🇺🇸 TAFAMIDIS MEGLUMINE in United States

FDA authorised TAFAMIDIS MEGLUMINE on 1 June 2021 · 338 US adverse-event reports

Marketing authorisation

FDA — authorised 1 June 2021

  • Application: NDA211996
  • Marketing authorisation holder: FOLDRX PHARMS
  • Indication: Labeling
  • Status: approved

Read official source →

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. Cardiac Failure — 72 reports (21.3%)
  2. Death — 58 reports (17.16%)
  3. Acute Kidney Injury — 39 reports (11.54%)
  4. Off Label Use — 34 reports (10.06%)
  5. Dyspnoea — 29 reports (8.58%)
  6. Atrial Fibrillation — 27 reports (7.99%)
  7. Syncope — 22 reports (6.51%)
  8. Product Use In Unapproved Indication — 20 reports (5.92%)
  9. Fatigue — 19 reports (5.62%)
  10. Pyrexia — 18 reports (5.33%)

Source database →

TAFAMIDIS MEGLUMINE 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 TAFAMIDIS MEGLUMINE approved in United States?

Yes. FDA authorised it on 1 June 2021.

Who is the marketing authorisation holder for TAFAMIDIS MEGLUMINE in United States?

FOLDRX PHARMS holds the US marketing authorisation.