Pravastatin

Bile acid sequestrants such as cholestyramine (Questran) may reduce the absorption of pravastatin from the intestine and thereby reduce its effects. Therefore, pravastatin should be taken one hour before or four hours after bile acid sequestrants. The use of pravastatin with nicotinic acid, gemfibrozil (Lopid) or other drugs that cause liver or muscle problems may increase the risk of muscle problems.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• erythromycin (Erythrocin)
• clarithromycin (Biaxin)
• cyclosporine (Restasis, Sandimmune, Neoral)
• other immunosuppressive drugs such as medications used by cancer patients, transplant patients, or patients with inflammatory diseases like arthritis
• other cholesterol-lowering drugs such as fenofibrate (Tricor), gemfibrozil (Lopid), and niacin (Niaspan, nicotinic acid)

This is not a complete list of pravastatin drug interactions.  Ask your doctor or pharmacist for more information.

Before taking pravastatin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to pravastatin or any of the ingredients in pravastatin tablets
• have or have had liver disease
• drink more than two alcoholic beverages per day
• have low blood pressure
• have or have had seizures, thyroid disease, or kidney disease
• are scheduled to have surgery, including dental surgery
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

• Store pravastatin at room temperature between 20° to 25°C (68° to 77°F).
• Protect from moisture and light.
• Keep pravastatin and all medicines out of the reach of children.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Chest pain.
• Change in eyesight.
• Not able to pass urine or change in how much urine is passed.
• This medicine may cause muscle pain, tenderness, or weakness. Sometimes, a very bad muscle problem may happen that may lead to kidney problems. Rarely, deaths have happened in people who get these problems when taking drugs like this one. Call your doctor right away if you have muscle pain, tenderness, or weakness that is not normal (with or without fever or feeling out of sorts). Call your doctor right away if you have muscle signs that last after your doctor has told you to stop taking pravastatin.
• Very bad and sometimes deadly liver problems have happened with this medicine. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about pravastatin, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about pravastatin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using pravastatin.

Review Date: October 4, 2017

How Supplied

Pravastatin Sodium Tablets USP, 10 mg are white to off-white, oval-shaped, biconvex uncoated tablets debossed with the logo of 'ZC46' on one side and plain on the other side and are supplied as follows:

NDC 68382-070-16 in bottles of 90 tablets

NDC 68382-070-05 in bottles of 500 tablets

Pravastatin Sodium Tablets USP, 20 mg are white to off-white, oval-shaped, biconvex uncoated tablets debossed with the logo of 'ZC45' on one side and plain on the other side and are supplied as follows:

NDC 68382-071-16 in bottles of 90 tablets

NDC 68382-071-05 in bottles of 500 tablets

NDC 68382-071-10 in bottles of 1000 tablets

Pravastatin Sodium Tablets USP, 40 mg are white to off-white, oval-shaped, biconvex uncoated tablets debossed with the logo of 'ZC44' on one side and plain on the other side and are supplied as follows:

NDC 68382-072-16 in bottles of 90 tablets

NDC 68382-072-05 in bottles of 500 tablets

Pravastatin Sodium Tablets USP, 80 mg are white to off-white, oval-shaped, biconvex uncoated tablets debossed with the logo of 'ZC43' on one side and plain on the other side and are supplied as follows:

NDC 68382-073-16 in bottles of 90 tablets

NDC 68382-073-05 in bottles of 500 tablets

Storage

Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].

Keep tightly closed (protect from moisture). Protect from light.

NDC 68382-070-05 in bottle of 500 tablets

Pravastatin Sodium Tablets USP, 10 mg

Rx only

500 tablets

ZYDUS

NDC 68382-071-05 in bottle of 500 tablets

Pravastatin Sodium Tablets USP, 20 mg

Rx only

500 tablets

ZYDUS

NDC 68382-072-05 in bottle of 500 tablets

Pravastatin Sodium Tablets USP, 40 mg

Rx only

500 tablets

ZYDUS

NDC 68382-073-05 in bottle of 500 tablets

Pravastatin Sodium Tablets USP, 80 mg

Rx only

500 tablets

ZYDUS

Hyperlipidemia

Dysbetalipoproteinemia: Treatment of primary dysbetalipoproteinemia (Fredrickson type III) in patients who do not respond adequately to diet.

Heterozygous familial hypercholesterolemia: Adjunct to diet in children ≥8 years and adolescents with heterozygous familial hypercholesterolemia (HeFH) if after an adequate trial of diet therapy the following findings are present: LDL-C ≥190 mg/dL or LDL ≥160 mg/dL with positive family history of premature cardiovascular disease (CVD), or with 2 or more other CVD risk factors.

Hypercholesterolemia and mixed dyslipidemia: Adjunct to diet to reduce elevated total cholesterol, LDL-C, apo B, and triglyceride (TG) levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb).

Limitations of use: Has not been studied in conditions where the major lipid abnormality is elevation of chylomicrons (Fredrickson types I and V).

Prevention of cardiovascular disease

Primary prevention of cardiovascular disease: To reduce the risk of myocardial infarction, revascularization procedures and cardiovascular mortality in hypercholesterolemic patients without established coronary heart disease (CHD).

Secondary prevention of cardiovascular disease: To slow the progression of coronary atherosclerosis; to reduce the risk of myocardial infarction, revascularization procedures, and total mortality; and to reduce the risk of stroke and transient ischemic attacks (TIA) in patients with established CHD.

Guideline recommendations: Primary and secondary prevention of atherosclerotic cardiovascular disease (ASCVD) to reduce the risk of ASCVD in select adult patients (ACC/AHA [Stone 2013]; NLA [Jacobson 2015]). Refer to respective guideline for specific recommendations.

Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.

Severe impairment: Initial: 10 mg once daily

Administer without regard to meals.

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light.

Acipimox: May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors. Monitor therapy

Antacids: May decrease the serum concentration of HMG-CoA Reductase Inhibitors. Monitor therapy

Antihepaciviral Combination Products: May increase the serum concentration of Pravastatin. Management: Limit the pravastatin dose to a maximum of 40 mg per day when used with antihepaciviral combination products and monitor patients for evidence of pravastatin toxicities (eg, myopathy). Consider therapy modification

Asunaprevir: May increase the serum concentration of HMG-CoA Reductase Inhibitors. Monitor therapy

Bezafibrate: May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors. Bezafibrate may increase the serum concentration of HMG-CoA Reductase Inhibitors. More specifically, bezafibrate may increase the serum concentration of fluvastatin Management: Monitor patients closely for myopathy with concomitant use of bezafibrate and HMG-CoA reductase inhibitors. Concomitant use is contraindicated in patients predisposed to myopathy and alternative therapy should be considered. Consider therapy modification

Bile Acid Sequestrants: May decrease the serum concentration of Pravastatin. Management: Administer pravastatin at least 1 hour before or 4 hours after administration of bile-acid resins (eg, cholestyramine, colestipol, colesevelam) to minimize the risk for any significant interaction. Consider therapy modification

Boceprevir: May increase the serum concentration of Pravastatin. Monitor therapy

Ciprofibrate: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors. Management: Avoid the use of HMG-CoA reductase inhibitors and ciprofibrate if possible. If concomitant therapy is considered, benefits should be carefully weighed against the risks, and patients should be monitored closely for signs/symptoms of muscle toxicity. Consider therapy modification

Clarithromycin: May increase the serum concentration of Pravastatin. Management: Limit pravastatin to a maximum of 40 mg/day (for adults) when used in combination with clarithromycin. If this combination is used, monitor patients more closely for evidence of pravastatin toxicity. Consider therapy modification

Colchicine: May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors. Colchicine may increase the serum concentration of HMG-CoA Reductase Inhibitors. Consider therapy modification

CycloSPORINE (Systemic): May increase the serum concentration of Pravastatin. Pravastatin may increase the serum concentration of CycloSPORINE (Systemic). Management: Limit pravastatin to 20 mg/day in patients who are also receiving cyclosporine. Consider therapy modification

Daclatasvir: May increase the serum concentration of HMG-CoA Reductase Inhibitors. Monitor therapy

DAPTOmycin: HMG-CoA Reductase Inhibitors may enhance the adverse/toxic effect of DAPTOmycin. Specifically, the risk of skeletal muscle toxicity may be increased. Management: Consider temporarily stopping HMG-CoA reductase inhibitor therapy prior to daptomycin. If used together, regular (i.e., at least weekly) monitoring of CPK concentrations is recommended. Consider therapy modification

Darunavir: May increase the serum concentration of Pravastatin. This effect has been demonstrated with darunavir/ritonavir and may occur with darunavir/cobicistat. The individual contributions of darunavir, ritonavir, and cobicistat are unknown. Monitor therapy

Efavirenz: May decrease the serum concentration of Pravastatin. Monitor therapy

Eltrombopag: May increase the serum concentration of OATP1B1/SLCO1B1 Substrates. Monitor therapy

Erythromycin (Systemic): May increase the serum concentration of Pravastatin. Monitor therapy

Fenofibrate and Derivatives: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors. Monitor therapy

Fosphenytoin: May decrease the serum concentration of HMG-CoA Reductase Inhibitors. Consider therapy modification

Fusidic Acid (Systemic): May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors. Specifically, the risk for muscle toxicities, including rhabdomyolysis may be significantly increased. Management: Avoid concurrent use whenever possible. Use is listed as contraindicated in product characteristic summaries in several countries, although UK labeling suggests that use could be considered under exceptional circumstances and with close supervision. Avoid combination

Gemfibrozil: May enhance the myopathic (rhabdomyolysis) effect of Pravastatin. Gemfibrozil may increase the serum concentration of Pravastatin. Avoid combination

Glecaprevir and Pibrentasvir: May increase the serum concentration of HMG-CoA Reductase Inhibitors. Management: Use the lowest statin dose possible if combined with glecaprevir/pibrentasvir and monitor for increased statin effects/toxicities. Avoid concomitant use with atorva-, simva-, or lovastatin. Limit rosuvastatin to 10 mg daily and reduce pravastatin dose 50% Consider therapy modification

Itraconazole: May increase the serum concentration of Pravastatin. Monitor therapy

Lanthanum: HMG-CoA Reductase Inhibitors may decrease the serum concentration of Lanthanum. Management: Administer HMG-CoA reductase inhibitors at least two hours before or after lanthanum. Consider therapy modification

Nelfinavir: May decrease the serum concentration of Pravastatin. Monitor therapy

Niacin: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors. Monitor therapy

Niacinamide: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors. Monitor therapy

PARoxetine: Pravastatin may enhance the adverse/toxic effect of PARoxetine. Specifically, blood glucose elevations may occur with the combination. Monitor therapy

PAZOPanib: HMG-CoA Reductase Inhibitors may enhance the hepatotoxic effect of PAZOPanib. Specifically, the risk for increased serum transaminase concentrations may be increased. Management: Simvastatin is specifically implicated in the interaction. There is a lack of data regarding risk with other statins, but caution appears warranted with any statins. Atorvastatin should be avoided due to P-gp inhibition. Monitor therapy

Phenytoin: May decrease the serum concentration of HMG-CoA Reductase Inhibitors. Consider therapy modification

Raltegravir: May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors. Monitor therapy

Red Yeast Rice: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors. Avoid combination

Repaglinide: HMG-CoA Reductase Inhibitors may increase the serum concentration of Repaglinide. Monitor therapy

Rifamycin Derivatives: May decrease the serum concentration of HMG-CoA Reductase Inhibitors. Management: Consider use of noninteracting antilipemic agents (note: pitavastatin concentrations may increase with rifamycin treatment). Monitor for altered HMG-CoA reductase inhibitor effects. Rifabutin and fluvastatin, or possibly pravastatin, may pose lower risk. Consider therapy modification

Rupatadine: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors. Specifically, the risk for increased CPK and/or other muscle toxicities may be increased. Monitor therapy

Saquinavir: May decrease the serum concentration of Pravastatin. This effect has only been demonstrated with saquinavir/ritonavir. The individual contributions of saquinavir and ritonavir are unknown. Monitor therapy

Simeprevir: May increase the serum concentration of Pravastatin. Monitor therapy

Telaprevir: May increase the serum concentration of Pravastatin. Monitor therapy

Telithromycin: May increase the serum concentration of Pravastatin. Monitor therapy

Teriflunomide: May increase the serum concentration of OATP1B1/SLCO1B1 Substrates. Monitor therapy

Trabectedin: HMG-CoA Reductase Inhibitors may enhance the myopathic (rhabdomyolysis) effect of Trabectedin. Monitor therapy

Vitamin K Antagonists (eg, warfarin): HMG-CoA Reductase Inhibitors may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy

Voxilaprevir: May increase the serum concentration of HMG-CoA Reductase Inhibitors. Management: Use the lowest statin dose possible if combined with voxilaprevir and monitor patients for increased statin effects/toxicities. Avoid concomitant use of voxilaprevir with rosuvastatin or pitavastatin, and limit pravastatin doses to 40 mg daily. Consider therapy modification

As reported in short-term trials; safety and tolerability with long-term use were similar to placebo.

