Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
ENTADFI vs ADCIRCA
Clinician-reviewed, head-to-head comparison of mechanism, dosing, pharmacokinetics, and safety profiles.
Last clinically reviewed: July 2026 · OpiCalc Medical Review Team
Combination of a 5α-reductase inhibitor (finasteride) and a phosphodiesterase 5 inhibitor (tadalafil). Finasteride inhibits type II 5α-reductase, preventing conversion of testosterone to dihydrotestosterone, reducing prostate growth. Tadalafil inhibits PDE5, increasing c GMP in smooth muscle, causing relaxation of the prostate and bladder neck.
Phosphodiesterase-5 (PDE5) inhibitor; increases c GMP in pulmonary vascular smooth muscle, leading to vasodilation.
Treatment of signs and symptoms of benign prostatic hyperplasia (BPH),Treatment of BPH in men with an enlarged prostate to improve symptoms, reduce risk of acute urinary retention, and reduce need for surgery
Treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise capacity and delay clinical worsening.,Off-label: Erectile dysfunction (not FDA-approved for this indication in the context of PAH).
5 mg orally once daily.
10 mg orally three times daily.
Finasteride: terminal half-life ~6-8 hours (range 4-12 h) in young adults, 8 hours in elderly. Tadalafil: terminal half-life ~17.5 hours (range 11-28 h), supporting once-daily dosing.
Terminal half-life: 10–15 hours in healthy adults; prolonged in hepatic impairment (Child-Pugh B/C: up to 30 hours); clinical context: supports twice-daily dosing
Finasteride is metabolized primarily via CYP3A4. Tadalafil is metabolized mainly by CYP3A4.
Primarily metabolized by CYP3A4 (major) and CYP2C9 (minor) hepatic enzymes.
ENTADFI (finasteride 5 mg and tadalafil 5 mg) is a fixed-dose combination. Finasteride is excreted 57% in feces (as metabolites) and 39% in urine (<1% as unchanged). Tadalafil is excreted primarily as metabolites, with 61% in feces and 36% in urine; <0.001% of dose is excreted unchanged in urine.
Renal: ~70% (metabolites and unchanged drug), Fecal: ~20%, Biliary: minor
Finasteride: ~90% bound to plasma proteins (mainly albumin). Tadalafil: ~94% bound to plasma proteins (mainly albumin).
96% bound to albumin and alpha-1-acid glycoprotein
Finasteride: Vd ≈ 76 L (approx 1.1 L/kg based on 70 kg). Tadalafil: Vd ≈ 63-77 L (approx 0.9-1.1 L/kg), indicating extensive tissue distribution.
Vd: 0.4–0.7 L/kg; suggests distribution into total body water and moderate tissue binding
Finasteride 5 mg: oral bioavailability ~63% (range 56-74%). Tadalafil 5 mg: oral bioavailability ~80% (relative to intravenous); absorption not affected by food.
Oral: 80%; absolute bioavailability: 50% due to first-pass metabolism
No dose adjustment required for mild to moderate renal impairment. Not recommended in severe renal impairment (e GFR <30 m L/min/1.73 m²).
No dose adjustment required for mild to moderate renal impairment; avoid use in severe impairment (Cr Cl <30 m L/min) due to lack of data.
Contraindicated in Child-Pugh class B and C hepatic impairment. No dose adjustment required for Child-Pugh class A.
Mild to moderate hepatic impairment (Child-Pugh A or B): 10 mg orally once daily; severe hepatic impairment (Child-Pugh C): contraindicated.
Not approved for use in pediatric patients.
Not established for patients <18 years.
No specific dose adjustment required; however, monitor for adverse effects due to potential age-related renal and hepatic decline.
No specific dose adjustment, but caution due to increased sensitivity; monitor renal function.
No FDA black box warning.
Do not use in patients taking nitrates (regularly or intermittently) due to risk of severe hypotension.
