Zetia Side Effects

Generic Name: ezetimibe

Note: This document contains side effect information about ezetimibe. Some of the dosage forms listed on this page may not apply to the brand name Zetia.

Some side effects of Zetia may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to ezetimibe: oral tablet

Along with its needed effects, ezetimibe (the active ingredient contained in Zetia) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Frequency not determined
  • Abdominal fullness
  • black tarry stools
  • bleeding gums
  • bloating
  • blood in urine or stools
  • chills
  • constipation
  • darkened urine
  • fast heartbeat
  • fever
  • gaseous abdominal pain
  • general tiredness or weakness
  • indigestion
  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
  • loss of appetite
  • light-colored stools
  • muscle cramps or spasms
  • muscular tenderness, wasting or weakness
  • nausea
  • pains in stomach, side or abdomen, possibly radiating to the back
  • pinpoint red spots on skin
  • recurrent fever
  • severe nausea
  • skin rash
  • unusual bleeding or bruising
  • upper right abdominal pain
  • vomiting
  • yellow eyes or skin

Some side effects of ezetimibe may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Fever
  • headache
  • muscle pain
  • runny nose
  • sore throat
Less common
  • Back pain
  • body aches or pain
  • chest pain
  • chills
  • cold or flu-like symptoms
  • congestion
  • coughing
  • diarrhea
  • difficulty in moving
  • dizziness
  • dryness or soreness of throat
  • hoarseness
  • muscle pain or stiffness
  • pain in joints
  • pain or tenderness around eyes and cheekbones
  • shortness of breath or troubled breathing
  • stomach pain
  • stuffy nose
  • tender, swollen glands in neck
  • tightness of chest or wheezing
  • trouble in swallowing
  • unusual tiredness or weakness
  • voice changes

For Healthcare Professionals

Applies to ezetimibe: oral tablet


General side effects including fatigue (2.2%) have been reported.


Gastrointestinal side effects including diarrhea (3.7%) and abdominal pain (3.0%) have been reported. Pancreatitis and nausea have also been reported in postmarketing experience.

A case of ezetimibe-induced acute pancreatitis occurred two weeks after initiating therapy. Following discontinuation of ezetimibe the patient's symptoms resolved and pancreatic enzyme levels normalized.


Immunologic side effects including sinusitis (3.6%), pharyngitis (2.3%), and viral infection (2.2%) have been reported.


Musculoskeletal side effects including back pain (4.1%) and arthralgia (3.8%) have been reported. Other effects including myalgia, arthralgia, elevated creatine phosphokinase, and rare reports of myopathy/rhabdomyolysis have been reported in postmarketing experience.


Respiratory side effects including coughing (2.3%) have been reported.


Hypersensitivity reactions including angioedema, anaphylaxis, rash, urticaria, and erythema multiforme have been reported in postmarketing experience.


Hepatic side effects including elevations in liver transaminases, hepatitis, cholelithiasis, and cholecystitis have been reported in postmarketing experience.


Hematologic side effects including thrombocytopenia have been reported in postmarketing experience.

Nervous system

Nervous system side effects including dizziness, paresthesia, and headache have been associated with ezetimibe (the active ingredient contained in Zetia) in postmarketing experience.


Psychiatric side effects including depression have been reported during the postmarketing experience.

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