Ezetimibe Side Effects

Some side effects of ezetimibe 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

Get emergency medical help if you have any of these signs of an allergic reaction while taking ezetimibe: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• unusual muscle weakness, tenderness, or pain;

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• chest pain;

• pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate); or

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects of ezetimibe may include:

• numbness or tingly feeling;

• mild stomach pain, diarrhea;

• tired feeling;

• headache;

• dizziness;

• depressed mood;

• runny or stuffy nose, cold symptoms;

• joint pain, back pain; or

• cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to ezetimibe: oral tablet

General

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

Gastrointestinal

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

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

Musculoskeletal

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

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

Hypersensitivity

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

Hepatic

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

Hematologic

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 in postmarketing experience.

Psychiatric

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

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