Propylthiouracil Side Effects

Please note - some side effects for Propylthiouracil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Propylthiouracil - for the Consumer

Propylthiouracil

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Propylthiouracil:

Dizziness; drowsiness; headache; mild hair loss; mild muscle pain; taste changes or loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in amount of urine; coughing up blood; joint pain; red, swollen, blistered, or peeling skin; shortness of breath; skin numbness or tingling; swollen or painful lymph nodes; symptoms of infection (eg, fever, chills, sore throat, cough, severe or persistent headache); symptoms of liver problems (eg, dark urine; loss of appetite; pale stools; severe or persistent nausea, stomach pain, or vomiting; yellowing of the skin or eyes); unusual bleeding or bruising; unusual swelling; unusual or persistent tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Propylthiouracil Side Effects - for the Professional

Propylthiouracil

Major adverse reactions (much less common than the minor adverse reactions) include liver injury resulting in hepatitis, liver failure, a need for liver transplantation or death. Inhibition of myelopoiesis (agranulocytosis, granulopenia, and thrombocytopenia), aplastic anemia, drug fever, a lupus-like syndrome (including splenomegaly and vasculitis), hepatitis, periarteritis, and hypoprothrombinemia and bleeding have been reported. Nephritis, glomerulonephritis, interstitial pneumonitis, exfoliative dermatitis, and erythema nodosum have been reported. Reports of a vasculitis syndrome associated with the presence of anti-neutrophilic cytoplasmic antibodies (ANCA) have also been received. Manifestations of ANCA-positive vasculitis may include rapidly progressive glomerulonephritis (crescentic and pauci-immune necrotizing glomerulonephritis), sometimes leading to acute renal failure; pulmonary infiltrates or alveolar hemorrhage; skin ulcers; and leukocytoclastic vasculitis. Minor adverse reactions include skin rash, urticaria, 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.

It should be noted that about 10% of patients with untreated hyperthyroidism have leukopenia (white blood cell count of less than 4,000/mm3), often with relative granulopenia.

Side Effects by Body System - for Healthcare Professionals

General

In general the overall incidence of side effects is relatively low (1% to 5%). Serious side effects may occur. These have included agranulocytosis, hepatitis, and vasculitis.

Hematologic

Hematologic side effects have included agranulocytosis (0.5%), granulocytopenia, and thrombocytopenia, as well as rare reports of aplastic anemia. Transient leukopenia is reported in up to 12% of patients, although this may occur in untreated hyperthyroid patients as well. Hypoprothrombinemia and bleeding have been reported.

Agranulocytosis occurs in approximately 0.5% of patients treated with propylthiouracil. Onset is typically within the first three months of therapy but isolated cases have occurred much later. Risk may be greater in patients over 40 years of age and in females.

Rare cases of aplastic anemia are also reported, although recovery in these cases is relatively high (73%).

Hepatic

Propylthiouracil-induced hepatotoxicity occurs rarely, although the exact incidence is unknown. Most cases present as hepatocellular hepatitis, with or without jaundice. Cholestatic jaundice is also reported. While many cases resolve with discontinuation of propylthiouracil therapy and supportive care, fatalities have occurred despite aggressive therapy.

While severe hepatotoxicity appears to be rare, transient and asymptomatic elevations in transaminases may occur in up to 28% of patients.

Hepatic side effects have included hepatocellular hepatitis with or without jaundice, cholestatic jaundice, hepatic encephalopathy, fulminant hepatic necrosis, splenomegaly, and elevations in liver function tests. Fatal hepatitis has been reported.

Dermatologic

Dermatologic side effects have included rash, urticaria, hair loss, and skin pigmentation. Exfoliative dermatitis and erythema nodosum have also been reported. Cases of cutaneous vasculitis resulting in death have been reported.

Erythema nodosum and fatal cases of cutaneous vasculitis are reported with propylthiouracil. In addition, purpuric rash, maculopapular rash, or bullous hemorrhagic lesions may occur in conjunction with other adverse effects of propylthiouracil such as hepatotoxicity or hematologic toxicity.

Immunologic

Immunologic side effects have included hepatic, hematologic, respiratory, and dermatologic effects. Vasculitis has been associated with propylthiouracil therapy as have positive ANA titers and a lupus-like syndrome.

Antineutrophil cytoplasmic antibodies against human neutrophil elastase as well as against proteinase 3 and/or myeloperoxidase were documented in six patients who developed vasculitis during propylthiouracil therapy for hyperthyroidism.

Clinical improvement and disappearance of or decline in antibodies were noted upon discontinuation of propylthiouracil in all six patients. Such antibodies were absent in seven other patients who did not develop vasculitis during propylthiouracil therapy for hyperthyroidism.

Respiratory

Respiratory side effects have included two cases of interstitial pneumonitis. Pulmonary infiltrates or alveolar hemorrhage have also been reported.

Manifestations of a vasculitic syndrome with the presence of anti-neutrophilic cytoplasmic antibodies (ANCA) have included alveolar hemorrhage or pulmonary infiltrates.

Nervous system

Nervous system side effects have included paresthesia, headache, drowsiness, neuritis, and vertigo.

Renal

Renal side effects have rarely included acute interstitial nephritis and renal failure.

Manifestations of a vasculitic syndrome with the presence of anti-neutrophilic cytoplasmic antibodies (ANCA) have included rapidly progressing glomerulonephritis (crescentic and pauci-immune necrotizing glomerulonephritis) sometimes leading to acute renal failure.

Cardiovascular

Cardiovascular side effects have included a case report of superior vena cava syndrome.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, epigastric distress, and taste disturbances.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, myalgia, frank arthritis, and polymyositis.

Metabolic

Metabolic side effects have included a case report of severe hypocalcemia.

Other

Other side effects have included tinnitus, reversible sensorineural hearing loss, sialadenopathy, lymphadenopathy, and fever.

Reversible sensorineural hearing loss characterized by tinnitus and impaired hearing is reported in at least two cases. Fatigue, weight loss, and lupus-like syndrome accompanied the hearing loss in one case. In the other, migratory polyarthritis, fever, chills, and nonproductive cough were noted. Symptoms resolved after discontinuation of propylthiouracil.

Manifestations of a vasculitic syndrome with the presence of anti-neutrophilic cytoplasmic antibodies (ANCA) have included fever and leukocytoclastic vasculitis.

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