10% discount using “BOX10” code for order above $499 + Free Shipping
myrxbox-logo
A-Ret 0.1% Gel 1 Aldactone 3 Allegra 2 Allegra M 1 Antiflu 75 2 Assurans 1 Asthalin respiratory solution 1 Augmentin 3 Azicip 250 (Zpac) 1 Azicip 500 (Zpac) 1 Azipro 250 (Zpac) 1 Azipro 500 (Zpac) 1 Bactrim d.s. 1 Balila 1 Belustine 40 1 Betaloc 50 1 Biltee 1 Bimat 0.03% Sterile Drops 1 Budecort 4 Careprost 0.03% Sterile Drops 1 Caverta 3 Cefix 1 Cenforce 6 Cenforce D 1 Cenforce FM 1 Cenforce Professional 1 Cialis 2 Cipmolnu 200 1 Cipmox 2 Claribid 250 1 Claribid 500 1 Climax Spray 1 Covilife 4 Covilife cream 1 Covilife MBD 1 Dabur Shilajit Gold Capsules 1 DOXENORM – LBX 1 DOXT – SL 1 Duprost 1 Duralast 1 Duratia 4 Dutas 1 Efil 3 Eltroxin 6 Emeset 2 Falcigo 2 Famcimac 500 1 Febucip 80 1 Febutec 40 1 Fildena 5 Fildena CT 1 Fildena Professional 1 Fildena Super Active 1 Fildena XXX 1 Floxip 1 Fluka 1 Fluvir (Tamiflu) 1 Fluvoxin 1 Glez 1 HealthVit 1 Imiquad Cream 1 Ipca – Hydroxychloroquine 2 Ivanorm 3 Iverheal 2 Iverheal 3 1 Iverjohn 1 Ivrea 1 Ivrea 1 1 John Lee – Ivermectin 2 Kamagra 2 Kamagra Oral Jelly 1 Laretol 1 Larinate 1 Levoflox 3 Levoquin 2 Low Dose Naltrexone (LDN) 3 LQuin 3 Lumigan 0.1% Sterile Drops 1 Lupimeb 1 Mebex 2 Medrol 3 Megalis 2 Methycobal injection (Vitamin B12) 1 Mirago 1 Modula 1 MONONATE DS 1 MONONATE SP 1 Montair 1 Montair FX 1 Movfor 200 1 Naprosyn 250 1 Naprosyn 500 1 Nervigesic 1 Netazox 500 1 Niclosig 1 Nizonide 500 1 Norsunate 2 Olmecip 1 Olmecip AM (Benicar) 1 Olmecip H (Benicar HCT) 1 Olmecip H 40 (Benicar) 1 Olmecip Trio (Benicar) 1 Omlecip 1 Omnacortil 4 Opsutan 1 Orokinase  Tablet 1 P-Force 1 Panacure 150 Tablet 1 Penegra 2 Pirfenex 200 1 Pirfenex 400 1 Predmet 3 Primovir 1 Radinate 1 Retina Ac Gel 1 Retina-A 0.025% Cream 1 Retina-A 0.04% Gel 1 Retina-A 0.05% Cream 1 Retina-A 0.1% Gel 1 Ridsunate 3 Rupanex 1 Rupanex – M 1 Rybelsus 3 Slim Trim Active 2 Stephonex 500 1 Super Kamagra 1 Symbicort Turbuhaler 3 T bact 1 Tadact 2 Tadaflo 3 Tadora 1 Tamodex 20 1 Tazzle 3 Tentex Royal Capsules 1 UPRISE-D3 1 Valcivir 2 Valif 1 Vidalista 6 Vidalista Black 1 Vidalista CT 1 Vidalista Professional 1 Vilitra 4 Wormentel 4 Zinconia – 50 1 Zocon DT 1

Propylthiouracil


FDA-approved label information

Reproduced from the FDA Structured Product Label via the openFDA API. Label version: December 26, 2023.

Status
Human Prescription Drug
Brand names
Propylthiouracil
Route
Oral
Drug class
Thyroid Hormone Synthesis Inhibitor [EPC]

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 when an antithyroid drug is indicated during or just prior to the first trimester of pregnancy (see Warnings and Precautions ).

Description

DESCRIPTION Propylthiouracil, USP is one of the thiocarbamide compounds. It is a white, crystalline substance that has a bitter taste and is very slightly soluble in water. Propylthiouracil, USP is an antithyroid drug administered orally. The structural formula is: Each tablet contains propylthiouracil, USP 50 mg and the following inactive ingredients: calcium stearate, corn starch, lactose monohydrate and pregelatinized starch. image description

Indications and usage

INDICATIONS AND USAGE Propylthiouracil 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.

Contraindications

CONTRAINDICATIONS Propylthiouracil is contraindicated in patients who have demonstrated hypersensitivity to the drug or any of the other product components.

