🇺🇸 5-ASA in United States

993 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. Crohn^S Disease — 204 reports (20.54%)
  2. Colitis Ulcerative — 164 reports (16.52%)
  3. Off Label Use — 133 reports (13.39%)
  4. Drug Ineffective — 117 reports (11.78%)
  5. Condition Aggravated — 100 reports (10.07%)
  6. Abdominal Pain — 63 reports (6.34%)
  7. Diarrhoea — 60 reports (6.04%)
  8. Fatigue — 54 reports (5.44%)
  9. Nausea — 50 reports (5.04%)
  10. Malaise — 48 reports (4.83%)

Source database →

5-ASA in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is 5-ASA approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for 5-ASA in United States?

Centre Hospitalier Universitaire de Saint Etienne is the originator. The local marketing authorisation holder may differ — check the official source linked above.