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Activase Adverse Events Reported to the FDA Over Time

How are Activase adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Activase, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Activase is flagged as the suspect drug causing the adverse event.

Most Common Activase Adverse Events Reported to the FDA

What are the most common Activase adverse events reported to the FDA?

Death
325 (10.14%)
Cerebral Haemorrhage
115 (3.59%)
Drug Ineffective
87 (2.71%)
Haemorrhage Intracranial
70 (2.18%)
Haemorrhage
55 (1.72%)
Angioedema
43 (1.34%)
Chest Pain
38 (1.19%)
Hypotension
33 (1.03%)
Pulmonary Embolism
32 (1%)
Cerebrovascular Accident
31 (.97%)
Dyspnoea
31 (.97%)
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Respiratory Failure
31 (.97%)
Pneumonia
30 (.94%)
Brain Oedema
29 (.9%)
Anaphylactic Reaction
26 (.81%)
Convulsion
25 (.78%)
Cardiac Arrest
24 (.75%)
Haemorrhagic Cerebral Infarction
23 (.72%)
Ischaemic Stroke
22 (.69%)
Atrial Fibrillation
21 (.66%)
Cerebral Infarction
21 (.66%)
Intraocular Pressure Increased
21 (.66%)
Hypertension
20 (.62%)
Multi-organ Failure
20 (.62%)
Coma
19 (.59%)
Deep Vein Thrombosis
18 (.56%)
Loss Of Consciousness
18 (.56%)
Nausea
18 (.56%)
Ventricular Tachycardia
18 (.56%)
Blood Pressure Decreased
17 (.53%)
Myocardial Infarction
17 (.53%)
Anaphylactic Shock
16 (.5%)
Epilepsy
16 (.5%)
Haematoma
16 (.5%)
Haemorrhagic Transformation Stroke
16 (.5%)
Hemiparesis
16 (.5%)
Acute Myocardial Infarction
15 (.47%)
Bradycardia
15 (.47%)
Swollen Tongue
15 (.47%)
Ventricular Fibrillation
15 (.47%)
Vomiting
15 (.47%)
Brain Herniation
13 (.41%)
Chest Discomfort
13 (.41%)
Cns Ventriculitis
13 (.41%)
Pain
13 (.41%)
Abdominal Pain
12 (.37%)
Cardiogenic Shock
12 (.37%)
Cyanosis
12 (.37%)
Depressed Level Of Consciousness
12 (.37%)
Intraventricular Haemorrhage
12 (.37%)
Myocardial Rupture
12 (.37%)
Pneumonia Aspiration
12 (.37%)
Renal Failure Acute
12 (.37%)
Cardiac Failure
11 (.34%)
Cardiac Tamponade
11 (.34%)
Compartment Syndrome
11 (.34%)
Disease Recurrence
11 (.34%)
Epistaxis
11 (.34%)
Haemoptysis
11 (.34%)
Medication Error
11 (.34%)
Shock
11 (.34%)
Aortic Aneurysm Rupture
10 (.31%)
Aphasia
10 (.31%)
Cardio-respiratory Arrest
10 (.31%)
Headache
10 (.31%)
Overdose
10 (.31%)
Renal Failure
10 (.31%)
Sepsis
10 (.31%)
Aortic Dissection
9 (.28%)
Blood Pressure Increased
9 (.28%)
Cerebral Haematoma
9 (.28%)
Disseminated Intravascular Coagulat...
9 (.28%)
Intracardiac Thrombus
9 (.28%)
Subarachnoid Haemorrhage
9 (.28%)
Tachycardia
9 (.28%)
Arrhythmia
8 (.25%)
Asthma
8 (.25%)
Dermatitis Bullous
8 (.25%)
Drug Exposure During Pregnancy
8 (.25%)
Drug Interaction
8 (.25%)
Dysphagia
8 (.25%)
Glaucoma
8 (.25%)
Haemoglobin Decreased
8 (.25%)
Haemorrhagic Stroke
8 (.25%)
Hyperhidrosis
8 (.25%)
Hypersensitivity
8 (.25%)
Hypoaesthesia
8 (.25%)
Pulmonary Oedema
8 (.25%)
Thrombocytopenia
8 (.25%)
Tongue Oedema
8 (.25%)
Ventricular Extrasystoles
8 (.25%)
Anxiety
7 (.22%)
Artery Dissection
7 (.22%)
Bacteraemia
7 (.22%)
Blood Creatine Phosphokinase Increa...
7 (.22%)
Brain Death
7 (.22%)
Disease Progression
7 (.22%)
General Physical Health Deteriorati...
7 (.22%)
Hydrocephalus
7 (.22%)
Liver Disorder
7 (.22%)
Pruritus Generalised
7 (.22%)

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This graph shows the top adverse events submitted to the FDA for Activase, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Activase is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Activase

What are the most common Activase adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Activase, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Activase is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Activase According to Those Reporting Adverse Events

Why are people taking Activase, according to those reporting adverse events to the FDA?

Acute Myocardial Infarction
335
Ischaemic Stroke
242
Myocardial Infarction
131
Product Used For Unknown Indication
124
Cerebrovascular Accident
112
Cerebral Infarction
94
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Pulmonary Embolism
80
Drug Use For Unknown Indication
45
Retinal Haemorrhage
43
Cerebral Artery Embolism
39
Embolic Stroke
31
Cerebral Artery Occlusion
27
Thrombolysis
26
Catheter Related Complication
22
Thrombosis
21
Deep Vein Thrombosis
18
Retinal Vein Occlusion
17
Intraventricular Haemorrhage
16
Embolism
15
Medical Device Complication
15
Cerebral Thrombosis
12
Peripheral Ischaemia
11
Cerebral Haemorrhage
10
Cerebral Ischaemia
9
Chest Pain
8
Coagulopathy
8
Ischaemia
8
Arterial Thrombosis
7
Retinal Artery Occlusion
7
Thrombotic Cerebral Infarction
7
Arterial Occlusive Disease
7
Angina Unstable
7
Cardiac Arrest
7
Vena Cava Thrombosis
7
Venoocclusive Liver Disease
7
Infarction
6
Macular Degeneration
6
Pleural Infection
6
Hydrocephalus
6
Angioplasty
5
Intracardiac Thrombus
5
Cardio-respiratory Arrest
5
Basilar Artery Thrombosis
5
Renal Vein Thrombosis
5
Device Occlusion
5
Thrombosis Prophylaxis
4
Basilar Artery Occlusion
4
Cerebral Venous Thrombosis
4
Aortic Thrombosis
4
Poor Peripheral Circulation
4
Cerebrovascular Disorder
4

Drug Labels

LabelLabelerEffective
Cathflo ActivaseGenentech, Inc.07-MAR-12
ActivaseGenentech, Inc.08-MAR-12

Activase Case Reports

What Activase safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Activase. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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