FDA has added a boxed warning to the label for propylthiouracil to include
information about reports of severe liver injury and liver failure, including
some deaths, in adults and children using this medication. Propylthiouracil is
a drug used to treat overactive thyroid (hyperthyroidism).
Recommendations:
Tell your health care professional about any medication you are taking or
medical conditions you may have before taking propylthiouracil.
Read the Medication Guide that comes with each prescription for
propylthiouracil to better understand the potential risks and benefits of your
medication.
Contact your health care professional if you have fever, loss of appetite,
nausea, vomiting, tiredness, itchiness, dark colored urine, or yellowing of
your skin or eyes while taking propylthiouracil.
Propylthiouracil may be the treatment of choice during and just before the
first trimester of pregnancy (weeks 1–12). Talk to your health care
professional if you are pregnant, or plan to become pregnant, and are taking a
medication to treat hyperthyroidism.
Don’t stop taking propylthiouracil unless told to do so by your health care
professional.
For more information, see FDA’s Drug Safety Communication on
propylthiouracil8.: