Lipitor Side Effects

Please note - some side effects for Lipitor may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Lipitor - for the Consumer

Lipitor

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lipitor:

Constipation; gas; headache; stomach pain or upset; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bone, joint, or tendon pain; change in the amount of urine produced; chest pain; dark urine; fever, chills, or persistent sore throat; flu-like symptoms; joint pain; muscle pain, tenderness, or weakness (with or without fever or fatigue); painful or frequent urination; pale stools; red, swollen, blistered, or peeling skin; severe stomach pain; swelling of the hands, ankles, or feet; yellowing of the eyes or skin.

Lipitor Side Effects - for the Professional

Lipitor

Lipitor is generally well-tolerated. Adverse reactions have usually been mild and transient. In controlled clinical studies of 2502 patients, <2% of patients were discontinued due to adverse experiences attributable to atorvastatin. The most frequent adverse events thought to be related to atorvastatin were constipation, flatulence, dyspepsia, and abdominal pain.

Clinical Adverse Experiences

Adverse experiences reported in ≥2% of patients in placebo-controlled clinical studies of atorvastatin, regardless of causality assessment, are shown in Table 8.

In ASCOT involving 10,305 participants treated with Lipitor 10 mg daily (n=5,168) or placebo (n=5,137), the safety and tolerability profile of the group treated with Lipitor was comparable to that of the group treated with placebo during a median of 3.3 years of follow-up.

In CARDS involving 2838 subjects with type 2 diabetes treated with Lipitor 10 mg daily (n=1428) or placebo (n=1410), there was no difference in the overall frequency of adverse events or serious adverse events between the treatment groups during a median follow-up of 3.9 years. No cases of rhabdomyolysis were reported.

In TNT involving 10,001 subjects with clinically evident CHD treated with Lipitor 10 mg daily (n=5006) or Lipitor 80 mg daily (n=4995), there were more serious adverse events and discontinuations due to adverse events in the high-dose atorvastatin group (92, 1.8%; 497, 9.9%, respectively) as compared to the low-dose group (69, 1.4%; 404, 8.1%, respectively) during a median follow-up of 4.9 years. Persistent transaminase elevations (≥3 × ULN twice within 4–10 days) occurred in 62 (1.3%) individuals with atorvastatin 80 mg and in nine (0.2%) individuals with atorvastatin 10 mg. Elevations of CK (≥ 10 × ULN) were low overall, but were higher in the high-dose atorvastatin treatment group (13, 0.3%) compared to the low-dose atorvastatin group (6, 0.1%).

In IDEAL involving 8,888 subjects treated with Lipitor 80 mg/day (n=4439) or simvastatin 20–40 mg daily (n=4449), there was no difference in the overall frequency of adverse events or serious adverse events between the treatment groups during a median follow-up of 4.8 years.

The following adverse events were reported, regardless of causality assessment in patients treated with atorvastatin in clinical trials. The events in italics occurred in ≥2% of patients and the events in plain type occurred in <2% of patients.

Body as a Whole: Chest pain, face edema, fever, neck rigidity, malaise, photosensitivity reaction, generalized edema.

Digestive System: Nausea, gastroenteritis, liver function tests abnormal, colitis, vomiting, gastritis, dry mouth, rectal hemorrhage, esophagitis, eructation, glossitis, mouth ulceration, anorexia, increased appetite, stomatitis, biliary pain, cheilitis, duodenal ulcer, dysphagia, enteritis, melena, gum hemorrhage, stomach ulcer, tenesmus, ulcerative stomatitis, hepatitis, pancreatitis, cholestatic jaundice.

Respiratory System: Bronchitis, rhinitis, pneumonia, dyspnea, asthma, epistaxis.

Nervous System: Insomnia, dizziness, paresthesia, somnolence, amnesia, abnormal dreams, libido decreased, emotional lability, incoordination, peripheral neuropathy, torticollis, facial paralysis, hyperkinesia, depression, hypesthesia, hypertonia.

Musculoskeletal System: Arthritis, leg cramps, bursitis, tenosynovitis, myasthenia, tendinous contracture, myositis.

