Pravachol Side Effects
Generic Name: pravastatin
Note: This document contains side effect information about pravastatin. Some of the dosage forms listed on this page may not apply to the brand name Pravachol.
Some side effects of Pravachol 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 pravastatin: oral tablet
Along with its needed effects, pravastatin (the active ingredient contained in Pravachol) 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 pravastatin:More common
- Difficulty with moving
- muscle or bone pain
- muscle stiffness
- pain in the joints
- pain, localized
- Arm, back, or jaw pain
- chest pain or discomfort
- dark-colored urine
- difficult or labored breathing
- ear congestion
- fast or irregular heartbeat
- general feeling of discomfort or illness
- loss of appetite
- muscle cramps or spasms
- muscular tenderness, wasting, or weakness
- nasal congestion
- runny nose
- sore throat
- swollen joints
- tightness in the chest
- trouble with sleeping
- unusual tiredness or weakness
Some side effects of pravastatin 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
- Stomach pain
- Acid or sour stomach
- bloated or full feeling
- blurred vision or other changes in vision
- difficult or painful urination
- difficulty having a bowel movement (stool)
- double vision
- fear or nervousness
- feeling sad or empty
- increased urge to urinate during the night
- loss of interest or pleasure
- pain in the chest below the breastbone
- passing gas
- stomach discomfort or upset
- trouble concentrating
For Healthcare Professionals
Applies to pravastatin: oral tablet
Hepatic side effects of pravastatin (the active ingredient contained in Pravachol) 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.
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.
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.
One case of myopathy and one of dermatomyositis associated with pravastatin (the active ingredient contained in Pravachol) 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.
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.
Gastrointestinal side effects of pravastatin (the active ingredient contained in Pravachol) 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.
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.
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.
Nervous system side effects of pravastatin (the active ingredient contained in Pravachol) 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.
Renal side effects of HMG-CoA reductase inhibitors have included myoglobinuria and acute renal failure secondary to rhabdomyolysis.
Dermatologic side effects of pravastatin (the active ingredient contained in Pravachol) 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.
Hypersensitivity reactions have rarely occurred with HMG-CoA reductase inhibitors. Anaphylaxis, angioedema, urticaria, fever, chills, flushing, malaise, and dyspnea have been reported.
Immunologic side effects of HMG-CoA reductase inhibitors have included a lupus-like syndrome, positive ANA, elevated ESR, polymyalgia rheumatica, and vasculitis.
Ocular side effects of HMG-CoA reductase inhibitors have included progression of cataracts and ophthalmoplegia. There are no data associating pravastatin (the active ingredient contained in Pravachol) with lens opacities in humans.
Psychiatric side effects of pravastatin (the active ingredient contained in Pravachol) 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.
Genitourinary side effects of HMG-CoA reductase inhibitors have included erectile dysfunction, impotence and testicular pain.
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.
Oncologic side effects including hepatocellular carcinomas and malignant lymphomas have been associated with pravastatin (the active ingredient contained in Pravachol) in animal studies. Long-term clinical trials are needed to define the cancer risk in humans.
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