This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Activase (Alteplase) 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 (288)
Death (152)
Life Threatening Events (41)
Disability (10)
Reports by Reaction Type
Death (80),
Chest Pain (32),
Cerebral Haemorrhage (28),
Angioedema (20),
Dyspnoea (16),
Haemorrhage (14),
Brain Oedema (14),
Ventricular Tachycardia (11),
Nausea (10),
Haemorrhage Intracranial (10),
Hypertension (10),
Chest Discomfort (9)
Below are a few examples of reports where side effects / adverse reactions may be related to Activase (Alteplase). For a complete list or a specific selection of reports, please use the links above.
Possible Activase side effects in male
Reported by a physician from Germany on 2012-08-27
Patient: male, weighing 100.0 kg (220.0 pounds)
Reactions: Angioedema, Tongue Oedema, Macroglossia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Activase
Indication: Cerebrovascular Accident
Ramipril
Administration route: Oral
Indication: Hypertension
Other drugs received by patient: Insulin; Spiriva; Bayotensin; Fluticasone Propionate / Salmeterol
Possible Activase side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Activase
Indication: Lung Neoplasm Malignant
Tarceva
Indication: Lung Neoplasm Malignant
Possible Activase side effects in 43 year old male
Reported by a physician from United States on 2012-08-24
Patient: 43 year old male
Reactions: Ventricular Extrasystoles, Metabolic Acidosis, Atrioventricular Block Complete, Hypoxia, Cardiac Arrest, Pulseless Electrical Activity
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Activase
Possible Activase side effects in 64 year old female
Reported by a physician from United States on 2012-08-24
Patient: 64 year old female
Reactions: Chest Pain, Blood Pressure Decreased, Cardiogenic Shock, Infarction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Activase
Possible Activase side effects in 68 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-23
Patient: 68 year old female
Reactions: Fibrin D Dimer Increased, Fibrin Degradation Products Increased
Drug(s) suspected as cause:
Activase
Indication: Embolic Stroke
Start date: 2012-06-19
End date: 2012-06-19
Radicut
Indication: Embolic Stroke
Start date: 2012-06-19
End date: 2012-06-28
Other drugs received by patient: Glyceol; Warfarin Potassium; Insulin; Heparin Sodium
Possible Activase side effects in male
Reported by a physician from United States on 2012-08-23
Patient: male
Reactions: Arterial Thrombosis Limb, Chest Pain
Drug(s) suspected as cause:
Activase
Possible Activase side effects in male
Reported by a physician from United States on 2012-08-23
Patient: male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Activase
Indication: Lung Neoplasm Malignant
Tarceva
Indication: Embolism
Tarceva
Indication: Lung Neoplasm Malignant
Possible Activase side effects in 37 year old male
Reported by a physician from United States on 2012-08-23
Patient: 37 year old male
Reactions: Atelectasis, Ventricular Extrasystoles, Polycythaemia, Ventricular Tachycardia, Extrasystoles, Chest Pain, Blood Pressure Decreased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Activase
Other drugs received by patient: Procardia; Nitro-BID; Capoten; Lopressor
Possible Activase side effects in female
Reported by a physician from United States on 2012-08-23
Patient: female
Reactions: Dyspnoea, Nausea, Pain, Erythema, Joint Swelling, Oedema Peripheral, Dizziness, Sinus Tachycardia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Activase
Other drugs received by patient: Lopressor
Possible Activase side effects in 63 year old male
Reported by a physician from Japan on 2012-08-23
Patient: 63 year old male
Reactions: Embolic Stroke, Haemorrhagic Cerebral Infarction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Activase
Indication: Embolic Stroke
Start date: 2011-06-03
Heparin Sodium
Dosage: 10 kiu/day
Indication: Embolic Stroke
Radicut
Indication: Embolic Stroke
Other drugs received by patient: Warfarin Potassium
Possible Activase side effects in 43 year old male
Reported by a physician from United States on 2012-08-21
Patient: 43 year old male
Reactions: Arrhythmia Supraventricular, Metabolic Acidosis, Hypotension, Supraventricular Tachycardia, Pain, Ventricular Arrhythmia, Cardiogenic Shock, NO Therapeutic Response, Bradycardia, Cardiac Arrest, Lethargy
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Activase
Other drugs received by patient: Morphine; Nitro Drip
Possible Activase side effects in 58 year old female
Reported by a physician from United States on 2012-08-21
Patient: 58 year old female
Reactions: Dyspnoea, Pleurisy, Pulmonary Congestion, Pulmonary Embolism
Drug(s) suspected as cause:
Activase
Other drugs received by patient: Tagamet; Premarin; Ventolin; Nitroglycerin; Proventil; Amitriptyline Hydrochloride
Possible Activase side effects in male
Reported by a physician from United States on 2012-08-21
Patient: male
Reactions: Oedema Peripheral
Drug(s) suspected as cause:
Activase
Other drugs received by patient: Heparin; Norvasc; Lopressor
Possible Activase side effects in male
Reported by a pharmacist from United States on 2012-08-21
Patient: male, weighing 79.9 kg (175.8 pounds)
