Argatroban
Argatroban is an intravenous blood thinner (a direct thrombin inhibitor) used to prevent or treat blood clots in adults with heparin-induced thrombocytopenia (HIT), and as an anticoagulant during a heart procedure called percutaneous coronary intervention (PCI) in adults with or at risk for HIT.
🧬 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 17 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 →
Argatroban is a hospital-only IV blood thinner that blocks thrombin directly, without needing antithrombin III (the helper protein heparin relies on), making it a standard specialist choice for adults with heparin-induced thrombocytopenia (HIT, a heparin reaction that drops platelets and raises clot risk), including during PCI to open heart arteries; it has been on the market since about 2005 and is available generically. Apart from bleeding, it is generally well tolerated, though low blood pressure, nausea and minor oozing at a groin puncture site can occur. Serious bleeding is the thing to watch, with no specific antidote, so report blood in stool, vomiting blood or new bruising right away.
Clinical pearls
- Mention any liver disease, since argatroban is cleared by the liver and its effect can linger beyond 4 hours after stopping.
- Kidney problems need no dose change, one reason it is often favored when kidney function is poor.
- During the switch to warfarin, argatroban itself pushes the INR clotting test higher, so overlap readings need careful interpretation.
- After HIT, avoid every form of heparin, including IV line flushes, and make sure it is recorded as a heparin allergy.
Patient information guide A plain-language walkthrough of Argatroban, written from its FDA label.
What Argatroban is used for
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Argatroban is a blood thinner given into a vein for these uses in adults:
- Preventing or treating blood clots (thrombosis) in people with heparin-induced thrombocytopenia (HIT).
- Acting as an anticoagulant in people with or at risk for HIT who are having percutaneous coronary intervention (PCI).
How Argatroban works
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Argatroban is a direct thrombin inhibitor. It attaches to thrombin, the protein that helps blood clot, and blocks it. This stops fibrin (the clot mesh) from forming and reduces platelet clumping.
It works on both free thrombin and thrombin already stuck in a clot. It does not need antithrombin III to work.
Argatroban dosage
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Argatroban is given only by healthcare professionals as an IV infusion. Some vials need dilution, while others are ready to use.
- HIT: heparin is stopped first, and argatroban is given as a continuous infusion. Blood clotting (aPTT) is checked about 2 hours after starting and after any dose change.
- PCI: a bolus is given over 3 to 5 minutes, followed by a continuous infusion. A clotting test (ACT) is checked soon after to confirm the procedure can go ahead.
Your care team sets and adjusts the dose, and food or missed doses are not a concern.
Dosing details from the FDA-approved label
From the Argatroban 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.
- Heparin-Induced Thrombocytopenia (adult patients without hepatic impairment)
- 2 mcg/kg/min administered as a continuous infusion (1 mg/mL final concentration)
- Before administering, discontinue heparin therapy and obtain a baseline aPTT
- Maximum: not to exceed 10 mcg/kg/min
- After initiation, adjust the dose as necessary to obtain a steady-state aPTT of 1.5 to 3 times the initial baseline value (not to exceed 100 seconds); check the aPTT 2 hours after initiation and after any dose change
- Percutaneous Coronary Intervention (patients with or at risk for heparin-induced thrombocytopenia)
- Initiate infusion at 25 mcg/kg/min and administer a bolus of 350 mcg/kg via a large bore intravenous line over 3 to 5 minutes
- If ACT is less than 300 seconds, give an additional bolus of 150 mcg/kg and increase infusion to 30 mcg/kg/min
- If ACT is greater than 450 seconds, decrease infusion to 15 mcg/kg/min
- Check ACT 5 to 10 minutes after the bolus; PCI may proceed if ACT is greater than 300 seconds; target ACT 300 to 450 seconds; in case of dissection, impending abrupt closure, thrombus formation, or inability to maintain ACT over 300 seconds, additional 150 mcg/kg boluses may be given and infusion increased to 40 mcg/kg/min
