The frequencies of adverse events are ranked according to the following: Common (> 1/100, < 1/10); uncommon (> 1/1000, < 1/100), rare (> 1/10000, < 1/1000), very rare (< 1/10000), not known (cannot be estimated from the available data).
Immune system disorders: Rare:
Hypersensitivity reactions including angioedema.
Common: Diabetes mellitus*.
Nervous system disorders:
Common: Headache, dizziness.
Common: Constipation, nausea, abdominal pain.
Skin and subcutaneous tissue disorders:
Uncommon: Pruritus, rash and urticaria.
Musculoskeletal, connective tissue and bone disorders:
Rare: Myopathy (including myositis) and rhabdomyolysis.
Note: *Frequency will depend on the presence or absence of risk factors (fasting blood glucose ≥ 5.6 mmol/L, BMI > 30 kg/m2
, raised triglycerides, history of hypertension).
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. A minor increase in shift 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 is not predictive acute or progressive renal disease.
Skeletal muscle effects:
Rare cases of rhabdomyolysis which were occasionally associated with the impairment of renal function have been reported with Rosuvastatin and with other marketed Statins.
As with other HMG-CoA reductase inhibitors, a dose-related increase in transaminases and CK have been observed in a small number of patients taking Rosuvastatin; the majority of cases were mild, asymptomatic and transient. If CK levels are elevated (> 5 x ULN), treatment should be discontinued. Increases in HbA1c have also been observed in patients treated with Rosuvastatin.
Post Marketing experience:
In addition to above, the following adverse event have been reported with Rosuvastatin and with other marketed Statins.
Frequency unknown: Thrombocytopenia.
Very rare: Jaundice, hepatitis.
Rare: Increased hepatic transaminases.
Frequency unknown: Immune-mediated necrotizing myopathy.
Very rare: Arthralgia.
Nervous system disorders:
Very rare: Polyneuropathy, memory loss.
Frequency unknown: Depression, sleep disorders (including insomnia and nightmares).
Reproductive system and breast disorders:
Frequency unknown: Gynaecomastia.