fluenza
Uncommon
Psychiatric disorders
depression; insomnia; sleep disorder
Uncommon
Nervous system disorders
dizziness; dysgeusia; headache; paraesthesia
Uncommon
Cardiac disorders
sinus bradycardia
Uncommon
Vascular disorders:
hot flush
Uncommon
Respiratory, thoracic and mediastinal disorders
dyspnea
Uncommon
Gastrointestinal disorders
diarrhoea
Common
abdominal discomfort; abdominal distension; abdominal pain; abdominal pain lower; abdominal pain upper; constipation; dyspepsia; flatulence; frequent bowel movements; gastritis; nausea; stomach discomfort
Uncommon
Skin and subcutaneous tissue disorders
acne; urticaria
Uncommon
Musculoskeletal and connective tissue disorders
myalgia
Common
arthralgia; back pain; muscle fatigue; muscle spasms; muscular weakness; pain in extremity
Uncommon
General disorders and administration site conditions:
asthenia; fatigue; malaise; edema
Uncommon
Investigations:
ALT and/or AST increased; alkaline phosphatase increased; blood creatine phosphokinase (CPK) increased; gamma-glutamyltransferase increased; hepatic enzyme increased; liver function test abnormal; weight increased
Uncommon
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 section 4.4.)
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: thrombocytopaenia
Immune system disorders: hypersensitivity, including anaphylaxis, angioedema, rash, and urticaria
Metabolism and nutrition disorders: decreased appetite; anorexia; hyperglycaemia; hypoglycaemia
Psychiatric disorders: nightmares
Nervous system disorders: hypoesthesia; amnesia; peripheral neuropathy
Eye disorders: vision blurred; visual disturbance
Ear and labyrinth disorders: tinnitus; hearing loss
Vascular Disorders: hypertension
Respiratory, Thoracic and Mediastinal Disorders: cough; pharyngolaryngeal pain; epistaxis
Gastrointestinal disorders: pancreatitis; gastro-oesophageal reflux disease; eructation; vomiting; dry mouth
Hepatobiliary disorders: hepatitis; cholelithiasis; cholecystitis; cholestasis; fatal and non-fatal hepatic failure
Skin and subcutaneous tissue disorders: alopecia; skin rash; pruritus; erythema multiforme; angioneurotic oedema; dermatitis bullous including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis
Musculoskeletal and connective tissue disorders: myopathy/rhabdomyolysis; neck pain; joint swelling; myositis; immune-mediated necrotizing myopathy (frequency not known) (see section 4.4)
Reproductive system and breast di |