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Argatroban Injection 250 mg/2.5 mL (100 mg/mL) must be diluted 100-fold by mixing with 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or Lactated Ringer’s Injection to a final concentration of 1 mg/mL. ( 2.1 ) Argatroban Injection 50 mg/50 mL (1 mg/mL) is ready for intravenous infusion. Dilution is not required. ( 2.1 ) Heparin-Induced Thrombocytopenia The dose for heparin-induced thrombocytopenia without hepatic impairment is 2 mcg/kg/min administered as a continuous infusion. ( 2.2 ) Percutaneous Coronary Intervention The dose for patients with or at risk for heparin-induced thrombocytopenia undergoing percutaneous coronary intervention is started at 25 mcg/kg/min and a bolus of 350 mcg/kg administered via a large bore intravenous line over 3 to 5 minutes. ( 2.3 ) 2.1 Preparation for Intravenous Administration Argatroban Injection 250 mg/2.5 mL (100 mg/mL) must be diluted 100-fold prior to infusion. Argatroban should not be mixed with other drugs prior to dilution. Dilution is not required for Argatroban Injection 50 mg/50 mL (1 mg/mL). Argatroban Injection 250 mg/2.5 mL (100 mg/mL) Argatroban 250 mg/2.5 mL (100 mg/mL) should be diluted in 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or Lactated Ringer’s Injection to a final concentration of 1 mg/mL. The contents of each 2.5-mL vial should be diluted 100-fold by mixing with 250 mL of diluent. Use 250 mg (2.5 mL) per 250 mL of diluent or 500 mg (5 mL) per 500 mL of diluent. The constituted solution must be mixed by repeated inversion of the diluent bag for 1 minute. Upon preparation, the solution may show slight but brief haziness due to the formation of microprecipitates that rapidly dissolve upon mixing. Use of diluent at room temperature is recommended. Colder temperatures can slow down the rate of dissolution of precipitates. The final solution must be clear before use. The pH of the intravenous solution prepared as recommended is 3.2 to 7.5. Solutions prepared as recommended are stable at controlled room temperature, 20º to 25ºC (68º to 77ºF) (see USP) in ambient indoor light for 24 hours; therefore, light-resistant measures such as foil protection for intravenous lines are unnecessary.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Argatroban side effects
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Common side effects seen in studies include:
Common side effects
- Shortness of breath (dyspnea)
- Low blood pressure (hypotension)
- Fever
- Diarrhea
- Nausea and vomiting
- Chest pain (more common during PCI)
- Back pain and headache (during PCI)
- Minor bleeding, such as in the stomach or gut, urine, or at the groin
When to get medical help
- Signs of bleeding, such as unexplained bruising, blood in urine or stool, vomiting blood, coughing up blood, or a sudden drop in blood pressure. Tell your care team right away.
- Bleeding in the brain or behind the abdomen (intracranial or retroperitoneal hemorrhage) has been reported.
- Allergic reactions, including breathing problems, rash, or widespread reactions. Tell your care team right away.
- Heart attack, chest pain, or cardiac arrest, which were reported in clinical studies.
Argatroban warnings and precautions
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Bleeding is the main risk and can occur anywhere, including the brain. Risk is higher with severe high blood pressure, recent spinal procedures or major surgery, bleeding disorders, and stomach ulcers.
- Using it with antiplatelet drugs, thrombolytics, or other anticoagulants may raise bleeding risk.
- Liver problems slow how fast the body clears argatroban, so lower doses and closer monitoring are needed.
- It can raise PT and INR results, which affects testing when warfarin is also used.
Argatroban interactions
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Argatroban can interact with other drugs that affect clotting or blood tests.
- Heparin: time is allowed for its effect to fade before argatroban starts.
- Warfarin: raises PT and INR more than warfarin alone.
- Antiplatelets, thrombolytics, other anticoagulants: may increase bleeding.
- Thrombolytics and glycoprotein IIb/IIIa antagonists: safety and effectiveness together have not been established.
Interactions listed in the FDA-approved label
From the Argatroban prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Heparin: Heparin's effect on the aPTT must decrease before argatroban is started after heparin is stopped. Allow sufficient time for heparin's effect on the aPTT to decrease prior to initiation of argatroban therapy.
- Warfarin (oral anticoagulant): Concomitant use of argatroban and warfarin results in prolongation of the prothrombin time (PT) and INR; pharmacokinetic interactions have not been demonstrated with a 7.5 mg single oral dose.
- Aspirin or acetaminophen: No drug-drug interactions have been demonstrated between argatroban and concomitantly administered aspirin or acetaminophen.
