Rosuvastatin Sandoz Adverse Reactions

The adverse reactions seen with Rosuvastatin Sandoz are generally mild and transient. In controlled clinical trials, less than 4% of rosuvastatin-treated patients were withdrawn due to adverse reactions.
List of adverse reactions: Based on data from clinical studies and extensive post-marketing experience, the following list presents the adverse reaction profile for rosuvastatin. Adverse reactions listed as follows are classified according to frequency and system organ class (SOC).
The evaluation of undesirable effects is based on the following information on frequency: Very common (≥ 1/10); 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); Not known (cannot be estimated from the available data).
Adverse reactions based on data from clinical studies and post-marketing experience: Blood and lymphatic system disorders: Rare: Thrombocytopenia.
Immune system disorders: Rare: Hypersensitivity reactions including angioedema.
Endocrine disorders: Common: Diabetes mellitus¹.
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, dyspnoea.
Gastrointestinal disorders: Common: Constipation, nausea, abdominal pain.
Rare: Pancreatitis.
Not known: Diarrhoea.
Hepatobiliary disorders: Rare: Increased hepatic transaminases.
Very rare: Jaundice, hepatitis.
Skin and subcutaneous tissue disorders: Uncommon: Pruritus, rash, urticaria.
Not known: Stevens-Johnson syndrome, Drug reaction with eosinophilia and systemic symptoms (DRESS).
Musculoskeletal and connective tissue disorders: Common: Myalgia.
Rare: Myopathy (including myositis), rhabdomyolysis, lupus-like syndrome, muscle rupture.
Very rare: Arthralgia.
Not known: Immune-mediated necrotising myopathy, Tendon disorders, sometimes complicated by rupture.
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.
¹ 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 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, 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.
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 in patients 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.
The following adverse events have been reported with some statins: Sexual dysfunction; Exceptional cases of interstitial lung disease, especially with long term therapy (see Precautions).
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.
Paediatric 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.