At a glance
What is it—and why does it matter?
PRR/ROR detect statistical disproportionality in reporting, which can be influenced by reporting biases and does not establish causality. The labeling lists renal dialysis dependency as a contraindication to eptifibatide therapy. The labeled dosage form/strength is a premixed eptifibatide injection at 0.75 mg/mL (75 mg/100 mL) in a single-dose Galaxy container, intended only for IV infusion (not IV bolus). The labeling states there are no pediatric studies establishing safety or efficacy for eptifibatide.
Sources for this introduction: [1] [2] [3] [4]
This published profile is a reference in progress. Findings retain their source context; missing topics are marked below.
What is it?
A molecule, not a product name.
This profile does not yet contain a published summary for this topic. This is a coverage gap, not evidence that no research exists.
How does it work?
Target, response, and disposition.
Mechanism
Because the data come from spontaneous reporting, the results reflect reporting patterns and signal detection rather than incidence rates or causality.
- Source records
- 1
- Independent studies
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“We extracted reports listing the 3 GPIs as the primary suspect from the US Food and Drug Administration Adverse Event Reporting System database.”
Pharmacovigilance analysis of glycoprotein IIb/IIIa inhibitors: A FAERS-based signal detection study. · Abstract
pubmed:42566619:34196e1f4897:34196e1f4897
Mechanism
Adverse events were coded into preferred terms and then mapped to system organ classes.
- Source records
- 1
- Independent studies
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Adverse events were systematically coded using preferred terms and subsequently mapped to system organ classes.”
Pharmacovigilance analysis of glycoprotein IIb/IIIa inhibitors: A FAERS-based signal detection study. · Abstract
pubmed:42566619:34196e1f4897:34196e1f4897
Mechanism
Eptifibatide is described as an antagonist of the platelet glycoprotein IIb/IIIa receptor (GPIIb/IIIa).
- Source records
- 1
- Independent studies
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“including the administration of the GPIIb/IIIa antagonist eptifibatide as rescue therapy.”
Adaptive Antithrombotic Strategy for Tandem Occlusion Stroke: Escalating Therapy After Thrombectomy and Stenting. · Abstract
pubmed:42121987:e45891704c21:e45891704c21
Mechanism
Activity for eptifibatide is assessed using an assay measuring inhibition of human platelet aggregation.
- Source records
- 1
- Independent studies
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Assay: inhibition of human platelet aggregation.”
IUPHAR interactions for eptifibatide · Interaction 78539
iuphar-interactions:6585:785d0178f0b6:785d0178f0b6
Mechanism
The study compared safety signals for tirofiban, abciximab, and eptifibatide using FAERS.
- Source records
- 1
- Independent studies
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“This study compares the safety signals of 3 glycoprotein IIb/IIIa inhibitors (GPIs) - tirofiban, abciximab, and eptifibatide - using the US Food and Drug Administration Adverse Event Reporting System, aiming to guide clinical application.”
Pharmacovigilance analysis of glycoprotein IIb/IIIa inhibitors: A FAERS-based signal detection study. · Abstract
pubmed:42566619:34196e1f4897:34196e1f4897
Mechanism
PRR/ROR detect statistical disproportionality in reporting, which can be influenced by reporting biases and does not establish causality.
- Source records
- 1
- Independent studies
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“To identify potential safety signals, we employed disproportionality analysis algorithms, including the proportional reporting ratio and reporting odds ratio, with predefined thresholds for signal detection.”
Pharmacovigilance analysis of glycoprotein IIb/IIIa inhibitors: A FAERS-based signal detection study. · Abstract
pubmed:42566619:34196e1f4897:34196e1f4897
What has been studied?
What the evidence says.
Studied populations
The labeling states there are no pediatric studies establishing safety or efficacy for eptifibatide.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Safety and effectiveness of eptifibatide in pediatric patients have not been studied.”
These highlights do not include all the information needed to use EPTIFIBATIDE INJECTION safely and effectively. See full prescribing information for EPTIFIBATIDE INJECTION.EPTIFIBATIDE injection, for intravenous infusion only; not for intravenous bolus useInitial U.S. Approval: 1998 · 8.4 Pediatric Use
dailymed:5f46b76b-5c83-49b9-ada8-4ad5cf81a38c:94a1ea6e264c:94a1ea6e264c
Risks and interactions
Risks, organized for scanning.
