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Atorvastatin Calcium, Film Coated

Source: OpenFDA label data · Not medical advice · For personal tracking only

The most user-facing sections are shown first. FDA professional label details are kept below and collapsed because they can be technical, repetitive, or difficult to read out of context.

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Reported Side Effects

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Common or Likely

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Hives

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FDA label warnings

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6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the label: Myopathy and Rhabdomyolysis [see Warnings and Precautions ( 5.1 )] Liver enzyme abnormalities [see Warnings and Precautions ( 5.3 )] Most common adverse reactions (incidence ≥ 2%) in patients treated with atorvastatin in placebo-controlled trials regardless of causality were: nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection ( 6.1 )

To report SUSPECTED ADVERSE REACTIONS, contact Biocon Pharma Inc., at 1-866-924-6266 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1 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

Professional label: Usage and Indications

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  • Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia
  • Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate
  • In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet

Professional label: Dosage Details

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  • Dose range: 10 mg to 80 mg once daily . Recommended start dose: 10 mg or 20 mg once daily
  • Patients requiring large LDL-C reduction (>45%) may start at 40 mg once daily
  • Pediatric patients with HeFH: starting dose: 10 mg once daily; dose range: 10 to 20 mg/day for patients 10 years to 17 years of age . Hyperlipidemia and Mixed Dyslipidemia

In the atorvastatin placebo-controlled clinical trial database of 16,066 patients (8,755 atorvastatin vs

7,311 placebo

age range 10 to 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 atorvastatin 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 atorvastatin 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 patients treated with atorvastatin in placebo controlled trials (n=8,755) were: nasopharyngitis (8.3%), arthralgia (6.9%), diarrhea (6.8%), pain in extremity (6.0%), and urinary tract infection (5.7%)

Table 2 summarizes the frequency of clinical adverse reactions, regardless of causality, reported in ≥ 2% and at a rate greater than placebo in patients treated with atorvastatin (n=8,755), from seventeen placebo-controlled trials

Table 2: Clinical Adverse Reactions Occurring in ≥ 2% in Patients Treated with any Dose of Atorvastatin and at an Incidence Greater than Placebo Regardless of Causality (% of Patients)

Adverse Reaction Adverse Reaction ≥ 2% in any dose greater than placebo Any dose N=8,755 10 mg N=3,908 20 mg N=188 40 mg N=604 80 mg N=4,055 Placebo N=7,311 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 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 ( 14.1 )] involving 10,305 participants (age range 40 to 80 years, 19% women

94.6% Caucasians, 2.6% Africans, 1.5% South Asians, 1.3% mixed/other) treated with atorvastatin 10 mg daily (n=5,168) or placebo (n=5,137), the safety and tolerability profile of the group treated with atorvastatin 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 ( 14.1 )] involving 2,838 subjects (age range 39 to 77 years, 32% women

94.3% Caucasians, 2.4% South Asians, 2.3% Afro-Caribbean, 1.0% other) with type 2 diabetes treated with atorvastatin 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 ( 14.1 )] involving 10,001 subjects (age range 29 to 78 years, 19% women

94.1% Caucasians, 2.9% Blacks, 1.0% Asians, 2.0% other) with clinically evident CHD treated with atorvastatin 10 mg daily (n=5,006) or atorvastatin 80 mg daily (n=4,995), 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 (≥3 x ULN twice within 4 to 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 x 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%)