Drug · FAERS side-effect profile with label screen
Dutasteride side effects: what 8,083 FDA adverse event reports show
Drug class
5-alpha Reductase Inhibitor
FDA label (Established Pharmacologic Class)
Who reports
8,083 reports · 79% serious · 1,106 with death outcome · 5% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Dutasteride capsules 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.
FDA label, Indications and Usage
What it is
Dutasteride capsules are a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 2Lab value / disease marker 5Not in label — unassessed 30
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 989 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Minimum inhibitory concentration | 24 | 6,823.2 3,172.6–14,674.7ROR 6,843.5 · χ² 42,806 / p <1e-300 | 746.0 EB05 527.6 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=24 · 100% clinician | no trial data cached |
| Spirometry abnormal | 282 | 2,421.3 2,060.5–2,845.3ROR 2,508.8 · χ² 349,303 / p <1e-300 | 1,146.8 EB05 1,038.8 · IC025 +8.4 3/3 methods agree | Lab value / disease marker | serious n=282 | no trial data cached |
| Mite allergy | 285 | 2,113.7 1,809.6–2,469.0ROR 2,190.9 · χ² 328,432 / p <1e-300 | 1,073.7 EB05 973.1 · IC025 +8.4 3/3 methods agree | Not in label — unassessed | serious n=285 | no trial data cached |
| Mycotic allergy | 285 | 1,333.1 1,157.2–1,535.8ROR 1,381.8 · χ² 248,557 / p <1e-300 | 827.7 EB05 750.1 · IC025 +8.2 3/3 methods agree | Not in label — unassessed | serious n=285 | no trial data cached |
| Dust allergy | 288 | 1,109.8 968.1–1,272.2ROR 1,150.8 · χ² 221,766 / p <1e-300 | 736.2 EB05 667.6 · IC025 +8.2 3/3 methods agree | Not in label — unassessed | serious n=288 | no trial data cached |
| Pulmonary vasculitis | 148 | 1,012.5 838.1–1,223.3ROR 1,031.4 · χ² 106,435 / p <1e-300 | 663.1 EB05 578.2 · IC025 +7.4 3/3 methods agree | Not in label — unassessed | serious n=148 | no trial data cached |
| Total lung capacity abnormal | 99 | 914.5 727.7–1,149.2ROR 925.8 · χ² 65,880 / p <1e-300 | 595.9 EB05 503.7 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious n=99 | no trial data cached |
| Occupational exposure to air contaminants | 10 | 752.6 371.9–1,522.7ROR 753.5 · χ² 5,233 / p <1e-300 | 275.6 EB05 160.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Capillaritis | 58 | 716.9 536.3–958.5ROR 722.1 · χ² 31,834 / p <1e-300 | 472.5 EB05 379.0 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=58 | no trial data cached |
| Amaurosis fugax | 224 | 688.9 595.4–797.1ROR 708.5 · χ² 120,689 / p <1e-300 | 518.8 EB05 464.2 · IC025 +7.7 3/3 methods agree | Not in label — unassessed | serious n=224 · 94% clinician | no trial data cached |
| Conjunctivitis allergic | 297 | 662.5 584.3–751.3ROR 687.8 · χ² 155,317 / p <1e-300 | 509.1 EB05 462.3 · IC025 +7.9 3/3 methods agree | Not in label — unassessed | serious n=297 | no trial data cached |
| Antineutrophil cytoplasmic antibody positive | 103 | 427.8 347.7–526.5ROR 433.3 · χ² 37,214 / p <1e-300 | 343.3 EB05 291.1 · IC025 +6.7 3/3 methods agree | Lab value / disease marker | serious n=103 | no trial data cached |
| Neuritis | 151 | 282.4 239.1–333.6ROR 287.8 · χ² 37,886 / p <1e-300 | 246.5 EB05 215.3 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=151 | no trial data cached |
| Subarachnoid haematoma | 13 | 277.2 156.5–491.1ROR 277.6 · χ² 2,983 / p <1e-300 | 183.3 EB05 114.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Antimicrobial susceptibility test resistant | 30 | 276.1 189.6–402.2ROR 277.1 · χ² 7,176 / p <1e-300 | 215.3 EB05 158.1 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=30 · 100% clinician | no trial data cached |
| Normochromic normocytic anaemia | 286 | 273.4 242.5–308.2ROR 283.4 · χ² 69,883 / p <1e-300 | 243.1 EB05 220.3 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious n=286 | no trial data cached |
