Rosucres-10/Rosucres-20 Adverse Reactions

The following serious adverse reactions are discussed in greater detail in other sections of the monograph: Rhabdomyolysis with myoglobinuria and acute renal failure and myopathy (including myositis).
Liver enzyme abnormalities in the Rosuvastatin controlled clinical trials database (placebo or active controlled) of 5394 patients with a mean treatment duration of 15 weeks, 1.4% of patients discontinued due to adverse reactions. The most common adverse reactions that led to treatment discontinuation were: myalgia, abdominal pain, nausea.
The most commonly reported adverse reactions (incidence >2%) in the Rosuvastatin controlled clinical trial database of 5394 patients were: headache, myalgia, abdominal pain, asthenia, nausea.
Postmarketing Experience: The following adverse reactions have been identified during post approval use of Rosuvastatin: arthralgia, fatal and non-fatal hepatic failure, hepatitis, jaundice, thrombocytopenia, depression, sleep disorders (including insomnia and nightmares) and gynecomastia. Because these reactions are reported voluntarily from a population of uncertain size, it is no always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
There have been rare reports of immune-mediated necrotizing myopathy associated with statin use.
There have been rare postmarketing 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 nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).