This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Angiomax (Bivalirudin) 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 (71)
Death (23)
Life Threatening Events (23)
Disability (3)
Reports by Reaction Type
Thrombosis in Device (18),
Off Label Use (10),
Coronary Artery Thrombosis (6),
Acute Myocardial Infarction (6),
Myocardial Infarction (6),
Haemorrhage (5),
Drug Ineffective (4),
Coronary Artery Occlusion (4),
Chest Pain (4),
Procedural Complication (4),
Hypersensitivity (3),
Activated Partial Thromboplastin Time Prolonged (3)
Below are a few examples of reports where side effects / adverse reactions may be related to Angiomax (Bivalirudin). For a complete list or a specific selection of reports, please use the links above.
Possible Angiomax side effects in female
Reported by a physician from Sweden on 2012-08-24
Patient: female
Reactions: Cerebral Haematoma
Adverse event resulted in: death, life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Brilinta
Dosage: 180 mg loading dose
Administration route: Oral
Indication: Acute Myocardial Infarction
Start date: 2012-08-10
Aspirin
Administration route: Oral
Indication: Acute Myocardial Infarction
Start date: 2012-08-10
End date: 2012-08-10
Angiomax
Start date: 2012-08-10
End date: 2012-08-10
Other drugs received by patient: Simvastatin; Isorbidmononitrat; Ramipril
Possible Angiomax side effects in female
Reported by a physician from Sweden on 2012-08-20
Patient: female
Reactions: Pulmonary Haemorrhage
Adverse event resulted in: death
Drug(s) suspected as cause:
Angiomax
Brilinta
Administration route: Oral
Warfarin Sodium
Administration route: Oral
Possible Angiomax side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20
Patient:
Reactions: Thrombosis in Device
Drug(s) suspected as cause:
Angiomax
Brilinta
Administration route: Oral
Possible Angiomax side effects in
Reported by a consumer/non-health professional from United States on 2012-08-20
Patient:
Reactions: Thrombosis in Device
Drug(s) suspected as cause:
Brilinta
Administration route: Oral
Angiomax
Possible Angiomax side effects in female
Reported by a physician from Sweden on 2012-08-17
Patient: female
Reactions: Cerebral Haematoma
Adverse event resulted in: death, life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Brilinta
Dosage: 180 mg loading dose
Administration route: Oral
Indication: Acute Myocardial Infarction
Start date: 2012-08-10
Angiomax
Start date: 2012-08-10
End date: 2012-08-10
Aspirin
Administration route: Oral
Indication: Acute Myocardial Infarction
Start date: 2012-08-10
End date: 2012-08-10
Other drugs received by patient: Simvastatin; Ramipril; Isorbidmononitrat
Possible Angiomax side effects in 52 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-08
Patient: 52 year old male, weighing 78.4 kg (172.5 pounds)
Reactions: Hypersensitivity, Respiratory Depression
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Angiomax
Dosage: 12 ml, bolus, intravenous, 28 ml/hr, intravenous
Indication: Percutaneous Coronary Intervention
Start date: 2012-08-01
End date: 2012-08-01
Angiomax
Dosage: 12 ml, bolus, intravenous, 28 ml/hr, intravenous
Indication: Percutaneous Coronary Intervention
Start date: 2012-08-01
Contrast Media
Start date: 2012-08-01
End date: 2012-08-01
Adenosine
Indication: Arterial Therapeutic Procedure
Start date: 2012-08-01
End date: 2012-08-01
Possible Angiomax side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-07
Patient: male
Reactions: Procedural Pain, Drug Ineffective, Pain, Coagulation Time Abnormal, Coronary NO-Reflow Phenomenon, Medication Error, Drug Administration Error, Vascular Access Complication, Infusion Site Extravasation
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Angiomax
Dosage: 0.75 mg/kg, bolus, intravenous, 1.75 mg/kg/hr, intravenous, bolus, intravenous
Indication: Coronary Angioplasty
Start date: 2012-07-25
Angiomax
Dosage: 0.75 mg/kg, bolus, intravenous, 1.75 mg/kg/hr, intravenous, bolus, intravenous
Indication: Coronary Angioplasty
Start date: 2012-07-25
Other drugs received by patient: Fentanyl; Versed; Heparin; Reopro
Possible Angiomax side effects in male
Reported by a physician from United States on 2012-07-31
Patient: male
