Vivacor Adverse Reactions

The adverse events seen with VIVACOR are generally mild and transient. In controlled clinical trials, less than 4% of VIVACOR-treated patients were withdrawn due to adverse events. This withdrawal rate was comparable to that reported in patients receiving placebo. (See Table 3.)

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As with other HMG-CoA reductase inhibitors, the incidence of adverse drug reactions tends to be dose dependent.
Renal Effects: Refer to Precautions.
Skeletal muscle effects: As with other HMG-CoA reductase inhibitors, effects on skeletal muscle e.g. myalgia and myopathy (including myositis), have been reported in VIVACOR-treated patients. Rare cases of rhabdomyolysis, which were occasionally associated with impairment of renal function, have been reported with rosuvastatin and with other marketed statins.
A dose-related increase in CK levels has been observed in a small number of patients taking rosuvastatin; the majority of cases were mild, asymptomatic and transient. If CK levels are elevated (>5x Upper Limit of Normal), treatment should be temporarily 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.
Post Marketing Experience: In addition to the previous text, the following adverse events have been reported during post marketing experience for VIVACOR.
Eye disorders: Frequency unknown: ocular myasthenia.
Haematological disorders: Frequency unknown: thrombocytopenia.
Hepatobiliary disorders: Very rare: Jaundice, hepatitis; Rare: Increased hepatic transaminases.
Musculoskeletal disorders: Frequency unknown: immune-mediated necrotizing myopathy; Very rare: arthralgia.
As with other HMG-CoA reductase inhibitors, the reporting rate for rhabdomyolysis in post-marketing use is higher at the highest marketed dose.
Nervous system disorder: Very rare: memory loss; frequency unknown: peripheral neuropathy, myasthenia gravis.
Psychiatric disorders: Frequency unknown: depression, sleep disorders (including insomnia and nightmares).
Reproductive system and breast disorders: Frequency unknown: gynaecomastia.
Skin and subcutaneous tissue disorders: Frequency unknown: drug reaction with eosinophilia and systemic symptoms (DRESS), lichenoid drug eruption.
Children and adolescents 6 to 17 years of age: The safety profile of VIVACOR is similar in children or adolescent patients and adults although creatine kinase (CK) elevations >10x ULN and muscle symptoms following exercise or increased physical activity, which resolved with continued treatment, were observed more frequently in a clinical trial of children and adolescents. However, the same special warnings and special precautions for use in adults also apply to children and adolescents (see Precautions).