Hypersensitivity reactions,Sudden decrease in hearing or tinnitus,Prostate cancer screening and monitoring,Cardiovascular risk with sexual activity,Contraindicated with organic nitrates and GC stimulators (e.g., riociguat),Risk of priapism,Hepatic impairment dose adjustment,Renal impairment dose adjustment,Use of alpha-blockers,Antihypertensive effects,Risk of hypotension with concomitant alcohol
Risk of hypotension, especially with nitrates or alpha-blockers.,Hematologic effects: increased risk of bleeding due to antiplatelet activity; caution with bleeding disorders or anticoagulants.,Vision loss: non-arteritic anterior ischemic optic neuropathy (NAION) has been reported; discontinue if sudden vision loss occurs.,Hearing loss: sudden decrease or loss of hearing; may be accompanied by tinnitus or dizziness.,Use caution in patients with left ventricular outflow obstruction (e.g., aortic stenosis) or severely impaired autonomic control of blood pressure.,Dose adjustment required with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir).
Hypersensitivity to finasteride, tadalafil, or any component,Concurrent use of any organic nitrate,Concurrent use of guanylate cyclase stimulators (e.g., riociguat),Women, especially during pregnancy (finasteride teratogenicity)
Concomitant use of nitrates (any form) or nitric oxide donors.,Concomitant use with riociguat or other guanylate cyclase stimulators.,Known hypersensitivity to tadalafil or any component of the product.,Severe hepatic impairment (Child-Pugh class C).
Grapefruit juice may increase tadalafil plasma concentrations; avoid concurrent consumption. High-fat meals may delay tadalafil absorption but do not affect overall exposure. There are no significant food interactions with finasteride.
Avoid grapefruit and grapefruit juice as they may increase tadalafil levels and risk of side effects. No other significant food interactions. High-fat meals may delay absorption but do not require dose adjustment.
ENTADFI (finasteride and tadalafil) is contraindicated in pregnancy. Finasteride is a 5α-reductase inhibitor that inhibits conversion of testosterone to dihydrotestosterone (DHT) and can cause abnormal development of external genitalia in male fetuses. First trimester exposure is associated with hypospadias and other genital malformations. There is no human data for second and third trimester; however, based on mechanism, risks persist throughout pregnancy. Tadalafil, a PDE5 inhibitor, is Pregnancy Category B; no fetal harm is known in animals, but human data are limited.
Pregnancy Category B. Animal studies have not demonstrated fetal risk, but there are no adequate and well-controlled studies in pregnant women. First trimester: risk cannot be ruled out; use only if clearly needed. Second and third trimesters: no known fetal risks, but caution advised due to maternal hypotension risk.
No data available on ENTADFI (finasteride/tadalafil) in human milk. Finasteride is excreted in rat milk, but M/P ratio is unknown. Tadalafil is excreted in animal milk; M/P ratio unknown. Due to potential for adverse effects on lactating infant, especially from finasteride (possible interference with androgen metabolism), breastfeeding is not recommended during treatment and for at least 1 month after last dose.
Not recommended. Excretion in human milk unknown. M/P ratio not established. Risk of hypotension in neonate. Alternative feeding method advised during therapy and for 48 hours after last dose.
ENTADFI is contraindicated in pregnancy; no dosing adjustments are recommended because use is not permitted. If inadvertently administered, discontinue immediately. There are no established pharmacokinetic changes in pregnancy for finasteride or tadalafil; however, pregnancy-induced changes in drug metabolism are not expected to alter the need for dose adjustment because the drug is not used during gestation.
No specific pharmacokinetic data in pregnancy. Standard dose (40 mg orally once daily) recommended. Monitor for hypotension; dose adjustment not routinely required unless maternal hypotension develops.
ENTADFI (finasteride and tadalafil fixed-dose combination) is used for benign prostatic hyperplasia (BPH). Finasteride reduces DHT, improving symptoms and reducing risk of acute urinary retention; tadalafil enhances smooth muscle relaxation via PDE5 inhibition. Monitor PSA levels during therapy (finasteride halves PSA). Assess cardiovascular status before initiating tadalafil; avoid concurrent nitrates. Caution in hepatic impairment (tadalafil exposure increased). Advise patients that therapeutic effect may take 3-6 months.