Reactions: Heart Rate Decreased, Hypersensitivity, Mouth Haemorrhage, Blood Pressure Decreased
Adverse event resulted in: death
Drug(s) suspected as cause:
Angiomax
Possible Angiomax side effects in 62 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-30
Patient: 62 year old male, weighing 59.0 kg (129.8 pounds)
Reactions: Agitation, Haemorrhage Intracranial, Coma Scale Abnormal, Pupil Fixed, Acute Myocardial Infarction, Loss of Consciousness
Adverse event resulted in: death
Drug(s) suspected as cause:
Prasugrel (Prasugrel)
Dosage: 600 mg, oral
Administration route: Oral
Start date: 2011-08-30
End date: 2011-08-30
Aspirin
Dosage: 75 mg, qd, oral
Administration route: Oral
Indication: Acute Coronary Syndrome
Start date: 2011-08-26
End date: 2011-08-30
Enoxaparin Sodium
Dosage: 60 mg, bid, subcutaneous
Indication: Acute Coronary Syndrome
Start date: 2011-08-26
End date: 2011-08-30
Angiomax
Dosage: 105 mg/hr, intravenous
Start date: 2011-08-30
End date: 2011-08-30
Clopidogrel
Dosage: 75 mg, qd, oral
Administration route: Oral
Indication: Acute Coronary Syndrome
Start date: 2011-08-26
End date: 2011-08-30
Other drugs received by patient: Beclomethasone Dipropionate; Albuterol Sulfate
Possible Angiomax side effects in 70 year old male
Reported by a physician from United States on 2012-07-24
Patient: 70 year old male
Reactions: Cardiogenic Shock
Adverse event resulted in: death
Drug(s) suspected as cause:
Angiomax
Possible Angiomax side effects in 73 year old male
Reported by a health professional (non-physician/pharmacist) from Italy on 2012-07-12
Patient: 73 year old male
Reactions: Subdural Haematoma, Hemiparesis
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Angiomax
Dosage: 0.7 mg/kg, intravenous
Indication: Coronary Angioplasty
Start date: 2012-04-13
End date: 2012-04-13
Clopidogrel
Dosage: unk
Indication: Coronary Angioplasty
End date: 2012-04-13
Aspirin
Dosage: 100 mg
Indication: Coronary Angioplasty
End date: 2012-04-13
Possible Angiomax side effects in 69 year old male
Reported by a physician from Italy on 2012-07-11
Patient: 69 year old male, weighing 63.0 kg (138.6 pounds)
Reactions: Product Quality Issue, Angina Pectoris, Drug Ineffective, Myocardial Infarction, Electrocardiogram ST Segment Elevation, Thrombosis in Device
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Angiomax
Dosage: 0.75 mg/kg, bolus, intravenous 1.75 mg/kg, hr 0.25 mg/kg, hr for 75 minutes, intravenous
Indication: Percutaneous Coronary Intervention
Start date: 2012-03-27
End date: 2012-03-27
Angiomax
Dosage: 0.75 mg/kg, bolus, intravenous 1.75 mg/kg, hr 0.25 mg/kg, hr for 75 minutes, intravenous
Indication: Percutaneous Coronary Intervention
Start date: 2012-03-27
End date: 2012-03-27
Angiomax
Dosage: 0.75 mg/kg, bolus, intravenous 1.75 mg/kg, hr 0.25 mg/kg, hr for 75 minutes, intravenous
Indication: Percutaneous Coronary Intervention
Start date: 2012-03-27
End date: 2012-03-27
Other drugs received by patient: ASA (Asa); Hypoglycemic Oral Drug; Atorvastatin Calcium; Prasugrel (Prasugrel)
Possible Angiomax side effects in 63 year old female
Reported by a physician from Italy on 2012-07-11
Patient: 63 year old female, weighing 76.0 kg (167.2 pounds)
Reactions: Product Quality Issue, Vomiting, Drug Ineffective, Coronary Artery Stenosis, Incorrect Drug Administration Duration, Myocardial Infarction, Shock, Thrombosis in Device
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Angiomax
Dosage: 0.75 mg/kg, bolus, intravenous;
Indication: Percutaneous Coronary Intervention
Start date: 2012-03-20
End date: 2012-03-20
Angiomax
Dosage: 0.75 mg/kg, bolus, intravenous;
Indication: Percutaneous Coronary Intervention
Start date: 2012-03-21
End date: 2012-03-21
Angiomax
Dosage: 0.75 mg/kg, bolus, intravenous;
Indication: Percutaneous Coronary Intervention
Start date: 2012-03-20
End date: 2012-03-21
Other drugs received by patient: Heparin; ...; ...; Ticagrelor; Aspirin; Atorvastatin Calcium
Possible Angiomax side effects in male
Reported by a health professional (non-physician/pharmacist) from Italy on 2012-07-11
Patient: male
Reactions: Tracheal Haemorrhage, Respiratory Arrest
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Angiomax
Indication: Percutaneous Coronary Intervention