- Thrombolytic agents: The safety and effectiveness of argatroban with thrombolytic agents have not been established.
- Glycoprotein IIb/IIIa antagonists: The safety and effectiveness of argatroban with glycoprotein IIb/IIIa antagonists have not been established.
Read the label’s full interactions text
7 DRUG INTERACTIONS • Heparin: Allow sufficient time for heparin's effect on activated partial thromboplastin time (aPTT) to decrease before initiating Argatroban Injection therapy. ( 7.1 ) • Warfarin: Concomitant use results in increased prolongation of PT and INR. ( 7.2 ) • Thrombolytic agents or glycoprotein IIb/IIIa antagonists: Safety and effectiveness of concomitant use with argatroban have not been established. ( 7.4 , 7.5 ) 7.1 Heparin If argatroban is to be initiated after cessation of heparin therapy, allow sufficient time for heparin's effect on the aPTT to decrease prior to initiation of argatroban therapy. 7.2 Oral Anticoagulant Agents Pharmacokinetic drug-drug interactions between argatroban and warfarin (7.5 mg single oral dose) have not been demonstrated. However, the concomitant use of argatroban and warfarin (5 to 7.5 mg initial oral dose, followed by 2.5 to 6 mg/day orally for 6 to 10 days) results in prolongation of the prothrombin time (PT) and International Normalized Ratio (INR) [see Dosage and Administration ( 2.5 ) and Clinical Pharmacology ( 12.2 )] . 7.3 Aspirin/Acetaminophen No drug-drug interactions have been demonstrated between argatroban and concomitantly administered aspirin or acetaminophen [see Clinical Pharmacology ( 12.3 )] . 7.4 Thrombolytic Agents The safety and effectiveness of argatroban with thrombolytic agents have not been established [see Adverse Reactions ( 6.1 )] . 7.5 Glycoprotein IIb/IIIa Antagonists The safety and effectiveness of argatroban with glycoprotein IIb/IIIa antagonists have not been established.
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 Argatroban
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- Not for people with major bleeding or a past allergic reaction to argatroban.
- Tell your care team about liver disease.
- Tell them about recent surgery, spinal procedures, bleeding disorders, ulcers, or severe high blood pressure.
- Pregnancy: limited data do not suggest harm, but bleeding risk exists for mother and baby, and newborns are monitored for bleeding.
- Breastfeeding: it is unknown if it passes into human milk. Discuss with your doctor.
- Children: safety and effectiveness have not been established.
- Kidney disease: no dose adjustment is needed.
Argatroban overdose
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Too much argatroban can cause excessive blood thinning, with or without bleeding. Treatment is to stop the drug or lower the dose, and clotting tests usually return to baseline within 2 to 4 hours, though this can take longer with liver problems. There is no specific antidote. For life-threatening bleeding, argatroban is stopped immediately. You can also contact Poison Help at 1-800-222-1222.
What Argatroban does in the body
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During a continuous infusion, argatroban's blood levels and blood-thinning effect rise together in a predictable way. Steady levels are usually reached within 1 to 3 hours. It lengthens clotting tests such as aPTT, ACT, PT, INR, and thrombin time in a dose-dependent way. With warfarin, it raises the INR beyond warfarin alone.
How your body processes Argatroban
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Argatroban spreads mainly through the fluid outside cells, and about half is bound to blood proteins. The liver breaks it down, and most of it leaves through the feces. Its half-life is about 39 to 51 minutes, and it is cleared more slowly in people with liver impairment. Kidney problems do not significantly change how it is cleared, and about 20% is removed by dialysis.
How to store Argatroban
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Store the vials in original carton at 20° to 25° C (68° to 77° F) . Do not freeze. protect from light.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Argatroban: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Argatroban — the kind of thing our pharmacy team would talk through with you at the counter.
What is argatroban for?
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How will I get argatroban?
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What side effects should I expect?
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When should I tell my nurse or doctor right away?
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Can I take it with other blood thinners?
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Is it safe in pregnancy or with liver problems?
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Is Argatroban available over the counter?
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When was Argatroban first available?
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Who makes Argatroban?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Argatroban on HelloPharmacist
Argatroban forms and strengths (how it comes)
Argatroban 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.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Argatroban inactive ingredients by manufacturer.
