Zetia Side Effects

Generic Name: ezetimibe

Please note - some side effects for Zetia may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Zetia - for the Consumer

Zetia

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 Zetia:

Diarrhea; 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); chest pain; dark urine; numbness or tingling of the skin; unexplained muscle pain, tenderness, or weakness; yellowing of the eyes or skin.

Zetia Side Effects - for the Professional

Zetia

• Common adverse reactions in clinical trials:
  • Zetia co-administered with a statin (incidence ≥2% and greater than statin alone):
    • nasopharyngitis, myalgia, upper respiratory tract infection, arthralgia, and diarrhea (6)
  • Zetia administered alone (incidence ≥2% and greater than placebo):
    • upper respiratory tract infection, diarrhea, arthralgia, sinusitis, and pain in extremity (6)
  
  

  To report SUSPECTED ADVERSE REACTIONS, contact Merck/Schering-Plough Pharmaceuticals at 1-866-637-2501 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Side Effects by Body System

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, and urticaria 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.

Psychiatric

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

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