Rosuvastatin Side Effects
Some side effects of rosuvastatin 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
Along with its needed effects, rosuvastatin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking rosuvastatin:Rare
- Dark-colored urine
- muscle cramps or spasms
- muscle pain, stiffness, tenderness, wasting, or weakness
- unusual tiredness or weakness
- Abdominal or stomach pain
- clay-colored stools
- skin rash
- unpleasant breath odor
- vomiting of blood
- yellow eyes or skin
Some side effects of rosuvastatin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Body aches or pain
- dry or sore throat
- runny nose
- tender, swollen glands in the neck
- trouble swallowing
- voice changes
- Accidental injury
- accumulation of pus, swollen, red, or tender area of infection near a tooth
- acid or sour stomach
- arm, back, or jaw pain
- bladder pain
- bloated or full feeling
- bloody or cloudy urine
- blurred vision
- burning feeling in the chest or stomach
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain or discomfort
- chest tightness or heaviness
- difficult or labored breathing
- difficult, burning, or painful urination
- difficulty with moving
- dry mouth
- excess air or gas in the stomach or intestines
- excessive muscle tone
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling faint
- feeling of constant movement of self or surroundings
- feeling of warmth or heat
- feeling sad or empty
- flushed, dry skin
- flushing or redness of the skin especially on the face and neck
- fruit-like breath odor
- general feeling of discomfort or illness
- increased hunger
- increased thirst
- increased urination
- itching skin
- lack of appetite
- lack or loss of strength
- loss of appetite
- loss of consciousness
- loss of interest or pleasure
- muscle tension or tightness
- neck pain
- nerve pain
- pain or swelling in the arms or legs without any injury
- pain or tenderness around the eyes and cheekbones
- pain, swelling, or redness in the joints
- pale skin
- passing gas
- pounding in the ears
- sensation of spinning
- shortness of breath
- slow heartbeat
- stomach pain, discomfort, tenderness, or upset
- stuffy nose
- swelling of the hands, ankles, feet, or lower legs
- trouble concentrating
- trouble sleeping
- troubled breathing
- unable to sleep
- unexplained weight loss
- unusual bleeding or bruising
For Healthcare Professionals
Applies to rosuvastatin: oral tablet
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 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 side effects including various forms of renal failure have been reported in patients taking rosuvastatin, 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 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.
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 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 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 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 side effects including hypertension, angina pectoris, vasodilation and palpitations have been reported.
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 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 side effects including rash and pruritus have been reported.
Other abnormal laboratory values associated with rosuvastatin therapy have included elevated creatine phosphokinase, transaminases, glutamyl transpeptidase, alkaline phosphatase, bilirubin, and hyperglycemia, as well as thyroid function abnormalities.
Genitourinary side effects associated with other HMG-CoA reductase inhibitors have included erectile dysfunction, impotence, and testicular pain.
Hypersensitivity reactions are reported rarely with HMG-CoA reductase inhibitors and include anaphylaxis, angioedema, allergic reaction, urticaria, fever, chills, flushing, malaise, and dyspnea.
More about rosuvastatin
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