Gastrointestinal side effects of pravastatin have included nausea and vomiting (0.5% to 7.3%), diarrhea (2.0% to 6.2%), abdominal pain (0.3% to 5.4%), constipation, flatulence, and heartburn. Gastrointestinal side effects reported with HMG-CoA reductase inhibitors have included pancreatitis and anorexia.
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Hypersensitivity reactions have rarely occurred with HMG-CoA reductase inhibitors. Anaphylaxis, angioedema, urticaria, fever, chills, flushing, malaise, and dyspnea have been reported.
Dermatologic side effects of pravastatin have included rash (0.9% to 4.0%) and a case report of bullous erythematous lesions. Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity, purpura, and alopecia have occurred with HMG-CoA reductase inhibitors.
Endocrine side effects of gynecomastia and thyroid function abnormalities have been reported. Endocrine side effects associated with other HMG-CoA reductase inhibitors have included hypospermia. 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.
If any of the following side effects occur while taking pravastatin, check with your doctor immediay:
Persistent elevations in liver function tests three times normal values have been reported in up to 1.3% of patients in clinical trials. In one review of 1,142 patients, elevations in serum transaminases led to discontinuation of pravastatin in 1% of patients. Clinical monitoring of hepatic function is recommended and pravastatin should be discontinued in patients with persistent, significant elevations (three times normal) in liver function parameters.
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Halkin, et al report a case in which use of both lovastatin and pravastatin on different occasions in the same patient lead to reversible impotence. The impotence resolved within 2 weeks after discontinuation of the HMG-CoA reductase inhibitor.
Approval History Calendar Drug history at FDA.
Some pravastatin side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:
Immunologic side effects of HMG-CoA reductase inhibitors have included a lupus-like syndrome, positive ANA, elevated ESR, polymyalgia rheumatica, and vasculitis.
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. One case of myopathy and one of dermatomyositis associated with pravastatin have been reported in the literature. Patients should be instructed to promptly report symptoms of muscle pain, weakness, or tenderness. If such symptoms develop, creatine kinase should be measured and if markedly elevated, pravastatin should be discontinued. The value of routine monitoring of creatine kinase is not known. A case of asymptomatic pravastatin-induced rhabdomyolysis has been reported in a patient receiving the drug for 3 years. Following discontinuation of pravastatin, the patient's serum creatine kinase levels returned to normal after 3 weeks.
Hepatic side effects of pravastatin have included elevated in liver function tests (1.3%). HMG-CoA reductase inhibitors have reported hepatic side effects of hepatitis, including chronic active hepatitis, cholestatic jaundice, fatty change in the liver, cirrhosis, and fulminant hepatic necrosis.
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Oncologic side effects including hepatocellular carcinomas and malignant lymphomas have been associated with pravastatin in animal studies. Long-term clinical trials are needed to define the cancer risk in humans.
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Genitourinary side effects of HMG-CoA reductase inhibitors have included erectile dysfunction, impotence and testicular pain.
As well as its needed effects, pravastatin may cause unwanted side effects that require medical attention.
It is possible that some side effects of pravastatin may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
Availability Rx Prescription only.
Pregnancy Category X Not for use in pregnancy.
For Healthcare Professionals Applies to pravastatin: oral tablet.
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CSA Schedule N Not a controlled drug.
Nervous system side effects of pravastatin have included headache (0.6% to 6.2%), dizziness, drowsiness, and weakness. Cranial nerve dysfunction, tremor, vertigo, fatigue, weight loss, memory loss, decline in cognitive function, paresthesias, peripheral neuropathy, and peripheral nerve palsy have been reported with HMG-CoA reductase inhibitors.
Musculoskeletal side effects of pravastatin have included elevations in creatine kinase, myopathy, and a case report of dermatomyositis. Musculoskeletal side effects reported with HMG-CoA reductase inhibitors have included rhabdomyolysis, arthralgia, and tendon rupture. 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 of HMG-CoA reductase inhibitors have included myoglobinuria and acute renal failure secondary to rhabdomyolysis.
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.
Psychiatric side effects of pravastatin have included insomnia and other sleep disturbances. Other psychiatric side effects of HMG-CoA reductase inhibitors have included decreased libido, anxiety, depression, suicidal thoughts, delusions, paranoia, agitation, and nightmares.
Applies to pravastatin: oral tablet.
Ocular side effects of HMG-CoA reductase inhibitors have included progression of cataracts and ophthalmoplegia. There are no data associating pravastatin with lens opacities in humans.
Hematologic side effects including hemolytic anemia, thrombocytopenia, thrombotic thrombocytopenic purpura (TTP), and leukopenia have occurred with some HMG-CoA reductase inhibitors. These effects may be manifestations of a hypersensitivity reaction.
Gastrointestinal side effects have been among the most common symptoms reported by patients on pravastatin. These symptoms tended to be mild and transient in nature and resolved with continued therapy.
Pravastatin side effects