MID-VOLUME · FEMALE-LED
misoprostol Side Effects
misoprostol (also sold as Cytotec) sits MID-VOLUME #325 of 524 by FAERS report count. Lead signal: FEMALE-LED - 85% of sex-coded reports are female (7,473 F / 1,360 M). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 9,536
- FAERS reports
FDA Adverse Event Reporting System extract for misoprostol. Stamp set WATCHLIST · DEATH-HEAVY · HOSP-HEAVY. How figures are compiled.
misoprostol reporting skew - 85% of sex-coded reports are female (7,473 F / 1,360 M). Volume band MID-VOLUME #325 of 524 by FAERS report count; caseload WATCHLIST.
Mid-book FAERS page for misoprostol (Cytotec) (9,536 reports). Signature FEMALE-LED. Dominant age band on file: 18-44. Educational reference only.
Counts from the openFDA FAERS extract (2003–2025). Stamps WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
HAEMORRHAGE leads 1,258 of 9,536 reports
FEMALE-LED reporters · age peak 18-44
Female-led reporters (85% of sex-coded rows)
Age peak 18-44 (4,697 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (729 reports, 7.6%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 102 |
| FOETAL EXPOSURE DURING PREGNANCY | 98 |
| INTERSTITIAL LUNG DISEASE | 52 |
| HEART DISEASE CONGENITAL | 46 |
| VENTRICULAR SEPTAL DEFECT | 45 |
| PNEUMONIA | 42 |
| PREMATURE BABY | 42 |
| SEPSIS | 42 |
| CARDIAC ARREST | 39 |
| CARDIAC SEPTAL DEFECT | 38 |
| CONGENITAL CARDIOVASCULAR ANOMALY | 38 |
| TRUNCUS ARTERIOSUS PERSISTENT | 38 |
| RESPIRATORY FAILURE | 36 |
| LOW BIRTH WEIGHT BABY | 35 |
| FOETAL DEATH | 33 |
| DIARRHOEA | 31 |
| MATERNAL EXPOSURE DURING PREGNANCY | 31 |
| PYREXIA | 31 |
| ABORTION INDUCED | 30 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (2,942, 30.9% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| HAEMORRHAGE | 416 |
| ABORTION INCOMPLETE | 277 |
| ANAEMIA | 269 |
| PYREXIA | 228 |
| VOMITING | 211 |
| NAUSEA | 193 |
| PAIN | 186 |
| DIZZINESS | 171 |
| ABDOMINAL PAIN | 160 |
| FATIGUE | 123 |
| MALAISE | 122 |
| DIARRHOEA | 121 |
| PNEUMONIA | 112 |
| MENORRHAGIA | 109 |
| INFECTION | 106 |
| MUSCLE SPASMS | 95 |
| DYSPNOEA | 92 |
| PAIN IN EXTREMITY | 89 |
How to read misoprostol FAERS figures (WATCHLIST · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 9,536 voluntary reports linked to misoprostol (Cytotec), 2003-2025. Death is listed on 729 (7.6%). Hospitalization appears on 2,942 (30.9%). Top co-reported indication: Abortion Induced.
Mid-volume extract - treat DEATH-HEAVY · HOSP-HEAVY as signal-detection rates next to 85% of sex-coded reports are female (7,473 F / 1,360 M).
Read with misoprostol
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 9,450 FAERS cases (Δ 86 lighter vs misoprostol); DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
ABS(total_reports) peer at 9,400 FAERS cases (Δ 136 lighter vs misoprostol); DEATH-RARE · HOSP-LIGHT · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
ABS(total_reports) peer at 9,764 FAERS cases (Δ 228 heavier vs misoprostol); DEATH-MARKED · HOSP-MID · FEMALE-LED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
ABS(total_reports) peer at 9,780 FAERS cases (Δ 244 heavier vs misoprostol); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 54.5 pp vs misoprostol's DEATH-HEAVY): CASELOAD · HOSP-MID.
misoprostol stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload WATCHLIST and the label guide.