Ezentia Adverse Reactions

The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information: Liver enzyme abnormalities (see Precautions).
Rhabdomyolysis and myopathy (see Precautions).
In patients with a median treatment duration of 12 weeks (range 0 to 39 weeks), 3.3% of patients on ezetimibe discontinued due to adverse reactions. The most common adverse reactions in the group of patients treated with ezetimibe that led to treatment discontinuation were: Arthralgia (0.3%), Dizziness (0.2%), Gamma-glutamyltransferase increased (0.2%).
The most commonly reported adverse reactions (incidence ≥2%) with ezetimibe monotherapy were: upper respiratory tract infection (4.3%), diarrhea (4.1%), arthralgia (3.0%), sinusitis (2.8%), and pain in extremity (2.7%).
In patients with a median treatment duration of 8 weeks (range 0 to 112 weeks), 4.0% of patients on ezetimibe+statin and 3.3% of patients on statin alone discontinued due to adverse reactions. The most common adverse reactions in the group of patients treated with ezetimibe+statin that led to treatment discontinuation and occurred at a rate greater than statin alone were: Alanine aminotransferase increased (0.6%); Myalgia (0.5%); Fatigue, aspartate aminotransferase increased, headache, and pain in extremity (each at 0.2%).
The most commonly reported adverse reactions (incidence ≥2% and greater than statin alone) with ezetimibe+statin were: nasopharyngitis (3.7%), myalgia (3.2%), upper respiratory tract infection (2.9%), arthralgia (2.6%) and diarrhea (2.5%).
Monotherapy: Patients with primary hyperlipidemia (age range 9-86 years, 50% women, 90% Caucasians, 5% Blacks, 3% Hispanics, 2% Asians) and elevated LDL-C were treated with ezetimibe 10 mg/day for a median treatment duration of 12 weeks (range 0 to 39 weeks).
Adverse reactions reported in ≥2% of patients treated with ezetimibe regardless of causality assessment, are shown in Table 3. (See Table 3.)

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Patients with primary hyperlipidemia (age range 10-93 years, 48% women, 85% Caucasians, 7% Blacks, 4% Hispanics, 3% Asians) and elevated LDL-C were treated with ezetimibe 10 mg/day concurrently with or added to on-going statin therapy for a median treatment duration of 8 weeks (range 0 to 112 weeks).
The incidence of consecutive increased transaminases (≥3 X ULN) was higher in patients receiving ezetimibe administered with statins (1.3%) than in patients treated with statins alone (0.4%) (see Precautions).
Clinical adverse reactions reported in ≥2% of patients treated with ezetimibe + statin and at an incidence greater than statin, regardless of causality assessment, are shown in Table 4. (See Table 4.)

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Combination with Fenofibrate: In patients with mixed dyslipidemia (age range 20-76 years, 44% women, 79% Caucasians, 0.1% Blacks, 11% Hispanics, 5% Asians) treated for up to 12 weeks and patients treated for up to an additional 48 weeks evaluated co-administration of ezetimibe and fenofibrate. This study was not designed to compare treatment groups for infrequent events. Incidence rates (95% CI) for clinically important elevations (≥3 X ULN, consecutive) in hepatic transaminase levels were 4.5% (1.9, 8.8) and 2.7% (1.2, 5.4) for fenofibrate monotherapy and ezetimibe co-administered with fenofibrate, respectively, adjusted for treatment exposure. Corresponding incidence rates for cholecystectomy were 0.6% (95% CI: 0.0%, 3.1%) and 1.7% (95% CI: 0.6%, 4.0%) for fenofibrate monotherapy and ezetimibe co-administered with fenofibrate, respectively (see Interactions). The numbers of patients exposed to co-administration therapy as well as fenofibrate and ezetimibe monotherapy were inadequate to assess gallbladder disease risk. There were no CPK elevations >10 X ULN in any of the treatment groups.
The following additional adverse reactions have also been reported ezetimibe: Hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria; erythema multiforme; arthralgia; myalgia; elevated creatine phosphokinase; myopathy/rhabdomyolysis (see Precautions); elevations in liver transaminases; hepatitis; abdominal pain; thrombocytopenia; pancreatitis; nausea; dizziness; paresthesia; depression; headache; cholelithiasis; cholecystitis.
In addition to the adverse events mentioned above cough, flatulence, dyspepsia; gastroesophageal reflux disease; constipation, dyspnoea, muscle spasms; neck pain, decreased appetite, hot flush, hypertension, chest pain, pain, dry mouth, gastritis, pruritis, muscular weakness, asthenia and edema peripheral have also been reported.