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Ezetimibe Side Effects

For the Consumer

Applies to ezetimibe: oral tablet

Along with its needed effects, ezetimibe 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 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

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

Gastrointestinal

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

Immunologic

Postmarketing reports: Anaphylaxis[Ref]

Musculoskeletal

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

Respiratory

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

Hypersensitivity

Postmarketing reports: Hypersensitivity reaction[Ref]

Hepatic

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

Hematologic

Postmarketing reports: Thrombocytopenia[Ref]

Nervous system

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

Psychiatric

Postmarketing reports: Depression[Ref]

Cardiovascular

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

Dermatologic

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

Metabolic

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

Other

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

References

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

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

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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