Start date: 2012-04-17
End date: 2012-04-17
Reopro
Indication: Percutaneous Coronary Intervention
Start date: 2012-04-17
End date: 2012-04-17
Other drugs received by patient: Acetylsalicylic Acid SRT
Possible Angiomax side effects in 83 year old female
Reported by a physician from United States on 2012-07-11
Patient: 83 year old female
Reactions: Haemorrhage, Coronary Artery Occlusion, Thrombosis in Device
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Angiomax
Other drugs received by patient: Reopro; Aspirin; Prasugrel (Prasugrel)
Possible Angiomax side effects in 53 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-28
Patient: 53 year old male, weighing 104.5 kg (229.9 pounds)
Reactions: Coronary Artery Thrombosis
Drug(s) suspected as cause:
Angiomax
Dosage: 16 ml, bolus, intravenous, 36.4 ml, hr, intravenous
Indication: Percutaneous Coronary Intervention
Start date: 2012-05-01
End date: 2012-05-01
Angiomax
Dosage: 16 ml, bolus, intravenous, 36.4 ml, hr, intravenous
Indication: Percutaneous Coronary Intervention
Start date: 2012-05-01
End date: 2012-05-01
Other drugs received by patient: Prasugrel (Prasugrel); Aspirin
Possible Angiomax side effects in 50 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-21
Patient: 50 year old female
Reactions: Cardio-Respiratory Arrest, Haemorrhage, Coronary Artery Thrombosis, Heparin-Induced Thrombocytopenia, Thrombosis in Device
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Angiomax
Dosage: per hour, intravenous (not otherwise specified)
Start date: 2012-04-23
Heparin Sodium
Dosage: 1800 iu
Indication: Product Used FOR Unknown Indication
Start date: 2012-04-21
End date: 2012-04-22
Angiomax
Dosage: 0.75 ug/kg, bolus, intravenous bolus
Indication: Percutaneous Coronary Intervention
Start date: 2012-04-23
Other drugs received by patient: Famotidine; Clopidegrel; Insulin; Atenolol; Fluoxetine; Fenofibrate
Possible Angiomax side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-15
Patient: female
Reactions: Coronary Artery Occlusion, Coagulation Time Prolonged
Adverse event resulted in: death
Drug(s) suspected as cause:
Angiomax
Possible Angiomax side effects in 59 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-14
Patient: 59 year old female
Reactions: Coronary Artery Dissection, Procedural Complication, Acute Myocardial Infarction, Device Occlusion
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Angiomax
Other drugs received by patient: Effient
Possible Angiomax side effects in 81 year old female
Reported by a physician from United States on 2012-06-14
Patient: 81 year old female, weighing 99.8 kg (219.6 pounds)
Reactions: Off Label Use, Cardiac Tamponade, Right Atrial Pressure Increased, Cardiac Perforation, Hypotension, Pericardial Haemorrhage
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Angiomax
Other drugs received by patient: Lasix; Cozaar; Sodium Chloride; Flovent (Fluiticasone Propionate); Calcium Plus D (Calcium, Colecalciferol); Versed; Fentanyl; Heparin; Aspirin; Florastor (Saccharomyces Boulardii); Nexium; Pravachol; Omeprazole; Fioricet with Codeine (Butalbital, Caffeine, Codeine Phosphate, Parace; Klor-CON; Betapace; Fish OIL; Systane (Macrogol, Propylene Glycol); Lidocaine; Ancef; Toprol-XL
Possible Angiomax side effects in
Reported by a physician from United States on 2012-06-14
Patient: , weighing 70.8 kg (155.8 pounds)
Reactions: Ventricular Tachycardia, Coagulation Time Prolonged
Drug(s) suspected as cause:
Angiomax
Possible Angiomax side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-31
Patient: female
Reactions: Platelet Function Test Abnormal
Drug(s) suspected as cause:
Effient
Dosage: maintenance dose
Indication: Coronary Revascularisation
Start date: 2012-05-01
Reopro
Indication: Vascular Operation
Start date: 2012-05-01
Effient
Dosage: maintenance dose
Indication: Percutaneous Coronary Intervention
Start date: 2012-05-01
Effient
Dosage: maintenance dose
Start date: 2012-05-01
Effient
Dosage: loading dose
Start date: 2012-05-01
Effient
Dosage: loading dose
Indication: Acute Coronary Syndrome
Start date: 2012-05-01
Angiomax
Indication: Coronary Revascularisation
Start date: 2012-05-01
Effient
Dosage: loading dose
Indication: Acute Myocardial Infarction
