Data sources include Micromedex (updated Sep 26th, 2014), Cerner Multum (updated Oct 16th, 2014), Wolters Kluwer (updated Oct 9th, 2014) and others. To view content sources and attributions, refer to our editorial policy.
Generic Name: rosuvastatin.
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Cardiovascular side effects including hypertension, angina pectoris, vasodilation and palpitations have been reported.
Hypersensitivity reactions are reported rarely with HMG-CoA reductase inhibitors and include anaphylaxis, angioedema, allergic reaction, urticaria, fever, chills, flushing, malaise, and dyspnea.
You should check with your doctor immediay if any of these side effects occur when taking rosuvastatin:
Not all side effects for Crestor may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
Gastrointestinal side effects including diarrhea, dyspepsia, nausea, constipation, gastroenteritis, vomiting, flatulence, periodontal abscess and gastritis have been reported. Gastrointestinal side effects associated with other HMG-CoA reductase inhibitors have included abdominal pain, pancreatitis, and anorexia.
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CSA Schedule N Not a controlled drug.
Endocrine side effects including diabetes mellitus have been reported. Endocrine side effects associated with other HMG-CoA reductase inhibitors have included hypospermia, gynecomastia and thyroid function abnormalities. In addition, acid maltase deficiency (the genetic disorder also referred to as Pompe's Disease) has been revealed following HMG-CoA therapy in at least one presymptomatic patient.
Note: This page contains information about the side effects of rosuvastatin. Some of the dosage forms included on this document may not apply to the brand name Crestor.
Other side effects including flu syndrome, urinary tract infection, peripheral edema, abdominal pain, accidental injury, chest pain, infection, pain, pelvic pain and neck pain have been reported.
Other abnormal laboratory values associated with rosuvastatin (the active ingredient contained in Crestor) therapy have included elevated creatine phosphokinase, transaminases, glutamyl transpeptidase, alkaline phosphatase, bilirubin, and hyperglycemia, as well as thyroid function abnormalities.
Musculoskeletal side effects including myalgia, asthenia, back pain, arthritis, arthralgia and pathological fracture have been reported. Musculoskeletal side effects reported with other HMG-CoA reductase inhibitors have included elevated creatine kinase, myopathy, rhabdomyolysis, tendon rupture, and dermatomyositis. In addition, some data have suggested that exposure to HMG-CoA reductase inhibitors is associated with a decreased risk of bone fractures in persons older than 50 years of age.
Some of the side effects that can occur with rosuvastatin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to l you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
Pregnancy Category X Not for use in pregnancy.
Hepatic side effects including elevations in serum transaminases, hepatitis, and rare cases of jaundice have been reported. Other hepatic side effects reported with HMG-CoA reductase inhibitors have included chronic active hepatitis, fatty changes in the liver, cirrhosis, fulminant hepatic necrosis, and liver failure.
Respiratory side effects including pharyngitis, rhinitis, sinusitis, bronchitis, cough, dyspnea, pneumonia and asthma have been reported.
Applies to rosuvastatin: oral tablet.
Renal side effects including various forms of renal failure have been reported in patients taking rosuvastatin (the active ingredient contained in Crestor) although causality has not been determined. Patients who are candidates for statin therapy (e.g., patients with diabetes, hypertension, atherosclerosis, and/or heart failure) may also be at higher risk for kidney failure even when they are not taking statins. Proteinuria with or without hematuria has been reported during rosuvastatin therapy, and appears to be dose related.
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Nervous system side effects including headache, dizziness, insomnia, hypertonia, paresthesia, vertigo and neuralgia have been reported. Other nervous system side effects reported with HMG-CoA reductase inhibitors have included drowsiness, fatigue, weakness, cranial nerve dysfunction, tremor, memory loss, decline in cognitive function, peripheral neuropathy, polyneuropathy, and peripheral nerve palsy. Memory loss has been reported in postmarketing experience.
Approval History Calendar Drug history at FDA.
Availability Rx Prescription only.
Hematologic side effects including anemia and ecchymosis have been reported. Hematologic side effects including hemolytic anemia, thrombocytopenia, thrombotic thrombocytopenic purpura (TTP), and leukopenia have occurred with HMG-CoA reductase inhibitors. These effects may be manifestations of a hypersensitivity reaction.
For Healthcare Professionals Applies to rosuvastatin: oral tablet.
In addition to its needed effects, some unwanted effects may be caused by rosuvastatin (the active ingredient contained in Crestor). In the event that any of these side effects do occur, they may require medical attention.
Genitourinary side effects associated with other HMG-CoA reductase inhibitors have included erectile dysfunction, impotence, and testicular pain.
HMG-CoA reductase inhibitors (statins) have been associated with rare cases of severe myopathy and rhabdomyolysis, accompanied by increases in creatine kinase, myoglobinuria, proteinuria, and renal failure. Concomitant use with gemfibrozil (fibric acid derivatives), niacin, cyclosporine, erythromycin (macrolides) or azole antifungals may increase the incidence and severity of musculoskeletal side effects. Other variables associated with an increased risk of statin-induced myopathy include, advanced age, small body stature, female gender, renal and/or hepatic dysfunction, perioperative periods, hypothyroidism, diabetes mellitus, and alcoholism. Milder forms of myotoxicity (i.e., myalgia) are commonly reported and occur in approximay 5% to 7% of patients taking a statin drug. Patients should be instructed to report symptoms of muscle pain, weakness, or tenderness. If such symptoms develop, creatine kinase should be measured, and if elevated, rosuvastatin (the active ingredient contained in Crestor) should be discontinued. The value of regular monitoring of creatine kinase is not known.
Psychiatric side effects including depression and anxiety have been reported. Other psychiatric side effects of HMG-CoA reductase inhibitors have included decreased libido, insomnia, suicidal thoughts, delusions, paranoia, agitation, and nightmares. Psychiatric side effects reported postmarketing have included 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).
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Dermatologic side effects including rash and pruritus have been reported.
Crestor side effects