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What the label lists and what reports show

Bivalirudin side effects

Bivalirudin's FDA label: “Most common adverse reaction (>2%) was bleeding.” FAERS holds 959 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is haemorrhage (87 reports).

  • Generic listed

Check it at the source: the bivalirudin FDA label on DailyMed (effective September 30, 2019, Sandoz Inc); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Most common adverse reaction (>2%) was bleeding.

From the label: adverse reactions, continued

Most common adverse reaction (>2%) was bleeding. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the BAT trials, 79 of the 2161 (3.7%) patients undergoing PCI for treatment of unstable angina and randomized to bivalirudin experienced major bleeding events, which consisted of intracranial bleeding, retroperitoneal bleeding, and clinically overt bleeding with a decrease in hemoglobin greater than 3 g/dL or leading to a transfusion of greater than 2 units of blood. 6.2 Immunogenicity As with all peptides, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. …

Source: FDA drug label, Sandoz Inc, effective September 30, 2019 (SPL set ce56f806-7845-429d-a1ce-c2dbf79b22eb), via openFDA; the full label on DailyMed

What do FAERS reports show?

959 reports list bivalirudin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 152 are coded as a death and 416 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 17 reactions below, 1 is named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Drug Ineffective (a use or a product term, not a reaction)185
  • Off Label Use (a use or a product term, not a reaction)108
  • Haemorrhage (named in the label)87
  • Heparin-Induced Thrombocytopenia (a use or a product term, not a reaction)74
  • Gastrointestinal Haemorrhage43
  • Vascular Stent Thrombosis39
  • Thrombosis (a use or a product term, not a reaction)38
  • Acute Myocardial Infarction35
  • Hypotension33
  • Thrombosis In Device33
  • Cardiac Arrest24
  • Thrombocytopenia (a use or a product term, not a reaction)24
  • Deep Vein Thrombosis23
  • Haemorrhage Intracranial23
  • Pulmonary Embolism22
  • Ventricular Fibrillation21
  • Cardiogenic Shock19
  • Coagulopathy19
  • Condition Aggravated (a use or a product term, not a reaction)19
  • Acute Kidney Injury18
  • Death (an outcome recorded in the report)18
  • Drug Ineffective For Unapproved Indication (a use or a product term, not a reaction)18
  • Platelet Count Decreased18
  • Vascular Pseudoaneurysm18
  • Anaemia17

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Bivalirudin: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions