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Tirofiban

Tirofiban is an intravenous (IV) platelet-blocking medicine used in hospitals to lower the risk of death, heart attack, and repeat heart problems in people with non-ST elevation acute coronary syndrome (NSTE-ACS).

Brand name Aggrastat
Drug class Platelet Aggregation Inhibitor
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 22, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 6 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026 🚨Recall on record
Tirofiban at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Tirofiban (Aggrastat) is a specialist IV (into a vein) drug used in the hospital for non-ST elevation acute coronary syndrome (NSTE-ACS, certain heart attacks and unstable chest pain), blocking the GP IIb/IIIa receptor platelets use to clump, which lowers the risk of death, heart attack or another heart procedure; around since about 1998, it is available as a generic. Most people notice little beyond its most common side effect, oozing or bruising where the heart catheter went in. Tell your nurse right away about bleeding that will not stop, blood in urine or vomit, unusual bruising (it can sharply drop platelets) or allergy signs like trouble breathing.

Clinical pearls

  • Platelet counts are checked about six hours after starting and then daily, and both tirofiban and heparin stop if they drop.
  • If you had low platelets after tirofiban or a similar drug before, say so, since the risk may be higher.
  • Kidney function sets the infusion rate, and tirofiban has not been established for people on hemodialysis.
  • It runs as a steady drip for up to 18 hours, and its platelet-blocking effect fades once the drip stops.
How you get itPrescription only
Comes asInjection
Earliest FDA record1998
Companies listing it with the FDA5
FDA label last updatedJan 1, 2025
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Tirofiban, written from its FDA label.

What Tirofiban is used for

▾

Tirofiban is used for one heart-related purpose across its supported products.

  • Reduces the rate of thrombotic cardiovascular events (death, heart attack, or refractory ischemia/repeat cardiac procedure) in non-ST elevation acute coronary syndrome (NSTE-ACS).
  • This applies to Aggrastat and to tirofiban hydrochloride injection products, all given intravenously.

How Tirofiban works

▾

Tirofiban is a reversible blocker of the GP IIb/IIIa receptor on platelets. This receptor is the main way platelets clump together. Blocking it makes clots less likely to form.

With the recommended regimen, more than 90% of platelet clumping is blocked within 10 minutes. The effect fades after the infusion stops.

Tirofiban dosage

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Tirofiban is given only through an IV by healthcare professionals. An initial dose is given over about 5 minutes, followed by a continuous infusion for up to 18 hours. A lower infusion rate is used if kidney function is reduced. The dose is based on body weight and kidney function.

Dosing details from the FDA-approved label

From the Tirofiban prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Recommended dosage (patients with creatinine clearance >60 mL/min)
    • 25 mcg/kg administered intravenously within 5 minutes and then 0.15 mcg/kg/min for up to 18 hours
  • Patients with CrCl ≤60 mL/min (calculated using the Cockcroft-Gault equation with actual body weight)
    • 25 mcg/kg intravenously within 5 minutes and then 0.075 mcg/kg/min, for up to 18 hours
    • Reduced maintenance infusion rate for renal impairment
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Administer intravenously 25 mcg/kg within 5 minutes and then 0.15 mcg/kg/min for up to 18 hours. In patients with creatinine clearance ≤60 mL/min, give 25 mcg/kg within 5 minutes and then 0.075 mcg/kg/min. ( 2 ) 2.1 Recommended Dosage The recommended dosage is 25 mcg/kg administered intravenously within 5 minutes and then 0.15 mcg/kg/min for up to 18 hours. 2.2 Administration For intravenous use only. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. To open the 100 mL or 250 mL premixed bag, first tear off its foil overpouch. The plastic may be somewhat opaque because of moisture absorption during sterilization; the opacity will diminish gradually. Check for leaks by squeezing the inner bag firmly; if any leaks are found or sterility is suspect then the solution should be discarded. Do not use unless the solution is clear and the seal is intact. Administration Instructions Withdraw the bolus dose of AGGRASTAT from the 15 mL premixed bolus vial into a syringe. Alternatively, the bolus dose of AGGRASTAT may be administered from the 100 mL or 250 mL premixed bag. Do not dilute. Administer the bolus dose within 5 minutes via a syringe or IV pump. For patients ≥ 167 kg, it is recommended that the bolus dose be administered via syringe from the 15 mL premixed bolus vial, to ensure that delivery time does not exceed 5 minutes. Immediately following the bolus dose administration, administer the maintenance infusion the 100 mL premixed bag or the 250 mL premixed bag via an IV pump. Discard any unused portion left in the vial or bag.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Tirofiban side effects

▾

Bleeding is the most common side effect.

