🇺🇸 Remsima in United States

705 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 — 142 reports (20.14%)
  2. Off Label Use — 106 reports (15.04%)
  3. Drug Ineffective — 81 reports (11.49%)
  4. Overdose — 60 reports (8.51%)
  5. Underdose — 59 reports (8.37%)
  6. Erythema — 53 reports (7.52%)
  7. Malaise — 53 reports (7.52%)
  8. Inappropriate Schedule Of Drug Administration — 52 reports (7.38%)
  9. Headache — 51 reports (7.23%)
  10. Arthralgia — 48 reports (6.81%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Remsima approved in United States?

Yes. FDA has authorised it.

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

Ghurki Trust and Teaching Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.