Apo-Rosuvastatin Adverse Reactions

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 In controlled clinical trials less than 4% of rosuvastatin treated patients were withdrawn due to adverse events.
Common (≥1/100, <1/10): Headache, myalgia, asthenia, constipation, dizziness, nausea, abdominal pain, diabetes mellitus¹.
Uncommon (≥1/1000, <1/100): Pruritus, rash and urticaria.
Rare (≥1/10,000, <1/1000): Myopathy (including myositis), hypersensitivity reactions (including angioedema), rhabdomyolysis, pancreatitis.
¹ 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 (see Precautions and Pharmacology: Pharmacodynamics under Actions).
As with other HMG-CoA reductase inhibitors, the incidence of adverse drug reactions tends to be dose dependent.
Laboratory Effects: 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 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, and has not been shown to be predictive of acute or progressive renal disease.
Skeletal muscle effects: Effects on skeletal muscle e.g. myalgia, myopathy (including myositis) and rhabdomyolysis have been reported in rosuvastatin treated patients with all doses. 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 (> 10x ULN), 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 (see Precautions and Pharmacology: Pharmacodynamics under Actions); the majority of cases were mild, asymptomatic and transient.
Other effects: In a long-term controlled clinical trial rosuvastatin was shown to have no harmful effects on the ocular lens.
Post Marketing Experience: In addition to the previous text, the following adverse events have been reported during post marketing experience for rosuvastatin.
Nervous system disorders: Very rare: polyneuropathy, memory loss. Frequency unknown: peripheral neuropathy.
Respiratory, thoracic and mediastinal disorders: Not known: cough, dyspnoea.
Gastrointestinal disorders: Not known: diarrhoea.
Haematological disorders: Frequency unknown: thrombocytopenia.
Hepatobiliary disorders: Very rare: Jaundice, hepatitis. Rare: increased hepatic transaminases.
Skin and subcutaneous tissue disorders: Not known: Stevens-Johnson syndrome.
Musculoskeletal disorders: Not known: immune-mediated necrotising myopathy. Very Rare: arthralgia.
Renal disorders: Very rare: haematuria.
General disorders and administration site conditions: Not known: oedema.
Reproductive system and breast disorders: Not known: gynaecomastia.
As with other HMG-CoA reductase inhibitors, the reporting rate for rhabdomyolysis in post-marketing use is higher at the highest marketed dose.
The following adverse events have been reported with some statins: Depression, Sleep disturbances, including insomnia and nightmares.
There have been rare post-marketing 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 non-serious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).
Children and adolescents 10 to 17 years of age: The safety profile of rosuvastatin is similar in children or adolescent patients and adults although CK elevations > 10x ULN and muscle symptoms following exercise or increased physical activity, which resolved with continued treatment, were observed more frequently in clinical trials of children and adolescents. However, the same special warnings and special precautions for use in adults also apply to children and adolescents (see Precautions).