Injection
How this form is used
- Argatroban is used to prevent or treat thrombosis in adults with heparin-induced thrombocytopenia (HIT).
- Argatroban is used as an anticoagulant in adults with or at risk for HIT who are having percutaneous coronary intervention (PCI).
- Argatroban is given by intravenous infusion by a healthcare professional.
- Argatroban 250 mg/2.5 mL vials must be diluted before use, while the 50 mg/50 mL and 125 mg/125 mL vials are ready to use.
- Argatroban therapy is monitored with clotting tests (aPTT for HIT, ACT for PCI), and the dose is adjusted accordingly.
Argatroban on the U.S. market: products, makers and brands
How Argatroban 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.
12 companies list 17 Argatroban product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 2000.
Also listed with the FDA, not a patient dose form: Powder (7) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Argatroban is used (Medicaid data)
A general measure of how commonly Argatroban is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Argatroban is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Argatroban prescribed? Of the 1,601 medications we measure, Argatroban ranks #1,528 by Medicaid prescriptions — more than 5% of them.
Utilization by Argatroban product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
50 ML argatroban 1 MG/ML Injection
Summed across the 2 of 20 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1804735
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Argatroban, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 20 listed Argatroban NDCs with Medicaid activity.
Compare Argatroban products
A representative set of FDA-listed product records for Argatroban — 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 | ||||
| 1 mg/mL | Intravenous | Accord Healthcare Inc. | NDA | View NDC → |
| 100 mg/mL | Intravenous | Amneal Pharmaceuticals LLC | ANDA | View NDC → |
| 50 mg/50 mL | Intravenous | Caplin Steriles Limited | ANDA | View NDC → |
| 50 mg/50 mL | Intravenous | Eugia US LLC | NDA | View NDC → |
| 50 mg/50 mL | Intravenous | Fresenius Kabi USA, LLC | ANDA | View NDC → |
| 50 mg/50 mL | Intravenous | Gland Pharma Limited | ANDA | View NDC → |
| 125 mg/125 mL | Intravenous | Gland Pharma Limited | ANDA | View NDC → |
| 50 mg/50 mL | Intravenous | Hikma Pharmaceuticals USA Inc. × 2 listings | NDA | View NDC → |
| 250 mg/2.5 mL | Intravenous | Hikma Pharmaceuticals USA Inc. × 2 listings | NDA | View NDC → |
| 50 mg/50 mL | Intravenous | Mullan Pharmaceutical Inc. × 2 listings | ANDA | View NDC → |
| 250 mg/2.5 mL | Intravenous | Mylan Institutional LLC | ANDA | View NDC → |
| 250 mg/2.5 mL | Intravenous | Par Health USA, LLC | ANDA | View NDC → |
| 125 mg/125 mL | Intravenous | Plano Pharmaceuticals Inc. | NDA | View NDC → |
| 1 mg/mL | Intravenous | Sagent Pharmaceuticals | ANDA | View NDC → |
Showing 17 of 17 products — FDA National Drug Code Directory. See every product, package size and price: browse all 17 Argatroban NDCs →
Argatroban side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Argatroban — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Argatroban in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Argatroban FDA approval history
How Argatroban went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Argatroban 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 no Argatroban recalls since July 2021.
✅No Argatroban recalls on record since July 2021Source: 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.
RxCUI 15202 1 dose form · 4 strengths
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Dose form (SCDF) Injection RxCUI 1804730In current FDA listingsClinical drug / strength (SCD) 2.5 ML argatroban 100 MG/MLRxCUI 30835150 ML argatroban 1 MG/MLRxCUI 1804735125 ML argatroban 1 MG/MLRxCUI 1804737250 ML argatroban 1 MG/MLRxCUI 1804738
Look up RxCUI 15202 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.
Argatroban supply and shortage status
Whether Argatroban is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Who makes Argatroban: manufacturers and labelers
12 companies list Argatroban products with the FDA. By number of product records, the largest are Hikma Pharmaceuticals USA Inc., Gland Pharma Limited, Mullan Pharmaceutical Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Argatroban drug class (RxNorm)
Argatroban belongs to the Direct Thrombin Inhibitor class.
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 Argatroban 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.
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. Plano Pharmaceuticals 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 →