Warnings (older label format)

WARNINGS Liver Toxicity Liver injury resulting in liver failure, liver transplantation, or death, has been reported with propylthiouracil therapy in adult and pediatric patients. No cases of liver failure have been reported with the use of methimazole in pediatric patients. For this reason, propylthiouracil is not recommended for pediatric patients except when methimazole is not well-tolerated and surgery or radioactive iodine therapy are not appropriate therapies. Biochemical monitoring of liver function (bilirubin, alkaline phosphatase) and hepatocellular integrity (ALT, AST) is not expected to attenuate the risk of severe liver injury due to its rapid and unpredictable onset. Patients should be informed of the risk of liver failure. Patients should be instructed to report any symptoms of hepatic dysfunction (anorexia, pruritus, right upper quadrant pain, etc.), particularly in the first six months of therapy. When these symptoms occur, propylthiouracil should be discontinued immediately and liver function tests and ALT and AST levels obtained. Use in Pregnancy There are cases of liver injury, including liver failure and death, in women treated with propylthiouracil during pregnancy. Two reports of in utero exposure with liver failure and death of a newborn have been reported. If propylthiouracil is used during pregnancy, or if the patient becomes pregnant while taking propylthiouracil, the patient should be warned of the rare potential hazard to the mother and fetus of liver damage. Propylthiouracil crosses the placenta and can cause fetal goiter and cretinism when administered to a pregnant woman (see Precautions, Pregnancy ). After the first trimester of pregnancy, the use of an alternative antithyroid medication may be advisable (see Precautions, Pregnancy ). Agranulocytosis Agranulocytosis occurs in approximately 0.2% to 0.5% of patients and is a potentially life-threatening side effect of propylthiouracil therapy. Agranulocytosis typically occurs within the first 3 months of therapy. Patients should be instructed to immediately report any symptoms suggestive of agranulocytosis, such as fever or sore throat. Leukopenia, thrombocytopenia, and aplastic anemia (pancytopenia) may also occur. Propylthiouracil should be discontinued if agranulocytosis, aplastic anemia (pancytopenia) is suspected, and the patient’s bone marrow indices should be obtained. Vasculitis Cases of vasculitis resulting in severe complications and death have been reported in patients receiving propylthiouracil therapy. The cases of vasculitis include: glomerulonephritis, leukocytoclastic cutaneous vasculitis, alveolar/pulmonary hemorrhage, cerebral angiitis, and ischemic colitis. Most cases were associated with anti-neutrophilic cytoplasmic antibodies (ANCA)-positive vasculitis. In some cases, vasculitis resolved/improved with drug discontinuation; however, more severe cases required treatment with additional measures including corticosteroids, immunosuppressant therapy, and plasmapheresis. If vasculitis is suspected, discontinue therapy and initiate appropriate intervention. Hypothyroidism Propylthiouracil can cause hypothyroidism necessitating routine monitoring of TSH and free T4 levels with adjustments in dosing to maintain a euthyroid state. Because the drug readily crosses placental membranes, propylthiouracil can cause fetal goiter and cretinism when administered to a pregnant woman (see Precaution, Pregnancy ).

Adverse reactions

ADVERSE REACTIONS The following adverse reactions have been reported with the use of propylthiouracil. Because these events generally come from voluntary reporting from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Severe adverse reactions include liver injury presenting as hepatitis, liver failure necessitating liver transplantation or resulting in death (see WARNINGS ). Inhibition of myelopoiesis (agranulocytosis, granulopenia, aplastic anemia, and thrombocytopenia), drug fever, a lupus-like syndrome (including splenomegaly and vasculitis), periarteritis, hypoprothrombinemia, and bleeding have been reported. Nephritis, glomerulonephritis, interstitial pneumonitis, exfoliative dermatitis, and erythema nodosum have also been reported. There are reports of a vasculitis associated with the presence of anti-neutrophilic cytoplasmic antibodies (ANCA), resulting in severe complications and death (see WARNINGS ). There have been rare reports of serious hypersensitivity reactions (e.g., Stevens Johnson syndrome and toxic epidermal necrolysis) in patients treated with propylthiouracil. Other adverse reactions include skin rash, uticaria, nausea, vomiting, epigastric distress, arthralgia, paresthesias, loss of taste, taste perversion, abnormal loss of hair, myalgia, headache, pruritus, drowsiness, neuritis, edema, vertigo, skin pigmentation, jaundice, sialadenopathy, and lymphadenopathy.

Overdosage

OVERDOSAGE Signs and Symptoms Nausea, vomiting, epigastric distress, headache, fever, arthralgia, pruritus, edema, and pancytopenia. Agranulocytosis is the most serious effect. Rarely, exfoliative dermatitis, hepatitis, neuropathies or CNS stimulation or depression may occur. No information is available on the following: LD 50 ; concentration of propylthiouracil in biologic fluids associated with toxicity and/or death; the amount of drug in a single dose usually associated with symptoms of overdosage; or the amount of propylthiouracil in a single dose likely to be life-threatening. Treatment To obtain up-to-date information about the treatment of overdose, a good resource is the certified Regional Poison Control Center. In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in the patient. In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient’s medical status.

Source: US Food and Drug Administration, via the openFDA API. The FDA does not review, endorse or verify third-party reproductions of this data, and label information may have been updated since it was retrieved.
Read the current full label on DailyMed

FDA approval applies to the uses listed on the label. Approval status in your country may differ.

Sources

This glossary entry is general health information, not medical advice, not a diagnosis, and not a recommendation to use any medicine. Medicines described here may be prescription-only where you live. Always speak to a qualified doctor or pharmacist before starting, stopping, or changing any treatment.
Trustpilot logoTrustpilot
Great rating
TrustScore 4
3 reviews