Atorsan 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 list 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, muscle rupture, tendonopathy, sometimes complicated by rupture. Very rare: Lupus-like syndrome. Not known: Immune mediated necrotising myopathy (see Precautions).
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: Paediatric patients aged from 10 to 17 years of age treated with atorvastatin had an adverse experience profile generally similar to that of patients treated with placebo, the most common adverse experiences observed in both groups, regardless of causality assessment, were infections. No clinically significant effect on growth and sexual maturation was observed in a 3-year study based on the assessment of overall maturation and development, assessment of Tanner Stage, and measurement of height and weight. The safety and tolerability profile in paediatric patients was similar to the known safety profile of atorvastatin in adult patients.
The clinical safety database includes safety data for 520 paediatric patients who received atorvastatin, among which 7 patients were < 6 years old, 121 patients were in the age range of 6 to 9, and 392 patients were in the age range of 10 to 17.
Based on the data available, the frequency, type and severity of adverse reactions in children is similar to adults.
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),
Memory loss.