FDA has identified 32 AERS cases (22 adult and 10 pediatric) of serious liver injury associated with propylthiouracil use. Of the adult cases, 12 deaths and 5 liver transplants occurred. Among the pediatric patients, 1 case resulted in death and 6 in liver transplants.
In contrast, for methimazole 5 AERS cases of serious liver injury were identified. All five cases were in adult patients and 3 resulted in death.