MID-VOLUME · MALE-LED
dutasteride Side Effects
dutasteride (also sold as Avodart) sits MID-VOLUME #231 of 524 by FAERS report count. Lead signal: MALE-LED - 3% of sex-coded reports are female (653 F / 18,321 M). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 20,677
- FAERS reports
FDA Adverse Event Reporting System extract for dutasteride. Stamp set WATCHLIST · DEATH-HEAVY · HOSP-HEAVY. How figures are compiled.
dutasteride reporting skew - 3% of sex-coded reports are female (653 F / 18,321 M). Volume band MID-VOLUME #231 of 524 by FAERS report count; caseload WATCHLIST.
Mid-book FAERS page for dutasteride (Avodart) (20,677 reports). Signature MALE-LED. Dominant age band on file: 75+. Educational reference only.
Counts from the openFDA FAERS extract (2004–2025). Stamps WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · MALE-LED.
DYSPNOEA leads 1,233 of 20,677 reports
MALE-LED reporters · age peak 75+
Male-led reporters (97% of sex-coded rows)
Age peak 75+ (6,538 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (1,949 reports, 9.4%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 639 |
| DYSPNOEA | 312 |
| FALL | 271 |
| SEPSIS | 260 |
| DIARRHOEA | 258 |
| ASTHENIA | 248 |
| TACHYCARDIA | 241 |
| FATIGUE | 239 |
| CARDIO-RESPIRATORY ARREST | 237 |
| HAEMORRHAGIC STROKE | 235 |
| DIZZINESS | 232 |
| ALTERED STATE OF CONSCIOUSNESS | 220 |
| ARTHRALGIA | 219 |
| MALAISE | 219 |
| HAEMATEMESIS | 218 |
| CHILLS | 217 |
| ASCITES | 215 |
| COMA | 214 |
| PRURITUS | 214 |
| DECREASED APPETITE | 213 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (6,418, 31.0% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| DYSPNOEA | 627 |
| FALL | 392 |
| ASTHMA | 386 |
| WHEEZING | 380 |
| PNEUMONIA | 379 |
| CONDITION AGGRAVATED | 362 |
| ASTHENIA | 343 |
| PULMONARY EMBOLISM | 338 |
| SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION | 327 |
| PRODUCTIVE COUGH | 326 |
| THROMBOSIS | 310 |
| HYPOXIA | 304 |
| THERAPEUTIC PRODUCT EFFECT INCOMPLETE | 292 |
| ACUTE KIDNEY INJURY | 282 |
| ANAEMIA | 279 |
| CONJUNCTIVITIS ALLERGIC | 269 |
| DIARRHOEA | 269 |
| DUST ALLERGY | 267 |
| NORMOCHROMIC NORMOCYTIC ANAEMIA | 266 |
| MITE ALLERGY | 264 |
How to read dutasteride FAERS figures (WATCHLIST · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 20,677 voluntary reports linked to dutasteride (Avodart), 2004-2025. Death is listed on 1,949 (9.4%). Hospitalization appears on 6,418 (31.0%). Top co-reported indication: Product Used For Unknown Indication.
Mid-volume extract - treat DEATH-HEAVY · HOSP-HEAVY as signal-detection rates next to 3% of sex-coded reports are female (653 F / 18,321 M).
Read with dutasteride
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-HEAVY stamps.
ABS(total_reports) peer at 20,636 FAERS cases (Δ 41 lighter vs dutasteride); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · MALE-LED.
ABS(total_reports) peer at 20,544 FAERS cases (Δ 133 lighter vs dutasteride); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · MALE-LED.
ABS(total_reports) peer at 20,856 FAERS cases (Δ 179 heavier vs dutasteride); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · MALE-LED.
ABS(total_reports) peer at 20,453 FAERS cases (Δ 224 lighter vs dutasteride); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · MALE-LED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 52.7 pp vs dutasteride's DEATH-HEAVY): CASELOAD · HOSP-MID.
dutasteride stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload WATCHLIST and the label guide.