Common side effects

  • Bleeding (the most common side effect), often at the catheter access site
  • Swelling (edema)
  • Pelvic pain
  • Slow heartbeat (bradycardia)
  • Dizziness
  • Leg pain
  • Sweating
  • Lowered platelet counts

When to get medical help

  • Tell your care team right away about bleeding that won't stop, blood in urine or vomit, or coughing up blood
  • Report signs of a severe allergic reaction, such as trouble breathing or swelling, immediately
  • Low platelet counts can be severe, so your team will check blood tests; report unusual bruising or bleeding

Tirofiban warnings and precautions

▾
  • Serious bleeding: tirofiban is stopped if bleeding can't be controlled.
  • Low platelets: counts are monitored, and tirofiban and heparin are stopped if thrombocytopenia is confirmed.
  • Allergic reactions: severe reactions, including anaphylaxis, have occurred, often on the first day of infusion.

Tirofiban interactions

▾

Some drugs add to bleeding risk.

  • Fibrinolytics (clot dissolvers): higher bleeding risk
  • Anticoagulants (blood thinners): higher bleeding risk
  • Other antiplatelet drugs: higher bleeding risk
  • Diazepam: should not share an IV line with tirofiban

Interactions listed in the FDA-approved label

From the Tirofiban prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Fibrinolytics, anticoagulants and antiplatelet drugs: Concomitant use increases the risk of bleeding.
Read the label’s full interactions text

7 DRUG INTERACTIONS Concomitant use of fibrinolytics, anticoagulants and antiplatelet drugs increases the risk of bleeding. Coadministration of fibrinolytics, anticoagulants and antiplatelet agents, increases the risk of bleeding. ( 7 )

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Tirofiban

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  • Do not use with a severe allergy to tirofiban or its components.
  • Do not use with a history of low platelets after prior tirofiban.
  • Do not use with active internal bleeding, a bleeding disorder history, or major surgery or severe trauma in the past month.
  • Reduced kidney function needs a lower dose; not established with hemodialysis.
  • Older adults: no dose adjustment, though bleeding is more common in general.
  • Pregnancy: published reports have not shown an association with birth defects or pregnancy loss.
  • Breastfeeding: no human data; weigh benefits and risks.
  • Children: not established.

Tirofiban overdose

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In trials, accidental overdoses mostly caused bleeding, usually minor bleeding in mucous membranes and at catheter sites. Treatment involves assessing the patient and stopping or adjusting the infusion. Tirofiban can be removed by hemodialysis.

What Tirofiban does in the body

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Tirofiban inhibits platelet function and prolongs bleeding time. Its effect tracks its level in the blood. After the infusion stops, platelet function returns to near baseline in 4 to 8 hours in about 90% of patients with coronary artery disease. Adding heparin increases bleeding time.

How your body processes Tirofiban

▾

Tirofiban has a half-life of about 2 hours. It is cleared mostly by the kidneys, with about 65% in urine and 25% in feces, largely unchanged. Metabolism is limited. Clearance falls in people with reduced kidney function, but is not affected by sex, race, age, or liver impairment.

How to store Tirofiban

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Store at 25°C (77°F); excursions permitted between 15° and 30°C (59° and 86°F). Do not freeze. Protect from light during storage.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

202

Supplements & herbs that interact with Tirofiban

202 supplements and herbal products have documented interactions with Tirofiban in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 2
  • Moderate · 183
  • Minor · 17
Every supplement checked against Tirofiban — ranked by severity The full interaction hub: 2 major · 183 moderate · 17 minor · every one linked to its full report. Check Tirofiban against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Tirofiban: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Tirofiban — the kind of thing our pharmacy team would talk through with you at the counter.

What is tirofiban for?

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It lowers the chance of death, heart attack, or repeat heart problems in people with non-ST elevation acute coronary syndrome. It does this by keeping platelets from clumping into clots.

How will I get it?

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Only through an IV in a hospital setting. You get a quick starting dose and then a steady infusion for up to 18 hours. If your kidneys work less well, your team uses a lower rate.

What side effect should I expect most?

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Bleeding, often at the site where the catheter went in. Some people also have swelling, dizziness, leg or pelvic pain, sweating, or a slow heartbeat. Tell your nurse about anything unusual.

What should I report right away?

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Bleeding that won't stop, blood in urine or vomit, unusual bruising, or signs of a serious allergy like trouble breathing or swelling. Your team also checks your platelet counts with blood tests.

Can I get it with other blood thinners?

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Sometimes, but combining it with clot dissolvers, anticoagulants, or other antiplatelet drugs raises bleeding risk. Your care team weighs this carefully.

