Rosuvastatin Stella Adverse Reactions

There have been rare reports of cognitive impairment (e.g. memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These 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 3 weeks).
Increases with HbA1c and fasting blood glucose have been reported with statins. The risk of hyperglycemia, however, is outweighed by the reduction in vascular risk with statins. The adverse reactions seen with Rosuvastatin are generally mild and transient. Adverse reactions listed below are classified according to frequency and system organ class (SOC).
Blood and lymphatic system disorders: Rare: thrombocytopenia. Immune system disorders: Rare: hypersensitivity reactions includingangioedema.
Endocrine disorders: Common: diabetes mellitus [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)].
Psychiatric disorders: Not known: depression.
Nervous system disorders: Common: headache, dizziness; Very rare: polyneuropathy, memory loss; Not known: peripheral neuropathy, sleep disturbances (including insomnia and nightmares).
Respiratory, thoracic and mediastinal disorders: Not known: cough, dyspnea.
Gastrointestinal disorders: Common: constipation, nausea, abdominal pain; Rare: pancreatitis; Not known: diarrhea.
Hepatobiliary disorders: Rare: increased hepatic transaminases; Very rare: jaundice, hepatitis.
Skin and subcutaneous tissue disorders: Uncommon: pruritis, rash, urticaria; Not known: Stevens-Johnson syndrome.
Musculoskeletal and connective tissue disorders: Common: myalgia; Rare: myopathy (including myositis), rhabdomyolysis; Very rare: arthralgia; Not known: immune-mediated necrotizing myopathy.
Renal and urinary disorders: Very rare: haematuria.
Reproductive system and breast disorders: Very rare: gynaecomastia.
General disorders and administration site conditions: Common: asthenia; Not known: oedema.
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 trace to ++ or more were seen in <1% of patients at some time during treatment with 10 and 20 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. Available data has not identified a causal association between proteinuria and acute or progressive renal disease.
Haematuria has been observed in patients treated with Rosuvastatin but clinical 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 (>5 x ULN), treatment should be discontinued.
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.
The following adverse events have been reported with some statins: Sexual dysfunction.
Exceptional cases of interstitial lung disease, especially with long term therapy.
Tendon disorders, sometimes complicated by rupture.
The reporting rates for rhabdomyolysis, serious renal events and serious hepatic events (consisting mainly of increased hepatic transaminases) is higher at the 40 mg dose.