Drug side effects
misoprostol Side Effects
The reactions most often reported to the FDA for misoprostol (also sold as Cytotec), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 9,536
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2003 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of misoprostol come from 9,536 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 9,536 reports to the FDA Adverse Event Reporting System (FAERS) for misoprostol (Cytotec): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
9,536
Reports Mentioning Death
729
7.6% of reports — not proof the medicine caused the death
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 |
| 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 |
| 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 |
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 foetal exposure during pregnancy.
How to read these numbers
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.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to misoprostol's 9,536.
Read our methodology - how this data is sourced, computed, and verified.