Contraindications
The labeling lists renal dialysis dependency as a contraindication to eptifibatide therapy.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“•Dependency on renal dialysis”
These highlights do not include all the information needed to use EPTIFIBATIDE INJECTION safely and effectively. See full prescribing information for EPTIFIBATIDE INJECTION.EPTIFIBATIDE injection, for intravenous infusion only; not for intravenous bolus useInitial U.S. Approval: 1998 · 4 CONTRAINDICATIONS
dailymed:5f46b76b-5c83-49b9-ada8-4ad5cf81a38c:94a1ea6e264c:94a1ea6e264c
Interactions
The labeling warns that combining eptifibatide with multiple antithrombotic/antiplatelet drugs (including chronic NSAID use) increases bleeding risk.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Coadministration of antiplatelet agents, thrombolytics, heparin, aspirin, and chronic NSAID use increases the risk of bleeding.”
These highlights do not include all the information needed to use EPTIFIBATIDE INJECTION safely and effectively. See full prescribing information for EPTIFIBATIDE INJECTION.EPTIFIBATIDE injection, for intravenous infusion only; not for intravenous bolus useInitial U.S. Approval: 1998 · 7.1 Use of Thrombolytics, Anticoagulants, and Other Antiplatelet Agents
dailymed:5f46b76b-5c83-49b9-ada8-4ad5cf81a38c:94a1ea6e264c:94a1ea6e264c
Safety findings
Bleeding is a key safety risk for eptifibatide; the labeling states eptifibatide administration is associated with increased TIMI major and minor bleeding.
- Source records
- 2
- Regulatory records
- 2
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Administration of eptifibatide is associated with an increase in major and minor bleeding, as classified by the criteria of the Thrombolysis in Myocardial Infarction Study group (TIMI)[seeAdverse Reactions (6.1)].”
These highlights do not include all the information needed to use EPTIFIBATIDE INJECTION safely and effectively. See full prescribing information for EPTIFIBATIDE INJECTION.EPTIFIBATIDE injection, for intravenous infusion only; not for intravenous bolus useInitial U.S. Approval: 1998 · 5.1 Bleeding
dailymed:5f46b76b-5c83-49b9-ada8-4ad5cf81a38c:94a1ea6e264c:94a1ea6e264c - supports · Source-backed record
“Administration of eptifibatide is associated with an increase in major and minor bleeding, as classified by the criteria of the Thrombolysis in Myocardial Infarction Study group (TIMI)[seeAdverse Reactions (6.1)].”
These highlights do not include all the information needed to use EPTIFIBATIDE INJECTION safely and effectively. See full prescribing information for EPTIFIBATIDE INJECTION.EPTIFIBATIDE injection, for intravenous useInitial U.S. Approval: 1998 · 5.1 Bleeding
dailymed:88a37f9c-496b-4a6b-9665-4550abba04f1:08dddcadf442:08dddcadf442
Products and regulatory status
Same ingredient. Different records.
Regulatory status
For patients undergoing PCI (including intracoronary stenting), eptifibatide injection has an approved indication to reduce a composite endpoint of death, new MI, or urgent intervention.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new MI, or need for urgent intervention in patients undergoing PCI, including those undergoing intracoronary stenting[seeClinical Studies (14.1,14.2)].”
These highlights do not include all the information needed to use EPTIFIBATIDE INJECTION safely and effectively. See full prescribing information for EPTIFIBATIDE INJECTION.EPTIFIBATIDE injection, for intravenous useInitial U.S. Approval: 1998 · 1.2 Percutaneous Coronary Intervention (PCI)
dailymed:88a37f9c-496b-4a6b-9665-4550abba04f1:08dddcadf442:08dddcadf442
Regulatory status
For ACS (UA/NSTEMI), eptifibatide injection has an FDA-labeled indication to reduce a composite clinical endpoint (death or new MI), including in both medically managed patients and those undergoing PCI.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (MI) in patients with ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI).”
These highlights do not include all the information needed to use EPTIFIBATIDE INJECTION safely and effectively. See full prescribing information for EPTIFIBATIDE INJECTION.EPTIFIBATIDE injection, for intravenous infusion only; not for intravenous bolus useInitial U.S. Approval: 1998 · 1.1 Acute Coronary Syndrome (ACS)
dailymed:5f46b76b-5c83-49b9-ada8-4ad5cf81a38c:94a1ea6e264c:94a1ea6e264c
Regulatory status
For patients undergoing PCI (including intracoronary stenting), eptifibatide injection has a labeled indication to reduce a composite endpoint of death, new MI, or urgent intervention.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new MI, or need for urgent intervention in patients undergoing PCI, including those undergoing intracoronary stenting[seeClinical Studies (14.1,14.2)].”