Adcirca (tadalafil) is a PDE5 inhibitor indicated for pulmonary arterial hypertension (PAH) to improve exercise ability. It is dosed at 40 mg once daily, not as needed. Avoid use with nitrates due to risk of severe hypotension. Monitor for vision loss (non-arteritic anterior ischemic optic neuropathy) and hearing loss. Use caution in patients with hepatic impairment (Child-Pugh class B: reduce dose; class C: contraindicated). Dose adjustment required with potent CYP3A4 inhibitors (e.g., ketoconazole: reduce to 20 mg). Not recommended for severe renal impairment (Cr Cl <30 m L/min) or on hemodialysis.
Take ENTADFI at the same time daily with or without food.,Do not take more than one dose per day.,Avoid grapefruit juice as it may increase tadalafil levels.,Report sudden decrease in hearing or vision promptly.,Seek immediate medical help for erection lasting >4 hours.,Use contraception if partner is pregnant or may become pregnant (finasteride can cause fetal harm).,Do not donate blood during treatment and for 1 month after stopping.,Avoid alcohol excessively as it may increase risk of hypotension.
Take Adcirca exactly as prescribed, 40 mg once daily, at the same time each day. Do not take it as needed for erectile dysfunction.,Do not take Adcirca if you are taking any form of nitrate medication (e.g., nitroglycerin) or recreational drugs called 'poppers' (amyl nitrate) as this can cause a sudden dangerous drop in blood pressure.,Seek immediate medical attention if you experience sudden vision loss or decrease in hearing, as these may be signs of a serious side effect.,Avoid drinking large amounts of alcohol (e.g., 3 or more drinks) within a short time while taking Adcirca, as it may increase the risk of dizziness, lightheadedness, and fainting.,Inform your healthcare provider about all medications you take, including prescription, over-the-counter, and herbal products, especially alpha-blockers, erythromycin, or ritonavir.,Adcirca may cause dizziness. Do not drive or operate machinery until you know how the medicine affects you.
No interactions on record
No interactions on record
Explore head-to-head clinical comparisons of other medications in the same therapeutic classes.
Common clinical questions about ENTADFI vs ADCIRCA, answered by our medical review team.
ENTADFI is a 5-Alpha Reductase Inhibitor and PDE5 Inhibitor that works by Combination of a 5α-reductase inhibitor (finasteride) and a phosphodiesterase 5 inhibitor (tadalafil). Finasteride inhibits type II 5α-reductase, preventing conversion of testosterone to dihydrotestosterone, reducing prostate growth. Tadalafil inhibits PDE5, increasing c GMP in smooth muscle, causing relaxation of the prostate and bladder neck.. ADCIRCA is a PDE5 Inhibitor that works by Phosphodiesterase-5 (PDE5) inhibitor; increases c GMP in pulmonary vascular smooth muscle, leading to vasodilation.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.
Potency comparisons between ENTADFI and ADCIRCA depend on the specific clinical indication. These are agents from distinct pharmacological classes and are not directly interchangeable by dose. A physician or clinical pharmacist should guide any therapeutic switching decisions.
The standard adult dose of ENTADFI is: 5 mg orally once daily.. The standard adult dose of ADCIRCA is: 10 mg orally three times daily.. Dosing should always be individualized based on indication, renal and hepatic function, age, and other patient factors.
No direct drug-drug interaction has been formally documented between ENTADFI and ADCIRCA in current clinical databases. However, individual patient risk factors including other medications, organ function, and comorbidities should always be evaluated by a qualified healthcare provider.
The maternal-fetal safety profiles differ. ENTADFI is classified as Category C. ENTADFI (finasteride and tadalafil) is contraindicated in pregnancy. Finasteride is a 5α-reductase inhibitor that inhibits conversion of testosterone to dihydrotestosterone (DHT) a. ADCIRCA is classified as Category C. Pregnancy Category B. Animal studies have not demonstrated fetal risk, but there are no adequate and well-controlled studies in pregnant women. First trimester: risk cannot be rule. Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.