2.1%)
- Diarrhea (1.4%)
- Pain in extremity (1.4%)
- Myalgia (1.2%)
- Dizziness (1%)
-
<2% (uncertain causality)
- Body as a whole: Asthenia, face edema, fatigue, pain, peripheral edema
- Cardiovascular: Angina pectoris, chest pain, hypotension, myocardial infarction, postural hypotension, palpitations, syncope, tachycardia
- Digestive: Abnormal liver function tests, dry mouth, dysphagia, esophagitis, gastritis, gamma-glutamyl transpeptidase (GGTP) increased, loose stools, nausea, upper abdominal pain, vomiting, gastroesophageal reflux disease, hemorrhoidal hemorrhage, rectal hemorrhage
- Musculoskeletal: Arthralgia, neck pain
- Nervous: Dizziness, hypoesthesia, insomnia, paresthesia, somnolence, vertigo
- Renal and urinary: Renal impairment
- Respiratory: Dyspnea, epistaxis, pharyngitis
- Skin and appendages: Pruritus, rash, sweating
- Ophthalmologic: Blurred vision, changes in color vision, conjunctivitis (including conjunctival hyperemia), eye pain, lacrimation increase, swelling of eyelids
- Otologic: Sudden decrease in or loss of hearing, tinnitus
- Urogenital: Erection increased, spontaneous penile erection
<1%
Finasteride
- Ejaculation disorder (0.2-0.8%)
- Dyspnea (0.7%)
- Breast tenderness (0.4-0.7%)
- Rash (0.5%)
Postmarketing Reports
Finasteride
- Hypersensitivity reactions (eg, pruritus, urticaria, angioedema [including swelling of lips, tongue, throat, and face])
- Testicular pain
- Hematospermia
- Sexual dysfunction that continued after discontinuation of treatment
- Male infertility and/or poor seminal quality
- Depression
- Male breast cancer
Tadalafil
- Cardiovascular and cerebrovascular: Serious cardiovascular events, including myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, and tachycardia
- Body as a whole: Hypersensitivity reactions including urticaria, Stevens-Johnson syndrome, and exfoliative dermatitis
- Nervous: Migraine, seizure and seizure recurrence, transient global amnesia
- Ophthalmologic: Visual-field defect, retinal vein occlusion, retinal artery occlusion nonarteritic anterior ischemic optic neuropathy
- Otologic: Sudden decrease in or loss of hearing
- Urogenital: Priapism
Warnings
Contraindications
Known hypersensitivity to finasteride, tadalafil, or capsule components; hypersensitivity reactions have included Stevens-Johnson syndrome, exfoliative dermatitis, pruritus, urticaria, and angioedema
Pregnancy
Coadministration with nitrates or soluble guanylate cyclase (sGC) stimulators (eg, riociguat)
Cautions
Hypersensitivity reported; contraindicated with history of hypersensitivity to finasteride, tadalafil, or capsule components; discontinue immediately if hypersensitivity occurs
Before initiating, rule out other urologic conditions that may cause similar symptoms; prostate cancer and BPH may coexist
5-alpha-reductase inhibitors may increase risk of developing high-grade prostate cancer
Carefully monitor patients with large residual urinary volume and/or severely diminished urinary flow for obstructive uropathy; these patients may not be candidates for this therapy
Prolonged erection and priapism may occur; instruct patients who have an erection lasting >4 hr, whether painful or not, to seek emergency medical attention; caution with conditions that may predispose patient to priapism (eg, sickle cell anemia, multiple myeloma, leukemia) or with anatomic deformation of penis (eg, angulation, cavernosal fibrosis, Peyronie disease)
If sudden decrease or loss of hearing occurs, advise patients to stop taking finasteride/tadalafil and seek prompt medical care; these events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association with PDE5 inhibitors
Effect on bleeding
- Tadalafil is a selective PDE5 inhibitor; PDE5 is found in platelets
- When administered in combination with aspirin, tadalafil 20 mg did not prolong bleeding time relative to aspirin alone
- Finasteride/tadalafil has not been administered to patients with bleeding disorders or significant active peptic ulceration in clinical trials
- Although tadalafil has not been shown to increase bleeding times in healthy subjects, use caution in patients with bleeding disorders or significant active peptic ulceration after a careful risk-benefit assessment
Ocular adverse reactions
- Stop PDE5 inhibitors and seek medical attention if sudden vision loss occurs in 1 or both eyes
- May be a sign of nonarteritic anterior ischemic optic neuropathy (NAION), a rare condition and a cause of decreased vision, including permanent loss of vision, reported rarely postmarketing in temporal association with the use of PDE5 inhibitors
- The prescribing information lists the annual incidence of NAION as 2.5-11.8 cases/100,000 in men aged ≥50 yr
- Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in clinical trials; finasteride/tadalafil is not recommended in these patients
Prostate-specific antigen
- Finasteride reduces serum prostate-specific antigen (PSA) concentration by ~50% within 6 months of treatment
- This decrease is predictable over entire range of PSA values in patients with symptomatic BPH
