Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Propylthiouracil 50mg Tablets

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Propylthiouracil may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Propylthiouracil

Equivalent medicines (same active substance, strength and form)

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

FOR The active ingredient in Propylthiouracil Tablets is propylthiouracil, which belongs to a group of medicines called antithyroid drugs. These medicines work by reducing the production of a hormone called thyroxine by the thyroid gland (a gland located beneath the box in the throat that produces thyroid hormone and helps to regulate growth and metabolism). Propylthiouracil Tablets are used in the treatment and management of an overactive thyroid gland (hyperthyroidism).

Propylthiouracil Tablets may be taken during pregnancy but it may affect your unborn child's thyroid gland. If you need to take Propylthiouracil Tablets during pregnancy, you should be given the lowest effective dose and your thyroid function should be checked every four to six weeks. You should inform your doctor if you are breast-feeding or wish to start breast-feeding whilst taking Propylthiouracil Tablets. If you need to take Propylthiouracil Tablets whilst you are breast-feeding, you should be given the lowest effective dose and the infant's development and thyroid function should be monitored. Driving and using machinery Propylthiouracil Tablets are not known to affect the ability to drive or operate machinery. Important information for patients who have an intolerance to some sugars If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product, as it contains lactose.

How to take it

PROPYLTHIOURACIL TABLETS Your doctor will decide the dose which is best for you. Always follow your doctor's instructions completely and also follow any special instructions or warnings which appear on the label which the pharmacist has put on the package. If you do not understand, or are in any doubt, ask your doctor or pharmacist.

2. BEFORE YOU TAKE PROPYLTHIOURACIL TABLETS Do not take Propylthiouracil Tablets if you:

  • are severely allergic to propylthiouracil or any of the other ingredients of Propylthiouracil Tablets (see section 6 'What Propylthiouracil Tablets contain' for a full list of ingredients).
  • have a rare hereditary condition affecting the way your body handles some sugars.

Unless instructed differently, take your tablets with a glass of water.

If any of the above apply to you, you should not take Propylthiouracil Tablets. Propylthiouracil Tablets are not recommended for use in children under six years of age. Check with your doctor if any of the following applies to you:

  • Some cases of severe liver reactions, including cases with fatal outcome or requiring liver transplant, have been reported in both children and adults treated with propylthiouracil. You should inform your doctor immediately if you develop symptoms of liver disease, such as nausea, feeling sick, diarrhoea, yellow discolouration of the skin or eyes, dark urine, pale stools, bleeding easily, itching or chills.
  • If you have liver or kidney problems If any of the above applies to you, you should speak to your doctor before taking Propylthiouracil tablets.

Adults and the elderly The usual adult starting dose for Propylthiouracil Tablets is 300 to 600mg once a day, or in divided doses, until your condition is controlled. When your condition has been controlled (usually after one to two months) the dose is reduced to 50 to 150mg daily and continued for one to two years. Propylthiouracil Tablets are not recommended for use in children under six years of age. Children aged six to ten years of age In children aged six to ten years, the usual starting dose is 50 to 150mg once daily or in divided doses. Children over ten years of age In children over ten years, the usual starting dose is 150 to 300mg once daily or in divided doses. 106778/6

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Propylthiouracil 50mg – 56 & 100 Tablets Leaflet Wockhardt UK – (w) 210mm x (h) 290mm – 9 pt. Propylthiouracil_50mg_WUK Lit_106778-6.ai Adobe Illustrator CS5 Myriad Pro Regular / Bold 19th January, 2026

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  • 20TH JAN. 2026

CHANGE CONTROL : Version changes due to change in: Size/Layout Regulatory Changes in detail: • New regulatory text Process Black

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Non-Regulatory

If you have kidney or liver disease If you have kidney or liver disease your doctor will reduce your dose according to your condition. Laboratory tests Your doctor will normally arrange for you to have regular blood tests to ensure Propythiouracil Tablets are working properly. If you take more Propylthiouracil Tablets than you should If you accidentally take too many tablets contact your doctor or pharmacist or nearest hospital casualty department immediately. Take this leaflet and any remaining tablets with you to show the doctor or pharmacist. Signs that you have taken too many tablets include being sick, stomach pain, headache, fever, joint pain, itching, being pale, tiredness, frequent infections, unusual bleeding or unexplained bruising. Too high a dose over a period of time can cause a swelling of your thyroid (at the front of your neck) and your thyroid gland may become underactive in which case you may feel tired or cold or put on weight. If you miss a dose of Propylthiouracil Tablets If you forget to take a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. Do not take a double dose to make up for your forgotten tablet.

  • mild skin rashes
  • itching or reddening of the skin
  • hair loss
  • pain or stiffness of your muscles or joints
  • abnormal results of liver function tests. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the yellow card scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

Possible side effects

Do not store above 25°C.

