{
 "query": "finasteride",
 "ingredient": "finasteride",
 "slug": "finasteride",
 "rxcui": "25025",
 "brands": [
  "Proscar",
  "Propecia"
 ],
 "names": [
  "finasteride"
 ],
 "classes": [
  {
   "id": "G04CB",
   "name": "Testosterone-5-alpha reductase inhibitors"
  }
 ],
 "alternatives": [
  "dutasteride"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 67,
   "TOPICAL": 3
  },
  "boxed_warning": "",
  "indications_and_usage": "PROSCAR, is a 5\u03b1-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to ( 1.1 ): Improve symptoms Reduce the risk of acute urinary retention Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. PROSCAR administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed \u22654 point increase in American Urological Association (AUA) symptom score) ( 1.2 ). Limitations of Use : PROSCAR is not approved for the prevention of prostate cancer ( 1.3 ). 1.1 Monotherapy PROSCAR \u00ae is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: - Improve symptoms - Reduce the risk of acute urinary retention - Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. 1.2 Combination with Alpha-Blocker PROSCAR administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed \u22654 point increase in American U...",
  "contraindications": "is contraindicated in the following: Hypersensitivity to any component of this medication. Pregnancy. Finasteride use is contraindicated in females when they are or may potentially be pregnant. Because of the ability of Type II 5\u03b1-reductase inhibitors to inhibit the conversion of testosterone to 5\u03b1-dihydrotestosterone (DHT), finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant female who receives finasteride. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant female should be apprised of the potential hazard to the male fetus. [See also Warnings and Precautions (5.3) , Use in Specific Populations (8.1) , and How Supplied/Storage and Handling (16) .] In female rats, low doses of finasteride administered during pregnancy have produced abnormalities of the external genitalia in male offspring. Hypersensitivity to any components of this product ( 4 ). Females who are or may potentially be pregnant ( 4 , 5.3 , 8.1 , 16 ).",
  "warnings_and_cautions": "reduces serum prostate specific antigen (PSA) levels by approximately 50%. However, any confirmed increase in PSA while on PROSCAR 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 5\u03b1-reductase inhibitor ( 5.1 ). PROSCAR may increase the risk of high-grade prostate cancer ( 5.2 , 6.1 ). Females should not handle crushed or broken PROSCAR tablets when they are pregnant or may potentially be pregnant due to potential risk to a male fetus ( 5.3 , 8.1 , 16 ). PROSCAR is not indicated for use in pediatric patients or females ( 5.4 , 8.1 , 8.2 , 8.4 , 12.3 ). Prior to initiating treatment with PROSCAR for BPH, consideration should be given to other urological conditions that may cause similar symptoms ( 5.6 ). 5.1 Effects on Prostate Specific Antigen (PSA) and the Use of PSA in Prostate Cancer Detection In clinical studies, PROSCAR reduced serum PSA concentration by approximately 50% within six months of treatment. This decrease is predictable over the entire range of PSA values in patients with symptomatic BPH, although it may vary in individuals. For interpretation of serial PSAs in men taking...",
  "warnings": "",
  "adverse_reactions": "The drug-related adverse reactions, reported in \u22651% in patients treated with PROSCAR and greater than in patients treated with placebo over a 4-year study are: impotence, decreased libido, decreased volume of ejaculate, breast enlargement, breast tenderness and rash ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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. 4-Year Placebo-Controlled Study (PLESS) In PLESS, 1524 patients treated with PROSCAR and 1516 patients treated with placebo were evaluated for safety over a period of 4 years. The most frequently reported adverse reactions were related to sexual function. 3.7% (57 patients) treated with PROSCAR and 2.1% (32 patients) treated with placebo discontinued therapy as a result of adverse reactions related to sexual function, which are the most frequently reported ...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Increased Risk of High-Grade Prostate Cancer Patients should be informed that there was an increase in high-grade prostate cancer in men treated with 5\u03b1-reductase inhibitors indicated for BPH treatment, including PROSCAR, compared to those treated with placebo in studies looking at the use of these drugs to prevent prostate cancer [see Indications and Usage (1.3) , Warnings and Precautions (5.2) , and Adverse Reactions (6.1) ]. Exposure of Females \u2014 Risk to Male Fetus Physicians should inform patients that females who are pregnant or may potentially be pregnant should not handle crushed or broken PROSCAR tablets because of the possibility of absorption of finasteride and the subsequent potential risk to the male fetus. PROSCAR tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed. If a female who is pregnant or may potentially be pregnant comes in contact with crushed or broken PROSCAR tablets, the contact area should be washed immediately with soap and water [see Contraindications (4) , Warnings and...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Monotherapy PROSCAR 5 mg/day was initially evaluated in patients with symptoms of BPH and enlarged prostates by digital rectal examination in two 1-year, placebo-controlled, randomized, double-blind studies and their 5-year open extensions. PROSCAR was further evaluated in the PROSCAR Long-Term Efficacy and Safety Study (PLESS), a double-blind, randomized, placebo-controlled, 4-year, multicenter study. 3040 patients between the ages of 45 and 78, with moderate to severe symptoms of BPH and an enlarged prostate upon digital rectal examination, were randomized into the study (1524 to finasteride, 1516 to placebo) and 3016 patients were evaluable for efficacy. 1883 patients completed the 4-year study (1000 in the finasteride group, 883 in the placebo group). Effect on Symptom Score Symptoms were quantified using a score similar to the American Urological Association Symptom Score, which evaluated both obstructive symptoms (impairment of size and force of stream, sensation of incomplete bladder emptying, delayed or interrupted urination) and irritative symptoms (nocturia, daytime frequency, need to strain or push the flow of urine) by rating on a 0 to 5 scale for six symptoms and ...",
