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APIXABAN

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Apixaban Adverse Events Reported to the FDA Over Time

How are Apixaban adverse event reports trending over time?

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

Most Common Apixaban Adverse Events Reported to the FDA

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

Pneumonia
28 (1.88%)
Hypotension
24 (1.62%)
Overdose
24 (1.62%)
Renal Failure Acute
22 (1.48%)
Syncope
20 (1.35%)
Asthenia
19 (1.28%)
Haemoglobin Decreased
19 (1.28%)
Hypoxia
16 (1.08%)
Ischaemic Stroke
16 (1.08%)
Liver Function Test Abnormal
16 (1.08%)
Dyspnoea
15 (1.01%)
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Haematuria
15 (1.01%)
Urinary Tract Infection
15 (1.01%)
Cardiac Arrest
14 (.94%)
Cellulitis
14 (.94%)
Atrial Fibrillation
13 (.87%)
Cardiac Failure Congestive
13 (.87%)
Depressed Level Of Consciousness
13 (.87%)
Bronchopneumonia
12 (.81%)
Dizziness
12 (.81%)
Aspartate Aminotransferase Increase...
11 (.74%)
Accidental Overdose
10 (.67%)
Alanine Aminotransferase Increased
10 (.67%)
Hyponatraemia
10 (.67%)
Mental Status Changes
10 (.67%)
Nausea
10 (.67%)
Respiratory Failure
10 (.67%)
Confusional State
9 (.61%)
Haematocrit Decreased
9 (.61%)
Haematoma
9 (.61%)
International Normalised Ratio Incr...
9 (.61%)
Suicidal Ideation
9 (.61%)
Tremor
9 (.61%)
Upper Gastrointestinal Haemorrhage
9 (.61%)
Bradycardia
8 (.54%)
Cardiac Failure
8 (.54%)
Cardio-respiratory Arrest
8 (.54%)
Chest Pain
8 (.54%)
Cholelithiasis
8 (.54%)
Coma
8 (.54%)
Decreased Appetite
8 (.54%)
Haemorrhagic Stroke
8 (.54%)
Hiccups
8 (.54%)
Peripheral Embolism
8 (.54%)
Presyncope
8 (.54%)
Aortic Dissection
7 (.47%)
Cholecystitis
7 (.47%)
Condition Aggravated
7 (.47%)
Convulsion
7 (.47%)
Drug Withdrawal Syndrome
7 (.47%)
Gamma-glutamyltransferase Increased
7 (.47%)
Haemothorax
7 (.47%)
Hepatitis Toxic
7 (.47%)
Intentional Drug Misuse
7 (.47%)
Myocardial Infarction
7 (.47%)
Urinary Tract Infection Bacterial
7 (.47%)
Urticaria
7 (.47%)
Visual Impairment
7 (.47%)
Angioedema
6 (.4%)
Aortic Aneurysm Rupture
6 (.4%)
Cardiopulmonary Failure
6 (.4%)
Cerebrovascular Accident
6 (.4%)
Drug Interaction
6 (.4%)
Electrocardiogram Qt Prolonged
6 (.4%)
Fall
6 (.4%)
Gastrointestinal Haemorrhage
6 (.4%)
Haemorrhage
6 (.4%)
Mental Disorder
6 (.4%)
Oropharyngeal Pain
6 (.4%)
Pleural Effusion
6 (.4%)
Pulmonary Haemorrhage
6 (.4%)
Rectal Haemorrhage
6 (.4%)
Renal Failure
6 (.4%)
Somnolence
6 (.4%)
Suicide Attempt
6 (.4%)
Vomiting
6 (.4%)
Acute Myocardial Infarction
5 (.34%)
Anaemia
5 (.34%)
Arthralgia
5 (.34%)
Back Pain
5 (.34%)
Blood Bilirubin Increased
5 (.34%)
Cerebral Infarction
5 (.34%)
Deep Vein Thrombosis
5 (.34%)
Drug Level Increased
5 (.34%)
Haematemesis
5 (.34%)
Hyperkalaemia
5 (.34%)
Hypersensitivity
5 (.34%)
Metastatic Neoplasm
5 (.34%)
Oedema Peripheral
5 (.34%)
Pancytopenia
5 (.34%)
Psychiatric Decompensation
5 (.34%)
Pulmonary Embolism
5 (.34%)
Sepsis
5 (.34%)
Angina Pectoris
4 (.27%)
Angina Unstable
4 (.27%)
Arthropathy
4 (.27%)
Cardiac Enzymes Increased
4 (.27%)
Cardiomyopathy
4 (.27%)
Carotid Artery Stenosis
4 (.27%)
Cerebral Atrophy
4 (.27%)
Chronic Obstructive Pulmonary Disea...
4 (.27%)

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

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

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

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

Thrombosis Prophylaxis
263
Embolism
85
Acute Coronary Syndrome
16
Embolism Arterial
16
Atrial Fibrillation
9
Arrhythmia Prophylaxis
4
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Product Used For Unknown Indication
3
Prophylaxis
2
Cerebrovascular Accident Prophylaxi...
2
Cardiac Failure
1
Knee Operation
1

Drug Labels

LabelLabelerEffective
EliquisE.R. Squibb & Sons, L.L.C.28-DEC-12

Apixaban Case Reports

What Apixaban 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 Apixaban. 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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