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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

Severity: Minor

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


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


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.[Ref]

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.[Ref]


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


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.[Ref]


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


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


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


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

Nervous system

Nervous system side effects including dizziness, paresthesia, and headache have been associated with ezetimibe in postmarketing experience.


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


1. "Product Information. Zetia (ezetimibe)." Schering Corporation, Kenilworth, NJ.

2. Ahmad I, Ruby E, Usman H, Hotiana M, Hussain M, Rahman F "Ezetimibe-induced acute pancreatitis." South Med J 100 (2007): 409-10

3. Havranek JM, Wolfsen AR, Warnke GA, Phillips PS "Monotherapy with ezetimibe causing myopathy." Am J Med 119 (2006): 285-6

4. Pattis P, Wiedermann CJ "Ezetimibe-associated immune thrombocytopenia." Ann Pharmacother 42 (2008): 430-3

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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