🇺🇸 Ovitrelle in United States

962 US adverse-event reports

Marketing authorisation

FDA

• Status: approved

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: 27 March 2025 – 27 March 2026
• Total reports: 962

Most-reported reactions

1. Ovarian Hyperstimulation Syndrome — 423 reports (43.97%)
2. Ascites — 207 reports (21.52%)
3. Dyspnoea — 79 reports (8.21%)
4. Abdominal Pain — 51 reports (5.3%)
5. Pleural Effusion — 50 reports (5.2%)
6. Abortion Spontaneous — 43 reports (4.47%)
7. Nausea — 38 reports (3.95%)
8. Abdominal Pain Lower — 25 reports (2.6%)
9. Abdominal Distension — 23 reports (2.39%)
10. Pain — 23 reports (2.39%)

Source database →

Frequently asked questions

Is Ovitrelle approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Ovitrelle in United States?

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