PROPYLTHIOURACIL
PROPYLTHIOURACIL is indicated for the treatment of Graves' Disease; Hyperthyroidism; Toxic Multinodular Goiter.
Details
- Status
- Discontinued
- First Approved
- 1947-07-28
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
PROPYLTHIOURACIL Approval History
What PROPYLTHIOURACIL Treats
3 indicationsPROPYLTHIOURACIL is approved for 3 conditions since its original approval in 1947. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Graves' Disease
- Hyperthyroidism
- Toxic Multinodular Goiter
PROPYLTHIOURACIL Boxed Warning
WARNING 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 w...
WARNING 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 ).
PROPYLTHIOURACIL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05118542 | 19-06-0752 | Ph 3 | completed | Effect of Hyperthyroidism and Its Treatment in Graves' Disease to Early Marker of Atherosclerosis |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PROPYLTHIOURACIL FDA Label Details
Indications & Usage
FDA Label (PDF)PROPYLTHIOURACIL is indicated for the treatment of Graves' Disease; Hyperthyroidism; Toxic Multinodular Goiter.
WARNING 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 w...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.