| Fev1/fvc ratio decreased | 11 | 260.6 140.2–484.4ROR 261.0 · χ² 2,351 / p <1e-300 | 168.2 EB05 100.2 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious n=11 | no trial data cached |
| Genitalia external ambiguous | 14 | 225.3 130.5–388.9ROR 225.7 · χ² 2,671 / p <1e-300 | 161.9 EB05 102.5 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=14 | no trial data cached |
| Eosinophilic granulomatosis with polyangiitis | 146 | 202.3 171.1–239.0ROR 206.0 · χ² 26,913 / p <1e-300 | 183.1 EB05 159.5 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=146 | no trial data cached |
| Respiratory symptom | 159 | 156.1 133.2–182.9ROR 159.2 · χ² 22,953 / p <1e-300 | 144.7 EB05 126.8 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=159 | no trial data cached |
| Drug dispensed to wrong patient | 48 | 139.1 104.1–185.8ROR 139.9 · χ² 6,111 / p <1e-300 | 125.5 EB05 98.4 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=48 · 92% clinician | no trial data cached |
| Contraindicated product prescribed | 77 | 125.3 99.8–157.4ROR 126.5 · χ² 8,936 / p <1e-300 | 116.1 EB05 96.0 · IC025 +5.7 3/3 methods agree | Reporting / coding artifact | ♀ 100% (drug 5%) · 100% consumer | no trial data cached |
| Urinary tract disorder | 196 | 118.2 102.6–136.1ROR 121.1 · χ² 21,658 / p <1e-300 | 111.8 EB05 99.3 · IC025 +6.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=195 · 96% clinician | no trial data cached |
| Forced expiratory volume decreased | 118 | 112.6 93.7–135.2ROR 114.2 · χ² 12,394 / p <1e-300 | 106.1 EB05 90.9 · IC025 +5.9 3/3 methods agree | Lab value / disease marker | serious n=118 | no trial data cached |
| Post 5-alpha-reductase inhibitor syndrome | 10 | 104.9 55.7–197.3ROR 105.0 · χ² 891 / p 5e-196 | 85.0 EB05 49.3 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | no trial data cached |
| Arteriosclerosis coronary artery | 235 | 95.7 84.1–108.8ROR 98.5 · χ² 21,134 / p <1e-300 | 91.6 EB05 82.2 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=235 | no trial data cached |
| Haemorrhagic stroke | 243 | 82.7 73.0–93.8ROR 85.3 · χ² 18,935 / p <1e-300 | 79.7 EB05 71.6 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 58.6 · 93% clinician | no trial data cached |
| Arteriosclerosis | 260 | 73.6 65.2–83.0ROR 76.0 · χ² 18,026 / p <1e-300 | 71.2 EB05 64.2 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 54.0 | no trial data cached |
| Pulmonary alveolar haemorrhage | 153 | 72.8 62.1–85.4ROR 74.2 · χ² 10,473 / p <1e-300 | 70.2 EB05 61.4 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=153 | no trial data cached |
| Floppy iris syndrome | 10 | 71.7 38.2–134.3ROR 71.8 · χ² 611 / p 4e-135 | 61.9 EB05 35.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Neurological symptom | 152 | 71.4 60.8–83.7ROR 72.7 · χ² 10,195 / p <1e-300 | 68.9 EB05 60.2 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=152 | no trial data cached |
| Forced vital capacity decreased | 17 | 69.8 43.1–113.0ROR 70.0 · χ² 1,057 / p 5e-232 | 63.4 EB05 41.9 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Full blood count abnormal | 269 | 67.9 60.3–76.5ROR 70.2 · χ² 17,216 / p <1e-300 | 65.9 EB05 59.5 · IC025 +5.7 3/3 methods agree | Lab value / disease marker | serious PRR 63.8 | no trial data cached |
| Nodule | 285 | 57.9 51.6–65.0ROR 60.0 · χ² 15,536 / p <1e-300 | 56.4 EB05 51.1 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 63.7 | no trial data cached |
| Sleep disorder due to a general medical condition | 350 | 57.4 51.7–63.6ROR 59.9 · χ² 18,920 / p <1e-300 | 56.0 EB05 51.2 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 80.8 | no trial data cached |
| Ocular discomfort | 223 | 54.4 47.7–62.0ROR 55.9 · χ² 11,393 / p <1e-300 | 53.0 EB05 47.4 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=222 · 92% clinician | no trial data cached |
