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Reteplase Adverse Events Reported to the FDA Over Time

How are Reteplase adverse event reports trending over time?

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

Most Common Reteplase Adverse Events Reported to the FDA

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

Coronary Artery Stenosis
231 (5.65%)
Coronary Artery Disease
155 (3.79%)
Ventricular Fibrillation
99 (2.42%)
Gastrointestinal Haemorrhage
79 (1.93%)
Haemoglobin Decreased
79 (1.93%)
Cardiac Failure
70 (1.71%)
Atrial Fibrillation
63 (1.54%)
Cardiac Arrest
62 (1.52%)
Drug Interaction
57 (1.39%)
Thrombocytopenia
56 (1.37%)
Coronary Artery Occlusion
54 (1.32%)
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Myocardial Ischaemia
50 (1.22%)
Cardiogenic Shock
49 (1.2%)
Ejection Fraction Decreased
49 (1.2%)
Hypotension
45 (1.1%)
Myocardial Infarction
45 (1.1%)
Chest Pain
41 (1%)
Coronary Artery Thrombosis
39 (.95%)
Pneumonia
37 (.9%)
Pulmonary Oedema
37 (.9%)
Bradycardia
36 (.88%)
Cardiac Failure Congestive
32 (.78%)
Haematocrit Decreased
30 (.73%)
Angina Unstable
28 (.68%)
Arteriosclerosis Coronary Artery
28 (.68%)
Haematoma
28 (.68%)
Blood Glucose Increased
25 (.61%)
Angina Pectoris
24 (.59%)
Bronchopneumonia
24 (.59%)
Pericardial Haemorrhage
24 (.59%)
Mitral Valve Incompetence
23 (.56%)
Post Procedural Complication
23 (.56%)
Dizziness
22 (.54%)
Procedural Complication
22 (.54%)
Ventricular Tachycardia
22 (.54%)
Cardiac Tamponade
21 (.51%)
Dyspnoea
21 (.51%)
Myocardial Rupture
21 (.51%)
Intracardiac Thrombus
20 (.49%)
Vascular Pseudoaneurysm
20 (.49%)
Acute Myocardial Infarction
19 (.46%)
Blood Pressure Increased
19 (.46%)
Aspartate Aminotransferase Increase...
18 (.44%)
Blood Creatine Phosphokinase Mb Inc...
18 (.44%)
Blood Pressure Decreased
18 (.44%)
General Physical Health Deteriorati...
18 (.44%)
Puncture Site Haemorrhage
18 (.44%)
Atrioventricular Block Complete
16 (.39%)
Blood Creatine Phosphokinase Increa...
16 (.39%)
Cerebral Haemorrhage
16 (.39%)
Hypertension
16 (.39%)
Pericardial Effusion
16 (.39%)
Ventricular Hypokinesia
16 (.39%)
Activated Partial Thromboplastin Ti...
15 (.37%)
Blood Cholesterol Increased
15 (.37%)
Cardiac Procedure Complication
15 (.37%)
Ischaemia
15 (.37%)
Blood Pressure Systolic Increased
14 (.34%)
Haematemesis
14 (.34%)
Acute Respiratory Distress Syndrome
13 (.32%)
Injection Site Haemorrhage
13 (.32%)
Pyrexia
13 (.32%)
Renal Impairment
13 (.32%)
Respiratory Failure
13 (.32%)
Alanine Aminotransferase Increased
12 (.29%)
Condition Aggravated
12 (.29%)
Electrocardiogram St Segment Elevat...
12 (.29%)
Haemorrhage
12 (.29%)
Mallory-weiss Syndrome
12 (.29%)
Multi-organ Failure
12 (.29%)
Arrhythmia
11 (.27%)
Haemodynamic Instability
11 (.27%)
Haemorrhagic Stroke
11 (.27%)
Iatrogenic Injury
11 (.27%)
Renal Failure Acute
11 (.27%)
Ventricular Hypertrophy
11 (.27%)
White Blood Cell Count Increased
11 (.27%)
Anaemia
10 (.24%)
Anuria
10 (.24%)
Asthenia
10 (.24%)
Blood Creatinine Increased
10 (.24%)
Dilatation Atrial
10 (.24%)
Dilatation Ventricular
10 (.24%)
Epistaxis
10 (.24%)
Gastritis Erosive
10 (.24%)
Haemorrhage Intracranial
10 (.24%)
Nausea
10 (.24%)
Platelet Count Decreased
10 (.24%)
Thrombosis
10 (.24%)
Atrial Flutter
9 (.22%)
C-reactive Protein Increased
9 (.22%)
Electromechanical Dissociation
9 (.22%)
Haematuria
9 (.22%)
Non-cardiac Chest Pain
9 (.22%)
Post Procedural Haemorrhage
9 (.22%)
Productive Cough
9 (.22%)
Pulmonary Congestion
9 (.22%)
Troponin Increased
9 (.22%)
Aortic Arteriosclerosis
8 (.2%)
Arterial Rupture
8 (.2%)
Cardiac Aneurysm
8 (.2%)

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This graph shows the top adverse events submitted to the FDA for Reteplase, 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 Reteplase 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 Reteplase

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

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This graph shows the top categories of adverse events submitted to the FDA for Reteplase, 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 Reteplase 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 Reteplase According to Those Reporting Adverse Events

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

Acute Myocardial Infarction
910
Myocardial Infarction
42
Drug Use For Unknown Indication
6
Cerebrovascular Accident
5
Pulmonary Embolism
4
Thrombosis Prophylaxis
2
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Ischaemic Stroke
2
Aortic Bifurcation Graft
2
Thrombolysis
2
Peripheral Embolism
1
Femoral Artery Occlusion
1
Deep Vein Thrombosis
1
Thrombosis
1
Hypertension
1
Anticoagulant Therapy
1

Drug Labels

LabelLabelerEffective
RetavaseEKR Therapeutics, Inc.05-JAN-10

Reteplase Case Reports

What Reteplase 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 Reteplase. 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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