🇺🇸 Mesalamin in United States

FDA authorised Mesalamin on 31 January 1992 · 10 US adverse-event reports

Marketing authorisations

FDA — authorised 31 January 1992

  • Application: NDA019651
  • Marketing authorisation holder: APIL
  • Local brand name: ASACOL
  • Indication: TABLET, DELAYED RELEASE — ORAL
  • Status: approved

Read official source →

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. Abdominal Pain — 1 report (10%)
  2. Atrial Fibrillation — 1 report (10%)
  3. Back Pain — 1 report (10%)
  4. Blister — 1 report (10%)
  5. Crohn'S Disease — 1 report (10%)
  6. Dizziness — 1 report (10%)
  7. Drug Ineffective — 1 report (10%)
  8. Face Injury — 1 report (10%)
  9. Full Blood Count Decreased — 1 report (10%)
  10. Gastric Ulcer — 1 report (10%)

Source database →

Mesalamin in other countries

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

Other Other approved in United States

Frequently asked questions

Is Mesalamin approved in United States?

Yes. FDA authorised it on 31 January 1992; FDA has authorised it.

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

APIL holds the US marketing authorisation.