HIGH-VOLUME · FEMALE-LED
duloxetine Side Effects
duloxetine (also sold as Cymbalta) is HIGH-VOLUME in this FAERS book #111 of 524 by FAERS report count. Signature opener: FEMALE-LED - 70% of sex-coded reports are female (41,657 F / 17,542 M).
Data updated 2026-05-15
- 65,067
- FAERS reports
FAERS voluntary reports, 2004 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
duloxetine reporting skew - 70% of sex-coded reports are female (41,657 F / 17,542 M). Volume band HIGH-VOLUME #111 of 524 by FAERS report count; caseload CASELOAD.
High-report extract for duloxetine (Cymbalta): 65,067 FAERS rows (2004-2025). Top named reactions: FATIGUE, NAUSEA, PAIN. Outcome stamps DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2004–2025). Stamps CASELOAD · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
FATIGUE leads 4,787 of 65,067 reports
FEMALE-LED reporters · age peak 45-64
Female-led reporters (70% of sex-coded rows)
Age peak 45-64 (19,541 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (6,708 reports, 10.3%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| COMPLETED SUICIDE | 2,077 |
| DEATH | 1,663 |
| TOXICITY TO VARIOUS AGENTS | 1,449 |
| CARDIO-RESPIRATORY ARREST | 338 |
| CARDIAC ARREST | 333 |
| OVERDOSE | 305 |
| DRUG INTERACTION | 296 |
| DRUG ABUSE | 240 |
| RESPIRATORY ARREST | 230 |
| NAUSEA | 200 |
| PNEUMONIA | 186 |
| FALL | 160 |
| ACUTE KIDNEY INJURY | 158 |
| FATIGUE | 156 |
| DIARRHOEA | 155 |
| SUSPECTED SUICIDE | 141 |
| VOMITING | 140 |
| COVID-19 | 124 |
| POISONING | 122 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (20,822, 32.0% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| FALL | 1,482 |
| NAUSEA | 1,416 |
| FATIGUE | 1,226 |
| PAIN | 1,148 |
| DIARRHOEA | 1,098 |
| PNEUMONIA | 1,085 |
| DYSPNOEA | 1,063 |
| VOMITING | 1,059 |
| DRUG INTERACTION | 1,004 |
| ASTHENIA | 926 |
| HEADACHE | 904 |
| DIZZINESS | 900 |
| TOXICITY TO VARIOUS AGENTS | 869 |
| ACUTE KIDNEY INJURY | 820 |
| SOMNOLENCE | 818 |
| URINARY TRACT INFECTION | 735 |
| CONFUSIONAL STATE | 715 |
| HYPOTENSION | 697 |
How to read duloxetine FAERS figures (CASELOAD · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 65,067 voluntary reports linked to duloxetine (Cymbalta), 2004-2025. Death is listed on 6,708 (10.3%). Hospitalization appears on 20,822 (32.0%). Top co-reported indication: Product Used For Unknown Indication.
CASELOAD books overweight common drugs and loud reporting cultures; FEMALE-LED is the page opener, not a per-patient risk.
Read with duloxetine
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 65,260 FAERS cases (Δ 193 heavier vs duloxetine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
ABS(total_reports) peer at 64,488 FAERS cases (Δ 579 lighter vs duloxetine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
ABS(total_reports) peer at 64,404 FAERS cases (Δ 663 lighter vs duloxetine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
ABS(total_reports) peer at 64,119 FAERS cases (Δ 948 lighter vs duloxetine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 51.8 pp vs duloxetine's DEATH-HEAVY): CASELOAD · HOSP-MID.
duloxetine stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload CASELOAD and the label guide.