Atorvastatin Sandoz Adverse Reactions

Atorvastatin is generally well-tolerated. Adverse reactions have usually been mild and transient. In the atorvastatin placebo-controlled clinical trial database of 16,066 (8755 atorvastatin vs. 7311 placebo) patients treated for a median period of 53 weeks, 5.2% of patients on atorvastatin discontinued due to adverse reactions compared to 4.0% of patients on placebo.
The most frequent (≥1%) adverse effects that may be associated with atorvastatin therapy, reported in patients participating in placebo-controlled clinical studies include: Infections and infestations: nasopharyngitis.
Metabolism and nutrition disorders: hyperglycaemia.
Respiratory, thoracic and mediastinal disorders: pharyngolaryngeal pain, epistaxis.
Psychiatric disorders: insomnia.
Nervous system disorders: headache.
Gastrointestinal disorders: nausea, diarrhea, abdominal pain, dyspepsia, constipation, flatulence.
Musculoskeletal and connective tissue disorders: arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, myalgia, joint swelling.
General disorders and administration site conditions: asthenia.
Investigations: liver function test abnormal, blood creatine phosphokinase increased.
Additional adverse effects reported in atorvastatin placebo-controlled clinical trials include: Metabolism and nutrition disorders: hypoglycemia, hyperglycemia, anorexia.
Psychiatric disorders: nightmare.
Eye disorders: vision blurred.
Ear and labyrinth disorders: tinnitus.
Nervous system disorders: peripheral neuropathy, paresthesia.
Gastrointestinal disorders: abdominal discomfort, eructation, pancreatitis, vomiting.
Hepatobiliary disorders: hepatitis, cholestasis.
Skin and subcutaneous tissue disorders: alopecia, pruritus, rash, urticaria.
Musculoskeletal and connective tissue disorders: myopathy, myositis, muscle cramps, muscle fatigue, neck pain.
Reproductive system and breast disorders: impotence.
General disorders and administration site conditions: malaise, pyrexia.
Investigations: white blood cells urine positive.
Not all effects listed previously have been causally associated with atorvastatin therapy.
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 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.
Patients 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 in children ages 6 and above 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 pediatric patients was similar to the known safety profile of atorvastatin in adult patients.
Post-marketing Experience: In post-marketing experience, the following additional undesirable effects have been reported: Blood and lymphatic system disorders: thrombocytopenia.
Immune system disorders: allergic reactions (including anaphylaxis).
Injury, poisoning and procedural complications: tendon rupture.
Metabolism and nutrition disorders: weight gain.
Nervous system disorders: hypoesthesia, amnesia, dizziness, dysgeusia.
Gastrointestinal disorders: pancreatitis.
Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema, erythema multiforme, bullous rashes.
Musculoskeletal and connective tissue disorders: rhabdomyolysis, immune mediated necrotising myopathy, myositis, back pain.
General disorders and administration site conditions: chest pain, peripheral oedema, fatigue.
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 non-serious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).