🇺🇸 Omeprazol in United States

4,350 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.

Most-reported reactions

  1. Dyspnoea — 517 reports (11.89%)
  2. Nausea — 515 reports (11.84%)
  3. Drug Interaction — 495 reports (11.38%)
  4. Diarrhoea — 493 reports (11.33%)
  5. Fatigue — 471 reports (10.83%)
  6. Dizziness — 429 reports (9.86%)
  7. Pyrexia — 369 reports (8.48%)
  8. Vomiting — 366 reports (8.41%)
  9. Headache — 351 reports (8.07%)
  10. Anaemia — 344 reports (7.91%)

Source database →

Other Gastroenterology approved in United States

Frequently asked questions

Is Omeprazol approved in United States?

Yes. FDA has authorised it.

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

RenJi Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.