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Author: Admin | 2025-04-28
The clinical studies of a drugcannot be directly compared to rates in the clinical studies of another drugand may not reflect the rates observed in clinical practice.In the rosuvastatin calcium controlled clinical trialsdatabase (placebo or active-controlled) of 5394 patients with a mean treatmentduration of 15 weeks, 1.4% of patients discontinued due to adverse reactions.The most common adverse reactions that led to treatment discontinuation were: myalgia abdominal pain nauseThe most commonly reported adverse reactions (incidence ≥ 2%) in the rosuvastatin calcium controlled clinical trial database of5394 patients were: headache myalgia abdominal pain asthenia nauseaAdverse reactions reported in ≥ 2% of patients inplacebo-controlled clinical studies and at a rate greater than placebo areshown 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 inPlacebo-Controlled Trials (% of Patients ) Adverse Reactions Rosuvastatin calcium 5 mg N=291 Rosuvastatin calcium 10 mg N=283 Rosuvastatin calcium 20 mg N=64 Rosuvastatin calcium 40 mg N=106 Total Rosuvastatin calcium 5 mg to 40 mg N=744 Placebo N=382 Headache 5.5 4.9 3.1 8.5 5.5 5.0 Nausea 3.8 3.5 6.3 0 3.4 3.1 Myalgia 3.1 2.1 6.3 1.9 2.8 1.3 Asthenia 2.4 3.2 4.7 0.9 2.7 2.6 Constipation 2.1 2.1 4.7 2.8 2.4 2.4 1Adverse reactions by COSTART preferred term Other adverse reactions reported in clinical studies wereabdominal pain, dizziness, hypersensitivity (including rash, pruritus,urticaria, and angioedema) and pancreatitis. The following laboratory abnormalitieshave also been reported: dipstick-positive proteinuria and microscopic hematuria [see WARNINGS AND PRECAUTIONS]; elevated creatinephosphokinase, transaminases, glucose, glutamyl transpeptidase, alkalinephosphatase, and bilirubin; and thyroid function abnormalities.In a clinical trial, involving 981 participants treatedwith rosuvastatin 40 mg (n=700) or placebo (n=281) with a mean treatmentduration of 1.7 years, 5.6% of subjects treated with rosuvastatin calciumversus 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 andat a rate greater than placebo are shown in Table 2.Table 2: Adverse Reactions2 Reported in ≥ 2% of Patients Treated With
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