Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
ENTADFI vs PROPECIA
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 is a competitive and specific inhibitor of type II 5α-reductase, an intracellular enzyme that converts testosterone to dihydrotestosterone (DHT). By inhibiting 5α-reductase, finasteride reduces serum and intraprostatic DHT levels, decreasing androgenic stimulation of the prostate. In hair follicles, reduction of DHT levels slows hair loss and promotes hair regrowth.
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 male pattern hair loss (androgenetic alopecia) in men only,Treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate
5 mg orally once daily.
1 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 approximately 6-8 hours in young adults (range 4-12 hours), with clinical relevance for once-daily dosing; slightly prolonged in elderly (8-11 hours).
Finasteride is metabolized primarily via CYP3A4. Tadalafil is metabolized mainly by CYP3A4.
Finasteride is extensively metabolized in the liver, primarily via the cytochrome P450 3A4 enzyme system. Two major metabolites, t-butyl side chain hydroxylation and ω-hydroxylation, have been identified; these metabolites possess less than 20% of the 5α-reductase inhibitory activity of finasteride.
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; 57% excreted in feces (as metabolites), 39% in urine (as metabolites, <0.1% as unchanged finasteride).
Finasteride: ~90% bound to plasma proteins (mainly albumin). Tadalafil: ~94% bound to plasma proteins (mainly albumin).
Approximately 93% bound to plasma proteins (mainly albumin).
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.
Approximately 1.1 L/kg (range 0.9-1.3 L/kg), indicating extensive tissue distribution with penetration into seminal fluid and scalp tissue.
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 65% (range 60-70%); not affected by food.
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 any degree of renal impairment
Contraindicated in Child-Pugh class B and C hepatic impairment. No dose adjustment required for Child-Pugh class A.
No dose adjustment recommended; no studies in hepatic impairment
Not approved for use in pediatric patients.
Not indicated 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; limited data in elderly men with benign prostatic hyperplasia
No FDA black box warning.
PROPECIA is not approved for use in women or children. Finasteride is contraindicated in women who are or may become pregnant due to risk of abnormalities of the external genitalia of a male fetus. Women should not handle crushed or broken tablets when pregnant or may be pregnant.
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 prostate cancer: Finasteride may increase the risk of high-grade prostate cancer; digital rectal exam and PSA screening recommended before and during therapy.,Sexual dysfunction: Decreased libido, erectile dysfunction, ejaculation disorders, and decreased ejaculate volume have been reported; may persist after discontinuation.,Depression and suicidal ideation: Monitor for mood changes.,Breast cancer: Reported in men; evaluate any breast changes promptly.,Elevated PSA levels: Use caution interpreting PSA values in men on finasteride; adjust PSA levels by approximately 50% for clinical interpretation.,Hepatic impairment: Use with caution in patients with liver function abnormalities.,Pediatric use: Not indicated for use in children.
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 of the formulation,Women who are or may become pregnant (due to risk of hypospadias in male fetuses),Children (not indicated for use in pediatric patients)
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 clinically significant food interactions. May be taken with or without food. However, avoid excessive alcohol intake as it may exacerbate certain side effects (e.g., dizziness).
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.
Contraindicated in females of childbearing potential. Finasteride inhibits conversion of testosterone to DHT, and risk of hypospadias in male fetuses if exposure occurs during gestation. No adequate studies in pregnant women; animal studies show abnormal external genitalia in male offspring at doses 1-100 times human exposure.
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. M/P ratio unknown. Finasteride is excreted in rat milk; no human data.
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 dose adjustments applicable as drug is contraindicated in pregnancy.
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.
Monitor patients for sexual dysfunction (e.g., decreased libido, erectile dysfunction) which may persist after discontinuation. Finasteride lowers serum PSA by approximately 50%; when interpreting PSA values in men taking Propecia, double the measured value for prostate cancer screening. Use with caution in patients with liver impairment; hepatic metabolism is primary clearance route. Avoid handling crushed or broken tablets in women who are or may become pregnant due to risk of teratogenicity (fetal genital abnormalities). Onset of hair regrowth typically takes 3-6 months; continue use for at least 12 months before assessing efficacy.
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 exactly as prescribed, usually one tablet (1 mg) daily with or without food.,Do not stop or skip doses without consulting your doctor; continuous use is needed to maintain benefit.,It may take 3-6 months to see hair regrowth and up to 12 months for full effect.,Report any new or worsening sexual side effects (e.g., decreased libido, erectile dysfunction, ejaculation disorders) promptly.,Finasteride may increase the risk of high-grade prostate cancer; discuss screening risks with your doctor.,Do not donate blood while taking Propecia and for at least 1 month after stopping to prevent exposure to pregnant women.,Women who are pregnant or may become pregnant should not handle crushed or broken tablets due to risk of birth defects.,If a dose is missed, skip it and take the next dose at the usual time; do not double up.
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 PROPECIA, 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.. PROPECIA is a 5-alpha reductase inhibitor that works by Finasteride is a competitive and specific inhibitor of type II 5α-reductase, an intracellular enzyme that converts testosterone to dihydrotestosterone (DHT). By inhibiting 5α-reductase, finasteride reduces serum and intraprostatic DHT levels, decreasing androgenic stimulation of the prostate. In hair follicles, reduction of DHT levels slows hair loss and promotes hair regrowth.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.
Potency comparisons between ENTADFI and PROPECIA 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 PROPECIA is: 1 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 PROPECIA 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. PROPECIA is classified as Category C. Contraindicated in females of childbearing potential. Finasteride inhibits conversion of testosterone to DHT, and risk of hypospadias in male fetuses if exposure occurs during gest. Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.