misoprostol Side Effects
Also known as: Cytotec
Analysis of 9,536 adverse event reports submitted to the FDA from 2003 to 2025.
Total Reports
9,536
Death-Related
729
7.6% of reports
Hospitalizations
2,942
30.9% of reports
Top Indication
Abortion Induced
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 729 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| 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 |
| OFF LABEL USE | 40 |
| 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
Top reactions in 2,942 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| HAEMORRHAGE | 416 |
| ABORTION INCOMPLETE | 277 |
| ANAEMIA | 269 |
| OFF LABEL USE | 234 |
| PYREXIA | 228 |
| VOMITING | 211 |
| NAUSEA | 193 |
| PAIN | 186 |
| DIZZINESS | 171 |
| ABDOMINAL PAIN | 160 |
| DRUG INEFFECTIVE | 139 |
| FATIGUE | 123 |
| MALAISE | 122 |
| DIARRHOEA | 121 |
| PNEUMONIA | 112 |
| MENORRHAGIA | 109 |
| INFECTION | 106 |
| MUSCLE SPASMS | 95 |
| DYSPNOEA | 92 |
| PAIN IN EXTREMITY | 89 |
Nearby — Related Medications
What the FAERS Data Reveals About misoprostol Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 9,536 voluntary reports linked to misoprostol and its brand equivalents (Cytotec), spanning 2003 through 2025. Of those, 729 (7.6%) listed death as an outcome and 2,942 (30.9%) involved hospitalization. The most common indication reported alongside adverse events was Abortion Induced.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 84% were female and 15% male; age distribution skews toward 18-44, with 4,697 reports in that bracket. The single most reported reaction is haemorrhage with 1,258 submissions, followed by abortion incomplete and off label use.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.