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Ezetimibe Side Effects

In Summary

More frequently reported side effects include: upper respiratory tract infection. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to ezetimibe: oral tablet

In addition to its needed effects, some unwanted effects may be caused by ezetimibe. In the event that any of these side effects do occur, they may require 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

Minor Side Effects

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

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


The most frequently reported side effects were upper respiratory tract infection, diarrhea, arthralgia, sinusitis, and pain in extremity.[Ref]


Common (1% to 10%): Abdominal pain, diarrhea, flatulence
Uncommon (0.1% to 1%): Dyspepsia, gastroesophageal reflux disease, nausea
Postmarketing reports: Pancreatitis, constipation[Ref]


Postmarketing reports: Anaphylaxis[Ref]


Common (1% to 10%): Arthralgia, pain in extremity
Uncommon (0.1% to 1%): Muscle spasms, neck pain
Postmarketing reports: Myalgia, myopathy, rhabdomyolysis[Ref]


Common (1% to 10%): Upper respiratory tract infection, sinusitis
Uncommon (0.1% to 1%): Cough
Postmarketing reports: Dyspnea[Ref]


Postmarketing reports: Hypersensitivity reaction[Ref]


Uncommon (0.1% to 1%): Gamma-glutamyltransferase increased, liver function test abnormal, AST/ALT increased
Postmarketing reports: Hepatitis, liver transaminases increased, cholelithiasis, cholecystitis[Ref]


Postmarketing reports: Thrombocytopenia[Ref]

Nervous system

Uncommon (0.1% to 1%): Dizziness
Postmarketing reports: Paresthesia, headache[Ref]


Postmarketing reports: Depression[Ref]


Uncommon (0.1% to 1%): Hot flush, hypertension[Ref]


Postmarketing reports: Angioedema, rash, urticaria, erythema multiforme[Ref]


Uncommon (0.1% to 1%): Appetite decreased[Ref]


Common (1% to 10%): Fatigue, influenza
Uncommon (0.1% to 1%): Chest pain, pain, creatine phosphokinase increased
Postmarketing reports: Asthenia[Ref]


1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Zetia (ezetimibe)." Schering-Plough Corporation, Kenilworth, NJ.

3. Cerner Multum, Inc. "Australian Product Information." O 0

Not all side effects for ezetimibe may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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