Ezetrol Side Effects

Clinical studies of 8-14 weeks duration in which Ezetrol 10 mg daily was administered alone, with a statin or with fenofibrate in 3551 patients demonstrated: Ezetrol was generally well tolerated, adverse reactions were usually mild and transient, the overall incidence of side effects reported with Ezetrol was similar to that reported with placebo and the discontinuation rate due to adverse experiences was comparable between Ezetrol and placebo.
The following common (≥1/100, <1/10) drug-related adverse experiences were reported in patients taking Ezetrol alone (n=1691), co-administered with a statin (n=1675), or co-administered with fenofibrate (n=185).
Ezetrol Administered Alone: Headache; abdominal pain, diarrhea.
Ezetrol Co-Administered with a Statin: Headache, fatigue; abdominal pain, constipation, diarrhea, flatulence, nausea; increased ALT and AST; myalgia.
Ezetrol Co-Administered with Fenofibrate: Abdominal pain.
In a multicenter, double-blind, placebo-controlled clinical study in patients with mixed hyperlipidemia, 625 patients were treated for up to 12 weeks and 576 for up to 1 year. This study was not designed to compare treatment groups for infrequent events. Incidence rates (95% CI) for clinically important elevations (>3 times ULN, consecutive) in serum transaminases were 4.5% (1.9, 8.8) and 2.7% (1.2, 5.4) for fenofibrate monotherapy and Ezetrol co-administered with fenofibrate, respectively, adjusted for treatment exposure. Corresponding incidence rates for cholecystectomy were 0.6% (0, 3.1) and 1.7% (0.6, 4) for fenofibrate monotherapy and Ezetrol co-administered with fenofibrate, respectively (see Precautions). There were no CPK elevations >10 times ULN in either treatment group in this study.
Laboratory Values: In controlled clinical monotherapy trials, the incidence of clinically important elevations in serum transaminases (ALT and/or AST ≥3 times ULN, consecutive) was similar between Ezetrol (0.5%) and placebo (0.3%). In co-administration trials, the incidence was 1.3% for patients treated with Ezetrol 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 continued treatment. (See Precautions.)
Clinically important elevations of CPK (≥10 times ULN) in patients treated with Ezetrol administered alone or co-administered with a statin were similar to elevations seen with placebo or statin administered alone, respectively.
Post-Marketing Experience: The following adverse reactions have been reported in post-marketing experience, regardless of causality assessment: Hypersensitivity reactions, including anaphylaxis, angioedema and rash; myalgia; increased CPK; elevations of liver transaminases; hepatitis; thrombocytopenia; pancreatitis; nausea and very rarely, myopathy/rhabdomyolysis (see Precautions).