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Lipitor

Last reviewed on RxList: 7/31/2017
Lipitor Side Effects Center

Last reviewed on RxList 7/31/2017

Lipitor (atorvastatin) is a statin used for the treatment of elevated total cholesterol, LDL, triglycerides, and to elevate HDL cholesterol. Side effects of Lipitor include:

Contact your doctor if you experience serious side effects of Lipitor including:

The recommended dose of Lipitor is 10-80 mg daily. Erythromycin (E-Mycin), ketoconazole (Nizoral), itraconazole (Sporanox), cyclosporine (Sandimmune), indinavir (Crixivan) and ritonavir (Norvir) decrease elimination of Lipitor. Lipitor increases the effect of warfarin (Coumadin) and cholestyramine (Questran) decreases the absorption of Lipitor. Lipitor should not be taken during pregnancy because the developing fetus requires cholesterol for development, and Lipitor reduces the production of cholesterol. Lipitor passes into breast milk and could harm a nursing baby. Breastfeeding while taking Lipitor is not recommended.

Our Lipitor Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Lipitor Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking atorvastatin and call your doctor at once if you have any of these serious side effects:

  • unexplained muscle pain, tenderness, or weakness;
  • confusion, memory problems;
  • fever, unusual tiredness, and dark colored urine;
  • swelling, weight gain, urinating less than usual or not at all;
  • increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild muscle pain;
  • diarrhea; or
  • mild nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Lipitor (Atorvastatin Calcium)

Lipitor Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the label:

Rhabdomyolysis and myopathy [see WARNINGS AND PRECAUTIONS]

Liver enzyme abnormalities [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In the LIPITOR placebo-controlled clinical trial database of 16,066patients (8755 LIPITOR vs. 7311 placebo; age range 10-93 years, 39% women, 91% Caucasians, 3% Blacks, 2% Asians, 4% other)with a median treatment duration of 53 weeks, 9.7% of patients on LIPITOR and 9.5% of the patients on placebo discontinued due to adverse reactions regardless of causality. The five most common adverse reactions in patients treated with LIPITOR that led to treatment discontinuation and occurred at a rate greater than placebo were: myalgia (0.7%), diarrhea (0.5%), nausea (0.4%), alanine aminotransferase increase (0.4%), and hepatic enzyme increase (0.4%).

The most commonly reported adverse reactions(incidence ≥ 2%and greater than placebo) regardless of causality, in patient streated with LIPITOR in placebo controlled trials (n=8755) were: nasopharyngitis (8.3%), arthralgia (6.9%), diarrhea (6.8%), pain in extremity (6.0%), and urinary tract infection (5.7%).

Table 3 summarizes the frequency of clinicaladverse reactions, regardless of causality, reported in ≥ 2% and at a rate greater than placebo in patients treated with LIPITOR (n=8755), from seventeen placebo-controlled trials.

Table 3: Clinical adverse reactions occurring in ≥ 2% in patients treated with any dose of LIPITOR and at an incidence greater than placebo regardless of causality (% of patients).

Adverse Reaction* Any dose
N=8755
10 mg
N=3908
20 mg
N=188
40 mg
N=604
80 mg
N=4055
Placebo
N=7311
Nasopharyngitis 8.3 12.9 5.3 7.0 4.2 8.2
Arthralgia 6.9 8.9 11.7 10.6 4.3 6.5
Diarrhea 6.8 7.3 6.4 14.1 5.2 6.3
Pain in extremity 6.0 8.5 3.7 9.3 3.1 5.9
Urinary tract infection 5.7 6.9 6.4 8.0 4.1 5.6
Dyspepsia 4.7 5.9 3.2 6.0 3.3 4.3
Nausea 4.0 3.7 3.7 7.1 3.8 3.5
Musculoskeletal pain 3.8 5.2 3.2 5.1 2.3 3.6
Muscle Spasms 3.6 4.6 4.8 5.1 2.4 3.0
Myalgia 3.5 3.6 5.9 8.4 2.7 3.1
Insomnia 3.0 2.8 1.1 5.3 2.8 2.9
Pharyngolaryngeal pain 2.3 3.9 1.6 2.8 0.7 2.1
*Adverse Reaction ≥ 2% in any dose greater than placebo

Other Adverse Reactions Reported in Placebo-controlled Studies Include:

Body as a whole: malaise, pyrexia; Digestive system: abdominal discomfort, eructation, flatulence, hepatitis, cholestasis; Musculoskeletal system: musculoskeletal pain, muscle fatigue, neck pain, joint swelling; Metabolic and nutritional system: transaminases increase, liver function test abnormal, blood alkaline phosphatase increase, creatine phosphokinase increase, hyperglycemia; Nervous system: nightmare; Respiratory system: epistaxis; Skin and appendages: urticaria; Special senses: vision blurred, tinnitus; Urogenital system: white blood cells urine positive.

Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT)

In ASCOT [see Clinical Studies] involving 10,305 participants (age range 40-80 years, 19% women; 94.6% Caucasians, 2.6% Africans, 1.5% South Asians, 1.3% mixed/other) 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.

