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Applies to propylthiouracil: oral tablet
Oral route (Tablet)
Severe liver injury and acute liver failure, including fatalities, have been reported with propylthiouracil. Liver transplantation was required in some cases. Reserve propylthiouracil for patients who can not tolerate methimazole when radioactive iodine therapy or surgery are not appropriate treatment options. Propylthiouracil may be the preferred treatment when an antithyroid drug is indicated during or just prior to the first trimester of pregnancy, because of the risk of fetal abnormalities associated with methimazole.
Along with its needed effects, propylthiouracil may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking propylthiouracil:
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking propylthiouracil:
Symptoms of overdose
Some side effects of propylthiouracil may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
For Healthcare Professionals
Applies to propylthiouracil: oral tabletGeneral
The more commonly reported adverse events have included nausea, taste perversion, and itching.Hepatic
Liver injury resulting in liver failure presenting as hepatitis, liver failure necessitating liver transplantation or resulting in death, has been reported. Cases of liver injury and death were reported in women during pregnancy; two reports of liver failure and death have been received in newborns exposed to this drug in utero.
Common (1% to 10%): 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
Frequency not reported: Liver injury presenting as hepatitis, liver failure necessitating liver transplantation jaundice (usually cholestatic), hepatic necrosis, hepatic failureImmunologic
Vasculitis resulting in severe complications and death have been reported. These cases have included glomerulonephritis, leukocytoclastic cutaneous vasculitis, alveolar/pulmonary hemorrhage, cerebral angiitis, and ischemic colitis. Most were associated with anti-neutrophilic cytoplasmic antibodies (ANCA)-positive vasculitis.
Frequency not reported: Vasculitis syndrome, lupus-like syndrome (including splenomegaly and vasculitis), sialadenopathyHematologic
Rare (Less than 0.1%): Agranulocytosis, thrombocytopenia, leucopenia, aplastic anemia, pancytopenia, hemorrhage, granulocytopenia
Frequency not reported: Hypoprothrombinemia, lymphadenopathyDermatologic
Rare (0.01% to 0.1%): Stevens Johnson syndrome, toxic epidermal necrolysis
Very rare (less than 0.01%): Skin rash, urticaria
Frequency not reported: Exfoliative dermatitis, erythema nodosum, abnormal loss of hair, pruritus, skin pigmentation, lightening of hair color, lymphadenopathy, mild papular skin rashes, leukocytoclastic cutaneous vasculitisGastrointestinal
Rare (Less than 0.1%): Vomiting
Frequency not reported: Nausea, vomiting, epigastric distressGenitourinary
Frequency not reported: Increase of decrease in urinationMetabolic
Frequency not reported: EdemaMusculoskeletal
Frequency not reported: Periarteritis, arthralgia, myalgia, arthritis, myopathy, backacheNervous system
Frequency not reported: Paresthesias, loss of taste, taste perversion, headache, drowsiness, neuritis, vertigo, encephalopathy, numbness or tingling of fingers, toes, or face, cerebral angiitisOther
Frequency not reported: FeverOcular
Frequency not reported: Sore, red, watery eyes (recurrent keratitis, conjunctival disorders)Renal
Frequency not reported: Acute glomerulonephritis, nephritis, glomerulonephritisRespiratory
Frequency not reported: Interstitial pneumonitis, alveolar/pulmonary hemorrhage
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