🇺🇸 indometacin in United States

1,858 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. Drug Ineffective — 411 reports (22.12%)
  2. Pain — 237 reports (12.76%)
  3. Arthralgia — 194 reports (10.44%)
  4. Fatigue — 194 reports (10.44%)
  5. Rheumatoid Arthritis — 168 reports (9.04%)
  6. Vomiting — 136 reports (7.32%)
  7. Nausea — 135 reports (7.27%)
  8. Headache — 132 reports (7.1%)
  9. Off Label Use — 127 reports (6.84%)
  10. Joint Swelling — 124 reports (6.67%)

Source database →

Other Immunology approved in United States

Frequently asked questions

Is indometacin approved in United States?

Yes. FDA has authorised it.

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

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