1% to 10%:

Cardiovascular: Chest pain (4%)

Central nervous system: Headache (2% to 6%), fatigue (4%), dizziness (1% to 3%)

Dermatologic: Skin rash (4%)

Gastrointestinal: Nausea (≤7%), vomiting (≤7%), diarrhea (6%), heartburn (3%)

Genitourinary: Cystitis (interstitial; Huang 2015)

Hepatic: Increased serum transaminases (>3x normal on 2 occasions: 1%)

Infection: Influenza (2%)

Neuromuscular & skeletal: Myalgia (2%)

Respiratory: Cough (3%)

<1% (Limited to important or life-threatening): Amnesia (reversible), anaphylaxis, angioedema, cataract, change in libido, cholestatic jaundice, cognitive dysfunction (reversible), confusion (reversible), cranial nerve dysfunction, dermatomyositis, dysgeusia, erythema multiforme, fulminant hepatic necrosis, gynecomastia, hemolytic anemia, hepatic cirrhosis, hepatic neoplasm, hepatitis, hypersensitivity reaction, increased erythrocyte sedimentation rate, lupus-like syndrome, memory impairment (reversible), myasthenia, myopathy, neuropathy, pancreatitis, paresthesia, peripheral nerve palsy, polymyalgia rheumatica, positive ANA titer, purpura, rhabdomyolysis, Stevens-Johnson syndrome, tremor, vasculitis, vertigo

Use of pravastatin is contraindicated in pregnancy.

Adverse events were observed in some animal reproduction studies. Pravastatin was found to cross the placenta in an ex vivo study using term human placentas (Nanovskaya 2013). There are reports of congenital anomalies following maternal use of HMG-CoA reductase inhibitors in pregnancy; however, maternal disease, differences in specific agents used, and the low rates of exposure limit the interpretation of the available data (Godfrey 2012; Lecarpentier 2012). Cholesterol biosynthesis may be important in fetal development; serum cholesterol and triglycerides increase normally during pregnancy. The discontinuation of lipid lowering medications temporarily during pregnancy is not expected to have significant impact on the long term outcomes of primary hypercholesterolemia treatment.

HMG-CoA reductase Inhibitors should be discontinued prior to pregnancy (ADA 2013). If treatment of dyslipidemias is needed in pregnant women or in women of reproductive age, other agents are preferred (Berglund 2012; Stone 2013). The manufacturer recommends administration to women of childbearing potential only when conception is highly unlikely and patients have been informed of potential hazards.

Take pravastatin exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Pravastatin is usually taken once a day, with or without food. Take the medicine at the same time each day.

Pravastatin doses are based on age, and are lower in children and teenagers. People taking this medicine during childhood or adolescence may need a different dose as adults.

You may need to stop using pravastatin for a short time if you have:

• uncontrolled seizures;

• an electrolyte imbalance (such as high or low potassium levels in your blood);

• severely low blood pressure;

• a severe infection or illness; or

• surgery or a medical emergency.

While using this medicine, you may need frequent blood tests.

Pravastatin is only part of a complete treatment program that may also include diet, exercise, and weight control. Follow your doctor's instructions very closely.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

If you also take cholestyramine or colestipol, avoid taking them within 1 hour after or 4 hours before you take pravastatin.

