Crestor Adverse Reactions

The adverse events seen with CRESTOR are generally mild and transient. In controlled clinical trials, less than 4% of CRESTOR-treated patients were withdrawn due to adverse events.
The frequencies of adverse events are ranked according to the following: Common (>1/100, <1/10); Uncommon (>1/1,000, <1/100); Rare (>1/10,000, <1/1000); Very rare (<1/10,000); Not known (cannot be estimated from the available data).
Immune system disorders: Rare: hypersensitivity reactions including angioedema.
Endocrine disorders: Common: diabetes mellitus¹.
Nervous system disorders: Common: headache, dizziness.
Gastrointestinal disorders: Common: constipation, nausea, abdominal pain.
Rare: pancreatitis.
Skin and subcutaneous tissue disorders: Uncommon: pruritus, rash and urticaria.
Musculoskeletal, connective tissue and bone disorders: Common: myalgia.
Rare: myopathy (including myositis) and rhabdomyolysis.
General disorders: Common: asthenia.
¹Frequency 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 drug 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 CRESTOR. 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 and is not predictive acute or progressive renal disease.
Skeletal muscle effects: Rare cases of rhabdomyolysis which were occasionally associated with the impairment of renal function have been reported with rosuvastatin and with other marketed statins.
Laboratory effects: As with other HMG-CoA reductase inhibitors, a dose-related increase in transaminases and CK have been observed in a small number of patients taking rosuvastatin; the majority of cases were mild, asymptomatic and transient. If CK levels are elevated (>5 x ULN), treatment should be discontinued. Increases in HbA1c have also been observed in patients treated with rosuvastatin (see Precautions and Pharmacology: Pharmacodynamics under Actions).
Post marketing experience: In addition to the previously mentioned, the following adverse events have been reported during post marketing experience for CRESTOR: 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 necrotising 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 disorders: Very rare: polyneuropathy, 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.