Prescription medicine
Tirofiban Brand names: Aggrastat
Tirofiban (Aggrastat) is a prescription medicine with an FDA approval on record since 1998. FDA's NDC Directory lists it from 4 generic labelers.
- Generic listed
Check it at the source: the tirofiban FDA label on DailyMed (effective January 1, 2025, Medicure International Inc); the NDA 20913 record on Drugs@FDA; every tirofiban label on DailyMed.
Highlights of the record
FDA label of January 1, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageAGGRASTAT® is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).
Forms and strengths
- 3.75 mg/15ml
- 5 mg/100ml
- 12.5 mg/250ml
Injection (solution); injection.
On the market
- Earliest approval on file
- May 14, 1998 Aggrastat, Medicure; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first April 8, 2021; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 4 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2025 0 Class I among all firms' recalls; latest April 21, 2025
- FAERS reports
- 2,889 through July 30, 2026
What is tirofiban used for?
From the label: indications and usageAGGRASTAT® is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS). AGGRASTAT is a platelet aggregation inhibitor indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).
Conditions named in the indications of tirofiban's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Platelet Aggregation Inhibitor.
Source: FDA drug label (AGGRASTAT), Medicure International Inc, effective January 1, 2025 (SPL set fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f), via openFDA; the full label on DailyMed
Is there a generic for tirofiban (Aggrastat)?
The FDA approved the first generic tirofiban on April 8, 2021. 3 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists tirofiban from 4 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1998 earliest approval on file
- 2021 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has tirofiban been recalled?
The FDA's Enforcement Report lists 2 recalls naming tirofiban since 2025: 0 Class I (the most serious), 2 Class II, 0 Class III; 2 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 21, 2025 | Class II | Eugia US LLC | Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the tirofiban label say about other medicines?
The tirofiban label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 3 other medicines name tirofiban. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Heparin | warnings and precautions | If bleeding cannot be controlled discontinue AGGRASTAT. ( 5.1 ) Thrombocytopenia: Discontinue AGGRASTAT and heparin. |
Source: FDA drug label (AGGRASTAT), 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 for tirofiban?
The FDA Adverse Event Reporting System holds 2,889 reports that list tirofiban among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as tirofiban?
2 other medicines are given the same way (intravenous) and in the same FDA class as tirofiban or labeled mainly for the same use (heart attack and coronary artery disease), the same class first. Heart attack and coronary artery disease lists all 38 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Eptifibatide | Heart attack and coronary artery disease | 8 labelers | n/a | No current entry |
| Cangrelor | Heart attack and coronary artery disease | 1 labeler | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does tirofiban compare with medicines for the same use?
1 side-by-side page set tirofiban beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other platelet aggregation inhibitors
- the pharmacologic class, with prices and generics
- Tirofiban side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other