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 In controlled clinical trials, less than 4% of Rosuvastatin-treated patients were withdrawn due to adverse events.
The frequencies of adverse events are ranked according to the following: Common (>1/100, <1/10); Uncommon (>1/1,000, <1/100); Rare (>1/10,000, <1/1000); Very rare (<1/10,000); Not known (cannot be estimated from the available data).
Immune system disorders:
Rare: hypersensitivity reactions including angioedema.
Common: diabetes mellitus1
Nervous system disorders:
Common: headache, dizziness.
Common: constipation, nausea, abdominal pain. Rare: pancreatitis.
Skin and subcutaneous tissue disorders:
Uncommon: pruritus, rash and urticaria.
Musculoskeletal, connective tissue and bone disorders:
Common: myalgia. Rare: myopathy (including myositis) and rhabdomyolysis.
Observed 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.
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 trace 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 shift 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.
Hematuria 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 in patients taking rosuvastatin; the majority of cases were mild, asymptomatic and transient. If CK levels are elevated (>5xULN), treatment should be discontinued.
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 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.
Not known: diarrhea.
Very rare: jaundice, hepatitis; rare: increased transaminases.
Skin and subcutaneous tissue disorders:
Not known: Stevens-Johnson syndrome.
Very rare: arthralgia.
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, sexual dysfunction, exceptional cases of interstitial lung disease, especially with long term therapy.
The reporting rates for rhabdomyolysis, serious renal events and serious hepatic events (consisting mainly of increased hepatic transaminases) are higher at the 40 mg dose.
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. In other respects, the safety profile of Rosuvastatin was similar in children and adolescents compared to adults.
Adverse reactions that occurred either during clinical studies or that were spontaneously reported are presented in the following table. Their frequency is defined using the following conventions: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000). Within each system organ class, adverse drug reactions are presented in order of decreasing seriousness. (See table.)
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