  "brand_name": "PROSCAR",
  "manufacturer": "Organon LLC",
  "application_number": "NDA020180",
  "pharm_class_epc": [
   "5-alpha Reductase Inhibitor [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260318",
  "set_id": "6f988153-fc74-4ca4-b29a-111f750c4a4b",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 50911,
  "serious": 32302,
  "death": 4368,
  "hospitalization": 13234,
  "primary_suspect": 50826,
  "top_reactions": [
   [
    "Fatigue",
    3625
   ],
   [
    "Erectile Dysfunction",
    3387
   ],
   [
    "Depression",
    3115
   ],
   [
    "Adverse Drug Reaction",
    2738
   ],
   [
    "Anxiety",
    2573
   ],
   [
    "Drug Ineffective",
    2178
   ],
   [
    "Death",
    2096
   ],
   [
    "Diarrhoea",
    2076
   ],
   [
    "Dizziness",
    2020
   ],
   [
    "Off Label Use",
    1914
   ],
   [
    "Insomnia",
    1885
   ],
   [
    "Asthenia",
    1838
   ],
   [
    "Dyspnoea",
    1801
   ],
   [
    "Sexual Dysfunction",
    1794
   ],
   [
    "Fall",
    1580
   ]
  ],
  "by_year": {
   "2019": 3987,
   "2020": 4428,
   "2021": 3681,
   "2022": 3264,
   "2023": 3089,
   "2024": 5084,
   "2025": 7347,
   "2026": 3323
  },
  "by_year_primary": {
   "2019": 3987,
   "2020": 4424,
   "2021": 3672,
   "2022": 3247,
   "2023": 3076,
   "2024": 5072,
   "2025": 7322,
   "2026": 3319
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20230207",
   "reason": "CGMP Deviations: recalling drug products following an FDA inspection.",
   "firm": "Accord Healthcare, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20161229",
   "reason": "Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.",
   "firm": "Hetero Drugs Ltd. - Unit 1",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 24,
  "nda": 2,
  "anda": 22,
  "first_approval": "19920619",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 44,
  "labeling_recent": 6,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ACTAVIS TOTOWA",
   "ACTAVIS TOTOWA TEVA",
   "ALKEM LABS LTD",
   "AUROBINDO PHARMA",
   "AUROBINDO PHARMA LTD",
   "CIPLA",
   "DR REDDYS LABS INC"
  ],
  "unapproved": false,
  "first_approval_fmt": "06/19/1992"
 },
 "trials": {
  "total": 95,
  "completed": 62,
  "terminated": 10,
  "with_results": 27,
  "industry": 53,
  "phase3": 20,
  "results_share": 0.43548387096774194,
  "terminated_share": 0.10526315789473684
 },
 "pubmed": {
  "rct": 239,
  "meta": 23,
  "recent_rct": 14,
  "cochrane": [
   {
    "pmid": "20927745",
    "title": "Finasteride for benign prostatic hyperplasia",
    "year": "2010"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "finasteride",
   "Proscar",
   "Propecia"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 7381373,
  "beneficiaries": 1835919,
  "spend": 96632654.44,
  "by_brand": [
   {
    "brand": "Finasteride",
    "claims": 7380163,
    "per_claim": 13.038602156,
    "is_generic": true
   },
   {
    "brand": "Proscar",
    "claims": 1210,
    "per_claim": 335.244,
    "is_generic": false
   }
  ],
  "per_claim": 13.09142004339843
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": {
  "section": "Allergy",
  "names": [
   "finasteride",
   "finasteride"
  ],
  "reason": "Oral finasteride 1 mg and topical finasteride are authorised for androgenetic alopecia in men. Finasteride is a 5-alpha-reductase inhibitor with very modest efficacy in this situation. The oral form increases hair density on the crown of the head by about 10% on average, while the topical form adds about 13 extra hairs/cm 2 on average compared to placebo (from a baseline density of about 200 hairs/ cm2). The effect persists only while treatment continues, and hair density returns to baseline levels when treatment is stopped. Notable adverse effects include sexual dysfunction (erectile dysfunct...",
  "edition": "2026",
  "qualifier": "oral finasteride 1 mg; topical finasteride",
  "qualified": true,
  "matched": "finasteride"
 },
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 15713,
  "fills": 7381373,
  "per_million": 2128.7367539887227,
  "ratio": 0.7687885094609158,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "Prescrire lists one form only (oral finasteride 1 mg; topical finasteride) as a drug to avoid; shown for context, no score effect",
    "2,129 FDA reports naming it as the suspect drug per million Medicare fills, 0.8x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.9x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 64,
   "letter": "C",
   "why": [
    "239 randomized trials and 23 systematic reviews/meta-analyses indexed in PubMed",
    "1 independent Cochrane review(s) exist",
    "Only 44% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 90,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 1 Class III across 22 generic makers (-2)",
    "6 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 90,
   "letter": "A",
   "why": [
    "Generic versions approved (22 applications)",
    "1 same-class alternative(s) (-10)"
   ],
   "weight": 0.1
  }
 },
 "total": 88,
 "grade": "A",
 "questions": [
  "An independent reviewer (Prescrire) lists this as a drug to avoid because the harms outweigh the benefits versus alternatives. What is your view on that?",
  "The most-reported problems in FDA's adverse event data are fatigue, erectile dysfunction, depression, adverse drug reaction. How would we recognize and handle those?",
  "Why this one over dutasteride? What would make you pick one of those instead?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}