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Activase (Alteplase) - Side Effect Reports to FDA

 
 



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 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 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 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 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 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 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 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 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 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



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

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