Ezetimibe Side Effects

Brand Names: Zetia

Please note - some side effects for Ezetimibe may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Ezetimibe - for the Consumer

Ezetimibe/Simvastatin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ezetimibe/Simvastatin:

Diarrhea; flu-like symptoms; headache; nausea; pain in the arms or legs; upper respiratory tract infection.

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); breathing problems (eg, persistent cough, shortness of breath); burning, numbness, or tingling; change in the amount of urine produced; dark or red-colored urine; decreased sexual ability; depression; dizziness; fast or irregular heartbeat; fever, chills, or persistent sore throat; joint pain; loss of appetite; memory problems; muscle tenderness, pain, or weakness (with or without fever and fatigue); pale stools; red, swollen, blistered, or peeling skin; severe or persistent nausea or stomach or back pain; shortness of breath; trouble sleeping; unusual bruising or bleeding; unusual tiredness or weakness; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Ezetimibe

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ezetimibe:

Diarrhea; dizziness; headache; joint pain; sinus inflammation; tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; dark urine; depression; fever, chills, or persistent sore throat; numbness or tingling of the skin; severe or persistent joint pain; severe stomach or back pain with nausea and vomiting; unexplained muscle pain, tenderness, or weakness; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

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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