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Activase (Alteplase) - Haemorrhage - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Haemorrhage (14)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Activase (Alteplase) where reactions include haemorrhage. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Activase side effects in 9 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-10

Patient: 9 year old male

Reactions: Haemorrhage, Motor Dysfunction, Disturbance in Attention, Intracranial Venous Sinus Thrombosis, Infarction

Drug(s) suspected as cause:
Activase
    Indication: Superior Sagittal Sinus Thrombosis

Pegaspargase
    Indication: Acute Lymphocytic Leukaemia

Other drugs received by patient: Vincristine



Possible Activase side effects in female

Reported by a physician from Australia on 2012-05-18

Patient: female

Reactions: Haemorrhage, Ischaemic Stroke, Haemorrhage Intracranial

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Pradaxa
    Indication: Atrial Fibrillation
    End date: 2011-11-16

Activase
    Indication: Thrombolysis

Other drugs received by patient: Metformin HCL; Perindopril Erbumine; Digoxin; Diamicron; Loratadine



Possible Activase side effects in 64 year old male

Reported by a consumer/non-health professional from United States on 2012-05-15

Patient: 64 year old male

Reactions: Blood Pressure Increased, Overdose, Haemorrhage, Dysphonia, Cerebral Infarction, Haemorrhage Intracranial, Drug Administration Error, Hemiplegia, Ill-Defined Disorder, Arrhythmia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Activase



Possible Activase side effects in male

Reported by a physician from India on 2012-04-16

Patient: male

Reactions: Death, Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Activase



Possible Activase side effects in 25 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-04-05

Patient: 25 year old female

Reactions: Electrocardiogram QT Prolonged, Abdominal Pain, Phaeochromocytoma, Haemorrhage, Tachycardia, Pulmonary Embolism, Pulmonary Congestion, Chest Pain, Pleural Effusion, Hypoxia, Arteriosclerosis, White Blood Cell Count Increased, Vomiting, Dyspnoea, Metabolic Acidosis, Neutrophil Count Increased, Anxiety, Haemoglobin Decreased, Electrocardiogram ST Segment Elevation, Cardiac Arrest, Hypertension, Pulseless Electrical Activity

Adverse event resulted in: death

Drug(s) suspected as cause:
Propranolol
    Dosage: 20 mg, unk
    Administration route: Oral
    Indication: Anxiety
    Start date: 2011-10-01
    End date: 2011-10-01

Activase
    Dosage: 50 mg, bid
    Indication: Pulmonary Embolism
    Start date: 2011-10-01
    End date: 2011-10-01

Other drugs received by patient: Midazolam; Suxamethonium; Morphine



Possible Activase side effects in 25 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-29

Patient: 25 year old female

Reactions: Electrocardiogram QT Prolonged, Abdominal Pain, Phaeochromocytoma, Haemorrhage, Tachycardia, Pulmonary Embolism, Chest Pain, Pulmonary Congestion, Pleural Effusion, Hypoxia, Arteriosclerosis, White Blood Cell Count Increased, Vomiting, Neutrophil Count Increased, Dyspnoea, Metabolic Acidosis, Haemoglobin Decreased, Anxiety, Electrocardiogram ST Segment Elevation, Hypertension, Cardiac Arrest, Pulseless Electrical Activity

Adverse event resulted in: death

Drug(s) suspected as cause:
Activase
    Dosage: 50 mg, bid
    Indication: Pulmonary Embolism
    Start date: 2011-10-01

Propranolol
    Dosage: 20 mg, unk
    Administration route: Oral
    Indication: Anxiety
    Start date: 2011-10-01

Other drugs received by patient: Morphine; Midazolam; Suxamethonium



Possible Activase side effects in 25 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-22

Patient: 25 year old female

Reactions: Electrocardiogram QT Prolonged, Metabolic Acidosis, Phaeochromocytoma, Neutrophil Count Increased, Haemorrhage, Haemoglobin Decreased, Pulmonary Congestion, Pleural Effusion, Hypoxia, Cardiac Arrest, Arteriosclerosis, Electrocardiogram ST Segment Elevation, Sinus Tachycardia, Pulseless Electrical Activity, White Blood Cell Count Increased

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Propranolol
    Dosage: 10 mg, unk
    Indication: Anxiety
    Start date: 2011-10-01

Activase
    Dosage: 50 mg, bid
    Indication: Pulmonary Embolism
    Start date: 2011-10-01

Other drugs received by patient: Suxamethonium; Morphine; Midazolam



Possible Activase side effects in female

Reported by a physician from United States on 2012-03-15

Patient: female

Reactions: Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Activase



Possible Activase side effects in 76 year old female

Reported by a physician from Australia on 2012-02-20

Patient: 76 year old female

Reactions: Haemorrhage, Ischaemic Stroke, Haemorrhage Intracranial

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Pradaxa
    Indication: Atrial Fibrillation

Activase
    Indication: Thrombolysis



Possible Activase side effects in 76 year old female

Reported by a physician from Australia on 2012-02-13

Patient: 76 year old female

Reactions: Haemorrhage, Haemorrhage Intracranial, Ischaemic Stroke

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Pradaxa
    Indication: Atrial Fibrillation

Activase
    Indication: Thrombolysis



Possible Activase side effects in 74 year old male

Reported by a physician from United Kingdom on 2012-01-20

Patient: 74 year old male, weighing 87.8 kg (193.2 pounds)

Reactions: Overdose, Haemorrhage, Brain Oedema, Brain Midline Shift, Convulsion, Cerebral Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Activase
    Indication: Thrombolysis

Activase
    Indication: Cerebrovascular Accident
    Start date: 2011-08-09
    End date: 2011-08-09



Possible Activase side effects in

Reported by a physician from Germany on 2011-11-29

Patient:

Reactions: Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Activase



Possible Activase side effects in 74 year old male

Reported by a physician from United Kingdom on 2011-11-04

Patient: 74 year old male, weighing 87.8 kg (193.2 pounds)

Reactions: Overdose, Haemorrhage, Brain Oedema, Brain Midline Shift, Convulsion, Cerebral Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Activase
    Indication: Cerebrovascular Accident
    Start date: 2011-08-09
    End date: 2011-08-09

Activase
    Indication: Thrombolysis



Possible Activase side effects in 75 year old female

Reported by a health professional (non-physician/pharmacist) from Poland on 2011-10-20

Patient: 75 year old female

Reactions: Blood Pressure Increased, Dysphagia, Haemorrhage, Urinary Tract Infection, Aphasia, Platelet Count Increased, Hemiparesis, Hemianopia, Ill-Defined Disorder, Cerebrovascular Accident, Loss of Consciousness, Pseudobulbar Palsy, Hemiplegia, Respiratory Tract Infection, Gaze Palsy

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Activase
    Indication: Ischaemic Stroke
    Start date: 2008-08-06
    End date: 2008-08-06

Activase

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