Avoid eating foods that are high in fat or cholesterol. Pravastatin will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

Grapefruit and grapefruit juice may interact with pravastatin and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Applies to pravastatin: oral tablet

General

The most frequently reported side effects were musculoskeletal pain, nausea/vomiting, upper respiratory tract infection, diarrhea, and headache.[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (up to 24.9%), musculoskeletal traumatism (10.2%)
Common (1% to 10%): Myalgia, muscle cramp, arthralgia
Uncommon (0.1% to 1%): Muscle weakness
Postmarketing reports: Myopathy, rhabdomyolysis, immune-mediated necrotizing myopathy, lupus erythematosus-like syndrome, polymyalgia rheumatica, arthritis, myositis, polymyositis, tendon disorder[Ref]

Gastrointestinal

Very common (10% or more): Nausea/vomiting (up to 10.5%)
Common (1% to 10%): Diarrhea, flatulence, dyspepsia/heartburn, abdominal distension, constipation
Uncommon (0.1% to 1%): Abdominal pain
Postmarketing reports: Pancreatitis[Ref]

Other

Very common (10% or more): Chest pain (up to 10%)
Common (1% to 10%): Fatigue, influenza, creatinine phosphokinase increased, edema, fever, weight gain, weight loss, viral infection
Uncommon (0.1% to 1%): Edema, weakness, hearing loss, tinnitus
Frequency not reported: Head/neck edema, vertigo
Postmarketing reports: Chills, asthenia[Ref]

Hepatic

Common (1% to 10%): ALT increased, GGT increased, AST increased
Postmarketing reports: Hepatitis, chronic active hepatitis, cholestatic jaundice, fatty change in liver, cirrhosis, fulminant hepatic necrosis, fatal hepatic failure, nonfatal hepatic failure, liver function test abnormalities[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness, paresthesia
Uncommon (0.1% to 1%): Numbness
Frequency not reported: Memory impairment, neuropathy/peripheral neuropathy, taste disturbance
Postmarketing reports: Intraocular movement impaired, facial paresis, peripheral nerve palsy, cognitive impairment, forgetfulness, amnesia[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (up to 21.2%)
Common (1% to 10%): Pharyngitis, rhinitis, cough, pulmonary infection, sinus abnormality/sinusitis, tracheobronchitis, dyspnea
Frequency not reported: Interstitial lung disease[Ref]

Dermatologic

Common (1% to 10%): Rash, dermatitis
Uncommon (0.1% to 1%): Pruritus, urticaria, scalp/hair abnormality, alopecia
Postmarketing reports: Skin discoloration, skin nodules, dry mucous membranes, changes to hair/nails, angioedema, dermatomyositis, purpura, photosensitivity, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome[Ref]

Cardiovascular

Common (1% to 10%): Angina pectoris
Uncommon (0.1% to 1%): Disturbance of rhythm, hypertension, myocardial infarction
Frequency not reported: Flushing
Postmarketing reports: Vasculitis[Ref]

Ocular

Common (1% to 10%): Blurred vision, diplopia
Uncommon (0.1% to 1%): Eye inflammation, lens opacity[Ref]

Psychiatric

Common (1% to 10%): Sleep disturbance, anxiety/nervousness, depression
Uncommon (0.1% to 1%): Insomnia
Frequency not reported: Libido change[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Dysuria, urinary frequency, nocturia, sexual dysfunction[Ref]

Endocrine

Postmarketing reports: Thyroid function abnormalities, gynecomastia[Ref]

Hematologic

Postmarketing reports: Hemolytic anemia, erythrocyte sedimentation rate increased, transient asymptomatic eosinophilia[Ref]

Immunologic

Frequency not reported: Allergic/hypersensitivity reaction
Postmarketing reports: Anaphylaxis, positive antinuclear antibodies[Ref]

Oncologic

Postmarketing reports: Hepatoma[Ref]

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

• Pravastatin may be used for the treatment of high cholesterol.
• Pravastatin works by blocking an enzyme, called HMG-CoA reductase, in the liver that makes different types of lipids (this is the collective term for fats and cholesterol). Pravastatin also boosts the breakdown of lipids.
• Pravastatin belongs to the class of medicines known as statins. Pravastatin is also known as an HMG-CoA reductase inhibitor.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, pravastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure.

Stop using pravastatin and call your doctor at once if you have:

• unexplained muscle pain, tenderness, or weakness;

• fever, unusual tiredness;

• dark colored urine;

• chest pain;

• upper stomach pain, loss of appetite; or

• jaundice (yellowing of the skin or eyes).

Common side effects may include:

• muscle or joint pain;

• nausea, vomiting, diarrhea;

• headache; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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