🇺🇸 indomethacin suppositories in United States

10 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. Ductus Arteriosus Stenosis Foetal — 2 reports (20%)
  2. Corneal Perforation — 1 report (10%)
  3. Foetal Exposure During Pregnancy — 1 report (10%)
  4. Oligohydramnios — 1 report (10%)
  5. Pneumothorax — 1 report (10%)
  6. Renal Failure — 1 report (10%)
  7. Reversible Cerebral Vasoconstriction Syndrome — 1 report (10%)
  8. Sepsis — 1 report (10%)
  9. Trisomy 21 — 1 report (10%)

Source database →

indomethacin suppositories 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 indomethacin suppositories approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for indomethacin suppositories in United States?

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