Drug
Resmetirom
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 | Hepatic Cirrhosis | 117 | 69.8 | 74.3 | signal |
| 2 | Aspartate Aminotransferase Increased | 141 | 29.5 | 31.8 | signal |
| 3 | Blood Bilirubin Increased | 68 | 27.9 | 28.9 | signal |
| 4 | Alanine Aminotransferase Increased | 149 | 26.9 | 29.1 | signal |
| 5 | Blood Alkaline Phosphatase Increased | 39 | 17.4 | 17.7 | signal |
| 6 | Jaundice | 34 | 14.0 | 14.2 | signal |
| 7 | Liver Function Test Increased | 25 | 13.0 | 13.2 | signal |
| 8 | Chromaturia | 25 | 12.3 | 12.4 | signal |
| 9 | Hepatic Enzyme Increased | 74 | 12.1 | 12.5 | signal |
| 10 | Therapy Interrupted | 73 | 11.7 | 12.2 | signal |
| 11 | Brain Fog | 13 | 9.9 | 9.9 | signal |
| 12 | Hyperbilirubinaemia | 8 | 8.6 | 8.6 | signal |
| 13 | Hepatomegaly | 7 | 7.9 | 7.9 | signal |
| 14 | Pruritus | 263 | 7.7 | 8.8 | signal |
| 15 | Urosepsis | 6 | 7.2 | 7.2 | signal |
| 16 | Hepatic Failure | 19 | 7.0 | 7.0 | signal |
| 17 | Splenomegaly | 7 | 6.6 | 6.6 | signal |
| 18 | Abdominal Pain Upper | 121 | 6.5 | 6.9 | signal |
| 19 | Flatulence | 32 | 6.3 | 6.4 | signal |
| 20 | Faeces Discoloured | 12 | 6.1 | 6.2 | signal |
| 21 | Cholelithiasis | 18 | 6.1 | 6.1 | signal |
| 22 | Liver Injury | 13 | 6.0 | 6.0 | signal |
| 23 | Eructation | 10 | 5.8 | 5.9 | signal |
| 24 | Hepatitis | 12 | 5.2 | 5.2 | signal |
| 25 | Disease Progression | 54 | 5.1 | 5.2 | signal |
| 26 | Hepatotoxicity | 10 | 5.0 | 5.0 | signal |
| 27 | Unevaluable Event | 34 | 5.0 | 5.1 | signal |
| 28 | Therapeutic Response Unexpected | 16 | 3.9 | 4.0 | signal |
| 29 | Blood Thyroid Stimulating Hormone Increased | 3 | 3.6 | 3.6 | no signal |
| 30 | Adverse Event | 27 | 3.2 | 3.3 | signal |
| 31 | No Adverse Event | 47 | 2.9 | 3.0 | signal |
| 32 | Glycosylated Haemoglobin Increased | 6 | 2.6 | 2.6 | signal |
| 33 | Dermatitis Atopic | 8 | 1.8 | 1.8 | no signal |
| 34 | Hepatic Cancer | 3 | 1.4 | 1.4 | no signal |