Misoprostol: adverse event reports filed with FDA

5,334

reports as suspect product

0% of all reports · about 238 a year

115

reports, 12 months to June 2026

103 in the 12 months before

44.6%

marked serious by the reporter

58.1% across the class

3.7%

record death among outcomes, as reported

196 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Misoprostol reports recording the termmedian drug in prostaglandin e1 analog

1. Abortion incomplete30.5%1,626
2. Haemorrhagebleeding29.9%1,595
3. Anaemialow red blood cells10.6%566
4. Pregnancypregnancy10.3%552
5. Painpain, site not specified7.5%400
6. Muscle spasmsmuscle cramps7%372
7. Off label useused for a purpose or in a way not on the label6.6%352
8. Dizzinesslight-headedness or unsteadiness5.8%308
9. Vomitingbeing sick5.4%286
10. Nauseafeeling sick4.9%260
11. Menorrhagiaheavy periods4.6%243
12. Abdominal painstomach or belly pain4.5%242
13. Pyrexiafever4.4%236
14. Drug ineffectivethe medicine did not work as expected3.8%203
15. Maternal exposure during pregnancythe mother took the medicine during pregnancy3.6%191
16. Exposure during pregnancythe medicine was taken during pregnancy3.1%168
17. Syncopefainting3.1%167
18. Endometritis3%161
19. Infectionan infection, type not specified2.7%143
20. Foetal exposure during pregnancythe unborn baby was exposed to the medicine2.6%137
21. Fatiguetiredness2.1%113
22. Astheniaweakness or lack of energy2%108
23. Malaisegeneral feeling of being unwell2%108
24. Drug hypersensitivityan allergic-type reaction to a medicine1.9%102
25. Drug intolerancethe medicine was not tolerated1.9%102
26. Drug ineffective for unapproved indication1.8%97
27. Chillschills or shivering1.8%94
28. Vaginal haemorrhagevaginal bleeding1.5%81
29. Dyspnoeashortness of breath1.4%74
30. Product use in unapproved indicationused for a purpose not on the label1.4%74

Top 30 of 526 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 3 drugs in the prostaglandin e1 analog class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 9,132 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 73.9% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 5,334 reports.

Drugs most often listed in the same reports

Other products listed in reports where Misoprostol is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the prostaglandin e1 analog class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Misoprostol as a suspect or interacting product; reports listing it only as a concomitant medication (1,997) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.