Regulatory PathRegulatory requirements compared

Active substance

Nifurtimox

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
LAMPIT30MG; 120MGtablet · oralBAYER HEALTHCAREPrescription6 Aug 2020

WHO WHO Model List of Essential Medicines (2025)

  • 6.5.5.2. American trypanosomiasis · core
    Chagas disease
    Oral > Solid > tablet: 30 mg (scored); 120 mg (scored)
  • 6.5.5.1.2. Medicines for the treatment of 2nd stage African trypanosomiasis · core
    Gambiense trypanosomiasis
    Oral > Solid > tablet: 30 mg (scored); 120 mg (scored)

Safety signals and safety-related labeling changes

All safety entries for nifurtimox →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.