Skin and Appendages: Pruritus, contact dermatitis, alopecia, dry skin, sweating, acne, urticaria, eczema, seborrhea, skin ulcer.

Urogenital System: Urinary tract infection, hematuria, albuminuria, urinary frequency, cystitis, impotence, dysuria, kidney calculus, nocturia, epididymitis, fibrocystic breast, vaginal hemorrhage, breast enlargement, metrorrhagia, nephritis, urinary incontinence, urinary retention, urinary urgency, abnormal ejaculation, uterine hemorrhage.

Special Senses: Amblyopia, tinnitus, dry eyes, refraction disorder, eye hemorrhage, deafness, glaucoma, parosmia, taste loss, taste perversion.

Cardiovascular System: Palpitation, vasodilatation, syncope, migraine, postural hypotension, phlebitis, arrhythmia, angina pectoris, hypertension.

Metabolic and Nutritional Disorders: Peripheral edema, hyperglycemia, creatine phosphokinase increased, gout, weight gain, hypoglycemia.

Hemic and Lymphatic System: Ecchymosis, anemia, lymphadenopathy, thrombocytopenia, petechia.

Postintroduction Reports

Adverse events associated with Lipitor therapy reported since market introduction, that are not listed above, regardless of causality assessment, include the following: anaphylaxis, angioneurotic edema, bullous rashes (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), rhabdomyolysis, fatigue, tendon rupture, and hepatic failure.

Pediatric Patients (ages 10–17 years)

In a 26-week controlled study in boys and postmenarchal girls (n=140), the safety and tolerability profile of Lipitor 10 to 20 mg daily was generally similar to that of placebo.

Side Effects by Body System

General

In general, atorvastatin has been well tolerated. Less than 2% of patients in premarketing clinical studies discontinued treatment due to adverse effects.

Gastrointestinal

Gastrointestinal side effects have been the most commonly reported. These have been reported in less than 4% of patients and have included constipation, flatulence, dyspepsia, and abdominal pain. Diarrhea has been reported in up to 5.3% of patients and may be dose-related. Other gastrointestinal side effects observed with HMG-CoA reductase inhibitors have included pancreatitis, anorexia, and vomiting. Most effects tended to be mild and transient.

Hepatic

In clinical trials, liver enzyme elevations returned to pretreatment levels upon discontinuation or dose reduction of atorvastatin. Nawrocki and colleagues reported elevated bilirubin levels in 2/30 patients and elevated AST and ALT levels in 1/30 patients.

Hepatic side effects including altered liver function have been observed with all HMG-CoA reductase inhibitors. In premarketing clinical trials, up to 0.7% of patients experienced persistent, elevated AST and/or ALT values greater than three times the upper normal limits on two or more occasions. Elevations of liver enzymes may be dose-related. Other hepatic side effects of the HMG-CoA class have included hepatitis, cholestatic jaundice, fatty changes in the liver, cirrhosis, fulminant hepatic necrosis, and liver failure.

Musculoskeletal

HMG-CoA reductase inhibitors (statins) have been associated with rare cases of severe myopathy and rhabdomyolysis, accompanied by increases in creatine kinase, myoglobinuria, proteinuria, and renal failure. Concomitant use with gemfibrozil (fibric acid derivatives), niacin, cyclosporine, erythromycin (macrolides) or azole antifungals may increase the incidence and severity of musculoskeletal side effects. Other variables associated with an increased risk of statin-induced myopathy include, advanced age, small body stature, female gender, renal and/or hepatic dysfunction, perioperative periods, hypothyroidism, diabetes mellitus, and alcoholism.

A case of atorvastatin-induced early-onset (after 4 doses) rhabdomyolysis has been reported in a patient with nephrotic syndrome. The authors suggest that the patient's underlying renal dysfunction may have predisposed the patient to rhabdomyolysis.