Like many medicines Propylthiouracil Tablets may cause side effects in some patients, although not everybody gets them.

Store in the original container or package in order to protect from light and moisture. Do not transfer the tablets to another container.

You should contact your doctor immediately if you develop any of the following side effects affecting your blood or liver, or if you think you have any type of infection:

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Symptoms of a serious problem affecting your blood:

  • sore throat
  • fever
  • mouth ulcers
  • unusual bleeding or unexplained bruising
  • unusual tiredness or weakness
  • feeling generally unwell.

Propylthiouracil Tablets should not be taken if they show signs of deterioration such as discoloration.

6. FURTHER INFORMATION What Propylthiouracil Tablets contain The active ingredient in Propylthiouracil Tablets is propylthiouracil. The tablets are available in one strength of 50mg.

Your doctor should check your blood if you develop an infection or if you are about to undergo surgery. You may need to stop your tablets if you have any blood problems.

The other ingredients in your tablets are lactose, maize starch, pregelatinised maize starch, magnesium stearate and sodium starch glycollate.

Symptoms of hepatitis (inflammation of your liver), liver failure or other forms of liver damage (some of which can cause death):

  • loss of appetite
  • itching
  • pain on the right side of your stomach
  • jaundice (yellowing of the skin and whites of the eyes)
  • a brain disease, which may affect your ability to think.

What Propylthiouracil Tablets look like and contents of the pack Propylthiouracil Tablets are white, circular tablets, rounded on both sides, with a breakline on one side and CP on the other.

You should contact your doctor immediately if you develop any of the above side effects. You should also contact your doctor immediately if you develop an allergic reaction, the symptoms of which are as follows: Symptoms of an allergic reaction:

  • difficulty in breathing
  • cough
  • swelling of your lymph glands (glands situated around the body which protect against the spread of infection)
  • arthritis (painful joints)
  • pain in the loins (lower back) or other symptoms of kidney problems
  • inflammation of your blood vessels (of the skin)
  • a rash across the bridge of your nose and across your cheeks. Other less serious side effects include:
  • feeling sick or being sick
  • stomach upsets
  • taste disturbance
  • headaches
  • hearing impairment

Propylthiouracil Tablets are available in polypropylene or polyethylene (plastic) tablet containers of 56 or 100 tablets. Marketing Authorisation Holder : Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK. Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK. Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio, please call, free of charge: 0800 198 5000 (UK Only) Please be ready to give the following information: Product name

Reference number

Propylthiouracil 50mg Tablets

29831/0179

This is a service provided by the Royal National Institute of Blind People. This leaflet was last revised in 01/2026

106778/6 Code: PB/Drugs/1802-OSP

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How to store it

PROPYLTHIOURACIL TABLETS Keep out of the sight and reach of children.

Stopping taking Propylthiouracil Tablets You should continue to take Propylthiouracil Tablets for as long as your doctor tells you. Do not stop taking the medicine without talking to your doctor first.

Do not take this medicine if the expiry date on the label has passed. The expiry date refers to the last day of that month.

Frequently asked questions about Propylthiouracil 50mg Tablets

How do I take Propylthiouracil 50mg Tablets?

Propylthiouracil 50mg Tablets comes as tablet containing 50mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Propylthiouracil 50mg Tablets?

The active substance in Propylthiouracil 50mg Tablets is propylthiouracil.

Are there equivalent medicines to Propylthiouracil 50mg Tablets?

Medicines with the same active substance, strength and form include: Propylthiouracil 50 mg Tablets. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Propylthiouracil 50mg Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Propylthiouracil 50mg Tablets without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Propylthiouracil (3 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Hyperthyroidism

4.2. Posology and method of administration

Adults and elderly:

Initially 300 to 600mg daily, once daily or in divided doses until the patient becomes euthyroid.

When the condition is controlled (usually after 1-2 months), the dose is reduced to 50 to 150mg daily and continued for 1-2 years.

In renal impairment:

GFR 10 to 50ml/min, 75% dose

GFR < 10ml/min, 50% dose

In hepatic disease:

Reduced dose

Children under 6 years:

Not recommended

Children 6-10 years:

Initially 50 to 150mg once daily or in divided doses

Children over 10 years:

Initially 150 to 300mg once daily or in divided doses

4.3. Contraindications

Previous severe hypersensitivity reaction e.g. agranulocytosis, hepatitis, vasculitis, nephritis.

Owing to the presence of Lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.4. Special warnings and precautions for use

Because of the risk of agranulocytosis it is advised that patients should be warned to report to their doctor in the event of a sore throat, fever, mouth ulcers, bruising, malaise, non-specific illness or other symptoms of infection immediately. A full blood count should be performed and treatment should be discontinued immediately if there is clinical or laboratory evidence of neutropenia.

