The adverse events seen with rosuvastatin are generally mild and transient. In controlled clinical trials, less than 4% of rosuvastatin-treated patients were withdrawn due to adverse events.
Adverse events are listed as follows by system organ class and frequency. Frequencies are defines as follows: Very common (≥1/10), Common (≥1/100 to <10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 and <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from available data).
Immune system disorders: Rare: hypersensitivity reactions including angioedema.
Endocrine disorders: Common: diabetes mellitus1.
Nervous system disorders: Common: headache, dizziness.
Gastrointestinal disorders: Common: constipation, nausea, abdominal pain; Rare: pancreatitis.
Skin and subcutaneous tissue disorders: Uncommon: pruritus, rash and urticaria.
Musculoskeletal and connective tissue disorders: Common: myalgia; Rare: myopathy (including myositis) and rhabdomyolysis.
General disorders and administration site conditions: Common: asthenia.
1Observed in the JUPITER study (reported overall frequency 2.8% in rosuvastatin and 2.3% in placebo) mostly in patients with fasting glucose 5.6 to 6.9 mmol/L.
As with other HMG-CoA reductase inhibitors, the incidence of adverse drug reactions tends to be dose dependent.
Renal effects: Proteinuria, detected by dipstick testing and mostly tubular in origin, has been observed in patients treated with rosuvastatin. Shifts in urine protein from none or tract to ++ or more were seen in <1% of patients at some time during treatment with 10 and 20 mg, and in approximately 3% of patients treated with 40 mg. A minor increase in shifts from none or trace to + was observed with the 20 mg dose. In most cases, proteinuria decreases or disappears spontaneously on continued therapy. Review of data from clinical trials and post-marketing experience to date has not identified a causal association between proteinuria and acute or progressive renal disease.
Haematuria has been observed in patients treated with rosuvastatin and clinical trial data show that the occurrence is low.
Skeletal muscle effects: Effects on skeletal muscle e.g. myalgia, myopathy (including myositis) and, rarely, rhabdomyolysis with and without acute renal failure have been reported in rosuvastatin-treated patients with all doses and in particular with doses >20 mg.
A dose-related increase in CK levels has been observed inpatients taking rosuvastatin; the majority of cases were mild, asymptomatic and transient. If CK levels are elevated (>5xULN), treatment should be discontinued (see Precautions).
Liver effects: As with other HMG-CoA reductase inhibitors, a dose-related increase in transaminases has been observed in a small number of patients taking rosuvastatin; the majority of cases were mild, asymptomatic and transient.
Post-marketing experience: In addition to the previously mentioned, the following adverse events have been reported during post marketing experience for rosuvastatin: Nervous system disorders: Very rare: polyneuropathy, memory loss.
Respiratory, thoracic and mediastinal disorders: Not known: cough, dyspnea.
Gastrointestinal disorders: Not known: diarrhea.
Hepatobiliary disorders: Very rare: jaundice, hepatitis; rare: increased hepatic transaminases.
Skin and subcutaneous tissue disorders: Not known: Stevens-Johnson syndrome.
Musculoskeletal disorders: Very rare: arthralgia.
Renal disorders: Very rare: hematuria.
General disorders and administration site conditions: Not known: edema.
The following adverse events have been reported with some statins: Depression.
Sleep disturbances, including insomnia and nightmares.
Exceptional cases of interstitial lung disease, especially with long term therapy (see Precautions).
The reporting rates of rhabdomyolysis, serious renal events and serious hepatic events (consisting mainly of increased hepatic transaminases) is higher at the 40 mg dose.
Pediatric population: Creatine kinase elevations >10xULN and muscle symptoms following exercise or increased physical activity were observed more frequently in a 52-week clinical trial of children and adolescents compared to adults (see Precautions). In other respects, the safety profile of rosuvastatin was similar in children and adolescents compared to adults.