Zyrova Adverse Reactions

5 mg: The following serious adverse reactions are discussed in greater detail in other sections of the label: Rhabdomyolysis with myoglobinuria and acute renal failure and myopathy; Liver enzyme abnormalities.
In the Rosuvastatin controlled clinical trials database ( placebo or active-controlled) 5.394 patients with a mean treatment durations 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 5.394 patients were; headache, myalgia, abdominal pain, asthenia, nausea.
10 mg & 20 mg: As with other HMG-CoA inhibitors, the incidence of adverse drug reactions tend to be dose-dependent with rosuvastatin. The adverse effects seen are generally mild and transient. Commonly reported adverse effects observed with Zyrova include myalgia, constipation, asthenia, abdominal pain and nausea. Other reported adverse effects include headache, diarrhea, dyspepsia, back pain and flu syndrome. Rare cases of myopathy and rhabdomyolysis have been reported with rosuvastatin. Symptomatic elevation of serum transaminase and CPK levels and occurrence of proteinuria have also been observed with Zyrova.
40 mg: The following serious adverse reactions are discussed in greater detail in other sections of the label: 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 postapproval 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 not 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).