Propylthiouracil may cause hypothrombinaemia and bleeding so prothrombin time should be monitored during therapy, especially prior to surgery.

Some cases of severe hepatic reactions, both in adults and children, including fatal cases and cases requiring a liver transplant have been reported with propylthiouracil. Time to onset has varied but in a majority of cases the liver reaction occurred within 6 months. If significant hepatic enzyme abnormalities develop during treatment with propylthiouracil the drug should be discontinued immediately (see 4.8).

Propylthiouracil should be used with caution in patients with renal impairment or hepatic disease (see 4.2 Posology and Method of Administration). Patients should be advised of the symptoms of hepatic dysfunction (anorexia, pruritus, right upper quadrant pain, etc) and told to report them immediately. The occurrence of hepatic necrosis may have fatal consequences (see section 4.8, Undesirable effects).

4.5. Interaction with other medicinal products and other forms of interaction

Drug induced changes in thyroid status may affect the dosage requirements for theophylline, digoxin or beta-blockers. The doses of theophylline, digoxin or beta-blockers may need to be reduced as thyroid function returns to normal.

Pre-treatment with propylthiouracil may reduce the effectiveness of radio-iodine (131I) therapy for hyperthyroidism. This is supported by four studies one of which, a randomised study in 80 patients, showed an approximate halving of cure rate one year after 131I therapy in patients pre-treated with propylthiouracil.

4.6. Pregnancy and lactation

Women of childbearing potential

Women of childbearing potential should be informed about the potential risks of propylthiouracil use during pregnancy.

Pregnancy

Hyperthyroidism in pregnant women should be adequately treated to prevent serious maternal and foetal complications.

Propylthiouracil is able to cross the human placenta and in high doses may cause foetal goitre and hypothyroidism.

Some epidemiological studies indicate that propylthiouracil use during pregnancy is associated with a slight increased risk of congenital malformations in comparison to women without hyperthyroidism, while others do not support this association. However, the risk appears to be comparable in magnitude to that observed in women with untreated overt hyperthyroidism.

Individual benefit/risk assessment is necessary before treatment with propylthiouracil during pregnancy. Propylthiouracil should be administered during pregnancy at the lowest effective dose without additional administration of thyroid hormones. If propylthiouracil is used during pregnancy, close maternal, foetal and neonatal monitoring is recommended.

Lactation

Propylthiouracil also transfers to breast milk but this does not preclude breast-feeding. Neonatal development and infant thyroid function should be closely monitored. The lowest effective dose should be used.

4.7. Effects on ability to drive and use machines

None known.

4.8. Undesirable effects

Blood and lymphatic system: Reversible leucopenia. Rarely, agranulocytosis, thrombocytopenia, leucopenia, aplastic anaemia, pancytopenia. A rare complication of therapy is a tendency to haemorrhage associated with hypoprothrombinaemia which may be controlled by the administration of phytomenadione.

Ear and labyrinth disorders: Rarely, hearing impairment may occur with propylthiouracil. The impairment usually becomes less marked after withdrawal of the drug.

Gastrointestinal: Nausea, gastrointestinal disturbances, taste perversion. Rarely vomiting.

General: Fever.

Hepatobiliary: Jaundice (usually cholestatic), hepatic necrosis (sometimes with fatal consequences), encephalopathy. More commonly, asymptomatic liver function test abnormalities (increased serum bilirubin, Alanine transaminase and / or alkaline phosphatase concentrations), which are reversible on dose reduction or discontinuation of treatment, may occur with propylthiouracil.

Frequency unknown: Hepatitis, hepatic failure.

Immune system: Interstitial pneumonitis, alveolar haemorrhage, lymphadenopathy, arthritis, nephritis, vasculitis and lupus erythematosus-like syndromes have occurred in some patients taking thiourea antithyroid drugs. An immune mechanism has been proposed. There have also been rare reports of acute glomerulonephritis. Hypersensitivity reactions may also be associated with the development of antineutrophil cytoplasmic antibodies (ANCA).

Musculoskeletal: Myopathy, arthralgia,

Nervous system: Headache.

Skin: Mild papular skin rashes, pruritus, urticaria, alopecia, cutaneous vasculitis.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Symptoms

Goitre and hypothyroidism may be induced by repeated over dosage. Single overdose is not dangerous. Overdose may manifest as vomiting, epigastric distress, headache, fever, arthralgia, pruritus, and pancytopenia.

Treatment

The treatment of propylthiouracil overdose should aim to minimise the amount of drug absorbed into the circulation. Treatment should involve liberal use of oral fluids. Activated charcoal may also be employed. General symptomatic and supportive measures should then be instituted. A full blood analysis should be considered because of the slight risk of haematological complications and appropriate therapy given if bone marrow depression develops.

There is no specific antidote for propylthiouracil.

💬 Ask about this leaflet

Ask anything about Propylthiouracil 50mg Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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