| Tachyarrhythmia | 50 | 52.9 40.0–70.0ROR 53.3 · χ² 2,446 / p <1e-300 | 50.9 EB05 40.1 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=50 | no trial data cached |
| Obstructive airways disorder | 196 | 46.4 40.3–53.3ROR 47.5 · χ² 8,502 / p <1e-300 | 45.4 EB05 40.3 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 34.6 | no trial data cached |
| Generalised oedema | 213 | 45.6 39.9–52.2ROR 46.9 · χ² 9,100 / p <1e-300 | 44.7 EB05 39.9 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 36.2 · 95% clinician | no trial data cached |
| Pulmonary function test abnormal | 27 | 45.6 31.2–66.7ROR 45.8 · χ² 1,114 / p 2e-244 | 43.5 EB05 31.4 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious n=27 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 803 | 3.7 3.5–3.9ROR 4.0 · χ² 1,611 / p <1e-300 | 3.7 EB05 3.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Fatigue (tiredness) | 627 | 2.1 1.9–2.3ROR 2.2 · χ² 371 / p 6e-83 | 2.1 EB05 2.0 · IC025 +0.9 | Not in label — unassessed | serious PRR 2.3 | no trial data cached |
| Diarrhoea (diarrhea) | 557 | 2.2 2.1–2.4ROR 2.3 · χ² 396 / p 2e-88 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Off label use (used outside approved label) | 523 | 1.6 1.4–1.7ROR 1.6 · χ² 110 / p 4e-26 | 1.6 EB05 1.5 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.7 | no trial data cached |
| Asthenia (weakness) | 510 | 3.5 3.2–3.8ROR 3.7 · χ² 934 / p 2e-205 | 3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Dizziness | 494 | 2.6 2.4–2.8ROR 2.7 · χ² 486 / p 7e-108 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
| Fall | 476 | 3.7 3.4–4.1ROR 3.9 · χ² 957 / p 2e-210 | 3.7 EB05 3.4 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Malaise (feeling unwell) | 437 | 2.6 2.4–2.8ROR 2.7 · χ² 430 / p 8e-96 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Condition aggravated | 434 | 3.7 3.4–4.1ROR 3.9 · χ² 877 / p 6e-193 | 3.7 EB05 3.4 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 | no trial data cached |
| Asthma | 422 | 9.8 8.9–10.8ROR 10.3 · χ² 3,330 / p <1e-300 | 9.7 EB05 9.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Wheezing | 416 | 18.4 16.7–20.2ROR 19.3 · χ² 6,783 / p <1e-300 | 18.2 EB05 16.8 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 18.2 | no trial data cached |
| Cough | 410 | 3.8 3.5–4.2ROR 4.0 · χ² 855 / p 3e-188 | 3.8 EB05 3.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Nausea | 408 | 1.3 1.2–1.5ROR 1.4 · χ² 37 / p 8e-10 | 1.3 EB05 1.2 · IC025 +0.3 | Not in label — unassessed | serious PRR 1.7 | no trial data cached |
| Arthralgia (joint pain) | 388 | 2.4 2.2–2.7ROR 2.5 · χ² 331 / p 2e-74 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Decreased appetite (loss of appetite) | 369 | 4.1 3.7–4.6ROR 4.3 · χ² 883 / p 2e-194 | 4.1 EB05 3.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Minimum inhibitory concentration — n=24, PRR 6,823.2
- Mite allergy — n=285, PRR 2,113.7
- Mycotic allergy — n=285, PRR 1,333.1
- Dust allergy — n=288, PRR 1,109.8
- Pulmonary vasculitis — n=148, PRR 1,012.5
- Total lung capacity abnormal — n=99, PRR 914.5
- Capillaritis — n=58, PRR 716.9
- Amaurosis fugax — n=224, PRR 688.9
- Conjunctivitis allergic — n=297, PRR 662.5
- Neuritis — n=151, PRR 282.4
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Dutasteride?
In FDA FAERS, the most frequently co-reported reaction terms for Dutasteride are dyspnoea, fatigue, diarrhoea, asthenia, dizziness, fall. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Dutasteride have an FDA boxed warning?
No. The FDA label retrieved for Dutasteride has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Dutasteride causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 2ad309b1-4497-8b9b-e063-6394a90aa9b4, effective 20250103; matched on
openfda.generic_name.exact:"DUTASTERIDE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,029 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.