Reactions: Bradycardia, Cerebral Haemorrhage, Cough
Adverse event resulted in: death
Drug(s) suspected as cause:
Activase
Other drugs received by patient: Oxygen; Regular Insulin; Labetalol HCL; Pantoprazole
Possible Activase side effects in 32 year old male
Reported by a physician from United States on 2012-08-21
Patient: 32 year old male
Reactions: Hypotension, Renal Failure Chronic, Exercise Tolerance Decreased, Death, Syncope, Sinus Headache, Pulmonary Oedema, Cardiac Failure Congestive
Adverse event resulted in: death
Drug(s) suspected as cause:
Activase
Possible Activase side effects in 45 year old male
Reported by a physician from United States on 2012-08-20
Patient: 45 year old male
Reactions: Supraventricular Tachycardia, Hypotension, Ventricular Arrhythmia, General Symptom
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Activase
Other drugs received by patient: Heparin; Quinidine HCL; Morphine Sulfate; Lidocaine; Nitroglycerin; Indocin
Possible Activase side effects in 38 year old male
Reported by a physician from United States on 2012-08-20
Patient: 38 year old male
Reactions: Blood Pressure Increased, Extrasystoles, Insomnia, Nervousness
Drug(s) suspected as cause:
Activase
Other drugs received by patient: Lidocaine; Heparin
Possible Activase side effects in 52 year old male
Reported by a physician from United States on 2012-08-20
Patient: 52 year old male
Reactions: Chest Pain, Postinfarction Angina, Ventricular Fibrillation, Cardiac Arrest
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Activase
Other drugs received by patient: Nitroglycerin Sublingual; Heparin; Nitroglycerin; Morphine Sulfate
Possible Activase side effects in male
Reported by a physician from United States on 2012-08-20
Patient: male
Reactions: Back Pain, Ventricular Tachycardia, Chest Pain, Electrocardiogram ST Segment Elevation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Activase
Possible Activase side effects in male
Reported by a physician from United States on 2012-08-20
Patient: male
Reactions: Chest Discomfort, Supraventricular Extrasystoles, Rales, Myocardial Infarction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Activase
Possible Activase side effects in male
Reported by a physician from United States on 2012-08-20
Patient: male
Reactions: Death, Cyanosis, Ventricular Tachycardia, Ventricular Fibrillation, Convulsion
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Activase
Indication: Cardiogenic Shock
Activase
Indication: Myocardial Infarction
Other drugs received by patient: Dopamine HCL; Lidocaine; Lidocaine Bolus
Possible Activase side effects in female
Reported by a physician from United States on 2012-08-20
Patient: female
Reactions: Product Quality Issue, Bacteraemia, Chills, Transmission of AN Infectious Agent VIA A Medicinal Product, Pyrexia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Activase
Possible Activase side effects in female
Reported by a physician from United States on 2012-08-20
Patient: female
Reactions: Chest Discomfort, Vomiting, Sinus Bradycardia
Drug(s) suspected as cause:
Activase
Other drugs received by patient: Lidocaine
Possible Activase side effects in male
Reported by a physician from United States on 2012-08-17
Patient: male
Reactions: Chest Pain
Drug(s) suspected as cause:
Activase
Other drugs received by patient: Nitroglycerin; Heparin; Aspirin; Procardia; Lidocaine
Possible Activase side effects in 57 year old male
Reported by a physician from United States on 2012-08-17
Patient: 57 year old male
Reactions: Pain
Drug(s) suspected as cause:
Activase
Other drugs received by patient: Heparin; Nitroglycerin; Lopressor
Possible Activase side effects in male
Reported by a physician from United States on 2012-08-17
Patient: male
Reactions: Myocardial Stunning
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Activase
Other drugs received by patient: Heparin; Nitroglycerin
Possible Activase side effects in male
Reported by a physician from United States on 2012-08-17
Patient: male
Reactions: Blood Creatine Phosphokinase Increased, Retching, Hypotension, Chest Pain, Bradycardia
Drug(s) suspected as cause:
Activase
Other drugs received by patient: Lidocaine; Nitroglycerin; Atropine
Possible Activase side effects in 63 year old female
Reported by a physician from United States on 2012-08-17
Patient: 63 year old female
Reactions: Chest Discomfort, Nausea, Dizziness, Arrhythmia
Drug(s) suspected as cause:
Activase
Other drugs received by patient: Solu-Medrol; Heparin; Morphine Sulfate; Benadryl; Lidocaine
Possible Activase side effects in male
Reported by a physician from United States on 2012-08-17
Patient: male
Reactions: Abdominal Discomfort, Dyspnoea, Nausea, Haemorrhage Intracranial, Aphasia, Chest Pain, Abdominal Distension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Activase
Other drugs received by patient: Aspirin
Possible Activase side effects in 56 year old female
Reported by a physician from United States on 2012-08-17
Patient: 56 year old female
Reactions: Oropharyngeal Pain, Headache, Electrocardiogram T Wave Inversion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Activase
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