These highlights do not include all the information needed to use EPTIFIBATIDE INJECTION safely and effectively. See full prescribing information for EPTIFIBATIDE INJECTION.EPTIFIBATIDE injection, for intravenous infusion only; not for intravenous bolus useInitial U.S. Approval: 1998 · 1.2 Percutaneous Coronary Intervention (PCI)
dailymed:5f46b76b-5c83-49b9-ada8-4ad5cf81a38c:94a1ea6e264c:94a1ea6e264c
Regulatory status
In ACS (unstable angina or NSTEMI), eptifibatide injection has an approved indication to reduce a composite endpoint of death or new myocardial infarction, including in patients treated medically or with percutaneous coronary intervention.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (MI) in patients with ACS (unstable angina [UA]/non-ST- elevation myocardial infarction [NSTEMI]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI).”
These highlights do not include all the information needed to use EPTIFIBATIDE INJECTION safely and effectively. See full prescribing information for EPTIFIBATIDE INJECTION.EPTIFIBATIDE injection, for intravenous useInitial U.S. Approval: 1998 · 1.1 Acute Coronary Syndrome (ACS)
dailymed:88a37f9c-496b-4a6b-9665-4550abba04f1:08dddcadf442:08dddcadf442
Administration context
The practical clinical context.
Administration
The labeled route for eptifibatide injection (Galaxy container) is intravenous infusion; intravenous bolus use is not indicated for this presentation.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Eptifibatide injection inGalaxycontainer is for intravenous infusion only, not for intravenous bolus use.”
These highlights do not include all the information needed to use EPTIFIBATIDE INJECTION safely and effectively. See full prescribing information for EPTIFIBATIDE INJECTION.EPTIFIBATIDE injection, for intravenous infusion only; not for intravenous bolus useInitial U.S. Approval: 1998 · 2 DOSAGE AND ADMINISTRATION
dailymed:5f46b76b-5c83-49b9-ada8-4ad5cf81a38c:94a1ea6e264c:94a1ea6e264c
Administration
Baseline labs are recommended prior to eptifibatide infusion to detect hemostatic abnormalities, with additional ACT measurement for PCI patients.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Before infusion of eptifibatide injection, the following laboratory tests should be performed to identify pre-existing hemostatic abnormalities: hematocrit or hemoglobin, platelet count, serum creatinine, and PT/aPTT. In patients undergoing PCI, the activated clotting time (ACT) should also be measured.”
These highlights do not include all the information needed to use EPTIFIBATIDE INJECTION safely and effectively. See full prescribing information for EPTIFIBATIDE INJECTION.EPTIFIBATIDE injection, for intravenous useInitial U.S. Approval: 1998 · 2 DOSAGE AND ADMINISTRATION
dailymed:88a37f9c-496b-4a6b-9665-4550abba04f1:08dddcadf442:08dddcadf442
Dose records
In ACS patients with normal renal function, the labeled regimen begins with a weight-based IV bolus (180 mcg/kg) followed by a maintenance infusion (2 mcg/kg/min).
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Patients withACS180 mcg/kg intravenous (IV) bolus as soon as possible after diagnosis, followed by continuous infusion of 2 mcg/kg/min”
These highlights do not include all the information needed to use EPTIFIBATIDE INJECTION safely and effectively. See full prescribing information for EPTIFIBATIDE INJECTION.EPTIFIBATIDE injection, for intravenous infusion only; not for intravenous bolus useInitial U.S. Approval: 1998 · 2.1 Dosage in Acute Coronary Syndrome (ACS)
dailymed:5f46b76b-5c83-49b9-ada8-4ad5cf81a38c:94a1ea6e264c:94a1ea6e264c
Dose records
The labeled ACS regimen for normal renal function is a 180 mcg/kg IV bolus followed by a 2 mcg/kg/min infusion.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Patients with ACS180 mcg/kg intravenous (IV) bolus as soon as possible after diagnosis, followed by continuous infusion of 2 mcg/kg/min”
These highlights do not include all the information needed to use EPTIFIBATIDE INJECTION safely and effectively. See full prescribing information for EPTIFIBATIDE INJECTION.EPTIFIBATIDE injection, for intravenous useInitial U.S. Approval: 1998 · 2.1 Dosage in Acute Coronary Syndrome (ACS)
dailymed:88a37f9c-496b-4a6b-9665-4550abba04f1:08dddcadf442:08dddcadf442
Dose records
In PCI patients with normal renal function, the labeled regimen includes two 180 mcg/kg IV boluses 10 minutes apart with a 2 mcg/kg/min infusion started immediately after the first bolus.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Patients with PCI180 mcg/kg IV bolus immediately before PCI followed by continuous infusion of 2 mcg/kg/min and a second bolus of 180 mcg/kg (given 10 minutes after the first bolus)”
These highlights do not include all the information needed to use EPTIFIBATIDE INJECTION safely and effectively. See full prescribing information for EPTIFIBATIDE INJECTION.EPTIFIBATIDE injection, for intravenous infusion only; not for intravenous bolus useInitial U.S. Approval: 1998 · 2.2 Dosage in Percutaneous Coronary Intervention (PCI)
dailymed:5f46b76b-5c83-49b9-ada8-4ad5cf81a38c:94a1ea6e264c:94a1ea6e264c
Dose records
The labeled dosage form/strength is a premixed eptifibatide injection at 0.75 mg/mL (75 mg/100 mL) in a single-dose Galaxy container, intended only for IV infusion (not IV bolus).
