Drug Safety Information for ZETIA (Ezetimibe)

Safety-related Labeling Changes for ZETIA (EZETIMIBE) Rx Drug: FDA Link

extensive changes to label including adverse reactions

Safety-related Labeling Changes for VYTORIN (EZETIMIBE; SIMVASTATIN) Rx Drug: FDA Link

Adverse Drug Reactions for ZETIA* (Ezetimibe)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with ZETIA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Myalgia*1677
2Nausea1595
3Fatigue*1439
4Dizziness1268
5Dyspnoea1200
6Drug ineffective1187
7Diarrhoea1100
8Asthenia1043
9Pain in extremity*1008
10Pain*1003
11Headache*988
12Arthralgia*979
13Flushing802
14Vomiting774
15Myocardial infarction767
16Fall742
17Pruritus738
18Muscle spasms*727
19Chest pain711
20Weight decreased688

* This side effect also appears in "Top 10 Side Effects of ZETIA " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking ZETIA
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Blood cholesterol increased*12355
2Product used for unknown indication10185
3Hypercholesterolaemia*5238
4Blood cholesterol*3537
5Hyperlipidaemia*2854
6Blood cholesterol abnormal1169
7Dyslipidaemia1052
8Cardiac disorder439
9Low density lipoprotein increased379
10Ill-defined disorder375

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for ZETIA

Total Reports Filed with FDA: 108563


Number of FDA Adverse Event Reports by Patient Age for ZETIA

Total Reports Filed with FDA: 108563*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ezetimibe (Zetia, Ezetrol, Sch58235, Ezetimibe)

Charts are based on 108563 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and ZETIA Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.