Musculoskeletal side effects have included uncomplicated myalgia and arthralgia. Milder forms of myotoxicity (i.e., myalgia) are commonly reported and occur in approximately 5% to 7% of patients taking a statin drug. Rhabdomyolysis and myopathy related to HMG-CoA reductase inhibitor use have been reported rarely. One case of atorvastatin-induced dermatomyositis has been reported. Tendon rupture has been reported in postmarketing surveillance.

Hematologic

Hematologic side effects including hemolytic anemia, thrombocytopenia, and leukopenia have occurred with HMG-CoA reductase inhibitors. These effects may be manifestations of a hypersensitivity reaction.

Nervous system

Nervous system side effects of headache and weakness have occurred with HMG-CoA reductase inhibitors. In addition, at least one case of polyneuropathy attributed to atorvastatin use has also been reported. Other nervous system side effects reported with HMG-CoA reductase inhibitors have included dizziness, drowsiness, fatigue, cranial nerve dysfunction, tremor, vertigo, memory loss, decline in cognitive function, paresthesias, peripheral neuropathy, and peripheral nerve palsy.

Renal

Renal side effects including acute renal failure secondary to rhabdomyolysis have been reported with HMG-CoA reductase inhibitors.

Endocrine

Endocrine side effects associated with the use of other HMG-CoA reductase inhibitors have included hypospermia, gynecomastia, and thyroid dysfunction. In addition, acid maltase deficiency (the genetic disorder also referred to as Pompe's Disease) has been revealed following HMG-CoA therapy in at least one presymptomatic patient.

Hypersensitivity

Hypersensitivity reactions have been observed rarely with HMG-CoA reductase inhibitors. Symptoms have included anaphylaxis, angioedema, allergic reaction, urticaria, fever, chills, flushing, malaise and dyspnea. Bullous rashes including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have occurred.

Psychiatric

Psychiatric side effects of HMG-CoA reductase inhibitors have included decreases in libido, anxiety, depression, and insomnia. In addition, nightmares have been associated with atorvastatin use.

Genitourinary

Genitourinary adverse effects associated with other HMG-CoA reductase inhibitors have included erectile dysfunction, impotence, and testicular pain. At least one case of hemorrhagic cystitis has been reported.

Dermatologic

Dermatologic reactions have occurred rarely. In premarketing trials, up to 3.8% of patients complained of a rash. Phototoxicity has also been associated with atorvastatin.

Cardiovascular

Analysis of study data has shown an increased risk of hemorrhagic stroke in patients treated with atorvastatin who had a stroke or TIA within 6 months preceding treatment compared to placebo.

Cardiovascular side effects occurring since market introduction have included angioneurotic edema, peripheral edema, and chest pain. Atorvastatin may also increase the incidence of hemorrhagic stroke in patients with a history of recent stroke or TIA.

Respiratory

Respiratory symptoms reported since market introduction have included bronchitis, rhinitis, pharyngitis, and sinusitis.

Ocular

Ocular side effects including a case of reversible ophthalmoplegia as well as a case of ocular myasthenia have been reported.

A 60-year-old woman with hypercholesterolemia treated with atorvastatin developed painless horizontal diplopia, vertigo, blurry vision, elevated anti-acetylcholine receptor (anti-AchR) antibodies levels, ataxia, and paresthesia of the upper extremities. No other medications were reported. Neurological exam revealed generalized hyperreflexia and finger-nose and gait ataxia. Ptosis was present in both upper eyelids. Discontinuation of atorvastatin resulted in symptom resolution and anti-AchR levels within normal limits.

A 67-year-old women treated for hypercholesterolemia with atorvastatin developed myogenic ptosis and variable incomitant horizontal and vertical strabismus consistent with ocular myasthenia. Following discontinuation of atorvastatin, the patient experienced significant clinical improvement with only mild residual aponeurotic ptosis after 2 months.

Immunologic

Immunologic side effects including a possible case of atorvastatin-induced reversible positive antinuclear antibodies have been reported.

Other

Other side effects reported during clinical trials (in more than 2% of patients) have included infection, accidental injury, flu syndrome, abdominal pain, and back pain. Fatigue and tendon rupture have been reported in postmarketing studies with atorvastatin.

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