Pravastatin Side Effects

Brand Names: Pravachol

Please note - some side effects for Pravastatin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Pravastatin - for the Consumer

Pravastatin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Pravastatin:

Headache; heartburn.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine produced; chest pain; dark urine; fever, chills, or persistent sore throat; flu-like symptoms; muscle pain, tenderness, or weakness (with or without fever or fatigue); pale stools; red, swollen, blistered, or peeling skin; severe stomach pain; vision changes; yellowing of the eyes or skin.

Pravastatin Side Effects - for the Professional

Pravastatin

Pravastatin is generally well tolerated; adverse reactions have usually been mild and transient. In 4 month-long placebo-controlled trials, 1.7% of Pravastatin-treated patients and 1.2% of placebo-treated patients were discontinued from treatment because of adverse experiences attributed to study drug therapy; this difference was not statistically significant..

Adverse Clinical Events

All adverse clinical events (regardless of attribution) reported in more than 2% of Pravastatin-treated patients in placebo-controlled trials of up to four months duration are identified in Table 6; also shown are the percentages of patients in whom these medical events were believed to be related or possibly related to the drug:

The safety and tolerability of Pravastatin at a dose of 80 mg in two controlled trials with a mean exposure of 8.6 months was similar to that of Pravastatin at lower doses except that 4 out of 464 patients taking 80 mg of Pravastatin had a single elevation of CK > 10X ULN compared to 0 out of 115 patients taking 40 mg of Pravastatin.

Long-Term Controlled Morbidity and Mortality Trials

Adverse event data were pooled from several double-blind, placebo-controlled trials (e.g., West of Scotland Coronary Prevention Study [WOS]; Pravastatin Limitation of Atherosclerosis in the Coronary Arteries study [PLAC I]; Pravastatin, Lipids and Atherosclerosis in the Carotids study [PLAC II]; Regression Growth Evaluation Statin Study [REGRESS]; and Kuopio Atherosclerosis Prevention Study [KAPS]) involving a total of 10,764 patients treated with Pravastatin 40 mg and 10,719 patients treated with placebo. The safety and tolerability profile in the Pravastatin group was comparable to that of the placebo group. Patients were exposed to Pravastatin for a mean of 4.0 to 5.1 years in, among other trials, WOS and 1.9 to 2.9 years in PLAC I, PLAC II, KAPS, and REGRESS. In these long-term trials, the most common reasons for discontinuation were mild, non-specific gastrointestinal complaints. Collectively, these trials represent 47,613 patient-years of exposure to Pravastatin. Events believed to be of probable, possible, or uncertain relationship to study drug, occurring in at least 1% of patients treated with Pravastatin in these studies are identified in Table 7.

Events of probable, possible, or uncertain relationship to study drug that occurred in < 1.0% of Pravastatin-treated patients in the long-term trials included the following; frequencies were similar in placebo-treated patients:

Dermatologic: pruritus, dermatitis, dryness skin, scalp hair abnormality (including alopecia), urticaria.

Endocrine/Metabolic: sexual dysfunction, libido change.

Gastrointestinal: decreased appetite.

General: fever, flushing.

Immunologic: allergy, edema head/neck.

Musculoskeletal: muscle weakness.

Nervous System: paresthesia, vertigo, insomnia, memory impairment, tremor, neuropathy (including peripheral neuropathy).

Special Senses: lens opacity, taste disturbance.

Postmarketing Experience

In addition to the events reported above, as with other drugs in this class, the following events have been reported rarely during postmarketing experience with Pravastatin, regardless of causality assessment:

Musculoskeletal: myopathy, rhabdomyolysis.

Nervous System: dysfunction of certain cranial nerves (including alteration of taste, impairment of extraocular movement, facial paresis), peripheral nerve palsy.

Hypersensitivity: anaphylaxis, angioedema, lupus erythematosus-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, purpura, hemolytic anemia, positive ANA, ESR increase, arthritis, arthralgia, asthenia, photosensitivity, chills, malaise, toxic epidermal necrolysis, erythema multiforme, including Stevens-Johnson syndrome.

Gastrointestinal: pancreatitis, hepatitis, including chronic active hepatitis, cholestatic jaundice, fatty change in liver, cirrhosis, fulminant hepatic necrosis, hepatoma.

Dermatologic: a variety of skin changes (e.g., nodules, discoloration, dryness of mucous membranes, changes to hair/nails).

Reproductive: gynecomastia.

Laboratory Abnormalities: Liver Function Test abnormalities, thyroid function abnormalities.

Laboratory Test Abnormalities

Increases in serum transaminase (ALT, AST) values and CPK have been observed.

Transient, asymptomatic eosinophilia has been reported. Eosinophil counts usually returned to normal despite continued therapy. Anemia, thrombocytopenia, and leukopenia have been reported with HMG-CoA reductase inhibitors.

Concomitant Therapy

Pravastatin has been administered concurrently with cholestyramine, colestipol, nicotinic acid, probucol and gemfibrozil. Preliminary data suggest that the addition of either probucol or gemfibrozil to therapy with lovastatin or Pravastatin is not associated with greater reduction in LDL-cholesterol than that achieved with lovastatin or Pravastatin alone. No adverse reactions unique to the combination or in addition to those previously reported for each drug alone have been reported. Myopathy and rhabdomyolysis (with or without acute renal failure) have been reported when another HMG-CoA reductase inhibitor was used in combination with immunosuppressive drugs, gemfibrozil, erythromycin, or lipid-lowering doses of nicotinic acid. Concomitant therapy with HMG-CoA reductase inhibitors and these agents is generally not recommended.

Pediatric Patients

In a two year, double-blind, placebo-controlled study involving 100 boys and 114 girls with HeFH, the safety and tolerability profile of Pravastatin was generally similar to that of placebo.

Side Effects by Body System

Hepatic

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.

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.

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.

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.

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

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.

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

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

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.

Renal

Renal side effects of HMG-CoA reductase inhibitors have included myoglobinuria and acute renal failure secondary to rhabdomyolysis.

Dermatologic

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

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

Hypersensitivity reactions have rarely occurred with HMG-CoA reductase inhibitors. Anaphylaxis, angioedema, urticaria, fever, chills, flushing, malaise, and dyspnea have been reported.

Immunologic

Immunologic side effects of HMG-CoA reductase inhibitors have included a lupus-like syndrome, positive ANA, elevated ESR, polymyalgia rheumatica, and vasculitis.

Ocular

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.

Psychiatric

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.

Genitourinary

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

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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