- For interpretation of serial PSAs in men taking finasteride/tadalafil, establish new PSA baseline at least 6 months after starting treatment, with PSA monitored periodically thereafter
Cardiovascular risks
- Patients with left ventricular outflow obstruction (eg, aortic stenosis, idiopathic hypertrophic subaortic stenosis) can be sensitive to vasodilator actions, including PDE5 inhibitors
-
Patients not included in safety/efficacy trials
- Until further information is available, not recommended for the following patients
- Myocardial infarction within last 90 days
- Unstable angina or angina occurring during sexual intercourse
- NYHA class 2 or greater heart failure in last 6 months
- Uncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension
- Stroke within last 6 months
Drug interaction overview
-
Organic nitrates
- Contraindicated
- Do not use finasteride/tadalafil in patients taking any form of organic nitrate or nitric oxide donors, either regularly and/or intermittently
- PDE5 inhibitors may potentiate the hypotensive effects of nitrates
- Discuss with patients if they experience anginal chest pain requiring nitroglycerin following intake of finasteride/tadalafil
- If medically necessary for a life-threatening situation, at least 48 hr should have elapsed after last dose of finasteride/tadalafil before nitrate administration considered; should still be administered under close medical supervision with appropriate hemodynamic monitoring
-
Guanylate cyclase stimulators
- Contraindicated
- Tadalafil may potentiate hypotensive effects of guanylate cyclase stimulators
-
Alpha-blockers or antihypertensives
- Not recommended
- Coadministration with other vasodilators may have additive and significant blood pressure–lowering effect, which may lead to symptomatic hypotension
- Discontinue alpha-blockers at least 1 day before starting finasteride/tadalafil
-
Alcohol
- Caution
- Alcohol and tadalafil act as mild vasodilators
- Substantial alcohol consumption (eg, ≥5 units) with tadalafil may cause orthostatic signs and symptoms, including increase in heart rate, decreased standing blood pressure, dizziness, and headache
-
Strong CYP3A4 inhibitors
- Not recommended
- Tadalafil is metabolized primarily by CYP3A4; coadministration with strong CYP3A4 inhibitors may increase tadalafil systemic absorption and increase risk for adverse effects
Pregnancy & Lactation
Pregnancy
Contraindicated in pregnant females and not indicated for use in females
Based on animal studies and finasteride mechanism of action, may cause abnormal development of external genitalia in a male fetus if administered to pregnant females
Pregnant females should not handle crushed or open capsules owing to possible absorption of finasteride and subsequent potential risk to a male fetus
If contact with crushed or broken capsules occurs, wash contact area immediately with soap and water
Lactation
Not indicated for use in females
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
Finasteride: Selective inhibitor of type1 and type 2 isoforms of 5-alpha-reductase, which results in inhibiting conversion of testosterone to dihydrotestosterone by alpha receptors located in stromal muscle cells;, this decreases prostate volume and improves voiding symptoms
Tadalafil: Phosphodiesterase-5 (PDE5) enzyme inhibitor; inhibits PDE5, thereby increasing cyclic guanosine monophosphate (cGMP) to allow smooth muscle relaxation of the corpus cavernosum, prostate, and bladder
The combination of tadalafil and finasteride has the greatest benefit in patients with large prostates, owing to the mechanism of tadalafil relaxing smooth muscle of the prostate and finasteride shrinking the prostate; this allows for alleviation of urinary symptoms
Absorption
Bioavailability
- Finasteride: 63%
- Tadalafil: Not determined
Peak plasma time
- Finasteride: 2 hr
- Tadalafil: 3 hr
Peak plasma concentration
- Finasteride: 43.22 ng/mL
- Tadalafil: 106.75 ng/mL
AUC
- Finasteride: 335.8 ng⋅h/mL
- Tadalafil: 2,507.5 ng⋅h/mL
Effect of food
High-fat, high-calorie meal (ie, 1,011 calorie meal [53% fat]): Decreased peak plasma concentration of finasteride and tadalafil by 29% and 23%; no effect on AUC
Distribution
Vd
- Finasteride: 76 L
- Tadalafil: 63 L
Protein bound
- Finasteride: ~90%
- Tadalafil: 94%
Metabolism
Finasteride: Extensive liver metabolism, primarily via CYP3A4; 2 metabolites identified with ≤20% of finasteride’s activity
Tadalafil: Metabolized by CYP3A4 to catechol metabolite, which then undergoes methylation and glucuronidation; not expected to be pharmacologically active
Elimination
Half-life
- Finasteride: 6.63 hr
- Tadalafil: 22.33 hr
Excretion
- Finasteride: Urine 39% as metabolites; feces 57%
- Tadalafil: Urine 36% as metabolites; feces 61% as metabolites
Administration
Oral Administration
Take on empty stomach without food at about the same time each day
Storage
Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
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Formulary
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