Atozet Adverse Reactions

Clinical Trials Experience: Adults: ATOZET: ATOZET (or coadministration of ezetimibe and atorvastatin equivalent to ATOZET) has been evaluated for safety in more than 2400 patients in 7 clinical trials. ATOZET was generally well tolerated.
The following common (≥1/100, <1/10) or uncommon (≥1/1000, <1/100) drug-related adverse experiences were reported in patients taking ATOZET: Infections and Infestations: Uncommon: influenza.
Psychiatric disorders: Uncommon: depression; insomnia; sleep disorder.
Nervous system disorders: Uncommon: dizziness; dysgeusia; headache; paresthesia.
Cardiac disorders: Uncommon: sinus bradycardia.
Vascular disorders: Uncommon: hot flush.
Respiratory, thoracic and mediastinal disorders: Uncommon: dyspnea.
Gastrointestinal disorders: Common: diarrhea.
Uncommon: abdominal discomfort; abdominal distension; abdominal pain; abdominal pain lower; abdominal pain upper; constipation; dyspepsia; flatulence; frequent bowel movements; gastritis; nausea; stomach discomfort.
Skin and subcutaneous tissue disorders: Uncommon: acne; urticaria.
Musculoskeletal and connective tissue disorders: Common: myalgia.
Uncommon: arthralgia; back pain; muscle fatigue; muscle spasms; muscular weakness; pain in extremity.
General disorders and administration site conditions: Uncommon: asthenia; fatigue; malaise; edema.
Investigations: Uncommon: ALT and/or AST increased; alkaline phosphatase increased; blood CK increased; gamma-glutamyltransferase increased; hepatic enzyme increased; liver function test abnormal; weight increased.
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 in transaminases were generally asymptomatic, not associated with cholestasis, and returned to baseline spontaneously or after discontinuation of therapy. [See Liver Enzymes under Precautions.]
None of the patients treated with ATOZET had CK levels ≥10 X ULN.
Post-marketing Experience and Other Clinical Trial Experience: The following additional adverse reactions have been reported in post-marketing use with ATOZET or in clinical studies or post-marketing use with ezetimibe or atorvastatin: Infections and infestations: nasopharyngitis.
Blood and lymphatic system disorders: thrombocytopenia.
Immune system disorders: hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria.
Metabolism and nutrition disorders: decreased appetite; anorexia; hyperglycemia; hypoglycemia.
Psychiatric disorders: nightmares.
Nervous system disorders: hypesthesia; peripheral neuropathy; myasthenia gravis [see Myasthenia Gravis/Ocular Myasthenia under Precautions].
There have been rare post-marketing 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).
Eye disorders: vision blurred; visual disturbance; ocular myasthenia [see Myasthenia Gravis/Ocular Myasthenia under Precautions].
Ear and labyrinth disorders: tinnitus; hearing loss.
Vascular disorders: hypertension.
Respiratory, thoracic, and mediastinal disorders: cough; pharyngolaryngeal pain; epistaxis.
Gastrointestinal disorders: dry mouth; pancreatitis; gastroesophageal reflux disease; eructation; vomiting.
Hepatobiliary disorders: hepatitis; cholelithiasis; cholecystitis; cholestasis.
Skin and subcutaneous tissue disorders: alopecia; pruritus; skin rash; erythema multiforme; angioneurotic oedema; dermatitis bullous including erythema multiforme; Stevens-Johnson syndrome and toxic epidermal necrolysis.
Musculoskeletal and connective tissue disorders: myopathy/rhabdomyolysis [See Myopathy/Rhabdomyolysis under Precautions.]; neck pain; joint swelling; myositis tendonopathy, sometimes complicated by rupture.
There have been very rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosuppressive agents [see Myopathy/Rhabdomyolysis under Precautions].
Reproductive system and breast disorders: gynecomastia.
General disorders and administration site conditions: chest pain; pain; edema peripheral; pyrexia.
Investigations: white blood cells urine positive.
Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including atorvastatin. The risk of hyperglycemia, however, is outweighed by the reduction in vascular risk with statins.
The following adverse events have been reported with some statins: sexual dysfunction; depression; exceptional cases of interstitial lung disease, especially with long term therapy; diabetes mellitus: frequency will depend on the presence or absence of risk factors (fasting blood glucose ≥5.6 mmol/L, BMI >30kg/m², raised triglycerides, history of hypertension).