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Argatroban

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Argatroban

Argatroban Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Argatroban Injection is used to prevent or treat thrombosis in adult patients with heparin-induced thrombocytopenia (HIT), and is also used as an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI). It is a synthetic direct thrombin inhibitor. This medication is available in generic form. Common side effects include nausea, vomiting, diarrhea, fever, or minor bleeding/irritation at the injection site.

The recommended initial dose of argatroban for adult patients without hepatic impairment is 2 mcg/kg/min, administered as a continuous infusion. Argatroban may interact with mifepristone, blood thinners, NSAIDs, anti-platelet drugs, medications that interact with alcohol, tipranavir, or any drugs that can increase your risk of bleeding. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant before using argatroban. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Argatroban Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Argatroban in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • feeling like you might pass out;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • blood in your urine;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • any bleeding that will not stop;
  • pain or burning when you urinate;
  • sudden numbness or weakness, problems with vision, speech, or balance;
  • sudden severe headache, confusion, sudden changes in your senses of taste or touch;
  • fever, chills, body aches, flu symptoms;
  • cough with yellow or green mucus, stabbing chest pain, feeling short of breath;
  • slow heart rate, weak pulse, slow breathing (breathing may stop); or
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Less serious side effects may include:

  • nausea, vomiting, diarrhea, stomach pain;
  • headache;
  • back pain; or
  • bleeding around the IV needle.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Argatroban (Argatroban Injection) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Argatroban Overview - Patient Information: Side Effects

SIDE EFFECTS: Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Argatroban (Argatroban Injection)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Argatroban FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Because clinical trials are conducted under widely varying conditions, adverse event 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 practice.

Adverse Events in Patients with HIT (With or Without Thrombosis)

The following safety information is based on all 568 patients treated with argatroban in Study 1 and Study 2. The safety profile of the patients from these studies is compared with that of 193 historical controls in which the adverse events were collected retrospectively. Adverse events are separated into hemorrhagic and non-hemorrhagic events.

Major bleeding was defined as bleeding that was overt and associated with a hemoglobin decrease ≥ 2 g/dL, that led to a transfusion of ≥ 2 units, or that was intracranial, retroperitoneal, or into a major prosthetic joint. Minor bleeding was overt bleeding that did not meet the criteria for major bleeding.

Table 4 gives an overview of the most frequently observed hemorrhagic events, presented separately by major and minor bleeding, sorted by decreasing occurrence among argatroban-treated patients with HIT (with or without thrombosis).

Table 4: Major and Minor Hemorrhagic Adverse Events in Patients With HIT*

  Argatroban-treated Patients
(Study 1 and Study 2)
(n = 568) %
Historical Control
(n = 193) %
Major Hemorrhagic Eventsa
Overall bleeding 5.3 6.7
Gastrointestinal 2.3 1.6
Genitourinary and hematuria 0.9 0.5
Decrease in hemoglobin and hematocrit 0.7 0
Multisystem hemorrhage and DIC 0.5 1
Limb and BKA stump 0.5 0
Intracranial hemorrhage 0 b 0.5
Minor Hemorrhagic Eventsa
Gastrointestinal 14.4 18.1
Genitourinary and hematuria 11.6 0.8
Decrease in hemoglobin and hematocrit 10.4 0
Groin 5.4 3.1
Hemoptysis 2.9 0.8
Brachial 2.4 0.8
*with or without thrombosis
a Patients may have experienced more than 1 adverse event.
b One patient experienced intracranial hemorrhage 4 days after discontinuation of argatroban and following therapy with urokinase and oral anticoagulation.
c The historical control group consisted of patients with a clinical diagnosis of HIT (with or without thrombosis) that were considered eligible by an independent medical panel.
DIC = disseminated intravascular coagulation. BKA = below-the-knee amputation

Table 5 gives an overview of the most frequently observed non-hemorrhagic events sorted by decreasing frequency of occurrence ( ≥ 2%) among argatroban-treated HIT/HITTS patients.

Table 5: Non-hemorrhagic Adverse Events in Patientsa With HITb

  Argatroban-treated Patients (Study 1 and Study 2)
(n = 568) %
Historical Controlc
(n = 193) %
Dyspnea 8.1 8.8
Hypotension 7.2 2.6
Fever 6.9 2.1
Diarrhea 6.2 1.6
Sepsis 6.0 12.4
Cardiac arrest 5.8 3.1
Nausea 4.8 0.5
Ventricular tachycardia 4.8 3.1
Pain 4.6 3.1
Urinary tract infection 4.6 5.2
Vomiting 4.2 0
Infection 3.7 3.6
Pneumonia 3.3 9.3
Atrial fibrillation 3.0 11.4
Coughing 2.8 1.6
Abnormal renal function 2.8 4.7
Abdominal pain 2.6 1.6
Cerebrovascular disorder 2.3 4.1
a Patients may have experienced more than 1 adverse event.
b with or without thrombosis
c The historical control group consisted of patients with a clinical diagnosis of HIT (with or without thrombosis) that were considered eligible by an independent medical panel.

Adverse Events in Patients with or at Risk for HIT Patients Undergoing PCI

The following safety information is based on 91 patients initially treated with argatroban and 21 patients subsequently re-exposed to argatroban for a total of 112 PCIs with argatroban anticoagulation. Adverse events are separated into hemorrhagic (Table 6) and non-hemorrhagic (Table 7) events.

Major bleeding was defined as bleeding that was overt and associated with a hemoglobin decrease > 5 g/dL, that led to transfusion of > 2 units, or that was intracranial, retroperitoneal, or into a major prosthetic joint.

The rate of major bleeding events in patients treated with argatroban in the PCI trials was 1.8%.

Table 6: Major and Minor Hemorrhagic Adverse Events in Patients With HIT Undergoing PCI

  Major Hemorrhagic Eventsa
Argatroban-treated Patients
(n = 112)b %
Retroperitoneal 0.9
Gastrointestinal 0.9
Intracranial 0
Minor Hemorrhagic Eventsa
Groin (bleeding or hematoma) 3.6
Gastrointestinal (includes hematemesis) 2.6
Genitourinary (includes hematuria) 1.8
Decrease in hemoglobin and/or hematocrit 1.8
CABG (coronary arteries) 1.8
Access site 0.9
Hemoptysis 0.9
Other 0.9
a Patients may have experienced more than 1 adverse event.
b 91 patients who underwent 112 interventions. CABG = coronary artery bypass graft

Table 7 gives an overview of the most frequently observed non-hemorrhagic events ( > 2%), sorted by decreasing frequency of occurrence among argatroban-treated PCI patients.

Table 7: Non-hemorrhagic Adverse Eventsa in Patients With HIT Undergoing PCI

  Argatroban Proceduresa
(n = 112)b %
Chest pain 15.2
Hypotension 10.7
Back pain 8.0
Nausea 7.1
Vomiting 6.3
Headache 5.4
Bradycardia 4.5
Abdominal pain 3.6
Fever 3.6
Myocardial infarction 3.6
a Patients may have experienced more than 1 adverse event.
b 91 patients who underwent 112 interventions.

There were 22 serious adverse events in 17 PCI patients (19.6% in 112 interventions). Table 8 lists the serious adverse events occurring in argatroban-treated-patients with or at risk for HIT undergoing PCI.

Table 8: Serious Adverse Events in Patients With HIT Undergoing PCIa

Coded Term Argatroban Proceduresb
(n = 112)
Myocardial infarction 4 (3.5%)
Angina Pectoris 2 (1.8%)
Coronary thrombosis 2 (1.8%)
Myocardial Ischemia 2 (1.8%)
Occlusion coronary 2 (1.8%)
Chest pain 1 (0.9%)
Fever 1 (0.9%)
Retroperitoneal hemorrhage 1 (0.9%)
Aortic stenosis 1 (0.9%)
Arterial thrombosis 1 (0.9%)
Gastrointestinal hemorrhage 1 (0.9%)
Gastrointestinal disorder (GERD) 1 (0.9%)
Cerebrovascular disorder 1 (0.9%)
Lung Edema disorder 1 (0.9%)
Vascular disorder 1 (0.9%)
a Individual events may also have been reported elsewhere (see Table 6 and 7).
b 91 patients underwent 112 procedures. Some patients may have experienced more than 1 event.

Intracranial Bleeding In Other Populations

Increased risks for intracranial bleeding have been observed in investigational studies of argatroban for other uses. In a study of patients with acute myocardial infarction receiving both argatroban and thrombolytic therapy (streptokinase or tissue plasminogen activator), the overall frequency of intracranial bleeding was 1% (8 out of 810 patients). Intracranial bleeding was not observed in 317 subjects or patients who did not receive concomitant thrombolysis [see DRUG INTERACTIONS].

The safety and effectiveness of argatroban for cardiac indications other than PCI in patients with HIT have not been established. Intracranial bleeding was also observed in a prospective, placebo-controlled study of argatroban in patients who had onset of acute stroke within 12 hours of study entry. Symptomatic intracranial hemorrhage was reported in 5 of 117 patients (4.3%) who received argatroban at 1 to 3 mcg/kg/min and in none of the 54 patients who received placebo. Asymptomatic intracranial hemorrhage occurred in 5 (4.3%) and 2 (3.7%) of the patients, respectively.

Allergic Reactions

One hundred fifty-six allergic reactions or suspected allergic reactions were observed in 1,127 individuals who were treated with argatroban in clinical pharmacology studies or for various clinical indications. About 95% (148/156) of these reactions occurred in patients who concomitantly received thrombolytic therapy (e.g., streptokinase) or contrast media.

Allergic reactions or suspected allergic reactions in populations other than patients with HIT (with or without thrombosis) include (in descending order or frequency):

  • Airway reactions (coughing, dyspnea): 10% or more
  • Skin reactions (rash, bullous eruption): 1 to < 10%
  • General reactions (vasodilation): 1 to 10%

Limited data are available on the potential formation of drug-related antibodies. Plasma from 12 healthy volunteers treated with argatroban over 6 days showed no evidence of neutralizing antibodies. No loss of anticoagulant activity was noted with repeated administration of argatroban to more than 40 patients.

Read the entire FDA prescribing information for Argatroban (Argatroban Injection) »

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Argatroban - User Reviews

Argatroban User Reviews

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Here is a collection of user reviews for the medication Argatroban sorted by most helpful. Patient Discussions FAQs

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