Active substance
Thiamazole
- US FDA 14
- Health Canada 4
- US price lines 2
- WHO EML 1
- Safety 4
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| METHIMAZOLE | 5MG; 10MG | tablet · oral | MYLAN | Prescription | 29 Mar 2000 |
| METHIMAZOLE | 5MG; 10MG | tablet · oral | CHARTWELL RX | Prescription | 27 Mar 2001 |
| METHIMAZOLE | 5MG; 10MG | tablet · oral | AIPING PHARM INC | Prescription | 18 Feb 2005 |
| METHIMAZOLE | 5MG; 10MG | tablet · oral | HERITAGE PHARMA | Prescription | 14 Dec 2007 |
| METHIMAZOLE | 5MG; 10MG | tablet · oral | RISING | Prescription | 7 Mar 2012 |
| METHIMAZOLE | 5MG; 10MG | tablet · oral | MACLEODS PHARMS | Prescription | 24 May 2023 |
| METHIMAZOLE | 5MG; 10MG | tablet · oral | BIONPHARMA | Prescription | 25 Sep 2023 |
| METHIMAZOLE | 5MG; 10MG | tablet · oral | SQUARE PHARMS PLC | Prescription | 5 Feb 2025 |
| TAPAZOLE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | KING PHARMS | Discontinued | 21 Jun 1950 |
| METHIMAZOLE | 20MG | tablet · oral | MYLAN | Discontinued | 29 Mar 2000 |
| TAPAZOLE | 5MG; 10MG | tablet · oral | KING PHARMS LLC | Discontinued | 31 Mar 2000 |
| METHIMAZOLE | 20MG | tablet · oral | AIPING PHARM INC | Discontinued | 18 Feb 2005 |
| METHIMAZOLE | 15MG | tablet · oral | DISCOVERY THERAP | Discontinued | 12 Jul 2005 |
| METHIMAZOLE | 5MG; 10MG | tablet · oral | SUN PHARM INDS INC | Discontinued | 25 Sep 2007 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| JAMP METHIMAZOLE | 02490625 | 5 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP METHIMAZOLE | 02490633 | 10 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| MAR-METHIMAZOLE | 02480107 | 5 MG | TABLET · ORAL | MARCAN PHARMACEUTICALS INC |
| MAR-METHIMAZOLE | 02480115 | 10 MG | TABLET · ORAL | MARCAN PHARMACEUTICALS INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | METHIMAZOLE 10 MG TABLET | $0.11705 | per EA | 23 Sep 2026 |
| US NADAC | METHIMAZOLE 5 MG TABLET | $0.07021 | per EA | 23 Sep 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)
- 18.7. Thyroid hormones and antithyroid medicines · core (EML); complementary (EMLc)
Thyrotoxicosis
Oral > Solid > tablet: 5 mg; 10 mg
Safety signals and safety-related labeling changes
- EMA PRAC 29 Nov 2018 PRAC signal: New information on the known risk of birth defects and neonatal disorders in case of exposure during pregnancy
Action for MAH: update of the product information: Yes - EMA PRAC 29 Nov 2018 PRAC signal: Pancreatitis
Action for MAH: update of the product information: Yes - EMA PRAC 12 Jul 2018 PRAC signal: Pancreatitis
Action for MAH: update of the product information: No - EMA PRAC 14 Jun 2018 PRAC signal: New information on the known risk of birth defects and neonatal disorders in case of exposure during pregnancy
Action for MAH: update of the product information: No
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.