Drug
Bivalirudin
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 | Ventricular Fibrillation | 21 | 41.3 | 42.2 | signal |
| 2 | Haemorrhage Intracranial | 23 | 33.6 | 34.4 | signal |
| 3 | Post Procedural Haemorrhage | 17 | 31.9 | 32.4 | signal |
| 4 | Cardiogenic Shock | 19 | 29.1 | 29.7 | signal |
| 5 | Acute Myocardial Infarction | 35 | 25.9 | 26.8 | signal |
| 6 | Coagulopathy | 19 | 25.0 | 25.5 | signal |
| 7 | Subarachnoid Haemorrhage | 9 | 19.3 | 19.5 | signal |
| 8 | Haemorrhage | 87 | 18.2 | 19.9 | signal |
| 9 | Disseminated Intravascular Coagulation | 10 | 15.5 | 15.6 | signal |
| 10 | Multi-organ Failure | 12 | 15.0 | 15.1 | signal |
| 11 | Ventricular Tachycardia | 11 | 14.5 | 14.7 | signal |
| 12 | Drug Resistance | 17 | 14.5 | 14.7 | signal |
| 13 | Subdural Haematoma | 9 | 13.7 | 13.8 | signal |
| 14 | Pericardial Effusion | 14 | 13.3 | 13.5 | signal |
| 15 | Haematoma | 15 | 12.6 | 12.8 | signal |
| 16 | Brain Oedema | 7 | 12.1 | 12.2 | signal |
| 17 | Multiple Organ Dysfunction Syndrome | 15 | 11.8 | 11.9 | signal |
| 18 | Pulmonary Hypertension | 11 | 11.5 | 11.6 | signal |
| 19 | Gastrointestinal Haemorrhage | 43 | 11.2 | 11.7 | signal |
| 20 | Thrombosis | 38 | 10.3 | 10.7 | signal |
| 21 | Shock | 10 | 9.6 | 9.7 | signal |
| 22 | Thrombotic Microangiopathy | 4 | 9.0 | 9.1 | signal |
| 23 | Ischaemic Stroke | 7 | 8.6 | 8.6 | signal |
| 24 | Fluid Overload | 5 | 7.4 | 7.4 | signal |
| 25 | Coronary Artery Occlusion | 4 | 6.3 | 6.4 | signal |
| 26 | Respiratory Depression | 3 | 5.3 | 5.4 | signal |
| 27 | Incorrect Route Of Drug Administration | 8 | 4.8 | 4.9 | signal |
| 28 | Drug Toxicity | 3 | 4.7 | 4.8 | signal |
| 29 | Product Substitution Issue | 10 | 3.8 | 3.8 | signal |
| 30 | Premature Baby | 5 | 3.6 | 3.6 | signal |