{ "query": "dutasteride", "ingredient": "dutasteride", "slug": "dutasteride", "rxcui": "228790", "brands": [ "Avodart" ], "names": [ "dutasteride" ], "classes": [ { "id": "G04CB", "name": "Testosterone-5-alpha reductase inhibitors" } ], "alternatives": [ "finasteride" ], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 23 }, "boxed_warning": "", "indications_and_usage": "Dutasteride is a 5 alpha-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, and reduce the risk of the need for BPH-related surgery. Dutasteride in combination with the alpha adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. ( 1.2 ) Limitations of Use: Dutasteride is not approved for the prevention of prostate cancer. ( 1.3 ) 1.1 Monotherapy Dutasteride capsules are 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 (AUR), and reduce the risk of the need for BPH-related surgery. 1.2 Combination With Alpha Adrenergic Antagonist Dutasteride in combination with the alpha adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. 1.3 Limitations of Use Dutasteride is not approved for the prevention of prostate cancer.", "contraindications": "Dutasteride is contraindicated for use in: Pregnancy. In animal reproduction and developmental toxicity trials, dutasteride inhibited development of male fetus external genitalia. Therefore, dutasteride may cause fetal harm when administered to a pregnant woman. If dutasteride is used during pregnancy or if the patient becomes pregnant while taking dutasteride, the patient should be apprised of the potential hazard to the fetus [see Warnings and Precautions (5.4) , Use in Specific Populations (8.1) ] . Women of childbearing potential [see Warnings and Precautions (5.4) , Use in Specific Populations (8.1) ] . Pediatric patients [see Use in Specific Populations (8.4) ] . Patients with previously demonstrated clinically significant hypersensitivity (e.g., serious skin reactions, angioedema) to dutasteride or other 5 alpha-reductase inhibitors [see Adverse Reactions (6.2) ] . Pregnancy and women of childbearing potential. ( 4 , 5.4 , 8.1 ) Pediatric patients. ( 4 ) Patients with previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema) to dutasteride or other 5 alpha-reductase inhibitors. ( 4 )", "warnings_and_cautions": "Dutasteride reduces serum prostate-specific antigen (PSA) concentration by approximately 50%. However, any confirmed increase in PSA while on dutasteride may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for untreated men. ( 5.1 ) Dutasteride may increase the risk of high-grade prostate cancer. ( 5.2 , 6.1 ) Prior to initiating treatment with dutasteride, consideration should be given to other urological conditions that may cause similar symptoms. ( 5.3 ) Women who are pregnant or could become pregnant should not handle dutasteride capsules due to potential risk to a male fetus. ( 5.4 , 8.1 ) Patients should not donate blood until 6 months after their last dose of dutasteride. ( 5.5 ) 5.1 Effects on Prostate-Specific Antigen (PSA) and the Use of PSA in Prostate Cancer Detection In clinical trials, dutasteride reduced serum PSA concentration by approximately 50% within 3 to 6 months of treatment. This decrease was predictable over the entire range of PSA values in patients with symptomatic BPH, although it may vary in individuals. Dutasteride may also cause decreases in serum PSA in the presence of prostate can...", "warnings": "", "adverse_reactions": "The most common adverse reactions, reported in \u22651% of patients treated with dutasteride and more commonly than in subjects treated with placebo, are impotence, decreased libido, ejaculation disorders, and breast disorders. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Banyan Pharma LLC at 1-888-328-0749 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 with rates in the clinical trial of another drug and may not reflect the rates observed in practice. From clinical trials with dutasteride as monotherapy or in combination with tamsulosin: The most common adverse reactions reported in subjects receiving dutasteride were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), and ejaculation disorders. The most common adverse reactions reported in subjects receiving combination therapy (dutasteride plus tamsulosin) were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), ejaculation disorders, and dizziness....", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "Warnings and Precautions, Evaluation for Other Urological Diseases ( 5.3 ) 03/2012", "information_for_patients": "See FDA-approved patient labeling ( Patient Information ). 17.1 PSA Monitoring Physicians should inform patients that dutasteride reduces serum PSA levels by approximately 50% within 3 to 6 months of therapy, although it may vary for each individual. For patients undergoing PSA screening, increases in PSA levels while on treatment with dutasteride may signal the presence of prostate cancer and should be evaluated by a healthcare provider [see Warnings and Precautions (5.1) ] . 17.2 Increased Risk of High-Grade Prostate Cancer Physicians should inform patients that there was an increase in high-grade prostate cancer in men treated with 5 alpha-reductase inhibitors (which are indicated for BPH treatment), including dutasteride, compared with those treated with placebo in trials looking at the use of these drugs to reduce the risk of prostate cancer [see Indications and Usage (1.3) , Warnings and Precautions (5.2) , Adverse Reactions (6.1) ] . 