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Index of reports
> Cases with Brain Oedema (14)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Activase (Alteplase) where reactions include brain oedema. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Activase side effects in male
Reported by a physician from United States on 2012-08-16
Patient: male
Reactions: Cardiac Failure, Bundle Branch Block, Brain Oedema, Encephalopathy, Renal Failure Chronic, Renal Failure Acute
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Activase
Other drugs received by patient: Epinephrine; Amiodarone
Possible Activase side effects in male
Reported by a physician from Germany on 2012-08-15
Patient: male, weighing 90.0 kg (198.0 pounds)
Reactions: Angioedema, Cerebral Infarction, Respiratory Failure, Brain Oedema, Endotracheal Intubation
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Activase
Possible Activase side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-13
Patient: male
Reactions: Speech Disorder, Dysphagia, Monoparesis, Brain Oedema
Drug(s) suspected as cause:
Activase
Possible Activase side effects in 76 year old female
Reported by a individual with unspecified qualification from Spain on 2012-07-17
Patient: 76 year old female
Reactions: Pupillary Reflex Impaired, Brain Herniation, Tachycardia, Coma, Subdural Haematoma, Areflexia, Tachypnoea, Brain Oedema
Adverse event resulted in: death
Drug(s) suspected as cause:
Activase
Other drugs received by patient: Enalapril Maleate; Levothyroxine Sodium; Doxazosin Mesylate; Acetylsalicylic Acid SRT; Insulin; Atorvastatin; Clopidogrel; Nitroglycerin
Possible Activase side effects in 62 year old male
Reported by a individual with unspecified qualification from Japan on 2012-05-01
Patient: 62 year old male
Reactions: Brain Oedema
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Activase
Possible Activase side effects in 72 year old female
Reported by a physician from Russian Federation on 2012-04-10
Patient: 72 year old female, weighing 74.0 kg (162.8 pounds)
Reactions: Cardiac Tamponade, Brain Oedema, Myocardial Rupture, Cerebral Haemorrhage
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Activase
Indication: Coronary Artery Disease
Activase
Dosage: once
Indication: Acute Myocardial Infarction
Start date: 2012-01-16
End date: 2012-01-16
Other drugs received by patient: Clopidogrel; Aspirin; Enoxaparin Sodium
Possible Activase side effects in 72 year old female
Reported by a physician from Russian Federation on 2012-03-29
Patient: 72 year old female, weighing 74.0 kg (162.8 pounds)
Reactions: Cardiac Tamponade, Brain Oedema, Myocardial Rupture, Cerebral Haemorrhage
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Activase
Dosage: once
Indication: Acute Myocardial Infarction
Start date: 2012-01-16
End date: 2012-01-16
Activase
Indication: Coronary Artery Disease
Other drugs received by patient: Clopidogrel; Enoxaparin Sodium; Aspirin
Possible Activase side effects in 62 year old male
Reported by a individual with unspecified qualification from Japan on 2012-03-14
Patient: 62 year old male
Reactions: Brain Oedema
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Activase
Possible Activase side effects in 70 year old male
Reported by a physician from Germany on 2012-03-09
Patient: 70 year old male, weighing 90.0 kg (198.0 pounds)
Reactions: Angioedema, Brain Oedema, Endotracheal Intubation
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Activase
Possible Activase side effects in 62 year old male
Reported by a individual with unspecified qualification from Japan on 2012-02-29
Patient: 62 year old male
Reactions: Brain Oedema
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Activase
Possible Activase side effects in 66 year old male
Reported by a individual with unspecified qualification from United States on 2012-02-10
Patient: 66 year old male
Reactions: Agitation, Pneumonia, Angioedema, Neurogenic Bladder, Atrial Flutter, Anaemia, Urinary Tract Infection, Antiphospholipid Antibodies, Pulmonary Embolism, Mental Status Changes, Cerebrovascular Accident, Liver Function Test Abnormal, Brain Oedema, Deep Vein Thrombosis
Adverse event resulted in: life threatening event, disablity
Drug(s) suspected as cause:
Activase
Indication: Ischaemic Stroke
Enalapril Maleate
Indication: Hypertension
Other drugs received by patient: Metoclopramide
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 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 66 year old male
Reported by a individual with unspecified qualification from United States on 2011-11-02
Patient: 66 year old male
Reactions: Agitation, Pneumonia, Angioedema, Neurogenic Bladder, Atrial Flutter, Antiphospholipid Antibodies, Urinary Tract Infection, Anaemia, Mental Status Changes, Pulmonary Embolism, Cerebrovascular Accident, Liver Function Test Abnormal, Brain Oedema, Deep Vein Thrombosis
Adverse event resulted in: life threatening event, disablity
Drug(s) suspected as cause:
Activase
Indication: Ischaemic Stroke
Enalapril Maleate
Indication: Hypertension
Other drugs received by patient: Metoprolol Tartrate
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