🇺🇸 METYROSINE in United States

FDA authorised METYROSINE on 24 July 2020 · 21 US adverse-event reports

Marketing authorisations

FDA — authorised 24 July 2020

  • Application: ANDA213734
  • Marketing authorisation holder: AMNEAL
  • Local brand name: METYROSINE
  • Indication: CAPSULE — 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. Off Label Use — 4 reports (19.05%)
  2. Drug Ineffective — 3 reports (14.29%)
  3. Hypotension — 3 reports (14.29%)
  4. Catecholamine Crisis — 2 reports (9.52%)
  5. Dizziness — 2 reports (9.52%)
  6. Pyrexia — 2 reports (9.52%)
  7. Vomiting — 2 reports (9.52%)
  8. Acute Myocardial Infarction — 1 report (4.76%)
  9. Acute Respiratory Distress Syndrome — 1 report (4.76%)
  10. Administration Site Extravasation — 1 report (4.76%)

Source database →

METYROSINE 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 METYROSINE approved in United States?

Yes. FDA authorised it on 24 July 2020; FDA has authorised it.

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

AMNEAL holds the US marketing authorisation.