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EZETIMIBE

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Ezetimibe Adverse Events Reported to the FDA Over Time

How are Ezetimibe adverse event reports trending over time?

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

Most Common Ezetimibe Adverse Events Reported to the FDA

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

Rhabdomyolysis
90 (2.72%)
Fatigue
80 (2.42%)
Myalgia
78 (2.36%)
Dizziness
72 (2.18%)
Paraesthesia
68 (2.06%)
Renal Failure Acute
67 (2.03%)
Completed Suicide
66 (2%)
Atrial Fibrillation
61 (1.84%)
Blood Creatine Phosphokinase Increa...
58 (1.75%)
Dyspnoea
58 (1.75%)
Oedema Peripheral
53 (1.6%)
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Feeling Abnormal
50 (1.51%)
Cardiac Murmur
49 (1.48%)
Ventricular Tachycardia
45 (1.36%)
Drug Interaction
44 (1.33%)
Drug Ineffective
43 (1.3%)
Venous Pressure Jugular Increased
42 (1.27%)
Oedema
38 (1.15%)
Dyspnoea Exertional
35 (1.06%)
Left Ventricular Dysfunction
35 (1.06%)
Dissociation
29 (.88%)
Alanine Aminotransferase Increased
28 (.85%)
Condition Aggravated
25 (.76%)
Pain In Extremity
25 (.76%)
Arthralgia
23 (.7%)
Blood Creatinine Increased
22 (.67%)
Headache
22 (.67%)
Muscular Weakness
22 (.67%)
Myopathy
21 (.64%)
Asthenia
20 (.6%)
Death
20 (.6%)
Hypotension
20 (.6%)
Abdominal Pain
19 (.57%)
Amyotrophic Lateral Sclerosis
19 (.57%)
Cardiac Arrest
18 (.54%)
Diarrhoea
17 (.51%)
Hepatic Enzyme Increased
17 (.51%)
Vomiting
17 (.51%)
Aspartate Aminotransferase Increase...
16 (.48%)
Gamma-glutamyltransferase Increased
15 (.45%)
Nausea
15 (.45%)
Cough
14 (.42%)
Depression
14 (.42%)
Fall
14 (.42%)
Liver Disorder
14 (.42%)
Pneumonia
14 (.42%)
Abdominal Pain Upper
13 (.39%)
Dehydration
13 (.39%)
Eosinophilia
13 (.39%)
Pancreatitis Acute
13 (.39%)
Pyrexia
13 (.39%)
Renal Failure
13 (.39%)
Abasia
12 (.36%)
Asthma
12 (.36%)
Chest Pain
12 (.36%)
Anaemia
11 (.33%)
Autoimmune Hepatitis
11 (.33%)
Blood Alkaline Phosphatase Increase...
11 (.33%)
Liver Function Test Abnormal
11 (.33%)
Blood Bilirubin Increased
10 (.3%)
Confusional State
10 (.3%)
Gastrointestinal Haemorrhage
10 (.3%)
Hyperkalaemia
10 (.3%)
Intentional Drug Misuse
10 (.3%)
Muscle Spasms
10 (.3%)
Poisoning
10 (.3%)
Hepatitis Acute
9 (.27%)
Left Ventricular Failure
9 (.27%)
Respiratory Arrest
9 (.27%)
Stevens-johnson Syndrome
9 (.27%)
Weight Decreased
9 (.27%)
Circulatory Collapse
8 (.24%)
Hepatitis
8 (.24%)
Insomnia
8 (.24%)
Lactic Acidosis
8 (.24%)
Malaise
8 (.24%)
Pain
8 (.24%)
Rash
8 (.24%)
Systemic Lupus Erythematosus
8 (.24%)
Acidosis
7 (.21%)
Amnesia
7 (.21%)
Blood Cholesterol Increased
7 (.21%)
Blood Potassium Increased
7 (.21%)
Cholelithiasis
7 (.21%)
Decreased Appetite
7 (.21%)
Disorientation
7 (.21%)
Dyspepsia
7 (.21%)
Erectile Dysfunction
7 (.21%)
Gait Disturbance
7 (.21%)
Hallucination, Visual
7 (.21%)
Hepatic Necrosis
7 (.21%)
Hypersensitivity
7 (.21%)
Myocardial Infarction
7 (.21%)
Renal Impairment
7 (.21%)
Tendon Rupture
7 (.21%)
Tracheitis
7 (.21%)
Aplastic Anaemia
6 (.18%)
Back Pain
6 (.18%)
Blood Triglycerides Increased
6 (.18%)
Cardio-respiratory Arrest
6 (.18%)
Constipation
6 (.18%)

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

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

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

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

Drug Use For Unknown Indication
278
Hypercholesterolaemia
244
Blood Cholesterol Increased
240
Product Used For Unknown Indication
233
Hyperlipidaemia
214
Blood Cholesterol
91
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Dyslipidaemia
82
Ill-defined Disorder
26
Prophylaxis
25
Acute Coronary Syndrome
17
Type Iia Hyperlipidaemia
17
Hypertension
15
Coronary Artery Disease
14
Lipid Metabolism Disorder
14
Blood Triglycerides Increased
13
Low Density Lipoprotein Increased
13
Mixed Hyperlipidaemia
12
Diabetes Mellitus
12
Coronary Artery Bypass
11
Myocardial Infarction
11
Blood Cholesterol Abnormal
8
Cardiac Disorder
8
Lipids Increased
5
Myocardial Ischaemia
3
Cardiac Failure
3
Postoperative Care
3
Suicide Attempt
3
Cardiovascular Event Prophylaxis
3
Lipids
3
Antifungal Prophylaxis
2
Completed Suicide
2
High Density Lipoprotein Decreased
2
Cardiovascular Disorder
2
Aortic Stenosis
2
High Density Lipoprotein Increased
2
Hypertriglyceridaemia
2
Acute Myocardial Infarction
2
Type 2 Diabetes Mellitus
2
Cardiac Failure Chronic
2
Hyper Hdl Cholesterolaemia
1
Lipoprotein (a) Abnormal
1
Low Density Lipoprotein
1
Cerebrovascular Accident Prophylaxi...
1
Ischaemic Cardiomyopathy
1
Familial Risk Factor
1
Metabolic Disorder
1
Arteriosclerosis Coronary Artery
1
Stent Placement
1
Type V Hyperlipidaemia
1
Ischaemic Heart Disease Prophylaxis
1
Muscle Disorder
1

Drug Labels

LabelLabelerEffective
ZetiaA-S Medication Solutions LLC08-SEP-09
ZetiaPhysicians Total Care, Inc.29-DEC-09
VytorinRebel Distributors Corp01-DEC-10
ZetiaRebel Distributors Corp26-JAN-11
VytorinPD-Rx Pharmaceuticals, Inc.01-NOV-11
VytorinPD-Rx Pharmaceuticals, Inc.24-JAN-12
ZetiaLake Erie Medical & Surgical Supply DBA Quality Care Products LLC19-MAR-12
ZetiaCardinal Health10-APR-12
VytorinPhysicians Total Care, Inc.06-SEP-12
VytorinMerck Sharp & Dohme Corp.13-FEB-13
ZetiaMerck Sharp & Dohme Corp.13-FEB-13
ZetiaCardinal Health29-APR-13
ZetiaCardinal Health29-APR-13

Ezetimibe Case Reports

What Ezetimibe 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 Ezetimibe. 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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