Eptifibatide side effects: what 766 FDA adverse event reports show

Eptifibatide · 21 reaction terms · 547 drug–reaction co-reports · data 2026-09-14

Drug class

Platelet Aggregation Inhibitor

FDA label (Established Pharmacologic Class)

Who reports

766 reports · 69% serious · 131 with death outcome · 28% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Eptifibatide injection is a platelet aggregation inhibitor indicated for: Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI). ( 1.1 ) Treatment of patients undergoing PCI (including intracorona.

FDA label, Indications and Usage

What it is

Eptifibatide is a cyclic heptapeptide containing 6 amino acids and 1 mercaptopropionyl (des-amino cysteinyl) residue. An interchain disulfide bridge is formed between the cysteine amide and the mercaptopropionyl moieties.

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 21 strongest signals

Labeled adverse reaction 2Labeled (related wording) 3Likely indication confounding 4Reporting / coding artifact 3Not in label — unassessed 9

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. 0 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
Subarachnoid haemorrhage	14	37.6 22.3–63.1ROR 38.2 · χ² 462 / p 9e-103	35.8 EB05 22.7 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 31.2	no trial data cached
Brain oedema	17	36.9 23.1–59.1ROR 37.7 · χ² 558 / p 1e-123	35.5 EB05 23.5 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 30.9	no trial data cached
Myocardial infarction (heart attack)	208	32.4 28.9–36.4ROR 44.1 · χ² 6,348 / p <1e-300	32.3 EB05 28.8 · IC025 +4.7 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 3.3 · 100% clinician	no trial data cached
Acute myocardial infarction	33	30.5 21.9–42.7ROR 31.9 · χ² 914 / p 5e-201	30.0 EB05 22.4 · IC025 +3.8 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 25.3 · 100% clinician	no trial data cached
Haematoma	26	27.4 18.8–40.0ROR 28.3 · χ² 635 / p 2e-140	26.9 EB05 19.3 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 22.8 · 96% clinician	no trial data cached
Cardiogenic shock	13	25.0 14.6–42.8ROR 25.4 · χ² 275 / p 4e-62	24.1 EB05 14.8 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 20.7	no trial data cached
Ventricular fibrillation	9	22.1 11.6–42.4ROR 22.4 · χ² 161 / p 3e-37	20.7 EB05 10.8 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 18.4	no trial data cached
Post procedural haemorrhage	9	21.1 11.0–40.4ROR 21.4 · χ² 153 / p 2e-35	19.7 EB05 10.1 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 19.5	no trial data cached
Gastric haemorrhage	8	18.9 9.5–37.7ROR 19.1 · χ² 118 / p 7e-28	17.0 EB05 7.7 · IC025 +2.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 16.3	no trial data cached
Disseminated intravascular coagulation	9	17.5 9.1–33.4ROR 17.7 · χ² 124 / p 5e-29	15.8 EB05 7.5 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 14.5	no trial data cached
Haemorrhage intracranial	9	16.4 8.6–31.5ROR 16.6 · χ² 115 / p 3e-27	14.6 EB05 6.9 · IC025 +2.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.7	no trial data cached
Drug resistance	15	16.0 9.7–26.4ROR 16.3 · χ² 196 / p 7e-45	15.2 EB05 9.1 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 14.9	no trial data cached
Thrombocytopenia (low platelets)	65	16.0 12.7–20.1ROR 17.4 · χ² 901 / p 3e-198	15.9 EB05 12.8 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.2 · 98% clinician	no trial data cached
Coronary artery occlusion	7	13.9 6.7–29.1ROR 14.0 · χ² 71 / p 1e-17	10.9 EB05 4.6 · IC025 +1.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 11.6	no trial data cached
Haemoptysis	14	13.7 8.2–23.0ROR 14.0 · χ² 153 / p 2e-35	12.6 EB05 7.2 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 11.9	no trial data cached
Cardio-respiratory arrest	19	12.4 7.9–19.3ROR 12.7 · χ² 188 / p 6e-43	11.5 EB05 7.3 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 10.3	no trial data cached
Cerebral haemorrhage	16	12.3 7.5–19.9ROR 12.5 · χ² 154 / p 9e-36	11.1 EB05 6.7 · IC025 +2.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.2	no trial data cached
