Medical Editor: John P. Cunha, DO, FACOEP
Rosuvastatin calcium tablets are an HMG Co A reductase inhibitor indicated for adult patients with hypertriglyceridemia as an adjunct to diet; adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet; and adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total C, and ApoB. Rosuvastatin calcium is available in generic form. Common side effects of rosuvastatin calcium include:
- muscle pain, abdominal
- hypersensitivity reactions (including rash, pruritus, hives, and swelling), and
The dose range for rosuvastatin calcium is 5 to 40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20. Rosuvastatin calcium may interact with cyclosporine, gemfibrozil, protease inhibitors, coumarin anticoagulants, niacin, fenofibrate, and colchicine. Tell your doctor all medications and supplements you use. Rosuvastatin calcium is not recommended for use during pregnancy; it may harm a fetus. Females should talk to their doctor about using contraceptives while taking rosuvastatin calcium. Rosuvastatin calcium passes into breast milk. Because of the possibility of unwanted effects on a nursing infant, breastfeeding while using rosuvastatin calcium is not recommended.
Our Rosuvastatin Calcium 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.
The following serious adverse reactions are discussed in greater detail in other sections of the label:
- Rhabdomyolysis with myoglobinuria and acute renal failure and myopathy (including myositis) [see WARNINGS AND PRECAUTIONS]
- Liver enzyme abnormalities [see WARNINGS AND PRECAUTIONS]
Clinical Studies Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.
In the rosuvastatin calcium controlled clinical trials database (placebo or active-controlled) of 5394 patients with a mean treatment duration of 15 weeks, 1.4% of patients discontinued due to adverse reactions. The most common adverse reactions that led to treatment discontinuation were:
- abdominal pain
The most commonly reported adverse reactions (incidence ≥ 2%) in the rosuvastatin calcium controlled clinical trial database of 5394 patients were:
- abdominal pain
Adverse reactions reported in ≥ 2% of patients in placebo-controlled clinical studies and at a rate greater than placebo are shown in Table 1. These studies had a treatment duration of up to 12 weeks.
Table 1: Adverse Reactions1 Reported in
≥ 2% of Patients Treated with Rosuvastatin calcium and > Placebo in
Placebo-Controlled Trials (% of Patients )
|Adverse Reactions||Rosuvastatin calcium 5 mg
|Rosuvastatin calcium 10 mg
|Rosuvastatin calcium 20 mg
|Rosuvastatin calcium 40 mg
|Total Rosuvastatin calcium 5 mg to 40 mg
|1Adverse reactions by COSTART preferred term|
Other adverse reactions reported in clinical studies were abdominal pain, dizziness, hypersensitivity (including rash, pruritus, urticaria, and angioedema) and pancreatitis. The following laboratory abnormalities have also been reported: dipstick-positive proteinuria and microscopic hematuria [see WARNINGS AND PRECAUTIONS]; elevated creatine phosphokinase, transaminases, glucose, glutamyl transpeptidase, alkaline phosphatase, and bilirubin; and thyroid function abnormalities.
In a clinical trial, involving 981 participants treated with rosuvastatin 40 mg (n=700) or placebo (n=281) with a mean treatment duration of 1.7 years, 5.6% of subjects treated with rosuvastatin calcium versus 2.8% of placebo-treated subjects discontinued due to adverse reactions. The most common adverse reactions that led to treatment discontinuation were: myalgia, hepatic enzyme increased, headache, and nausea.
Adverse reactions reported in ≥ 2% of patients and at a rate greater than placebo are shown in Table 2.
Table 2: Adverse Reactions2 Reported in
≥ 2% of Patients Treated With Rosuvastatin calcium and > Placebo in a
Trial (% of Patients )
|Adverse Reactions||Rosuvastatin calcium 40 mg
|ALT > 3x ULN*||2.2||0.7|
|*Frequency recorded as abnormal laboratory value
2Adverse reactions by MedDRA preferred term.
In a clinical trial, 17,802 participants were treated with rosuvastatin 20 mg (n=8901) or placebo (n=8901) for a mean duration of 2 years. A higher percentage of rosuvastatin-treated patients versus placebo-treated patients, 6.6% and 6.2%, respectively, discontinued study medication due to an adverse event, irrespective of treatment causality. Myalgia was the most common adverse reaction that led to treatment discontinuation.
There was a significantly higher frequency of diabetes mellitus reported in patients taking rosuvastatin (2.8%) versus patients taking placebo (2.3%). Mean HbA1c was significantly increased by 0.1% in rosuvastatin-treated patients compared to placebo-treated patients. The number of patients with a HbA1c > 6.5% at the end of the trial was significantly higher in rosuvastatin-treated versus placebotreated patients [see WARNINGS AND PRECAUTIONS].
Adverse reactions reported in ≥ 2% of patients and at a rate greater than placebo are shown in Table 3.
Table 3: Adverse Reactions3 Reported in
≥ 2% of Patients Treated with Rosuvastatin calcium and > Placebo in a
Trial (% of Patients )
|Adverse Reactions||Rosuvastatin calcium 20 mg
|3Treatment-emergent adverse reactions by MedDRA preferred term.|
The following adverse reactions have been identified during postapproval use of rosuvastatin calcium: arthralgia, fatal and non-fatal hepatic failure, hepatitis, jaundice, thrombocytopenia, depression, sleep disorders (including insomnia and nightmares), peripheral neuropathy and gynecomastia. 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.
There have been rare reports of immune-mediated necrotizing myopathy associated with statin 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 are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).
Read the entire FDA prescribing information for Rosuvastatin Calcium (rosuvastatin calcium)