Regulatory PathRegulatory requirements compared

Active substance

Pyrimethamine

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
DARAPRIM25MGtablet · oralTILDE SCIENCESPrescription23 Jan 1953
PYRIMETHAMINE25MGtablet · oralSANALUZPrescription28 Feb 2020
PYRIMETHAMINE25MGtablet · oralTEVA PHARMSPrescription13 Aug 2021
PYRIMETHAMINE25MGtablet · oralAUROBINDO PHARMA LTDPrescription25 Oct 2022
PYRIMETHAMINE25MGtablet · oralALVOGENDiscontinued27 Jul 2021

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACPYRIMETHAMINE 25 MG TABLET$137.00879per EA20 May 2026
NHS Drug TariffPyrimethamine 25mg tablets£13.0030 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

  • 6.5.4. Antipneumocystosis and antitoxoplasmosis medicines · core
    Toxoplasmosis
    Oral > Solid: 25 mg

Safety signals and safety-related labeling changes

All safety entries for pyrimethamine →

Combinations containing Pyrimethamine

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.