EZB Adverse Reactions

Monotherapy: The following are common (≥ 1/100, <1/10) or uncommon (≥ 1/1000, < 1/100).
Investigations: uncommon: ALT and/or AST increased; blood CPK increased; gamma-glutamyl-transferase increased; liver function test abnormal.
Respiratory disorders: uncommon: cough.
Gastrointestinal disorders: common: diarrhea; abdominal pain; flatulence; uncommon: dyspepsia; gastrooesophageal reflux disease; nausea.
Musculoskeletal and Connective tissue disorders: uncommon: arthralgia; muscle spasms; neck pain.
Metabolism and Nutrition disorders: uncommon: decreased appetite.
Vascular disorders: uncommon: hot flush; hypertension.
General disorders and Administration site condition: fatigue, chest pain, pain.
Co-administration with statin: Investigation: common: ALT and/or AST increased.
Nervous system disorders: common: headache; uncommon: paraesthesia.
Gastrointestinal disorders: uncommon: dry mouth; gastritis.
Skin and Subcutaneous tissue disorders: uncommon: pruritus; rash; urticaria.
Musculoskeletal and Connective tissue disorders: common: myalgia; uncommon: back pain; muscular weakness; pain in extremity.
General disorders and Administration site condition: uncommon: asthenia; edema peripheral.
Co-administration with fenofibrate: Gastrointestinal disorders: common: abdominal pain.
Other: Blood and lymphatic system disorders: thrombocytopenia.
Nervous system disorders: dizziness, paraesthesia.
Respiratory disorders: dyspnea.
Gastrointestinal disorders: pancreatitis, constipation.
Skin and subcutaneous tissue disorders: erythema multiforme.
Musculoskeletal and connective tissue disorder: myalgia, myopathy/rhabdomyolysis.
General disorders and administration site conditions: asthenia.
Immune system disorders: hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria.
Hepatobiliary disorders: hepatitis; cholelithiasis, cholecystitis.
Psychiatric disorders: depression.
Laboratory Values: In controlled clinical trial monotherapy trials, the incidence of clinically important elevations in serum transaminase (ALT and/or AST ≥ 3 X ULN, consecutive) was similar between ezetimibe (0.5%) and placebo (0.3%). In co-administration trials, the incidence was 1.3% for patients treated with ezetimibe co-administered with a statin and 0.4% for patients treated with a statin alone. These elevations were generally asymptomatic, not associated with cholestasis, and returned to baseline after discontinuation of therapy or with continuous treatment.
Clinically important elevations of CPK (≥ 10 X ULN) in patients treated with ezetimibe administered alone or co-administered with a statin were similar to elevations seen with placebo or statin administered alone, respectively.