pharmacopeia
GET
/api/v1/drug/finasteride
2D structure
(1S,3aS,3bS,5aR,9aR,9bS,11aS)-N-tert-butyl-9a,11a-dimethyl-7-oxo-1,2,3,3a,3b,4,5,5a,6,9b,10,11-dodecahydroindeno[5,4-f]quinoline-1-carboxamide
SMILES C[C@]12CC[C@H]3[C@H]([C@@H]1CC[C@@H]2C(=O)NC(C)(C)C)CC[C@@H]4[C@@]3(C=CC(=O)N4)C
InChIKey DBEPLOCGEIEOCV-WSBQPABSSA-N

Mechanism of action

Sourced from openFDA

Finasteride is a competitive and specific inhibitor of Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into DHT. Two distinct isozymes are found in mice, rats, monkeys, and humans: Type I and II.

5-alpha Reductase

Indications

Sourced from openFDA
  • & USAGE Finasteride tablets USP are indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY. Efficacy in bitemporal recession has not been established.

Contraindications

Sourced from openFDA
  • Finasteride tablets USP are contraindicated in the following: • Pregnancy. Finasteride use is contraindicated in women when they are or may potentially be pregnant.contraindicated

Dosage & administration

Sourced from openFDA

DOSAGE & ADMINISTRATION Finasteride tablets USP may be administered with or without meals. The recommended dose of finasteride tablets USP is one tablet (1 mg) taken once daily. In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit, which should be re-evaluated periodically. Withdrawal of treatment leads to reversal of effect within 12 months. • Finasteride tablets USP may be administered with or without meals ( 2 ). • One tablet (1 mg) taken once daily ( 2 ). • In general, daily use for three months or more is necessary before benefit is observed ( 2 ).

Warnings & precautions

Sourced from openFDA

Finasteride tablets USP are not indicated for use in women or pediatric patients ( 5.1 , 5.4 ). • Women should not handle crushed or broken finasteride tablets USP when they are pregnant or may potentially be pregnant due to potential risk to a male fetus ( 5.1 , 8.1 , 16 ). • Finasteride tablets USP causes a decrease in serum PSA levels. Any confirmed increase in PSA while on finasteride tablets USP may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for men not taking a 5α-reductase inhibitor ( 5.2 ). • 5α-reductase inhibitors may increase the risk of high-grade prostate cancer ( 5.3 , 6.1 ). 5.1 Exposure of Women - Risk to Male Fetus Finasteride tablets USP are not indicated for use in women. Women should not handle crushed or broken finasteride tablets USP, when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. Finasteride tablets USP are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed. [S ee Indications and Usage (1) , Contraindications (4) , Use in Specific Populations (8.1) , How Supplied/Storage and Handling (16) and Patient Counseling Information (17.1) . ] 5.2 Effects on Prostate Specific Antigen (PSA) In clinical studies with finasteride tablets USP in men 18 to 41 years of age, the mean value of serum prostate specific antigen (PSA) decreased from 0.7 ng/mL at baseline to 0.5 ng/mL at Month 12.

Adverse reactions

Sourced from openFDA

The most common adverse reactions, reported in ≥1% of patients treated with finasteride tablets USP and greater than in patients treated with placebo are: decreased libido, erectile dysfunction and ejaculation disorder ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Clinical Studies for Finasteride Tablets USP 1 mg in the Treatment of Male Pattern Hair Loss In three controlled clinical trials for finasteride tablets USP of 12-month duration, 1.4% of patients taking finasteride tablets USP (n=945) were discontinued due to adverse experiences that were considered to be possibly, probably or definitely drug-related (1.6% for placebo; n=934). Clinical adverse experiences that were reported as possibly, probably or definitely drug-related in ≥1% of patients treated with finasteride tablets USP or placebo are presented in Table 1.

Use in specific populations

Sourced from openFDA

8.1 Pregnancy Teratogenic Effects : Pregnancy Category X [ see Contraindications (4) ]. Finasteride tablets USP is contraindicated for use in women who are or may become pregnant. Finasteride tablets USP are Type II 5α-reductase inhibitor that prevents conversion of testosterone to 5α-dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia. In animal studies, finasteride caused abnormal development of external genitalia in male fetuses. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the male fetus. Abnormal male genital development is an expected consequence when conversion of testosterone to 5α-dihydrotestosterone (DHT) is inhibited by 5α-reductase inhibitors. These outcomes are similar to those reported in male infants with genetic 5α-reductase deficiency. Women could be exposed to finasteride through contact with crushed or broken finasteride tablets or semen from a male partner taking finasteride tablets USP. With regard to finasteride exposure through the skin, finasteride tablets USP are coated and will prevent skin contact with finasteride during normal handling if the tablets have not been crushed or broken.

