🇺🇸 cipralex in United States

4,918 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: 4,918

Most-reported reactions

1. Fatigue — 622 reports (12.65%)
2. Nausea — 611 reports (12.42%)
3. Off Label Use — 586 reports (11.92%)
4. Drug Ineffective — 537 reports (10.92%)
5. Dizziness — 462 reports (9.39%)
6. Headache — 453 reports (9.21%)
7. Diarrhoea — 429 reports (8.72%)
8. Dyspnoea — 424 reports (8.62%)
9. Arthralgia — 399 reports (8.11%)
10. Weight Increased — 395 reports (8.03%)

Source database →

Frequently asked questions

Is cipralex approved in United States?

Yes. FDA has authorised it.

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

RWTH Aachen University is the originator. The local marketing authorisation holder may differ — check the official source linked above.