What the label lists and what reports show
Eptifibatide side effects
Eptifibatide's FDA label: “Bleeding and hypotension are the most commonly reported adverse reactions.” FAERS holds 766 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 thrombocytopenia (65 reports).
- Generic listed
Check it at the source: the eptifibatide FDA label on DailyMed (effective May 28, 2021, Mylan Institutional LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsBleeding and hypotension are the most commonly reported adverse reactions.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | PURSUET (ACS) Placebo n (%) | Eptifibatide Injection 180/2 n (%) |
|---|---|---|
| Patients | 4696 | 4679 |
| Major bleeding | 425 (9.3%) | 498 (10.8%) |
| Minor bleeding | 347 (7.6%) | 604 (13.1%) |
| Requiring transfusions | 490 (10.4%) | 601 (12.8%) |
| Patients | 1024 | 1040 |
| Major bleeding | 4 (0.4%) | 13 (1.3%) |
| Minor bleeding | 18 (2%) | 29 (3%) |
| Requiring transfusions | 11 (1.1%) | 16 (1.5%) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reaction is also discussed elsewhere in the labeling: • Bleeding [see Contraindications (4) and Warnings and Precautions (5.1) ] Bleeding and hypotension are the most commonly reported adverse reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. A total of 16,782 patients were treated in the Phase III clinical trials (Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Eptifibatide Therapy (PURSUET), Enhanced Suppression of the Platelet IIb/IIIa Receptor with Eptifibatide Therapy (ESPRET), and Eptifibatide to Minimize Platelet Aggregation and Prevent Coronary Thrombosis II (EMPACT II)) [see Clinical Studies (14)]. These 16,782 patients had a mean age of 62 years (range: 20 to 94 years). Eighty-nine percent of the patients were Caucasian, with the remainder being predominantly Black (5%) and Hispanic (5%). Sixty-eight percent were men. …
Source: FDA drug label, Mylan Institutional LLC, effective May 28, 2021 (SPL set 88a37f9c-496b-4a6b-9665-4550abba04f1), via openFDA; the full label on DailyMed
What do FAERS reports show?
766 reports list eptifibatide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 131 are coded as a death and 290 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 19 reactions below, 3 are 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Eptifibatide: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions