Atozet Adverse Reactions

Summary of the safety profile: ATOZET (or co-administration of ezetimibe and atorvastatin equivalent to ATOZET) has been evaluated for safety in more than 2400 patients in 7 clinical trials.
Tabulated list of adverse reactions: Adverse reactions observed in clinical studies of ATOZET (or co-administration of ezetimibe and atorvastatin equivalent to ATOZET) or ezetimibe or atorvastatin or reported from post-marketing use with ATOZET or ezetimibe or atorvastatin are listed in Table 4. These reactions are presented by system organ class and by frequency. Frequencies are defined as: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10,000, <1/1000); very rare (<1/10,000); and not known (cannot be estimated from the available data). (See Table 4.)

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Laboratory Values: In controlled clinical trials, the incidence of clinically important elevations in serum transaminases (ALT and/or AST ≥3 X ULN, consecutive) was 0.6% for patients treated with ATOZET. These elevations were generally asymptomatic, not associated with cholestasis, and returned to baseline spontaneously or after discontinuation of therapy (see Precautions).
There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).
Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors.
The following adverse events have been reported with some statins: sexual dysfunction; exceptional cases of interstitial lung disease, especially with long term therapy (see Precautions); diabetes mellitus: frequency will depend on the presence or absence of risk factors (fasting blood glucose ≥ 5.6 mmol/L, BMI > 30 kg/m², raised triglycerides, history of hypertension).