🇺🇸 METHOTREXATE SODIUM in United States

FDA authorised METHOTREXATE SODIUM on 1 August 1994 · 70,883 US adverse-event reports

Marketing authorisations

FDA — authorised 1 August 1994

  • Application: ANDA040054
  • Marketing authorisation holder: HIKMA
  • Status: supplemented

FDA — authorised 16 May 2024

  • Application: ANDA216453
  • Marketing authorisation holder: ELITE LABS INC
  • Status: approved

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. Drug Ineffective — 19,899 reports (28.07%)
  2. Drug Hypersensitivity — 7,830 reports (11.05%)
  3. Off Label Use — 6,398 reports (9.03%)
  4. Rheumatoid Arthritis — 5,805 reports (8.19%)
  5. Drug Intolerance — 5,643 reports (7.96%)
  6. Nausea — 5,479 reports (7.73%)
  7. Arthralgia — 5,218 reports (7.36%)
  8. Pain — 5,215 reports (7.36%)
  9. Condition Aggravated — 4,757 reports (6.71%)
  10. Fatigue — 4,639 reports (6.54%)

Source database →

METHOTREXATE SODIUM 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 METHOTREXATE SODIUM approved in United States?

Yes. FDA authorised it on 1 August 1994; FDA authorised it on 16 May 2024; FDA has authorised it.

Who is the marketing authorisation holder for METHOTREXATE SODIUM in United States?

HIKMA holds the US marketing authorisation.