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Adverse experiences occurring at an incidence ≥1% in patients participating in placebo-controlled clinical studies of atorvastatin and reported to be possibly, probably or definitely drug related are shown in Table 1 as follows. (See Table 1.)
Click on icon to see table/diagram/imageThe following additional adverse events were reported in placebo-controlled clinical trials during atorvastatin therapy: Muscle cramps, myositis, muscle fatigue, myopathy, paresthesia, peripheral neuropathy, pancreatitis, hepatitis, cholestatic jaundice, cholestasis, anorexia, vomiting, abdominal discomfort, alopecia, pruritus, rash, urticaria, erectile dysfunction, nightmare, blurred vision, tinnitus, eructation, neck pain, malaise, pyrexia and white blood cells urine positive.
In summary, the adverse events occurring at a frequency <1% are listed as follows: General Disorders and Administration Site Conditions: Malaise, pyrexia.
Gastrointestinal Disorders: Abdominal discomfort, eructation.
Hepatobiliary Disorders: Hepatitis, cholestasis.
Musculoskeletal and Connective Tissue Disorders: Muscle fatigue, neck pain.
Psychiatric Disorders: Nightmare.
Skin and Subcutaneous Tissue Disorders: Urticaria.
Eye Disorders: Blurred vision.
Ear and Labyrinth Disorders: Tinnitus.
Investigations: White blood cells urine positive.
Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10-17 years): In a 26-week controlled study in boys and postmenarchal girls (n=187, where 140 patients received atorvastatin), the safety and tolerability profile of atorvastatin 10-20 mg daily was similar to that of placebo. The adverse events reported in ≥1% of patients were as follows: Abdominal pain, depression and headache (see Pharmacology: Pharmacodynamics under Actions and Use in children under Precautions).
Laboratory Changes and Adverse Events: The criteria for clinically significant laboratory changes were >3 x ULN for liver enzymes and >5 x ULN for CK. A total of 8 unique subjects met ≥1 of these criteria during the double-blind phase. Hence, the incidence of patients who experienced abnormally high enzymatic levels (AST/ALT and CK) was >4% (8/187).
Five (5) atorvastatin and 1 placebo subjects had increases in CK >5 x ULN during the double-blind phase; 2 of the 5 atorvastatin-treated subjects had increases in CK >10 x ULN.
There were 2 subjects who had clinically significant increases in ALT.
Abnormal Hematologic and Clinical Chemistry Findings: Laboratory Tests: Increases in serum transaminase levels and serum glucose have been noted in clinical trials (see Precautions).
Post-Market Adverse Drug Reactions: The following adverse events have also been reported during post-marketing experience with atorvastatin, regardless of causality assessment: Rare Reports: Severe myopathy with or without rhabdomyolysis (see Precautions and Interactions).
Isolated Reports: Gynecomastia, thrombocytopenia, arthralgia and allergic reactions including urticaria, angioneurotic edema, anaphylaxis and bullous rashes (including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis); fatigue, back pain, chest pain, malaise, dizziness, amnesia, peripheral edema, weight gain, abdominal pain, insomnia, hypoesthesia, tinnitus, tendon rupture and dysgeusia.
Ophthalmologic Observations: see Precautions.
Cases of erectile dysfunction have been reported in association with the use of statins.
The following adverse events have been reported with some statins: Sleep disturbances including insomnia and nightmares; mood related disorders including depression; very rare cases of interstitial lungs disease, especially with long-term therapy. If it is suspected a patient has developed interstitial lung disease, statin therapy should be discontinued.
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