🇺🇸 Meglumine antimoniate in United States

34 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. Drug Ineffective — 8 reports (23.53%)
  2. Off Label Use — 5 reports (14.71%)
  3. Visceral Leishmaniasis — 4 reports (11.76%)
  4. Arterial Disorder — 3 reports (8.82%)
  5. Dizziness — 3 reports (8.82%)
  6. Renal Tubular Disorder — 3 reports (8.82%)
  7. Arthralgia — 2 reports (5.88%)
  8. Cutaneous Leishmaniasis — 2 reports (5.88%)
  9. Infection — 2 reports (5.88%)
  10. Lung Consolidation — 2 reports (5.88%)

Source database →

Meglumine antimoniate 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 Meglumine antimoniate approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Meglumine antimoniate in United States?

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