HIGH-VOLUME · FEMALE-LED
tirzepatide Side Effects
tirzepatide (also sold as Mounjaro, Zepbound) is HIGH-VOLUME in this FAERS book #62 of 524 by FAERS report count. Signature opener: FEMALE-LED - 76% of sex-coded reports are female (74,456 F / 24,157 M).
Data updated 2026-05-15
- 120,921
- FAERS reports
FAERS voluntary reports, 2015 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
tirzepatide reporting skew - 76% of sex-coded reports are female (74,456 F / 24,157 M). Volume band HIGH-VOLUME #62 of 524 by FAERS report count; caseload MEGA-CASE.
High-report extract for tirzepatide (Mounjaro): 120,921 FAERS rows (2015-2025). Top named reactions: INCORRECT DOSE ADMINISTERED, INJECTION SITE PAIN, NAUSEA. Outcome stamps DEATH-RARE · HOSP-LIGHT · FEMALE-LED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2015–2025). Stamps MEGA-CASE · DEATH-RARE · HOSP-LIGHT · FEMALE-LED.
INCORRECT DOSE ADMINISTERED leads 25,919 of 120,921 reports
FEMALE-LED reporters · age peak 45-64
Female-led reporters (76% of sex-coded rows)
Age peak 45-64 (42,427 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death is rare in this extract (652 / 120,921). Co-reported reactions in that thin subset:
| Reaction | Reports |
|---|---|
| DEATH | 261 |
| VOMITING | 39 |
| CARDIAC ARREST | 34 |
| DIARRHOEA | 32 |
| NAUSEA | 31 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 26 |
| MYOCARDIAL INFARCTION | 25 |
| DECREASED APPETITE | 22 |
| ACUTE KIDNEY INJURY | 20 |
| PANCREATITIS | 20 |
| PULMONARY EMBOLISM | 19 |
| SEPSIS | 19 |
| COMPLETED SUICIDE | 16 |
| HYPOGLYCAEMIA | 16 |
| PNEUMONIA | 16 |
| WEIGHT DECREASED | 15 |
| ABDOMINAL PAIN | 14 |
| DEHYDRATION | 14 |
| PANCREATIC CARCINOMA | 14 |
Reactions in Hospitalization Reports
Hospitalization is lighter here (7,276). Reactions in that subset:
| Reaction | Reports |
|---|---|
| VOMITING | 1,287 |
| NAUSEA | 1,147 |
| DIARRHOEA | 932 |
| DEHYDRATION | 726 |
| ABDOMINAL PAIN | 622 |
| IMPAIRED GASTRIC EMPTYING | 577 |
| CONSTIPATION | 478 |
| PANCREATITIS | 429 |
| DECREASED APPETITE | 373 |
| ABDOMINAL PAIN UPPER | 293 |
| INTESTINAL OBSTRUCTION | 289 |
| CHOLELITHIASIS | 271 |
| ACUTE KIDNEY INJURY | 268 |
| DIZZINESS | 250 |
| WEIGHT DECREASED | 226 |
| FATIGUE | 207 |
| DYSPEPSIA | 199 |
| ANXIETY | 174 |
| PANCREATITIS ACUTE | 169 |
How to read tirzepatide FAERS figures (MEGA-CASE · DEATH-RARE · HOSP-LIGHT)
FAERS holds 120,921 voluntary reports linked to tirzepatide (Mounjaro, Zepbound), 2015-2025. Death is listed on 652 (0.5%). Hospitalization appears on 7,276 (6.0%). Top co-reported indication: Product Used For Unknown Indication.
MEGA-CASE books overweight common drugs and loud reporting cultures; FEMALE-LED is the page opener, not a per-patient risk.
Read with tirzepatide
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-RARE · HOSP-LIGHT stamps.
ABS(total_reports) peer at 121,298 FAERS cases (Δ 377 heavier vs tirzepatide); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-RARE · HOSP-LIGHT · FEMALE-LED.
ABS(total_reports) peer at 119,507 FAERS cases (Δ 1,414 lighter vs tirzepatide); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-RARE · HOSP-LIGHT · FEMALE-LED.
ABS(total_reports) peer at 118,365 FAERS cases (Δ 2,556 lighter vs tirzepatide); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's MEGA-CASE · DEATH-RARE · HOSP-LIGHT · FEMALE-LED.
ABS(total_reports) peer at 117,869 FAERS cases (Δ 3,052 lighter vs tirzepatide); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-RARE · HOSP-LIGHT · FEMALE-LED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 61.6 pp vs tirzepatide's DEATH-RARE): CASELOAD · HOSP-MID.
tirzepatide sits in MEGA-CASE; high report volume tracks exposure and reporting culture more than per-patient risk. Methodology states the de-dup rules.