Collaborative Atorvastatin Diabetes Study (CARDS)

In CARDS [see Clinical Studies] involving 2,838 subjects (age range 39-77 years, 32% women; 94.3% Caucasians, 2.4% South Asians, 2.3% Afro-Caribbean, 1.0% other) with type 2 diabetes treated with LIPITOR 10 mg daily(n=1,428) or placebo (n=1,410), there was no difference in the overall frequency of adverse reactions or serious adverse reactions between the treatment groups during a median follow-up of 3.9 years. No cases of rhabdomyolysis were reported.

Treating to New Targets Study(TNT)

In TNT [see Clinical Studies] involving 10,001 subjects (age range 29-78 years, 19% women; 94.1% Caucasians, 2.9% Blacks, 1.0%Asians, 2.0% other) with clinically evident CHD treated with LIPITOR10mg daily (n=5006) orLIPITOR80 mg daily (n=4995), there were more serious adverse reactions and discontinuations due to adverse reactions 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 ( ≥ 3x ULN twice within 4-10days) occurred in 62 (1.3%) individuals with atorvastatin80mg andinnine(0.2%)individualswithatorvastatin10mg.ElevationsofCK( ≥ 10x 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%).

Incremental Decrease in Endpoints through Aggressive Lipid Lowering Study (IDEAL)

In IDEAL [see Clinical Studies] involving 8,888 subjects (age range 26-80 years, 19% women; 99.3% Caucasians, 0.4% Asians, 0.3% Blacks, 0.04% other) treated with LIPITOR80 mg/day (n=4439)or simvastatin 20-40 mg daily (n=4449), there was no difference in the overall frequency of adverse reactions or serious adverse reactions between the treatment groups during a median follow-up of 4.8 years.

Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL)

In SPARCL involving 4731 subjects (age range 21-92 years, 40% women; 93.3% Caucasians, 3.0% Blacks, 0.6% Asians, 3.1% other) without clinically evident CHD but with a stroke or transient ischemic attack (TIA) within the previous 6 months treated with LIPITOR 80 mg (n=2365) or placebo (n=2366) for a median follow-up of 4.9 years, there was a higher incidence of persistent hepatic transaminase elevations ( ≥ 3xULN twice within 4-10days) in the atorvastatin group (0.9%) compared to placebo (0.1%). Elevations of CK ( > 10 x ULN) were rare, but were higher in the atorvastatin group (0.1%) compared to placebo (0.0%). Diabetes was reported as an adverse reaction in 144 subjects (6.1%) in the atorvastatin group and 89 subjects (3.8%) in the placebo group [see WARNINGS AND PRECAUTIONS].

In a post-hoc analysis, LIPITOR 80 mg reduced the incidence of ischemic stroke(218/2365, 9.2% vs. 274/2366, 11.6%) and increased the incidence of hemorrhagic stroke (55/2365, 2.3% vs. 33/2366, 1.4%)compared to placebo. The incidence of fatal hemorrhagic stroke was similar between groups (17LIPITOR vs. 18placebo). The incidence of non-fatal hemorrhagic strokes was significantly greater in the atorvastatin group (38 non-fatal hemorrhagic strokes) as compared to the placebo group (16 non-fatal hemorrhagic strokes). Subjects who entered the study with a hemorrhagic stroke appeared to be at increased risk for hemorrhagic stroke [7 (16%) LIPITOR vs.2 (4%) placebo].

There were no significant differences between the treatment groups for all-cause mortality: 216 (9.1%) in the LIPITOR 80mg/day group vs. 211(8.9%)in the placebo group. The proportions of subjects who experienced cardiovascular death were numerically smaller in the LIPITOR80 mg group (3.3%) than in the placebo group (4.1%). The proportions of subjects who experienced non-cardiovascular death were numerically larger in the LIPITOR80 mg group (5.0%) than in the placebo group(4.0%).

Adverse Reactions From Clinical Studies Of LIPITOR In Pediatric Patients

In a 26-weekcontrolled study in boys and postmenarchal girls with HeFH (ages 10years to17 years)(n=140, 31% female; 92% Caucasians, 1.6% Blacks, 1.6% Asians, 4.8% other), the safety and tolerability profile of LIPITOR10 to 20mg daily, as an adjunct to diet to reduce total cholesterol, LDL-C, and apoB levels, was generally similar to that of placebo [see Use in Special Populations and Clinical Studies].

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of LIPITOR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Adverse reactions associated with LIPITOR therapy reported since market introduction, that are notlisted above, regardless of causality assessment, include the following: anaphylaxis, angioneurotic edema, bullous rashes (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), rhabdomyolysis, myositis, fatigue, tendon rupture, fatal and non-fatal hepatic failure, dizziness, depression, peripheral neuropathy, pancreatitis and interstitial lung disease.

There have been rare reports of immune-mediated necrotizing myopathy associated with stat in use [see WARNINGS AND PRECAUTIONS].

There have been rare postmarketing 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 aregenerally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) andsymptom resolution (median of 3 weeks).

Read the entire FDA prescribing information for Lipitor (Atorvastatin Calcium)

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