Bivalirudin side effects: what 959 FDA adverse event reports show

Bivalirudin · 30 reaction terms · 491 drug–reaction co-reports · data 2026-09-14

Drug class

Anti-coagulant, Direct Thrombin Inhibitor

FDA label (Established Pharmacologic Class)

Who reports

959 reports · 91% serious · 152 with death outcome · 37% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Bivalirudin for injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome.

FDA label, Indications and Usage

What it is

Bivalirudin for injection contains bivalirudin which is a specific and reversible direct thrombin inhibitor. Bivalirudin is a synthetic, 20 amino acid peptide, with the chemical name of D-phen.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 19 strongest signals

Labeled adverse reaction 1Labeled (related wording) 1Likely indication confounding 1Reporting / coding artifact 3Not in label — unassessed 13

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 11 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Ventricular fibrillation	21	41.3 27.0–63.1ROR 42.2 · χ² 785 / p 5e-173	39.9 EB05 27.5 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 26.1	no trial data cached
Haemorrhage intracranial	23	33.6 22.4–50.3ROR 34.4 · χ² 694 / p 3e-153	32.7 EB05 22.9 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 21.2	no trial data cached
Post procedural haemorrhage	17	31.9 19.9–51.1ROR 32.4 · χ² 478 / p 4e-106	30.8 EB05 20.4 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 22.5	no trial data cached
Cardiogenic shock	19	29.1 18.7–45.5ROR 29.7 · χ² 488 / p 2e-108	28.4 EB05 19.2 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 18.4	no trial data cached
Acute myocardial infarction	35	25.9 18.7–35.8ROR 26.8 · χ² 812 / p 5e-179	25.5 EB05 19.2 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 16.4 · 91% clinician	no trial data cached
Coagulopathy	19	25.0 16.0–39.1ROR 25.5 · χ² 414 / p 2e-92	24.4 EB05 16.5 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 15.6	no trial data cached
Haemorrhage	87	18.2 14.9–22.3ROR 19.9 · χ² 1,404 / p <1e-300	18.1 EB05 15.1 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.9 · 94% clinician	no trial data cached
Disseminated intravascular coagulation	10	15.5 8.4–28.7ROR 15.6 · χ² 121 / p 2e-28	13.9 EB05 6.9 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.8	no trial data cached
Multi-organ failure	12	15.0 8.5–26.3ROR 15.1 · χ² 143 / p 3e-33	13.7 EB05 7.4 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 9.5	no trial data cached
Ventricular tachycardia	11	14.5 8.1–26.1ROR 14.7 · χ² 125 / p 2e-29	13.0 EB05 6.7 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.4	no trial data cached
Drug resistance	17	14.5 9.0–23.2ROR 14.7 · χ² 200 / p 1e-45	13.7 EB05 8.5 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 9.7	no trial data cached
Pericardial effusion	14	13.3 7.9–22.4ROR 13.5 · χ² 147 / p 3e-34	12.1 EB05 6.9 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 8.5	no trial data cached
Haematoma	15	12.6 7.6–20.8ROR 12.8 · χ² 149 / p 1e-34	11.4 EB05 6.7 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.5	no trial data cached
Multiple organ dysfunction syndrome	15	11.8 7.1–19.4ROR 11.9 · χ² 137 / p 5e-32	10.5 EB05 6.2 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.4	no trial data cached
Pulmonary hypertension	11	11.5 6.4–20.7ROR 11.6 · χ² 95 / p 8e-23	9.6 EB05 5.1 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 7.4	no trial data cached
Gastrointestinal haemorrhage	43	11.2 8.4–15.0ROR 11.7 · χ² 390 / p 4e-87	10.8 EB05 8.2 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 7.0 · 98% clinician	no trial data cached
Thrombosis	38	10.3 7.5–14.1ROR 10.7 · χ² 311 / p 7e-70	9.8 EB05 7.3 · IC025 +2.7 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 6.8 · 94% clinician	no trial data cached
