BIVALIRUDIN

N/A

Manufactured by Accord Healthcare, Inc.

1,699 FDA adverse event reports analyzed

Last updated: 2026-04-15

About BIVALIRUDIN

BIVALIRUDIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Accord Healthcare, Inc.. The most commonly reported adverse reactions for BIVALIRUDIN include DRUG INEFFECTIVE, OFF LABEL USE, HAEMORRHAGE, HEPARIN-INDUCED THROMBOCYTOPENIA, GASTROINTESTINAL HAEMORRHAGE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BIVALIRUDIN.

Top Adverse Reactions

DRUG INEFFECTIVE177 reports
OFF LABEL USE107 reports
HAEMORRHAGE85 reports
HEPARIN INDUCED THROMBOCYTOPENIA71 reports
GASTROINTESTINAL HAEMORRHAGE43 reports
THROMBOSIS38 reports
ACUTE MYOCARDIAL INFARCTION35 reports
VASCULAR STENT THROMBOSIS35 reports
THROMBOSIS IN DEVICE33 reports
HYPOTENSION32 reports
CARDIAC ARREST24 reports
THROMBOCYTOPENIA24 reports
HAEMORRHAGE INTRACRANIAL23 reports
DEEP VEIN THROMBOSIS22 reports
PULMONARY EMBOLISM21 reports
VENTRICULAR FIBRILLATION21 reports
CARDIOGENIC SHOCK18 reports
DEATH18 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION18 reports
PLATELET COUNT DECREASED18 reports
VASCULAR PSEUDOANEURYSM18 reports
COAGULOPATHY17 reports
CONDITION AGGRAVATED17 reports
DRUG RESISTANCE17 reports
HAEMOGLOBIN DECREASED17 reports
POST PROCEDURAL HAEMORRHAGE17 reports
RESPIRATORY FAILURE17 reports
ACUTE KIDNEY INJURY16 reports
ANAEMIA16 reports
DRUG INTERACTION15 reports
DYSPNOEA15 reports
HAEMATOMA15 reports
MYOCARDIAL INFARCTION15 reports
PULMONARY ALVEOLAR HAEMORRHAGE15 reports
KOUNIS SYNDROME14 reports
PERICARDIAL EFFUSION14 reports
RETROPERITONEAL HAEMORRHAGE14 reports
CATHETER SITE HAEMORRHAGE13 reports
CHEST PAIN13 reports
COAGULATION TIME PROLONGED13 reports
PULMONARY HAEMORRHAGE13 reports
ATRIAL FIBRILLATION12 reports
CEREBRAL HAEMORRHAGE12 reports
MULTI ORGAN FAILURE12 reports
OVERDOSE12 reports
PRODUCT USE IN UNAPPROVED INDICATION12 reports
RENAL FAILURE12 reports
CARDIAC PROCEDURE COMPLICATION11 reports
HAEMOTHORAX11 reports
LABELLED DRUG DRUG INTERACTION MEDICATION ERROR11 reports
LOSS OF CONSCIOUSNESS11 reports
PROCEDURAL HAEMORRHAGE11 reports
PULMONARY HYPERTENSION11 reports
VENTRICULAR TACHYCARDIA11 reports
ABDOMINAL WALL HAEMATOMA10 reports
DISSEMINATED INTRAVASCULAR COAGULATION10 reports
EPISTAXIS10 reports
PNEUMONIA10 reports
PRODUCT SUBSTITUTION ISSUE10 reports
SHOCK10 reports
TREATMENT FAILURE10 reports
BRADYCARDIA9 reports
CEREBROVASCULAR ACCIDENT9 reports
INJURY9 reports
PHARYNGEAL HAEMORRHAGE9 reports
PRODUCT USE ISSUE9 reports
SUBARACHNOID HAEMORRHAGE9 reports
SUBDURAL HAEMATOMA9 reports
ABDOMINAL PAIN8 reports
ANXIETY8 reports
CARDIAC TAMPONADE8 reports
CORONARY ARTERY DISEASE8 reports
CORONARY ARTERY THROMBOSIS8 reports
HYPERTENSION8 reports
INCORRECT ROUTE OF DRUG ADMINISTRATION8 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME8 reports
NAUSEA8 reports
PERICARDIAL HAEMORRHAGE8 reports
PNEUMOTHORAX8 reports
RENAL VEIN THROMBOSIS8 reports
BLOOD CREATININE INCREASED7 reports
BRAIN OEDEMA7 reports
CARDIAC FAILURE7 reports
HYPOXIA7 reports
INTERNATIONAL NORMALISED RATIO INCREASED7 reports
ISCHAEMIC STROKE7 reports
LACTIC ACIDOSIS7 reports
NO ADVERSE EVENT7 reports
PLEURAL EFFUSION7 reports
POST PROCEDURAL COMPLICATION7 reports
PRODUCT QUALITY ISSUE7 reports
PUNCTURE SITE HAEMORRHAGE7 reports
RESPIRATORY DISTRESS7 reports
SEPSIS7 reports
SHOCK HAEMORRHAGIC7 reports
THERAPEUTIC RESPONSE DECREASED7 reports
VENA CAVA THROMBOSIS7 reports
ACUTE RESPIRATORY DISTRESS SYNDROME6 reports
AGITATION6 reports
ANGIOPATHY6 reports

Report Outcomes

Out of 936 classified reports for BIVALIRUDIN:

Serious 91.1%Non-Serious 8.9%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male446 (61.1%)
Female264 (36.2%)
Unknown20 (2.7%)

Reports by Age

Age 6228 reports
Age 5022 reports
Age 5920 reports
Age 6519 reports
Age 918 reports
Age 5718 reports
Age 6418 reports
Age 5217 reports
Age 6117 reports
Age 6616 reports
Age 6716 reports
Age 6916 reports
Age 4815 reports
Age 7715 reports
Age 5414 reports
Age 4411 reports
Age 4711 reports
Age 7111 reports
Age 7411 reports
Age 1510 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with BIVALIRUDIN?

This profile reflects 1,699 FDA FAERS reports that mention BIVALIRUDIN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BIVALIRUDIN?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, OFF LABEL USE, HAEMORRHAGE, HEPARIN-INDUCED THROMBOCYTOPENIA, GASTROINTESTINAL HAEMORRHAGE, THROMBOSIS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BIVALIRUDIN?

Labeling and FAERS entries often list Accord Healthcare, Inc. in connection with BIVALIRUDIN. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.