Prescription medicine
Propylthiouracil
Propylthiouracil is a prescription medicine with an FDA approval on record since 1947. FDA's NDC Directory lists it from 5 generic labelers, and pharmacies paid $0.269 per propylthiouracil 50 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the propylthiouracil FDA label on DailyMed (effective August 27, 2026, American Health Packaging); the NDA 6188 record on Drugs@FDA; every propylthiouracil label on DailyMed.
Highlights of the record
FDA label of August 27, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Severe liver injury and acute liver failure, in some cases fatal, have been reported in patients treated with propylthiouracil. These reports of hepatic reactions include cases requiring liver transplantation in adult and pediatric patients. Propylthiouracil should be reserved for patients who cannot tolerate methimazole and in whom radioactive iodine therapy or surgery are not appropriate treatments for the management of hyperthyroidism. Propylthiouracil may be the treatment of choice when an antithyroid drug is indicated during or just prior to the first trimester of pregnancy (see Warnings and Precautions ).
Used for
From the label: indications and usagePropylthiouracil is indicated: in patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter who are intolerant of methimazole and for whom surgery or radioactive iodine therapy is not an appropriate treatment option to ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy in patients who are intolerant of methimazole
Forms and strengths
- 50 mg
Tablet.
On the market
- Earliest approval on file
- July 28, 1947 Propylthiouracil, Ph Health; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 8 first July 24, 1970; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 7 of which 5 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.269 per tablet Propylthiouracil 50 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2012 0 Class I among all firms' recalls; latest December 7, 2012
- FAERS reports
- 2,050 through July 30, 2026
What is propylthiouracil used for?
From the label: indications and usagePropylthiouracil is indicated: in patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter who are intolerant of methimazole and for whom surgery or radioactive iodine therapy is not an appropriate treatment option to ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy in patients who are intolerant of methimazole
FDA pharmacologic class: Thyroid Hormone Synthesis Inhibitor.
Source: FDA drug label (Propylthiouracil), American Health Packaging, effective August 27, 2026 (SPL set d819e532-09ac-434a-84a6-636c4204c7aa), via openFDA; the full label on DailyMed
What does the patient leaflet for propylthiouracil say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about Propylthiouracil?Propylthiouracil can cause serious side effects, including: Severe liver problems. In some cases, liver problems can happen in people who take Propylthiouracil including: liver failure, the need for liver transplant, or death. Stop taking Propylthiouracil and call your doctor right away if you have any of these symptoms: fever itchiness loss of appetite pain or tenderness in your right upper stomach area (abdomen) nausea dark (tea colored) urine vomiting pale or light colored bowel movements (stools) tiredness yellowing of your skin or whites of your eyes Serious risks during pregnancy. Propylthiouracil may cause liver problems, liver failure and death in pregnant women and may harm your unborn baby. Propylthiouracil may also cause liver problems or death of infants born to women who take Propylthiouracil during certain trimesters of pregnancy. Propylthiouracil may be used when an antithyroid drug is needed during or just before the first trimester of pregnancy. If you get pregnant while taking Propylthiouracil, call your doctor right away about your therapy.
From the patient leaflet: What should I avoid while taking Propylthiouracil?Propylthiouracil can cause dizziness, drowsiness or sleepiness. If you have these symptoms do not drive, operate machinery, or do other dangerous activities until you know how Propylthiouracil affects you.
From the patient leaflet: How should I store Propylthiouracil?Store Propylthiouracil at room temperature between 15° to 30°C (59° to 86°F). Keep Propylthiouracil and all medicines out of the reach of children.
Source: FDA drug label (Propylthiouracil), American Health Packaging, effective August 27, 2026 (SPL set d819e532-09ac-434a-84a6-636c4204c7aa), via openFDA; the full label on DailyMed
Is there a generic for propylthiouracil?
The FDA approved the first generic propylthiouracil on July 24, 1970. 8 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists propylthiouracil from 5 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1947 earliest approval on file
- 1970 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for propylthiouracil?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.269 per Propylthiouracil 50 mg tablet, down 12% from $0.304 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Propylthiouracil 50 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Propylthiouracil 50 mg tablet | Generic | $0.269 per tablet | $8.06 | -12% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has propylthiouracil been recalled?
The FDA's Enforcement Report lists 1 recall naming propylthiouracil since 2012: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 7, 2012 | Class II | West-ward Pharmaceutical Corp. | Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tablet material and hydrocarbon oil with trace amounts of iron … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the propylthiouracil label say about other medicines?
The propylthiouracil label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 7 other medicines name propylthiouracil. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Methimazole | boxed warning | Propylthiouracil should be reserved for patients who cannot tolerate methimazole and in whom radioactive iodine therapy or surgery are not appropriate treatments for the management of hyperthyroidism. |
| Theophylline | drug interactions | Theophylline: Theophylline clearance may decrease when hyperthyroid patients on a stable theophylline regimen become euthyroid; a reduced dose of theophylline may be needed. |
| Warfarin | drug interactions | Drug Interactions Anticoagulants (oral): Due to the potential inhibition of vitamin K activity by propylthiouracil, the activity of oral anticoagulants (e.g., warfarin) may be increased; additional monitoring of PT/INR should be considered, especially before surgical procedures. |
Source: FDA drug label (Propylthiouracil), American Health Packaging, effective August 27, 2026 (SPL set d819e532-09ac-434a-84a6-636c4204c7aa), via openFDA; the full label on DailyMed
What do FAERS reports show for propylthiouracil?
The FDA Adverse Event Reporting System holds 2,050 reports that list propylthiouracil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 180 are coded as a death and 938 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other antithyroid medicines
- the pharmacologic class, with prices and generics
- Propylthiouracil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other