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Thionamide Antithyroid Agent Pregnancy: Women of childbearing potential should be informed about the potential risks of use in pregnancy. Hyperthyroidism in pregnancy should be adequately treated to prevent serious maternal and foetal complications. Propylthiouracil crosses the human placenta; animal reproductive toxicity data are insufficient and epidemiological studies give conflicting results on congenital malformation risk. An individual benefit/risk assessment is necessary; if used in pregnancy give the lowest effective dose without additional thyroid hormone, with close maternal, foetal and neonatal monitoring. Breast-feeding: present in breast milk in small amounts — monitor neonatal development closely in any nursing mother treated with this drug.

Propylthiouracil (PTU)

Brand names: Propylthiouracil (generic)

Used in: Thyroid Disorders

Propylthiouracil is an antithyroid drug used for hyperthyroidism, particularly in the first trimester of pregnancy and in thyroid storm, where it is preferred over carbimazole.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Management of hyperthyroidism: initial dose 300 mg to 600 mg given as a single daily dose, maintained until the patient becomes euthyroid, then reduced gradually to a maintenance dose of 50 mg to 150 mg as a single daily dose
Route: Oral
Frequency: Once daily (daily doses can be divided if preferred)
Max: No absolute maximum daily dose is stated in §4.2 (the highest stated regimens are the 300–600 mg/day initial dose and 200 mg every 4 to 6 hours for the first 24 hours in thyrotoxic crisis)
Source: UK SPC (eMC) for Propylthiouracil 100mg Tablets, §4.2 (https://www.medicines.org.uk/emc/product/14253/smpc). OTHER INDICATIONS — Preparation for surgery: as for management of hyperthyroidism, until the patient becomes euthyroid. Adjunct to radioactive iodine therapy: as for management of hyperthyroidism, for several weeks prior to radio-iodine treatment; withdraw propylthiouracil 2 to 4 days before irradiation, and note the radio-iodine dose may need adjusting because propylthiouracil may have a radioprotective effect. THYROTOXIC CRISIS: 200 mg every 4 to 6 hours for the first 24 hours, decreasing the dose as the crisis subsides. ELDERLY: the adult dose applies, but caution is advised in the presence of renal or hepatic impairment, where a dose reduction may be justified. PAEDIATRIC (given in the SPC but not as a single clean per-kg figure, hence paedDose is null — verify all of this against a children's formulary before use): juvenile hyperthyroidism — children aged 6–10 years, initial dose 50–150 mg daily; children over 10 years, initial dose 150–300 mg (or 150 mg/m2) daily; maintenance dose is determined by the patient's response. Treatment of hyperthyroidism in neonates: 5–10 mg/kg daily. 'No other specific children's doses are known.' MONITORING/SAFETY from §4.4: warn patients that fever, mouth ulcers, rashes or sore throat may indicate agranulocytosis — they should contact their doctor immediately and treatment should be stopped; perform a full blood count if there is clinical evidence of infection; use with extreme caution with other drugs known to cause agranulocytosis; use with caution in patients over 40 years old; propylthiouracil may cause hypoprothrombinaemia and bleeding, so monitor prothrombin time during therapy, especially before surgery; discontinue if clinically important abnormal liver function occurs (severe hepatic reactions including fatal cases and cases requiring liver transplant have been reported in adults and children, mostly within 6 months); prolonged therapy and/or excessive doses may cause hypothyroidism, so monitor thyroid function regularly; systemic vasculitis can occur at any time up to several years after starting and the risk may increase with prolonged use — discontinue promptly. Contains lactose — not for patients with rare hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. METHOD: administered by the oral route.

Dose adjustments

Renal

§4.4: decrease the dose in renal failure — if the glomerular filtration rate is 10–50 ml/min decrease the dose by 25%; if the GFR is <10 ml/min decrease the dose by 50%.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

US labelling (FDA)

Reference — US labelling, may differ from UK

DOSAGE AND ADMINISTRATION Propylthiouracil is administered orally. The total daily dosage is usually given in 3 equal doses at approximately 8-hour intervals. Adults The initial dose is 300 mg daily. In patients with severe hyperthyroidism, very large goiters, or both, the initial dose may be increased to 400 mg daily; an occasional patient will require 600 to 900 mg daily initially. The usual maintenance dose is 100 to 150 mg daily. Pediatric Patients Propylthiouracil is generally not recommended for use in the pediatric patient population except in rare instances in which other alternative therapies are not appropriate options. Studies evaluating appropriate dosing regimen have not been …

Source: US FDA prescribing information (openFDA / DailyMed), label dated 2023-12-26. Accessed 2026-06-12. US dosing and indications can differ from UK practice — use UK sources for prescribing decisions.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients

Side effects

  • Minor effects: rash, urticaria, pruritus, abnormal hair loss, skin pigmentation, oedema, nausea, vomiting, epigastric distress, loss of taste, arthralgia, myalgia, paraesthesia and headache
  • Leucopenia is a common adverse effect but is usually mild and reversible
  • Agranulocytosis — the most serious adverse effect, though incidence is very low; tends to occur within the first two months of therapy, with greater risk in patients over 40 years receiving larger doses
  • Hepatitis and hepatic failure (frequency unknown); severe hepatic reactions including encephalopathy, fulminant hepatic necrosis and death
  • Other severe but infrequent events: aplastic anaemia, drug fever, lupus-like syndrome, periarteritis, hypoprothrombinaemia, thrombocytopenia and bleeding; nephritis, interstitial pneumonitis, cutaneous and systemic vasculitis and polymyositis; hypersensitivity reactions may be associated with development of anti-neutrophil cytoplasmic antibodies (ANCA)

Interactions

  • The response of the thyroid gland to propylthiouracil may be impaired by a concurrent high iodine intake
  • Drug-induced changes in thyroid status may affect dosage requirements for theophylline and digitalis — the doses of digitalis and theophylline may need to be reduced as thyroid function returns to normal
  • §4.4: use with extreme caution in patients receiving other drugs known to cause agranulocytosis

Clinical monograph

How it works

It inhibits thyroid peroxidase (reducing thyroid hormone synthesis) and, at higher doses, the peripheral conversion of T4 to active T3.

Prescribing in practice

  • It carries a higher risk of severe hepatotoxicity than carbimazole, so it is reserved for specific situations.
  • Agranulocytosis is a key risk — advise stopping and seeking an urgent full blood count for sore throat, fever or mouth ulcers.
  • ANCA-associated vasculitis is a recognised rare effect.

Monitoring

Monitor thyroid function to titrate the dose, and liver function; check FBC urgently with infection symptoms.

Counselling the patient

  • Stop it and get an urgent blood test if you develop a sore throat, fever or mouth ulcers.
  • Report yellowing of the skin or eyes, or dark urine.

Evidence & guidelines

An antithyroid drug reserved for first-trimester pregnancy and thyroid storm, balanced against its hepatotoxicity.

Reference: MHRA Drug Safety Update 2010; British Thyroid Association Guidelines; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.