Is it safe in pregnancy?

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Published reports have not linked it to birth defects or pregnancy loss. A heart attack is dangerous in pregnancy, so your doctor weighs the benefit against any risk.

Is Tirofiban available over the counter?

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No. Tirofiban is a prescription medicine: every Tirofiban product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Tirofiban first available?

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The earliest FDA record we hold for Tirofiban is from 1998: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Tirofiban was first used.

Who makes Tirofiban?

▾
5 companies currently list Tirofiban products in the FDA's NDC Directory, including Medicure International Inc, Eugia US LLC, Nexus Pharmaceuticals LLC. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Tirofiban on HelloPharmacist

Detailed data & references for Tirofiban Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Tirofiban forms and strengths (how it comes)

Tirofiban is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

By injection · Into a vein
Brands Aggrastat
How this form is used
What it may be used for
  • Aggrastat is used to reduce thrombotic cardiovascular events in NSTE-ACS.
  • Tirofiban and Tirofiban Hydrochloride injection are used to reduce thrombotic cardiovascular events in NSTE-ACS.
Important instructions
  • Aggrastat is for intravenous use only, given as a bolus within 5 minutes and then a maintenance infusion.
  • Tirofiban Hydrochloride injection is for intravenous use only and is not diluted.
  • Tirofiban Hydrochloride should not be given through the same IV line as diazepam.
Available strengths 5 strengths
19 FDA-listed product records ⓘ

Tirofiban on the U.S. market: products, makers and brands

How Tirofiban appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

5 companies list 10 Tirofiban product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 1998. Brand names on the directory include Aggrastat; the rest are generics.

1
Dose forms ⓘ
5
Labelers (makers, repackagers, distributors)
3
Brand names
10
FDA-listed product records ⓘ
1998
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Medicure International Inc40%
Eugia US LLC20%
Nexus Pharmaceuticals LLC20%
Gland Pharma Limited10%
Sagent Pharmaceuticals10%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Compare Tirofiban products

A representative set of FDA-listed product records for Tirofiban — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Injection
5 mg/100 mL Intravenous Eugia US LLC ANDA View NDC →
12.5 mg/250 mL Intravenous Eugia US LLC ANDA View NDC →
12.5 mg/250 mL Intravenous Gland Pharma Limited ANDA View NDC →
3.75 mg/15 mL Intravenous Medicure International Inc × 2 listings NDA View NDC →
5 mg/100 mL Intravenous Medicure International Inc × 2 listings NDA View NDC →
50 mcg/mL Intravenous Nexus Pharmaceuticals LLC × 2 listings ANDA View NDC →
50 mcg/mL Intravenous Sagent Pharmaceuticals ANDA View NDC →

Showing 10 of 10 products — FDA National Drug Code Directory. See every product, package size and price: browse all 10 Tirofiban NDCs →

Tirofiban recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list one Tirofiban recall since July 2021, covering 2 product listings. It is still ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Apr 21, 2025 · Eugia US LLC
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
  • Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 0852… Lots: Lot# : 3TF24001, Exp 3/31/2026 FDA record D-0390-2025 →
  • Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520,… Lots: Lot #: 3TF24002A, Exp 11/30/2026 FDA record D-0389-2025 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Tirofiban RxCUI 73137 1 dose form · 3 strengths

Look up RxCUI 73137 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Tirofiban brand names

Tirofiban is sold under one brand name in the FDA directory — Aggrastat. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Aggrastat

Who makes Tirofiban: manufacturers and labelers

5 companies list Tirofiban products with the FDA. By number of product records, the largest are Medicure International Inc, Eugia US LLC, Nexus Pharmaceuticals LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Medicure International Inc 4 Eugia US LLC 2 Nexus Pharmaceuticals LLC 2 Gland Pharma Limited 1 Sagent Pharmaceuticals 1

Tirofiban drug class (RxNorm)

Tirofiban belongs to the Platelet Aggregation Inhibitor class.

Pharmacologic class Platelet Aggregation Inhibitor
Drug family (ATC) Platelet aggregation inhibitors excl. heparin

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Tirofiban page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jan 1, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Tirofiban.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Tirofiban after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
6
Finished products in the current FDA directory
10
Companies listing them (makers, repackagers, distributors)
5
FDA labeler codes behind them ⓘ
5
Linked representative label ⓘ
Medicure International Inc
Linked label effective
Jan 1, 2025
Composite sections available
23
Linked SPL Set ID
e850111f-e713-41a2-9c65-21c517cf5511
Linked SPL Document ID
d7b2e8c6-afd1-4e94-b780-ed2fc439e3f3
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Medicure International Inc is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →