This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Argatroban and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (118)
Death (50)
Life Threatening Events (15)
Disability (1)
Reports by Reaction Type
Cerebral Infarction (10),
Prothrombin Time Shortened (10),
Hepatic Function Abnormal (9),
Haemorrhage (9),
Pulmonary Alveolar Haemorrhage (8),
International Normalised Ratio Increased (8),
Gastrointestinal Haemorrhage (7),
Pyrexia (7),
Activated Partial Thromboplastin Time Prolonged (7),
Pneumonia (7),
Eosinophil Count Increased (7),
Pulmonary Embolism (5)
Below are a few examples of reports where side effects / adverse reactions may be related to Argatroban. For a complete list or a specific selection of reports, please use the links above.
Possible Argatroban side effects in 91 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-24
Patient: 91 year old female
Reactions: Heparin-Induced Thrombocytopenia
Drug(s) suspected as cause:
Argatroban
Dosage: unk
Start date: 2012-03-05
Heparin Sodium
Dosage: unk
Possible Argatroban side effects in 61 year old female
Reported by a pharmacist from United States on 2012-08-24
Patient: 61 year old female
Reactions: Thrombocytopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Argatroban
Other drugs received by patient: Amiodarone; Coumadin
Possible Argatroban side effects in 53 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-23
Patient: 53 year old male
Reactions: Heparin-Induced Thrombocytopenia
Drug(s) suspected as cause:
Argatroban
Dosage: unk
Start date: 2012-03-13
Heparin Sodium
Dosage: unk
Possible Argatroban side effects in 47 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-14
Patient: 47 year old female, weighing 44.0 kg (96.8 pounds)
Reactions: Hepatic Function Abnormal
Drug(s) suspected as cause:
Argatroban
Dosage: 1.3mcg/kg/min
Start date: 2011-06-16
End date: 2011-06-21
Argatroban
Dosage: 1.1mcg/kg/min
Start date: 2011-06-13
End date: 2011-06-16
Argatroban
Dosage: 0.7mcg/kg/min
Indication: Heparin-Induced Thrombocytopenia
Start date: 2011-06-09
End date: 2011-06-10
Argatroban
Dosage: 0.8 mcg/kg/min
Start date: 2011-06-10
End date: 2011-06-12
Argatroban
Dosage: 1.0mcg/kg/min
Start date: 2011-06-21
End date: 2011-06-23
Argatroban
Dosage: 1.0mcg/kg/min
Start date: 2011-06-12
End date: 2011-06-13
Warfarin Sodium
Dosage: 2 mg
Administration route: Oral
Start date: 2011-06-20
Other drugs received by patient: Warfarin Potassium; Warfarin Potassium; Heparin Sodium
Possible Argatroban side effects in 77 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-13
Patient: 77 year old female
Reactions: Diverticulum Intestinal Haemorrhagic, Shock Haemorrhagic, Platelet Count Decreased, Upper Gastrointestinal Haemorrhage
Adverse event resulted in: death
Drug(s) suspected as cause:
Argatroban
Possible Argatroban side effects in
Reported by a pharmacist from United States on 2012-08-09
Patient:
Reactions: Activated Partial Thromboplastin Time Prolonged
Drug(s) suspected as cause:
Argatroban
Possible Argatroban side effects in 77 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-09
Patient: 77 year old female
Reactions: Diverticulum Intestinal Haemorrhagic, Shock Haemorrhagic, Platelet Count Decreased, Upper Gastrointestinal Haemorrhage
Adverse event resulted in: death
Drug(s) suspected as cause:
Argatroban
Possible Argatroban side effects in male
Reported by a pharmacist from United States on 2012-08-07
Patient: male
Reactions: Infusion Site Extravasation
Drug(s) suspected as cause:
Argatroban
Possible Argatroban side effects in 56 year old female
Reported by a health professional (non-physician/pharmacist) from China on 2012-08-07
Patient: 56 year old female
Reactions: Syncope, Muscle Twitching
Drug(s) suspected as cause:
Argatroban
Other drugs received by patient: Ceftizoxime
Possible Argatroban side effects in 44 year old
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-01
Patient: 44 year old
Reactions: Activated Partial Thromboplastin Time Prolonged, Prothrombin Time Shortened
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Argatroban
Possible Argatroban side effects in 85 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-27
Patient: 85 year old male, weighing 45.3 kg (99.7 pounds)
Reactions: Cardio-Respiratory Arrest, Haemorrhage
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Argatroban
Other drugs received by patient: Nitroglycerin; Alfacalcidol; Calcium Carbonate; Warfarin; Lansoprazole
Possible Argatroban side effects in male
Reported by a physician from France on 2012-07-27
Patient: male
Reactions: Haemorrhage
Adverse event resulted in: death
Drug(s) suspected as cause:
Argatroban
Possible Argatroban side effects in 44 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-26
Patient: 44 year old male
Reactions: Activated Partial Thromboplastin Time Prolonged, Prothrombin Time Shortened
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Argatroban
Possible Argatroban side effects in 74 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-26
Patient: 74 year old male, weighing 82.0 kg (180.4 pounds)
Reactions: Interstitial Lung Disease
Adverse event resulted in: death
Drug(s) suspected as cause:
Argatroban
Dosage: 60 mg, unk
Indication: Embolic Stroke
Start date: 2011-09-05
End date: 2011-09-05
Cataclot
Dosage: 80 mg, unk
Indication: Embolic Stroke
Start date: 2011-09-05
End date: 2011-09-05
Edaravone
Dosage: 30 mg, 2x/day
Indication: Embolic Stroke
Start date: 2011-09-05
End date: 2011-09-05
Other drugs received by patient: Aspirin; Livalo; Grtpa; Aspirin
Possible Argatroban side effects in 40 year old female
Reported by a physician from France on 2012-07-25
Patient: 40 year old female
Reactions: Haemorrhage, Shock Haemorrhagic, Aneurysm, Splenic Infarction
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Argatroban
Dosage: 1 ug/kg/min
Indication: Heparin-Induced Thrombocytopenia
Start date: 2012-04-15
End date: 2012-04-24
Argatroban
Dosage: 1 ug/kg/min
Start date: 2012-04-24
End date: 2012-04-24
Argatroban
Dosage: 1 ug/kg/min
Start date: 2012-04-30
End date: 2012-05-18
Possible Argatroban side effects in female
Reported by a pharmacist from United States on 2012-07-25
Patient: female
Reactions: Thrombocytopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Argatroban
Other drugs received by patient: Amiodarone; Coumadin
Possible Argatroban side effects in 80 year old female
Reported by a physician from Japan on 2012-07-24
Patient: 80 year old female
Reactions: Drug Ineffective, Haemorrhagic Cerebral Infarction
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Argatroban
Dosage: 60 mg;qd;iv, 30 mg;x1, 60 mg;x1, 10 mg;qh;
Indication: Cerebrovascular Disorder
Argatroban
Dosage: 60 mg;qd;iv, 30 mg;x1, 60 mg;x1, 10 mg;qh;
Indication: Cerebrovascular Disorder
Other drugs received by patient: Dextran INJ; Urokinase
Possible Argatroban side effects in 65 year old female
Reported by a physician from United States on 2012-07-24
Patient: 65 year old female
Reactions: Thrombosis, Haematocrit Decreased, Coagulopathy, Coagulation Time Shortened, Cardiac Procedure Complication
Drug(s) suspected as cause:
Argatroban
Other drugs received by patient: Amicar
Possible Argatroban side effects in 85 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-23
Patient: 85 year old female, weighing 37.0 kg (81.4 pounds)
Reactions: Cardiac Failure Acute
Adverse event resulted in: death
Drug(s) suspected as cause:
Argatroban
Dosage: 10mg/hx2ml (3 in 1 wk)
Indication: Anticoagulant Therapy
Start date: 2010-02-08
End date: 2010-06-07
Argatroban
Dosage: 8mg/hx4h (3 in 1 wk)
Start date: 2010-07-23
End date: 2010-08-16
Other drugs received by patient: Lactomin; Heparin Sodium; Lansoprazole; Iron Sucrose; Lasix; Nespo; Mexirate; Warfarin
Possible Argatroban side effects in 40 year old female
Reported by a physician from France on 2012-07-20
Patient: 40 year old female
Reactions: Haemorrhage, Shock Haemorrhagic, Aneurysm, Splenic Infarction
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Argatroban
Dosage: 1 ug/kg/min
Start date: 2012-04-24
End date: 2012-04-24
Argatroban
Dosage: 1 ug/kg/min
Start date: 2012-04-30
End date: 2012-05-18
Argatroban
Dosage: 1 ug/kg/min
Indication: Heparin-Induced Thrombocytopenia
Start date: 2012-04-15
End date: 2012-04-24
Possible Argatroban side effects in male
Reported by a physician from France on 2012-07-19
Patient: male
Reactions: Haemorrhage
Adverse event resulted in: death
Drug(s) suspected as cause:
Argatroban
Possible Argatroban side effects in 74 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-19
Patient: 74 year old male, weighing 82.0 kg (180.4 pounds)
Reactions: Interstitial Lung Disease
Adverse event resulted in: death
Drug(s) suspected as cause:
Argatroban
Dosage: 60 mg, unk
Indication: Embolic Stroke
Start date: 2011-09-05
End date: 2011-09-05
Cataclot
Dosage: 80 mg, unk
Indication: Embolic Stroke
Start date: 2011-09-05
End date: 2011-09-05
Edaravone
Dosage: 30 mg, 2x/day
Indication: Embolic Stroke
Start date: 2011-09-05
End date: 2011-09-05
Other drugs received by patient: Grtpa; Aspirin; Aspirin; Livalo
Possible Argatroban side effects in 85 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-18
Patient: 85 year old female, weighing 37.0 kg (81.4 pounds)
Reactions: Cardiac Failure Acute
Adverse event resulted in: death
Drug(s) suspected as cause:
Argatroban
Dosage: 10mg/hx2ml (3 in 1 wk)
Indication: Anticoagulant Therapy
Start date: 2010-02-08
End date: 2010-06-07
Argatroban
Dosage: 8mg/hx4h (3 in 1 wk)
Start date: 2010-07-23
End date: 2010-08-16
Other drugs received by patient: Warfarin; Mexirate; Lansoprazole; Iron Sucrose; Nespo; Lactomin; Heparin Sodium; Lasix
Possible Argatroban side effects in
Reported by a pharmacist from United States on 2012-07-05
Patient:
Reactions: International Normalised Ratio Increased
Drug(s) suspected as cause:
Argatroban
Other drugs received by patient: Digoxin
Possible Argatroban side effects in 60 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-06-29
Patient: 60 year old female
Reactions: Drug Level Decreased
Drug(s) suspected as cause:
Argatroban
Dosage: 50 mg, daily
Indication: Heparin-Induced Thrombocytopenia
Start date: 2012-06-01
End date: 2012-06-03
Sandimmune
Dosage: 100 mg, 1x/day
Administration route: Oral
Start date: 2012-06-03
End date: 2012-06-03
Sandimmune
Dosage: 200 mg, 1x/day
Administration route: Oral
Start date: 2012-06-05
End date: 2012-06-05
Sandimmune
Dosage: 75 mg, 1x/day
Administration route: Oral
Indication: Heart Transplant
Start date: 2012-05-12
End date: 2012-06-02
Sandimmune
Dosage: 150 mg, 1x/day
Administration route: Oral
Start date: 2012-06-04
End date: 2012-06-04
Possible Argatroban side effects in female
Reported by a pharmacist from United States on 2012-06-29
Patient: female
Reactions: International Normalised Ratio Increased
Drug(s) suspected as cause:
Argatroban
Possible Argatroban side effects in female
Reported by a pharmacist from United States on 2012-06-28
Patient: female, weighing 91.4 kg (201.1 pounds)
Reactions: Drug Interaction, Coagulation Time Abnormal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Argatroban
Dosage: 2 mcg/kg/min, frequency: with frequent titration
Indication: Heparin-Induced Thrombocytopenia
Start date: 2007-03-25
End date: 2007-03-31
Zyvox
Dosage: frequency: bid q12 hrs
Indication: Urinary Tract Infection
Start date: 2007-03-27
Other drugs received by patient: Fragmin; Famotidine; Methylpednisolone Sodium Succinate; Warfarin Sodium
Possible Argatroban side effects in 44 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-06-27
Patient: 44 year old male, weighing 69.9 kg (153.8 pounds)
Reactions: Venous Thrombosis Limb
Drug(s) suspected as cause:
Argatroban
Possible Argatroban side effects in 64 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-06-26
Patient: 64 year old female
Reactions: Cerebral Haemorrhage
Adverse event resulted in: death
Drug(s) suspected as cause:
Activase
Indication: Embolic Stroke
Start date: 2012-01-16
End date: 2012-01-16
Argatroban
Start date: 2012-01-17
End date: 2012-01-17
Argatroban
Indication: Embolic Stroke
Start date: 2012-01-17
End date: 2012-01-17
Radicut
Indication: Embolic Stroke
Start date: 2012-01-16
Radicut
Possible Argatroban side effects in female
Reported by a pharmacist from United States on 2012-06-26
Patient: female
Reactions: Activated Partial Thromboplastin Time Abnormal
Drug(s) suspected as cause:
Argatroban
Dosage: 10 mcg/kg/min
Indication: Heparin-Induced Thrombocytopenia
Start date: 2012-06-20
Argatroban
Indication: Acute Myocardial Infarction
Other drugs received by patient: Metoprolol; Furosemide; Prednisone; Amlodipine; Nitroglycerin; Rosuvastatin; Acetylsalicylic Acid; Pantoprazole
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