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption In a study in 15 healthy young male subjects, the mean bioavailability of finasteride 1-mg tablets was 65% (range 26 to 170%), based on the ratio of area under the curve (AUC) relative to an intravenous (IV) reference dose. At steady state following dosing with 1 mg/day (n=12), maximum finasteride plasma concentration averaged 9.2 ng/mL (range, 4.9 to 13.7 ng/mL) and was reached 1 to 2 hours postdose ; AUC (0 to 24 hr) was 53 ng•hr/mL (range, 20 to 154 ng•hr/mL).

Overdosage

Sourced from openFDA

In clinical studies, single doses of finasteride up to 400 mg and multiple doses of finasteride up to 80 mg/day for three months did not result in adverse reactions. Until further experience is obtained, no specific treatment for an overdose with finasteride can be recommended. Significant lethality was observed in male and female mice at single oral doses of 1500 mg/m 2 (500 mg/kg)and in female and male rats at single oral doses of 2360 mg/m 2 (400 mg/kg)and 5900 mg/m 2 (1000 mg/kg), respectively.

Approval history

Sourced from openFDA
  • Jun 19, 1992NDANDA020180Organon
  • Dec 19, 1997NDANDA020788Organon
  • Jul 28, 2006ANDAANDA076436Dr Reddys Labs Inc
  • Dec 15, 2006ANDAANDA076511Teva
  • Feb 28, 2007ANDAANDA076437Dr Reddys Labs Ltd
  • Oct 30, 2007ANDAANDA078341Aurobindo Pharma
  • Feb 23, 2010ANDAANDA090121Accord Hlthcare
  • Jun 7, 2010ANDAANDA090061Hetero Labs Ltd Iii

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Finasteride, Tablet, 5 mg (NDC 0093-7355-05)To be discontinued
    Sponsor: Teva Pharmaceuticals USA, Inc.
    Updated
  • Finasteride, Tablet, 5 mg (NDC 0093-7355-56)To be discontinued
    Sponsor: Teva Pharmaceuticals USA, Inc.
    Updated
  • Finasteride, Tablet, 5 mg (NDC 0093-7355-98)To be discontinued
    Sponsor: Teva Pharmaceuticals USA, Inc.
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
58,942 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Erectile Dysfunction4,1197.0%
  2. 2Fatigue4,0236.8%
  3. 3Depression3,6416.2%
  4. 4Anxiety3,0505.2%
  5. 5Adverse Drug Reaction2,7664.7%
  6. 6Drug Ineffective2,5864.4%
  7. 7Dizziness2,4334.1%
  8. 8Sexual Dysfunction2,3814.0%
  9. 9Diarrhoea2,3033.9%
  10. 10Death2,2313.8%
  11. 11Asthenia2,1563.7%
  12. 12Dyspnoea2,1423.6%
  13. 13Insomnia2,0563.5%
  14. 14Off Label Use1,9463.3%
  15. 15Fall1,7643.0%

Literature

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Recent PubMed references pinned to Finasteride as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 91 ClinicalTrials.gov registrations naming Finasteride as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Structural analogs

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Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

Frequently asked questions

How does Finasteride work?
Finasteride is a competitive and specific inhibitor of Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into DHT. Two distinct isozymes are found in mice, rats, monkeys, and humans: Type I and II.
What is Finasteride used for?
According to FDA labeling, Finasteride carries indications including: & USAGE Finasteride tablets USP are indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY. Efficacy in bitemporal recession has not been established.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Finasteride?
Finasteride is classified as Other dermatologicals, Testosterone-5-alpha reductase inhibitors, 5-alpha Reductase Inhibitor, 5-alpha Reductase Inhibitors, Decreased Dihydrotestosterone Secretion.
What are the brand names for Finasteride?
Finasteride is marketed under brand names including Entadfi, Propecia, Proscar.
What are the contraindications for Finasteride?
Finasteride labeling lists contraindications including: Finasteride tablets USP are contraindicated in the following: • Pregnancy. Finasteride use is contraindicated in women when they are or may potentially be pregnant.. Always consult the full prescribing information and a clinician.
Note. Data for finasteride is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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