Atorvastatin Sandoz

Atorvastatin Sandoz Adverse Reactions





Zuellig Pharma


Full Prescribing Info
Adverse Reactions
In the atorvastatin placebo-controlled clinical trial database of 16,066 (8755 atorvastatin vs. 7311 placebo) patients treated for a mean period of 53 weeks, 5.2% of patients on atorvastatin discontinued due to adverse reactions compared to 4.0% of the patients on placebo.
Based on data from clinical studies and extensive post-marketing experience, the following table presents the adverse reaction profile for atorvastatin.
Estimated frequencies of reactions are ranked according to the following convention: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (≤1/10,000), not known (cannot be estimated from the available data).
Infections and infestations: Common: Nasopharyngitis.
Blood and lymphatic system disorders: Rare: thrombocytopenia.
Immune system disorders: Common: Allergic reactions; Very rare: Anaphylaxis.
Metabolism and nutrition disorders: Common: Hyperglycaemia; Uncommon: Hypoglycaemia, weight gain, anorexia.
Psychiatric disorders: Uncommon: Nightmare, insomnia.
Nervous system disorders: Common: Headache; Uncommon: Dizziness, paraesthesia, hypoaesthesia, dysgeusia, amnesia; Rare: Peripheral neuropathy.
Eye disorders: Uncommon: Vision blurred; Rare: Visual disturbance.
Ear and labyrinth disorders: Uncommon: Tinnitus; Very rare: Hearing loss.
Respiratory, thoracic and mediastinal disorders: Common: Pharyngolaryngeal pain, epistaxis.
Gastrointestinal disorders: Common: Constipation, flatulence, dyspepsia, nausea, diarrhoea; Uncommon: Vomiting, abdominal pain upper and lower, eructation, pancreatitis.
Hepatobiliary disorders: Uncommon: Hepatitis; Rare: Cholestasis; Very rare: Hepatic failure.
Skin and subcutaneous tissue disorders: Uncommon: Urticaria, skin rash, pruritus, alopecia; Rare: Angioneurotic oedema, dermatitis bullous including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.
Musculoskeletal and connective tissue disorders: Common: Myalgia, arthralgia, pain in extremity, muscle spasms, joint swelling, back pain; Uncommon: Neck pain, muscle fatigue; Rare: Myopathy, myositis, rhabdomyolysis, tendonopathy, sometimes complicated by rupture; Not known: Immune mediated necrotising myopathy.
Reproductive system and breast disorders: Very rare: Gynecomastia.
General disorders and administration site conditions: Uncommon: Malaise, asthenia, chest pain, peripheral oedema, fatigue, pyrexia.
Investigations: Common: Liver function test abnormal, blood creatine kinase increased; Uncommon: White blood cells urine positive.
As with other HMG-CoA reductase inhibitors elevated serum transaminases have been reported in patients receiving atorvastatin. These changes were usually mild, transient, and did not require interruption of treatment. Clinically important (>3 times upper normal limit) elevations in serum transaminases occurred in 0.8% patients on atorvastatin. These elevations were dose related and were reversible in all patients.
Elevated serum creatine kinase (CK) levels greater than 3 times upper limit of normal occurred in 2.5% of patients on atorvastatin, similar to other HMG-CoA reductase inhibitors in clinical trials. Levels above 10 times the normal upper range occurred in 0.4% atorvastatin-treated patients (see Precautions).
Paediatric Population: The clinical safety database includes safety data for 249 paediatric patients who received atorvastatin, among which 7 patients were <6 years old, 14 patients were in the age range of 6 to 9, and 228 patients were in the age range of 10 to 17.
Nervous system disorders: Common: Headache.
Gastrointestinal disorders: Common: Abdominal pain.
Investigations: Common: Alanine aminotransferase increased, blood creatine phosphokinase increased.
Based on the data available, frequency, type and severity of adverse reactions in children are expected to be the same as in adults. There is currently limited experience with respect to long-term safety in the paediatric population.
The following adverse events have been reported with some statins: Sexual dysfunction; depression; 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 >30kg/m2, raised triglycerides, history of hypertension).
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