Drug
Propylthiouracil
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Hyperthyroidism | 138 | 98.5 | 105.5 | signal |
| 2 | Cardiogenic Shock | 50 | 36.0 | 36.8 | signal |
| 3 | Acute Hepatic Failure | 46 | 34.7 | 35.5 | signal |
| 4 | Agranulocytosis | 60 | 33.3 | 34.3 | signal |
| 5 | Vasculitis | 32 | 28.1 | 28.6 | signal |
| 6 | Sinus Bradycardia | 16 | 16.9 | 17.0 | signal |
| 7 | Premature Baby | 49 | 16.6 | 17.0 | signal |
| 8 | Hepatic Encephalopathy | 15 | 16.5 | 16.6 | signal |
| 9 | Hepatotoxicity | 35 | 16.2 | 16.4 | signal |
| 10 | Premature Delivery | 25 | 16.0 | 16.2 | signal |
| 11 | Hypothyroidism | 47 | 15.1 | 15.4 | signal |
| 12 | Foetal Exposure During Pregnancy | 117 | 14.8 | 15.6 | signal |
| 13 | Circulatory Collapse | 24 | 14.4 | 14.5 | signal |
| 14 | Exposure During Pregnancy | 85 | 14.0 | 14.6 | signal |
| 15 | Drug-induced Liver Injury | 38 | 12.6 | 12.8 | signal |
| 16 | Caesarean Section | 14 | 12.2 | 12.3 | signal |
| 17 | Multiple Organ Dysfunction Syndrome | 33 | 12.1 | 12.3 | signal |
| 18 | Hyperbilirubinaemia | 11 | 10.9 | 11.0 | signal |
| 19 | Renal Tubular Necrosis | 10 | 10.4 | 10.5 | signal |
| 20 | Drug Reaction With Eosinophilia And Systemic Symptoms | 25 | 10.0 | 10.1 | signal |
| 21 | Cardiomegaly | 12 | 9.9 | 10.0 | signal |
| 22 | Maternal Exposure During Pregnancy | 76 | 8.8 | 9.1 | signal |
| 23 | Hepatitis | 22 | 8.8 | 8.9 | signal |
| 24 | Cholestasis | 16 | 8.6 | 8.6 | signal |
| 25 | Mitral Valve Incompetence | 9 | 8.1 | 8.2 | signal |
| 26 | Ventricular Tachycardia | 13 | 8.0 | 8.1 | signal |
| 27 | Hepatic Failure | 23 | 7.8 | 7.9 | signal |
| 28 | Blood Thyroid Stimulating Hormone Increased | 7 | 7.8 | 7.8 | signal |
| 29 | Eosinophilia | 13 | 7.6 | 7.7 | signal |
| 30 | Drug Exposure During Pregnancy | 25 | 7.4 | 7.5 | signal |
| 31 | Rhabdomyolysis | 30 | 7.4 | 7.5 | signal |
| 32 | Disseminated Intravascular Coagulation | 10 | 7.2 | 7.3 | signal |
| 33 | Sinus Tachycardia | 10 | 7.2 | 7.3 | signal |
| 34 | Cardiac Arrest | 55 | 6.8 | 7.0 | signal |
| 35 | Liver Injury | 16 | 6.8 | 6.8 | signal |
| 36 | Drug Toxicity | 9 | 6.7 | 6.7 | signal |
| 37 | Thyroid Disorder | 10 | 6.6 | 6.7 | signal |
| 38 | Brain Oedema | 8 | 6.5 | 6.5 | signal |
| 39 | Jaundice | 17 | 6.4 | 6.5 | signal |
| 40 | Product Physical Issue | 12 | 6.2 | 6.2 | signal |
| 41 | Adrenal Insufficiency | 7 | 6.0 | 6.0 | signal |
| 42 | International Normalised Ratio Increased | 16 | 5.7 | 5.7 | signal |
| 43 | Nephropathy | 5 | 5.5 | 5.5 | signal |
| 44 | Cardio-respiratory Arrest | 22 | 5.3 | 5.4 | signal |
| 45 | Treatment Noncompliance | 27 | 5.1 | 5.1 | signal |
| 46 | Toxic Skin Eruption | 5 | 5.1 | 5.1 | signal |
| 47 | Temperature Intolerance | 5 | 5.0 | 5.0 | signal |
| 48 | Red Blood Cell Sedimentation Rate Increased | 5 | 4.6 | 4.6 | signal |
| 49 | Drug Ineffective For Unapproved Indication | 24 | 4.4 | 4.4 | signal |
| 50 | Abortion Spontaneous | 17 | 4.3 | 4.4 | signal |
| 51 | Anorexia | 5 | 3.9 | 3.9 | signal |
| 52 | Cardiac Failure Congestive | 30 | 3.8 | 3.8 | signal |
| 53 | Cerebral Haemorrhage | 13 | 3.7 | 3.7 | signal |
| 54 | Myocarditis | 4 | 3.6 | 3.6 | signal |
| 55 | Rebound Effect | 4 | 3.6 | 3.6 | signal |
| 56 | Drug Resistance | 9 | 3.6 | 3.6 | signal |
| 57 | Hepatic Cytolysis | 4 | 3.3 | 3.4 | signal |
| 58 | No Therapeutic Response | 4 | 3.3 | 3.3 | signal |
| 59 | Abortion Induced | 3 | 3.3 | 3.3 | no signal |
| 60 | Hepatocellular Injury | 4 | 2.9 | 2.9 | no signal |
| 61 | Pregnancy | 5 | 2.5 | 2.5 | no signal |
| 62 | Product Taste Abnormal | 3 | 2.3 | 2.3 | no signal |
| 63 | Drug Dispensing Error | 3 | 2.0 | 2.0 | no signal |
| 64 | Application Site Pruritus | 3 | 1.4 | 1.4 | no signal |
| 65 | Intentional Overdose | 8 | 1.3 | 1.3 | no signal |
| 66 | Pharmaceutical Product Complaint | 3 | 1.2 | 1.2 | no signal |