Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
ENTADFI vs PROSCAR
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.
Finasteride inhibits 5α-reductase type II, preventing conversion of testosterone to dihydrotestosterone (DHT) in the prostate, reducing prostate volume and improving urinary symptoms.
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
Benign prostatic hyperplasia (BPH) to improve symptoms, reduce risk of acute urinary retention, and reduce need for surgery,Androgenetic alopecia (male pattern hair loss) - off-label for some formulations
5 mg orally once daily.
5 mg orally once 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 elimination half-life is 6-8 hours (range 4-12 hours) in young adults; prolonged to 8-10 hours in elderly (≥70 years), but no dose adjustment required. Steady-state reached after 2 weeks dosing.
Finasteride is metabolized primarily via CYP3A4. Tadalafil is metabolized mainly by CYP3A4.
Primarily metabolized by CYP3A4 to t-butyl side-chain hydroxylated metabolites; minor metabolism by other CYP 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.
Primarily hepatic metabolism (CYP3A4), metabolites excreted renally (39%) and fecally (57%) as unchanged drug and metabolites.
Finasteride: ~90% bound to plasma proteins (mainly albumin). Tadalafil: ~94% bound to plasma proteins (mainly albumin).
Approximately 90% bound to plasma proteins (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.
Apparent volume of distribution is 1.4 L/kg (range 0.8-2.0 L/kg), indicating extensive tissue distribution (including prostate, seminal vesicles, and skin).
Finasteride 5 mg: oral bioavailability ~63% (range 56-74%). Tadalafil 5 mg: oral bioavailability ~80% (relative to intravenous); absorption not affected by food.
Oral bioavailability is approximately 63-80% (mean 65% from tablet formulation); food does not significantly affect absorption (Cmax decreased by 8%, AUC unchanged).
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 adjustment required for renal impairment; dose adjustment not studied in GFR < 30 m L/min.
Contraindicated in Child-Pugh class B and C hepatic impairment. No dose adjustment required for Child-Pugh class A.
No specific guidelines for Child-Pugh A or B; use with caution in severe hepatic impairment.
Not approved for use in pediatric patients.
Not indicated for use in pediatric patients; safety and efficacy not established.
No specific dose adjustment required; however, monitor for adverse effects due to potential age-related renal and hepatic decline.
No specific dose adjustment required; normal adult dosing recommended.
No FDA black box warning.
Not approved for use in women or children; finasteride is contraindicated in women who are or may become pregnant due to risk of hypospadias in male fetuses.
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
Increased risk of high-grade prostate cancer (Gleason score 8-10) reported in clinical trials; monitor for urinary obstruction; evaluate for other urological diseases; potential for decreased serum PSA levels; sexual dysfunction (decreased libido, erectile dysfunction, ejaculation disorder) may persist after discontinuation; mood changes including depression; breast cancer risk not established.
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)
Hypersensitivity to finasteride or any component, women who are or may become pregnant, pediatric patients (not indicated).
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.
No significant food interactions. Can be taken with or without meals.
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.
Finasteride is contraindicated in pregnancy (Category X). In first trimester, exposure may cause hypospadias in male fetuses due to inhibition of 5α-reductase; second and third trimester risks include ambiguous genitalia in male fetuses. Avoid handling crushed tablets if pregnant.
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.
Finasteride is excreted in breast milk in very low amounts (M/P ratio 0.52). Limited data; use caution. Consider alternative therapy, especially in nursing mothers of male infants due to theoretical risk of antiandrogenic effects.
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.
Not applicable; use is contraindicated in pregnancy. No pharmacokinetic studies in pregnancy; no dose adjustments recommended for any trimester as use is not indicated.
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.
Proscar (finasteride 5 mg) is indicated for benign prostatic hyperplasia (BPH); not interchangeable with Propecia (1 mg) for alopecia. Onset of symptom improvement may take 6-12 months. Monitor serum PSA (multiply by 2 for first 2 years). May cause reversible decrease in libido, ejaculatory dysfunction. Avoid in women of childbearing potential due to teratogenicity (risk of hypospadias).
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 once daily with or without food.,Do not crush or split tablets.,Symptom improvement may take 6 months or longer.,Possible side effects include decreased libido, erectile dysfunction, or decreased semen volume.,Women who are pregnant or may become pregnant should not handle crushed or broken tablets.,Regular monitoring of PSA levels is required during treatment.,Do not donate blood while taking this medication.,Report any breast lumps or testicular pain to your healthcare provider.
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 PROSCAR, 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.. PROSCAR is a 5-Alpha Reductase Inhibitor that works by Finasteride inhibits 5α-reductase type II, preventing conversion of testosterone to dihydrotestosterone (DHT) in the prostate, reducing prostate volume and improving urinary symptoms.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.
Potency comparisons between ENTADFI and PROSCAR 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 PROSCAR is: 5 mg orally once 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 PROSCAR 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. PROSCAR is classified as Category C. Finasteride is contraindicated in pregnancy (Category X). In first trimester, exposure may cause hypospadias in male fetuses due to inhibition of 5α-reductase; second and third tri. Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.