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“•Injection: 75 mg of eptifibatide per 100 mL (0.75 mg/mL) in a single-doseGalaxycontainer, for intravenous infusion only, not for intravenous bolus use”
These highlights do not include all the information needed to use EPTIFIBATIDE INJECTION safely and effectively. See full prescribing information for EPTIFIBATIDE INJECTION.EPTIFIBATIDE injection, for intravenous infusion only; not for intravenous bolus useInitial U.S. Approval: 1998 · 3 DOSAGE FORMS AND STRENGTHS
dailymed:5f46b76b-5c83-49b9-ada8-4ad5cf81a38c:94a1ea6e264c:94a1ea6e264c
Dose records
The labeled PCI regimen (normal renal function) uses a double-bolus strategy (180 mcg/kg at 0 and 10 minutes) plus a 2 mcg/kg/min infusion.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Patients withPCI180 mcg/kg IV bolus immediately before PCI followed by continuous infusion of 2 mcg/kg/min and a second bolus of 180 mcg/kg (given 10 minutes after the first bolus)”
These highlights do not include all the information needed to use EPTIFIBATIDE INJECTION safely and effectively. See full prescribing information for EPTIFIBATIDE INJECTION.EPTIFIBATIDE injection, for intravenous useInitial U.S. Approval: 1998 · 2.2 Dosage in Percutaneous Coronary Intervention (PCI)
dailymed:88a37f9c-496b-4a6b-9665-4550abba04f1:08dddcadf442:08dddcadf442
Research status + gaps
What still needs better answers?
- No publishable claim yet for: effect, identity
- 109 compiled claim(s) withheld by automated assurance: assurance_score_below_0.58 (59), assurance_score_below_0.72 (45), current_regulatory_source_required (15), extraction_ambiguity (77), high_risk_requires_regulatory_or_two_independent_sources (48), no_direct_support (102), proposal_not_staged (3)
These are the limits of this profile, not an exhaustive list of scientific uncertainties.
References + discovery
Open the records yourself.
- These highlights do not include all the information needed to use EPTIFIBATIDE INJECTION safely and effectively. See full prescribing information for EPTIFIBATIDE INJECTION.EPTIFIBATIDE injection, for intravenous infusion only; not for intravenous bolus useInitial U.S. Approval: 1998 ↗
dailymed · published 2024-05-29 · retrieved 2026-09-04T19:33:29Z
- These highlights do not include all the information needed to use EPTIFIBATIDE INJECTION safely and effectively. See full prescribing information for EPTIFIBATIDE INJECTION.EPTIFIBATIDE injection, for intravenous useInitial U.S. Approval: 1998 ↗
dailymed · published 2021-05-28 · retrieved 2026-09-04T19:33:30Z
- IUPHAR interactions for eptifibatide ↗
iuphar-interactions · published 2026-08-26 · retrieved 2026-08-26T08:42:26Z
- Adaptive Antithrombotic Strategy for Tandem Occlusion Stroke: Escalating Therapy After Thrombectomy and Stenting. ↗
pubmed · published 2026-04-24 · retrieved 2026-08-26T08:42:26Z
- Pharmacovigilance analysis of glycoprotein IIb/IIIa inhibitors: A FAERS-based signal detection study. ↗
pubmed · published 2026-08-07 · retrieved 2026-08-26T08:42:26Z
Publication history and provenance
Version 7 · Automated assessment · 2026-09-04T19:33:30Z
0fa4bc5c32858c134352f146144e909a0f09ead2e992bcab2fc9cb3416e37028