Start date: 2012-05-01
Reopro
Indication: Percutaneous Coronary Intervention
Start date: 2012-05-01
Effient
Dosage: maintenance dose
Start date: 2012-05-01
Effient
Dosage: loading dose
Start date: 2012-05-01
Heparin
Indication: Percutaneous Coronary Intervention
Start date: 2012-05-01
Heparin
Indication: Vascular Operation
Start date: 2012-05-01
Angiomax
Indication: Acute Myocardial Infarction
Start date: 2012-05-01
Possible Angiomax side effects in male
Reported by a pharmacist from United States on 2012-05-23
Patient: male, weighing 77.0 kg (169.4 pounds)
Reactions: Pulmonary Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tnkase
Indication: Acute Myocardial Infarction
Start date: 2012-05-09
Angiomax
Indication: Product Used FOR Unknown Indication
Start date: 2012-05-09
Plavix
Indication: Product Used FOR Unknown Indication
Start date: 2012-05-09
Other drugs received by patient: Aspirin
Possible Angiomax side effects in 74 year old male
Reported by a health professional (non-physician/pharmacist) from Italy on 2012-05-09
Patient: 74 year old male
Reactions: Monoplegia, Cerebral Haematoma
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aspirin
Indication: Percutaneous Coronary Intervention
Clopidogrel
Indication: Percutaneous Coronary Intervention
Angiomax
Indication: Percutaneous Coronary Intervention
Possible Angiomax side effects in 50 year old female
Reported by a physician from United States on 2012-05-08
Patient: 50 year old female
Reactions: Cardio-Respiratory Arrest, Coronary Artery Thrombosis, Heparin-Induced Thrombocytopenia, Haemorrhage, Thrombocytopenia, Thrombosis in Device
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Angiomax
Dosage: 0.75 mg/kg, intravenous; 1.75 mg/kg, hr
Indication: Percutaneous Coronary Intervention
Heparin
Dosage: 1800 iu
Start date: 2012-04-21
End date: 2012-04-22
Other drugs received by patient: Prozac; Clopidegrel; Insulin (Insulin); Atenolol; Famotidine; Fenofibrate
Possible Angiomax side effects in 49 year old female
Reported by a physician from United States on 2012-05-08
Patient: 49 year old female, weighing 85.0 kg (187.0 pounds)
Reactions: Chest Pain, Coronary Artery Stenosis, Electrocardiogram ST Segment Elevation, Thrombosis in Device
Drug(s) suspected as cause:
Angiomax
Dosage: 13 ml, bolus, intravenous 30 ml, hr, intravenous 13 ml, bolus, intravenous 30 ml, hr, intravenous
Indication: Percutaneous Coronary Intervention
Start date: 2012-03-09
End date: 2012-03-09
Angiomax
Dosage: 13 ml, bolus, intravenous 30 ml, hr, intravenous 13 ml, bolus, intravenous 30 ml, hr, intravenous
Indication: Percutaneous Coronary Intervention
Start date: 2012-03-09
End date: 2012-03-09
Angiomax
Dosage: 13 ml, bolus, intravenous 30 ml, hr, intravenous 13 ml, bolus, intravenous 30 ml, hr, intravenous
Indication: Percutaneous Coronary Intervention
Start date: 2012-03-09
End date: 2012-03-09
Angiomax
Dosage: 13 ml, bolus, intravenous 30 ml, hr, intravenous 13 ml, bolus, intravenous 30 ml, hr, intravenous
Indication: Percutaneous Coronary Intervention
Start date: 2012-03-09
End date: 2012-03-09
Other drugs received by patient: Plavix; Isovue-370; Aspirin; Isovue-370
Possible Angiomax side effects in 73 year old female
Reported by a pharmacist from United States on 2012-05-01
Patient: 73 year old female
Reactions: Haemorrhage, Procedural Site Reaction, Blood Creatinine Increased
Drug(s) suspected as cause:
Angiomax
Angiomax
Dosage: , intravenous
Indication: Percutaneous Coronary Intervention
Possible Angiomax side effects in male
Reported by a physician from United States on 2012-05-01
Patient: male
Reactions: Cardio-Respiratory Arrest, Thrombosis in Device
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Angiomax
Possible Angiomax side effects in female
Reported by a physician from United States on 2012-05-01
Patient: female
Reactions: Coronary Artery Dissection, Procedural Complication, Thrombosis in Device
Drug(s) suspected as cause:
Angiomax
Possible Angiomax side effects in
Reported by a physician from United States on 2012-04-30
Patient:
Reactions: Off Label Use, Muscular Weakness, Haemorrhagic Stroke, Headache
Drug(s) suspected as cause:
Angiomax
Other drugs received by patient: Clopidogrel; Aspirin
|
