Crestor Side Effects

Generic name: rosuvastatin

Note: This document contains side effect information about rosuvastatin. Some of the dosage forms listed on this page may not apply to the brand name Crestor.

Some side effects of Crestor may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to rosuvastatin: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking rosuvastatin (the active ingredient contained in Crestor) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking rosuvastatin and call your doctor at once if you have any of these serious side effects:

• unexplained muscle pain, tenderness, or weakness;

• confusion, memory problems;

• fever, unusual tiredness, and dark colored urine;

• swelling, weight gain, urinating less than usual or not at all;

• increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects of rosuvastatin may include:

• headache, depressed mood;

• mild muscle pain;

• joint pain;

• sleep problems (insomnia), nightmares;

• constipation;

• mild nausea; or

• stomach pain or indigestion.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to rosuvastatin: oral tablet

Musculoskeletal

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 approximately 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.

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

Renal

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.

Hepatic

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

Respiratory side effects including pharyngitis, rhinitis, sinusitis, bronchitis, cough, dyspnea, pneumonia and asthma have been reported.

Nervous system

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.

Psychiatric

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).

Gastrointestinal

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.

Other

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.

Cardiovascular

Cardiovascular side effects including hypertension, angina pectoris, vasodilation and palpitations have been reported.

Endocrine

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.

Hematologic

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.

Dermatologic

Dermatologic side effects including rash and pruritus have been reported.

Other

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.

Genitourinary

Genitourinary side effects associated with other HMG-CoA reductase inhibitors have included erectile dysfunction, impotence, and testicular pain.

Hypersensitivity

Hypersensitivity reactions are reported rarely with HMG-CoA reductase inhibitors and include anaphylaxis, angioedema, allergic reaction, urticaria, fever, chills, flushing, malaise, and dyspnea.

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