🇺🇸 Metotrexate in United States

234 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. Arthralgia — 49 reports (20.94%)
  2. Drug Ineffective — 31 reports (13.25%)
  3. Off Label Use — 28 reports (11.97%)
  4. Pain In Extremity — 24 reports (10.26%)
  5. Pain — 20 reports (8.55%)
  6. Headache — 19 reports (8.12%)
  7. Fatigue — 18 reports (7.69%)
  8. Fall — 15 reports (6.41%)
  9. Nausea — 15 reports (6.41%)
  10. Pyrexia — 15 reports (6.41%)

Source database →

Metotrexate 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 Metotrexate approved in United States?

Yes. FDA has authorised it.

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

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