🇺🇸 Misoprostol (Cytotec) in United States

13 US adverse-event reports

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

• Window: 22 April 2025 – 22 April 2026
• Total reports: 13

Most-reported reactions

1. Caesarean Section — 2 reports (15.38%)
2. Exposure During Pregnancy — 2 reports (15.38%)
3. Vaginal Discharge — 2 reports (15.38%)
4. Abdominal Pain — 1 report (7.69%)
5. Abdominal Wall Haematoma — 1 report (7.69%)
6. Alopecia — 1 report (7.69%)
7. Aphthous Stomatitis — 1 report (7.69%)
8. Arthralgia — 1 report (7.69%)
9. Bacteria Urine Identified — 1 report (7.69%)
10. Blood Albumin Decreased — 1 report (7.69%)

Source database →

Frequently asked questions

Is Misoprostol (Cytotec) approved in United States?

Misoprostol (Cytotec) does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Misoprostol (Cytotec) in United States?

Wolfson Medical Center is the originator. The local marketing authorisation holder may differ — check the official source linked above.