17.3 Exposure of Women\u2014Risk to Male Fetus Physicians should inform patients that dutasteride capsules should not be handled by a woman who is pregnant or who could become pregnant because of the potential for absorption of dutasteride and the su...", "spl_medguide": "", "clinical_studies": "14.1 Monotherapy Dutasteride 0.5 mg/day (n = 2,167) or placebo (n = 2,158) was evaluated in male subjects with BPH in three 2-year multicenter, placebo-controlled, double-blind trials, each with 2-year open-label extensions (n = 2,340). More than 90% of the trial population was Caucasian. Subjects were at least 50 years of age with a serum PSA \u22651.5 ng/mL and <10 ng/mL and BPH diagnosed by medical history and physical examination, including enlarged prostate (\u226530 cc) and BPH symptoms that were moderate to severe according to the American Urological Association Symptom Index (AUA-SI). Most of the 4,325 subjects randomly assigned to receive either dutasteride or placebo completed 2 years of double-blind treatment (70% and 67%, respectively). Most of the 2,340 subjects in the trial extensions completed 2 additional years of open-label treatment (71%). Effect on Symptom Scores: Symptoms were quantified using the AUA-SI, a questionnaire that evaluates urinary symptoms (incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) by rating on a 0 to 5 scale for a total possible score of 35, with higher numerical total symptom scores representing greater se...", "brand_name": "DUTASTERIDE", "manufacturer": "Banyan Pharma LLC", "application_number": "ANDA204705", "pharm_class_epc": [ "5-alpha Reductase Inhibitor [EPC]" ], "route": [ "ORAL" ], "effective_time": "20260729", "set_id": "947644ea-bc35-41df-8a7a-874360c90192", "has_boxed_warning": false, "controlled": false, "mentions_rems": false }, "faers": { "total": 13954, "serious": 10841, "death": 1654, "hospitalization": 5471, "primary_suspect": 13871, "top_reactions": [ [ "Dyspnoea", 1052 ], [ "Fatigue", 931 ], [ "Diarrhoea", 770 ], [ "Off Label Use", 769 ], [ "Asthenia", 749 ], [ "Fall", 719 ], [ "Dizziness", 686 ], [ "Malaise", 597 ], [ "Drug Ineffective", 579 ], [ "Nausea", 555 ], [ "Cough", 539 ], [ "Condition Aggravated", 520 ], [ "Death", 509 ], [ "Arthralgia", 492 ], [ "Decreased Appetite", 488 ] ], "by_year": { "2019": 1186, "2020": 1089, "2021": 1032, "2022": 1118, "2023": 1404, "2024": 1202, "2025": 954, "2026": 454 }, "by_year_primary": { "2019": 1184, "2020": 1081, "2021": 1021, "2022": 1093, "2023": 1395, "2024": 1192, "2025": 950, "2026": 444 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [], "recall_total": 0, "drugsfda": { "applications": 20, "nda": 1, "anda": 19, "first_approval": "20011120", "rems": false, "rems_last": "", "labeling_supplements": 11, "labeling_recent": 0, "sponsors": [ "ACELLA", "ACTAVIS LABS FL INC", "AMNEAL PHARMS", "APOTEX", "ASCENT PHARMS INC", "AUROBINDO PHARMA LTD", "BARR", "CHARTWELL" ], "unapproved": false, "first_approval_fmt": "11/20/2001" }, "trials": { "total": 142, "completed": 108, "terminated": 11, "with_results": 44, "industry": 88, "phase3": 26, "results_share": 0.4074074074074074, "terminated_share": 0.07746478873239436 }, "pubmed": { "rct": 130, "meta": 14, "recent_rct": 12, "cochrane": [] }, "payments": { "year": "2024", "usd": 0.0, "records": 0, "by_name": [], "names_checked": [ "dutasteride", "Avodart" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 958575, "beneficiaries": 249612, "spend": 38287011.46, "by_brand": [ { "brand": "Dutasteride", "claims": 955565, "per_claim": 32.938865802, "is_generic": true }, { "brand": "Avodart", "claims": 3010, "per_claim": 2263.0512159, "is_generic": false } ], "per_claim": 39.94159190465013 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": "", "name": "", "matched": null, "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 2586, "fills": 958575, "per_million": 2697.7544793052184, "ratio": 0.9742879861262335, "median": 2768.949753790441 }, "scores": { "safety": { "score": 95, "letter": "A", "why": [ "2,698 FDA reports naming it as the suspect drug per million Medicare fills, 1.0x the median drug on this site", "Death share in reports is near or below the FAERS average (1.3x)", "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)" ], "weight": 0.35 }, "evidence": { "score": 52, "letter": "D", "why": [ "130 randomized trials and 14 systematic reviews/meta-analyses indexed in PubMed", "No Cochrane review found (-5)", "Only 41% of completed registered trials posted results (-8)" ], "weight": 0.25 }, "regulatory": { "score": 95, "letter": "A", "why": [ "No recalls on record since 2016", "Label lists recent major changes to warnings or indications (-5)" ], "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 (19 applications)", "1 same-class alternative(s) (-10)" ], "weight": 0.1 } }, "total": 84, "grade": "B", "questions": [ "The most-reported problems in FDA's adverse event data are dyspnoea, fatigue, diarrhoea. How would we recognize and handle those?", "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?", "Why this one over finasteride? 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.)" ] }