Shock	10	9.6 5.2–17.8ROR 9.7 · χ² 69 / p 6e-17	7.5 EB05 4.1 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 6.1	no trial data cached
Product substitution issue	10	3.8 2.1–7.0ROR 3.8 · χ² 18 / p 1e-5	3.3 EB05 2.0 · IC025 +0.7	Reporting / coding artifact	serious PRR 5.1	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Haemorrhage	87	18.2 14.9–22.3ROR 19.9 · χ² 1,404 / p <1e-300	18.1 EB05 15.1 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.9 · 94% clinician	no trial data cached
Gastrointestinal haemorrhage	43	11.2 8.4–15.0ROR 11.7 · χ² 390 / p 4e-87	10.8 EB05 8.2 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 7.0 · 98% clinician	no trial data cached
Thrombosis	38	10.3 7.5–14.1ROR 10.7 · χ² 311 / p 7e-70	9.8 EB05 7.3 · IC025 +2.7 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 6.8 · 94% clinician	no trial data cached
Acute myocardial infarction	35	25.9 18.7–35.8ROR 26.8 · χ² 812 / p 5e-179	25.5 EB05 19.2 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 16.4 · 91% clinician	no trial data cached
Haemorrhage intracranial	23	33.6 22.4–50.3ROR 34.4 · χ² 694 / p 3e-153	32.7 EB05 22.9 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 21.2	no trial data cached
Ventricular fibrillation	21	41.3 27.0–63.1ROR 42.2 · χ² 785 / p 5e-173	39.9 EB05 27.5 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 26.1	no trial data cached
Coagulopathy	19	25.0 16.0–39.1ROR 25.5 · χ² 414 / p 2e-92	24.4 EB05 16.5 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 15.6	no trial data cached
Cardiogenic shock	19	29.1 18.7–45.5ROR 29.7 · χ² 488 / p 2e-108	28.4 EB05 19.2 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 18.4	no trial data cached
Drug resistance	17	14.5 9.0–23.2ROR 14.7 · χ² 200 / p 1e-45	13.7 EB05 8.5 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 9.7	no trial data cached
Post procedural haemorrhage	17	31.9 19.9–51.1ROR 32.4 · χ² 478 / p 4e-106	30.8 EB05 20.4 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 22.5	no trial data cached
Multiple organ dysfunction syndrome	15	11.8 7.1–19.4ROR 11.9 · χ² 137 / p 5e-32	10.5 EB05 6.2 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.4	no trial data cached
Haematoma	15	12.6 7.6–20.8ROR 12.8 · χ² 149 / p 1e-34	11.4 EB05 6.7 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.5	no trial data cached
Pericardial effusion	14	13.3 7.9–22.4ROR 13.5 · χ² 147 / p 3e-34	12.1 EB05 6.9 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 8.5	no trial data cached
Multi-organ failure	12	15.0 8.5–26.3ROR 15.1 · χ² 143 / p 3e-33	13.7 EB05 7.4 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 9.5	no trial data cached
Pulmonary hypertension	11	11.5 6.4–20.7ROR 11.6 · χ² 95 / p 8e-23	9.6 EB05 5.1 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 7.4	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Ventricular fibrillation — n=21, PRR 41.3
Acute myocardial infarction — n=35, PRR 25.9
Gastrointestinal haemorrhage — n=43, PRR 11.2

✓ A hand-written Bradford Hill causality assessment exists for this drug: Bivalirudin ↔ Haemorrhage.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Bivalirudin?

In FDA FAERS, the most frequently co-reported reaction terms for Bivalirudin are haemorrhage, gastrointestinal haemorrhage, thrombosis, acute myocardial infarction, haemorrhage intracranial, ventricular fibrillation. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Bivalirudin have an FDA boxed warning?

No. The FDA label retrieved for Bivalirudin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Bivalirudin causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 19beb2ae-6064-3c24-fe50-0cee86896979, effective 20190716; matched on openfda.generic_name.exact:"BIVALIRUDIN")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 30 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.