Side effects observed with the use of rosuvastatin, usually expressed slightly and pass independently. As with other inhibitors of HMG-CoA reductase, the incidence of side effects is dose-dependent.
The incidence of adverse events is as follows, according to the WHO classification:
Often (> 1/100, <1/10); Infrequently (> 1/1000, <1/100); Rarely (> 1/10 000, <1/1 000); Very rarely (<1/10 000), including individual reports; The frequency is not set (can not be calculated from available data).
The immune system
Rarely: hypersensitivity reactions, including angioedema
From the endocrine system
Often: type 2 diabetes mellitus.
From the central nervous system
Often: headache, dizziness
From the side of the digestive tract
Often: constipation, nausea, abdominal pain
Rarely: pancreatitis
From the skin
Infrequent: itching, rash, urticaria
From the side of the musculoskeletal system
Often: myalgia
Rarely: myopathy (including myositis), rhabdomyolysis
Other
Often: asthenic syndrome
From the side of the urinary system
In patients who received rosuvastatin can be detected proteinuria. Changes in the amount of protein in the urine (from absence or trace amounts to ++ or more) are observed in less than 1% of patients receiving 10-20 mg of the drug and about 3% of patients receiving 40 mg of the drug. A slight change in the amount of protein in the urine was noted with a dose of 20 mg. In most cases, proteinuria decreases or disappears during therapy and does not indicate the onset or progression of an existing kidney disease.
From the side of the musculoskeletal system
When using rosuvastatin in all dosages and, especially when taking doses of the drug in excess of 20 mg, the following effects on the musculoskeletal system were reported: myalgia, myopathy (including myositis), in rare cases rhabdomyolysis with or without acute renal insufficiency.
A dose-related increase in creatine phosphokinase (CK) activity was observed in a small number of patients taking rosuvastatin. In most cases, it was insignificant, asymptomatic and temporary. In case of increased activity of CK (more than 5 times compared with the upper limit of the norm) therapy should be suspended.
From the side of the liver
With the use of rosuvastatin, a dose-dependent increase in the activity of "hepatic" transaminases in a small number of patients is observed. In most cases, it is insignificant, asymptomatic and temporary.
Laboratory indicators
Increase in the concentration of glucose, bilirubin, activity of gamma-glutamyltranspeptidase, alkaline phosphatase, thyroid dysfunction.
Postmarketing application
The following side effects have been reported in the post-marketing application of rosuvastatin:
On the part of the hematopoiesis system:
Rarely: thrombocytopenia.
From the side of the digestive tract
Very rarely: jaundice, hepatitis
Rarely: increased activity of "liver" transaminases
Frequency not established: diarrhea
From the side of the musculoskeletal system
Very rarely: arthralgia
The frequency is not established: immuno-mediated necrotizing myopathy.
From the central nervous system
Very rarely: polyneuropathy, memory loss
From the respiratory system
The frequency is not established: cough, shortness of breath.
From the side of the urinary system
Very rarely: hematuria.
From the skin and subcutaneous fat
Frequency not established: Stevens-Johnson syndrome
From the side of the reproductive system
Frequency not established: gynecomastia.
Other
Frequency not established: peripheral edema.
Some statins reported the following side effects: depression, sleep disturbances, including insomnia and nightmarish dreams, sexual dysfunction. Single cases of interstitial lung disease have been reported, especially with prolonged use of drugs.