Drug
Asciminib
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 | Cytopenia | 86 | 47.9 | 49.2 | signal |
| 2 | Haematotoxicity | 24 | 17.1 | 17.3 | signal |
| 3 | Pericardial Effusion | 59 | 17.0 | 17.3 | signal |
| 4 | Drug Resistance | 49 | 12.6 | 12.8 | signal |
| 5 | Hepatotoxicity | 38 | 11.3 | 11.5 | signal |
| 6 | Leukaemia | 16 | 11.2 | 11.3 | signal |
| 7 | Pleural Effusion | 99 | 10.8 | 11.1 | signal |
| 8 | Thrombocytopenia | 158 | 9.4 | 9.8 | signal |
| 9 | Leukocytosis | 25 | 9.1 | 9.2 | signal |
| 10 | Pancreatitis | 72 | 9.0 | 9.2 | signal |
| 11 | Drug Intolerance | 128 | 8.8 | 9.1 | signal |
| 12 | Splenomegaly | 14 | 7.9 | 7.9 | signal |
| 13 | Platelet Count Increased | 15 | 7.6 | 7.6 | signal |
| 14 | Pulmonary Hypertension | 24 | 7.6 | 7.6 | signal |
| 15 | Pancytopenia | 61 | 7.2 | 7.4 | signal |
| 16 | Pericarditis | 18 | 7.1 | 7.2 | signal |
| 17 | Arteriosclerosis | 10 | 7.0 | 7.0 | signal |
| 18 | Posterior Reversible Encephalopathy Syndrome | 10 | 6.9 | 7.0 | signal |
| 19 | Full Blood Count Decreased | 20 | 6.6 | 6.6 | signal |
| 20 | Brain Fog | 14 | 6.3 | 6.4 | signal |
| 21 | Bone Pain | 55 | 6.2 | 6.3 | signal |
| 22 | Supraventricular Tachycardia | 8 | 5.5 | 5.5 | signal |
| 23 | Malignant Neoplasm Progression | 85 | 5.5 | 5.6 | signal |
| 24 | Electrocardiogram Qt Prolonged | 29 | 5.3 | 5.4 | signal |
| 25 | Platelet Count Decreased | 81 | 5.0 | 5.1 | signal |
| 26 | Nephropathy | 7 | 4.9 | 4.9 | signal |
| 27 | Cerebral Infarction | 18 | 4.9 | 4.9 | signal |
| 28 | Bone Marrow Failure | 15 | 4.8 | 4.9 | signal |
| 29 | White Blood Cell Count Increased | 27 | 4.6 | 4.7 | signal |
| 30 | Transaminases Increased | 15 | 4.5 | 4.5 | signal |
| 31 | Treatment Failure | 54 | 4.3 | 4.4 | signal |
| 32 | Nephropathy Toxic | 7 | 4.2 | 4.2 | signal |
| 33 | Blood Bilirubin Increased | 17 | 4.1 | 4.2 | signal |
| 34 | Acute Myocardial Infarction | 18 | 4.0 | 4.0 | signal |
| 35 | Ventricular Tachycardia | 10 | 4.0 | 4.0 | signal |
| 36 | Malignant Melanoma | 8 | 3.9 | 3.9 | signal |
| 37 | Hepatic Cytolysis | 7 | 3.8 | 3.8 | signal |
| 38 | Musculoskeletal Pain | 30 | 3.8 | 3.8 | signal |
| 39 | Renal Impairment | 47 | 3.7 | 3.8 | signal |
| 40 | Dermatitis Allergic | 7 | 3.7 | 3.7 | signal |
| 41 | Transient Ischaemic Attack | 19 | 3.7 | 3.7 | signal |
| 42 | Myelodysplastic Syndrome | 8 | 3.7 | 3.7 | signal |
| 43 | Neutrophil Count Decreased | 22 | 3.6 | 3.6 | signal |
| 44 | Therapy Non-responder | 24 | 3.6 | 3.6 | signal |
| 45 | Hypertensive Crisis | 6 | 3.6 | 3.6 | signal |
| 46 | Therapeutic Response Decreased | 31 | 3.4 | 3.4 | signal |
| 47 | Myalgia | 80 | 3.1 | 3.2 | signal |
| 48 | Neutropenia | 62 | 3.0 | 3.1 | signal |
| 49 | Obstructive Airways Disorder | 5 | 3.0 | 3.0 | signal |
| 50 | Leukopenia | 21 | 2.8 | 2.8 | signal |
| 51 | Polyneuropathy | 5 | 2.8 | 2.8 | signal |
| 52 | Myelosuppression | 14 | 2.7 | 2.7 | signal |
| 53 | Decreased Immune Responsiveness | 4 | 2.7 | 2.7 | no signal |
| 54 | Neurotoxicity | 7 | 2.7 | 2.7 | signal |
| 55 | Tooth Disorder | 9 | 2.7 | 2.7 | signal |
| 56 | Product Administration Error | 8 | 2.6 | 2.7 | signal |
| 57 | Dementia | 11 | 2.6 | 2.6 | signal |
| 58 | Sudden Death | 4 | 2.5 | 2.5 | no signal |
| 59 | Laboratory Test Abnormal | 11 | 2.5 | 2.5 | signal |
| 60 | Ocular Discomfort | 4 | 2.4 | 2.4 | no signal |
| 61 | Nerve Injury | 4 | 2.4 | 2.4 | no signal |
| 62 | Cardiovascular Disorder | 9 | 2.3 | 2.3 | signal |
| 63 | Therapy Interrupted | 24 | 2.3 | 2.3 | signal |
| 64 | Pulmonary Arterial Hypertension | 5 | 2.3 | 2.3 | no signal |
| 65 | Hospitalisation | 52 | 2.3 | 2.3 | signal |
| 66 | Cerebrovascular Accident | 58 | 2.3 | 2.3 | signal |
| 67 | Cholestasis | 6 | 2.1 | 2.1 | no signal |
| 68 | Cardiac Disorder | 29 | 2.0 | 2.0 | signal |
| 69 | Neoplasm Malignant | 19 | 1.9 | 1.9 | no signal |
| 70 | Ischaemic Stroke | 5 | 1.8 | 1.8 | no signal |
| 71 | Myocarditis | 3 | 1.8 | 1.8 | no signal |
| 72 | Gastric Haemorrhage | 3 | 1.7 | 1.7 | no signal |
| 73 | Myocardial Infarction | 44 | 1.7 | 1.7 | no signal |
| 74 | Muscle Spasticity | 3 | 1.6 | 1.6 | no signal |
| 75 | Peritonitis | 5 | 1.6 | 1.6 | no signal |
| 76 | Product Availability Issue | 5 | 1.5 | 1.5 | no signal |
| 77 | Cytokine Release Syndrome | 4 | 1.4 | 1.4 | no signal |
| 78 | Gynaecomastia | 6 | 1.3 | 1.3 | no signal |
| 79 | Product Dispensing Error | 4 | 1.2 | 1.2 | no signal |
| 80 | Product Storage Error | 12 | 0.9 | 0.9 | no signal |
| 81 | Renal Cancer | 6 | 0.8 | 0.8 | no signal |
| 82 | Gastric Cancer | 3 | 0.8 | 0.8 | no signal |
| 83 | Tardive Dyskinesia | 3 | 0.7 | 0.7 | no signal |
| 84 | Product Adhesion Issue | 3 | 0.6 | 0.6 | no signal |
| 85 | Bladder Cancer | 3 | 0.3 | 0.3 | no signal |