What the label lists and what reports show
Tirofiban side effects
Tirofiban's FDA label: “Bleeding is the most commonly reported adverse reaction.” FAERS holds 2,889 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 (377 reports).
- Generic listed
Check it at the source: the tirofiban FDA label on DailyMed (effective January 1, 2025, Medicure International Inc); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsBleeding is the most commonly reported adverse reaction.
Table 4 Non-bleeding Adverse Reactions in PRISM-PLUS
| Reaction | AGGRASTAT + Heparin (N=1953) % | Heparin alone (N=1887) % |
|---|---|---|
| Edema/swelling | 2 | 1 |
| Pain, pelvic | 6 | 5 |
| Reaction, vasovagal | 2 | 1 |
| Bradycardia | 4 | 3 |
| Dissection, coronary artery | 5 | 4 |
| Pain, leg | 3 | 2 |
| Dizziness | 3 | 2 |
| Sweating | 2 | 1 |
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, continuedBleeding is the most commonly reported adverse reaction. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Medicure at 1-800-509-0544 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial 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 clinical practice. In the PRISM (Platelet Receptor Inhibition for Ischemic Syndrome Management), PRISM-PLUS (Platelet Receptor Inhibition for Ischemic Syndrome Management – Patients Limited by Unstable Signs and Symptoms) and RESTORE (Randomized Efficacy Study of Tirofiban for Outcomes and Restenosis) trials, 1946 patients received AGGRASTAT in combination with heparin and 2002 patients received AGGRASTAT alone for about 3 days. Forty-three percent of the population was >65 years of age and approximately 30% of patients were female. In clinical studies with the recommended regimen (25 mcg/kg bolus followed by a 0.15 mcg/kg/min maintenance infusion), AGGRASTAT was administered in combination with aspirin, clopidogrel and heparin or bivalirudin to over 8000 patients for typically ≤24 hours. Approximately 30% of the population was >65 years of age and approximately 25% were female. …
Source: FDA drug label, Medicure International Inc, effective January 1, 2025 (SPL set fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,889 reports list tirofiban among the medicines taken, each a report of something that happened, not proof the medicine caused it; 456 are coded as a death and 449 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. Reports rose sharply in 2019 (1,164, against a median of 77 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 20 reactions below, 2 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?
- Tirofiban: 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