Active substance
Propylthiouracil
- SFDA 2
- US FDA 16
- Health Canada 2
- US price lines 1
- NHS prices 3
- WHO EML 1
- Safety 5
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| Propylthiouracil MACLEODS | 50 mg | Tablet · Oral use | 50 Blister | SAR 57.35 | Generic · Prescription | Macleods Pharmaceuticals Ltd. | Valid |
| PROPYLTHIOURACIL 50MG TAB | 50 mg | Tablet · Oral use | 100 Tablet Container | SAR 15.20 | NCE · Prescription | WYETH | Withdrawn by MAH · Not Marketed |
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| PROPYLTHIOURACIL | 50MG | tablet · oral | PH HEALTH | Prescription | 28 Jul 1947 |
| PROPYLTHIOURACIL | 50MG | tablet · oral | QUAGEN | Prescription | 23 Jul 1971 |
| PROPYLTHIOURACIL | 50MG | tablet · oral | ACTAVIS ELIZABETH | Prescription | 9 Jan 1973 |
| PROPYLTHIOURACIL | 50MG | tablet · oral | MACLEODS PHARMS | Prescription | 10 May 2023 |
| PROPYLTHIOURACIL | 50MG | tablet · oral | LILLY | Discontinued | 29 Jul 1947 |
| PROPYLTHIOURACIL | 50MG | tablet · oral | CHARTWELL MOLECULAR | Discontinued | 24 Jul 1970 |
| PROPYLTHIOURACIL | 50MG | tablet · oral | IMPAX LABS | Discontinued | 10 Aug 1973 |
| PROPYLTHIOURACIL | 50MG | tablet · oral | SUN PHARM INDUSTRIES | Discontinued | 6 May 1974 |
| PROPYLTHIOURACIL | 50MG | tablet · oral | ANABOLIC | Discontinued | 19 Dec 1974 |
| PROPYLTHIOURACIL | 50MG | tablet · oral | WATSON LABS | Discontinued | 3 Mar 1977 |
| PROPYLTHIOURACIL | 50MG | tablet · oral | HALSEY | Discontinued | |
| PROPYLTHIOURACIL | 50MG | tablet · oral | ANI PHARMS | Discontinued | |
| PROPYLTHIOURACIL | 50MG | tablet · oral | TABLICAPS | Discontinued | |
| PROPYLTHIOURACIL | 50MG | tablet · oral | WATSON LABS | Discontinued | |
| PROPYLTHIOURACIL | 50MG | tablet · oral | ABBOTT | Discontinued | |
| PROPYLTHIOURACIL | 50MG | tablet · oral | CHARTWELL RX | Discontinued |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| HALYCIL | 02521059 | 50 MG | TABLET · ORAL | HALEWOOD CHEMICALS LIMITED |
| PROPYLTHIOURACIL TABLETS | 02523019 | 50 MG | TABLET · ORAL | PHEBRA CANADA INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | PROPYLTHIOURACIL 50 MG TABLET | $0.26873 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Propylthiouracil 100mg tablets | £57.88 | 56 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Propylthiouracil 25mg tablets | £37.65 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Propylthiouracil 50mg tablets | £9.27 | 56 tablet | 1 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)
- 18.7. Thyroid hormones and antithyroid medicines · core (EML); complementary (EMLc)
Thyrotoxicosis
Oral > Solid: 50 mg
Safety signals and safety-related labeling changes
- EMA PRAC 28 Oct 2021 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: No - EMA PRAC 8 Jul 2021 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: No - EMA PRAC 14 Jun 2019 PRAC signal: Congenital anomalies
Action for MAH: update of the product information: Yes - EMA PRAC 14 Feb 2019 PRAC signal: Congenital anomalies
Action for MAH: update of the product information: No - US FDA 19 Sep 2018 PROPYLTHIOURACIL — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
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.