No therapeutic response	5	11.1 4.6–26.5ROR 11.1 · χ² 36 / p 9e-10	7.1 EB05 2.9 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 5.1	no trial data cached
Multi-organ failure	7	10.9 5.2–22.8ROR 11.0 · χ² 54 / p 1e-13	8.0 EB05 3.7 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 9.1	no trial data cached
Coronary artery disease	11	9.9 5.5–17.8ROR 10.0 · χ² 79 / p 3e-19	8.0 EB05 4.4 · IC025 +1.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 8.3	no trial data cached
Haemorrhage	33	8.6 6.2–12.1ROR 9.0 · χ² 216 / p 3e-49	8.0 EB05 5.9 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.7 · 97% clinician	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
Myocardial infarction (heart attack)	208	32.4 28.9–36.4ROR 44.1 · χ² 6,348 / p <1e-300	32.3 EB05 28.8 · IC025 +4.7 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 3.3 · 100% clinician	no trial data cached
Thrombocytopenia (low platelets)	65	16.0 12.7–20.1ROR 17.4 · χ² 901 / p 3e-198	15.9 EB05 12.8 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.2 · 98% clinician	no trial data cached
Haemorrhage	33	8.6 6.2–12.1ROR 9.0 · χ² 216 / p 3e-49	8.0 EB05 5.9 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.7 · 97% clinician	no trial data cached
Acute myocardial infarction	33	30.5 21.9–42.7ROR 31.9 · χ² 914 / p 5e-201	30.0 EB05 22.4 · IC025 +3.8 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 25.3 · 100% clinician	no trial data cached
Haematoma	26	27.4 18.8–40.0ROR 28.3 · χ² 635 / p 2e-140	26.9 EB05 19.3 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 22.8 · 96% clinician	no trial data cached
Cardio-respiratory arrest	19	12.4 7.9–19.3ROR 12.7 · χ² 188 / p 6e-43	11.5 EB05 7.3 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 10.3	no trial data cached
Brain oedema	17	36.9 23.1–59.1ROR 37.7 · χ² 558 / p 1e-123	35.5 EB05 23.5 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 30.9	no trial data cached
Cerebral haemorrhage	16	12.3 7.5–19.9ROR 12.5 · χ² 154 / p 9e-36	11.1 EB05 6.7 · IC025 +2.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.2	no trial data cached
Drug resistance	15	16.0 9.7–26.4ROR 16.3 · χ² 196 / p 7e-45	15.2 EB05 9.1 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 14.9	no trial data cached
Haemoptysis	14	13.7 8.2–23.0ROR 14.0 · χ² 153 / p 2e-35	12.6 EB05 7.2 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 11.9	no trial data cached
Subarachnoid haemorrhage	14	37.6 22.3–63.1ROR 38.2 · χ² 462 / p 9e-103	35.8 EB05 22.7 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 31.2	no trial data cached
Cardiogenic shock	13	25.0 14.6–42.8ROR 25.4 · χ² 275 / p 4e-62	24.1 EB05 14.8 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 20.7	no trial data cached
Coronary artery disease	11	9.9 5.5–17.8ROR 10.0 · χ² 79 / p 3e-19	8.0 EB05 4.4 · IC025 +1.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 8.3	no trial data cached
Haemorrhage intracranial	9	16.4 8.6–31.5ROR 16.6 · χ² 115 / p 3e-27	14.6 EB05 6.9 · IC025 +2.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.7	no trial data cached
Disseminated intravascular coagulation	9	17.5 9.1–33.4ROR 17.7 · χ² 124 / p 5e-29	15.8 EB05 7.5 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 14.5	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.

Haematoma — n=26, PRR 27.4

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

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 Eptifibatide?

In FDA FAERS, the most frequently co-reported reaction terms for Eptifibatide are myocardial infarction, thrombocytopenia, haemorrhage, acute myocardial infarction, haematoma, cardio-respiratory arrest. 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 Eptifibatide have an FDA boxed warning?

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

Do FAERS signals prove that Eptifibatide 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 2ab98ecd-c578-4032-a3d5-ae14d58d86a7, effective 20260209; matched on openfda.generic_name.exact:"EPTIFIBATIDE")
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, 21 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.