Lipitor Adverse Reactions

Atorvastatin is generally well tolerated. Adverse reactions have usually been mild and transient. Less than 2% of patients were discontinued from clinical trials due to side effects attributed to atorvastatin. In the atorvastatin placebo-controlled clinical trial database of 16,066 (8755 Lipitor vs 7311 placebo) patient treated for a median period of 53 weeks, 5.2% of patients on atorvastatin discontinued due to adverse reactions compared to 4.0% of the patients on placebo.
The most frequent (≥1%) adverse effects associated with atorvastatin therapy, in patients participating in controlled clinical studies were: Infections and Infestations: nasopharyngitis.
Respiratory, Thoracic and Mediastinal Disorders: pharyngolaryngeal pain, epistaxis.
Psychiatric Disorders: insomnia, nightmare.
Nervous System Disorders: headache.
Gastrointestinal Disorders: nausea, diarrhea, abdominal pain, dyspepsia, constipation, flatulence.
Musculoskeletal and Connective Tissue Disorders: myalgia, arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, joint swelling.
Investigations: liver function test abnormal, blood creatine phosphokinase increased.
General Disorders and Administration Site Conditions: asthenia.
The following additional adverse effects have been reported in atorvastatin clinical trials: Eye Disorders: vision blurred.
Metabolism and Nutrition Disorders: hypoglycaemia, hyperglycemia, anorexia.
Nervous System Disorders: peripheral neuropathy, paresthesia.
Ear and Labyrinth Disorders: tinnitus.
Gastrointestinal Disorders: pancreatitis, vomiting, abdominal discomfort, eructation.
Hepatobiliary Disorders: hepatitis, cholestatic jaundice.
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: angioneurotic edema, malaise, pyrexia.
Cardiovascular: angina.
Investigations: white blood cells urine positive. Not all effects listed previously have been causally associated with atorvastatin therapy.
Pediatric Patients (10-17 years): Patients treated with atorvastatin had an adverse experience profile generally similar to that patients treated with placebo, the most common adverse experiences observed in both groups, regardless of causality assessment, were infections.
In post-marketing experiences, 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 necrotizing myopathy, myositis, back pain;
General Disorders and Administration Site Conditions: chest pain, peripheral edema, fatigue.