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Simvastatin belongs to a group of drugs called HMG CoA reductase inhibitors, or "statins."
Simvastatin is used to lower blood levels of "bad" cholesterol (low-density lipoprotein, or LDL), to increase levels of "good" cholesterol (high-density lipoprotein, or HDL), and to lower triglycerides (a type of fat in the blood).
Simvastatin is also used to lower the risk of stroke, heart attack, and other heart complications in people with diabetes, coronary heart disease, or other risk factors.
Simvastatin is used in adults and children who are at least 10 years old.
In rare cases, simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, potentially leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.
Never take simvastatin in larger amounts, or for longer than recommended by your doctor. Follow your doctor's dosing instructions very carefully. Taking too much of this medication may cause serious or life-threatening side effects.
Before taking this medicine, tell your doctor if you have ever had liver or kidney disease, diabetes, or a thyroid disorder, if you are of Chinese descent, or if you drink more than 2 alcoholic beverages daily.
Simvastatin can harm an unborn baby or cause birth defects. Do not use if you are pregnant or planning to become pregnant.
Grapefruit and grapefruit juice may interact with simvastatin and lead to potentially dangerous effects. Do not consume grapefruit products while taking this medication.
Some medicines can cause unwanted or dangerous effects when used with simvastatin. Your doctor may need to change your treatment plan if you use certain antibiotics or antifungal medicines, hepatitis C medication, heart medication, or medicines to treat HIV/AIDS.
Stop taking this medication and tell your doctor right away if you become pregnant.
You should not take this medicine if you are allergic to simvastatin, if you are pregnant or breast-feeding, or if you have active liver disease.
The following drugs can increase your risk of serious muscle problems if you take them together with simvastatin. These drugs should not be used while you are taking this medicine:
cyclosporine;
danazol;
gemfibrozil;
nefazodone;
an antibiotic--clarithromycin, erythromycin, telithromycin;
antifungal medication--itraconazole, ketoconazole, posaconazole, voriconazole;
hepatitis C medications--boceprevir, telaprevir; or
HIV/AIDS medication--atazanavir, cobicistat (Stribild, Tybost), darunavir, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir, tipranavir.
Before you start taking simvastatin, tell your doctor if you are already using any of these other medicines:
lomitapide; or
heart medication--amiodarone, amlodipine, diltiazem, dronedarone, ranolazine, verapamil.
To make sure simvastatin is safe for you, tell your doctor if you have:
history of liver disease;
history of kidney disease;
diabetes;
a thyroid disorder; or
if you drink more than 2 alcoholic beverages daily.
Simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, potentially leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).
FDA pregnancy category X. This medicine can harm an unborn baby or cause birth defects. Do not take simvastatin if you are pregnant. Stop taking this medication and tell your doctor right away if you become pregnant. Use effective birth control to avoid pregnancy while you are taking this medicine.
Simvastatin may pass into breast milk and could harm a nursing baby. Do not breast-feed while you are taking this medicine.
Take simvastatin exactly as prescribed. Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed. Taking too much of this medication may cause serious or life-threatening side effects.
Simvastatin is usually taken at bedtime or with an evening meal. If you take simvastatin more than once daily, take it with meals. Your doctor may occasionally change your dose to make sure you get the best results.
While using simvastatin, you may need frequent blood tests at your doctor's office.
You may need to take simvastatin on a long-term basis for the treatment of high cholesterol. You may need to stop using this medicine for a short time if you have surgery or a medical emergency. Do not stop taking this medicine unless your doctor tells you to.
Simvastatin is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.
Store at room temperature away from moisture, heat, and light.
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Grapefruit and grapefruit juice may interact with simvastatin and lead to unwanted side effects. Avoid the use of grapefruit products while taking this medicine.
Avoid eating foods that are high in fat or cholesterol. Simvastatin 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.
Get emergency medical help if you have any of these signs of an allergic reaction to simvastatin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
In rare cases, simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.
Also call your doctor at once if you have:
signs of a kidney problem--little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath; or
liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common simvastatin side effects may include:
headache;
constipation, nausea, stomach pain; 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.
Many drugs can interact with simvastatin. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment, especially:
delavirdine;
fenofibrate; or
fluconazole.
This list is not complete and many other drugs can interact with simvastatin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.
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.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Simvastatin (www.drugs.com/simvastatin.html).
More frequently reported side effects include: eczema and increased creatine phosphokinase in blood specimen. See below for a comprehensive list of adverse effects.
Applies to simvastatin: oral suspension, oral tablet
Along with its needed effects, simvastatin 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 simvastatin:
More common
Less common
Incidence not known
Some side effects of simvastatin 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:
Less common
Incidence not known
Applies to simvastatin: oral suspension, oral tablet
The more commonly reported adverse effects have included upper respiratory infection, headache, abdominal pain, constipation, and nausea.
This drug causes dose-related myopathy which, in rare cases maybe severe and sometimes take the form of rhabdomyolysis with or without renal failure secondary to myoglobinuria; rarely fatalities have occurred. The incidence of myopathy with the 80 mg dose has been reported as disproportionately higher than that observed at lower doses and the risk of myopathy with simvastatin 80 mg/day is greater compared with other statins with similar or greater LDL-C lowering efficacy.
Common (1% to 10%): Myalgia
Uncommon (0.1% to 1%): Myopathy
Frequency not reported: Elevations in creatine kinase, myopathy, dermatomyositis, arthralgia, tendon rupture
Postmarketing reports: Muscle cramps, myalgia, rhabdomyolysis
Common (1% to 10%): Elevations in liver function tests
Frequency not reported: Hepatitis (including chronic active hepatitis), cholestatic jaundice, fatty changes in the liver, cirrhosis, hepatic failure, fulminant hepatic necrosis
Postmarketing reports: Hepatic failure, hepatitis, jaundice
Persistent elevations in transaminases of up to 3 times the upper limit of normal (3xULN) have been reported in 1% of patients. With therapy discontinuation or interruption, transaminase levels generally returned to pretreatment levels. There have been rare postmarketing reports of hepatic failure.
Common (1% to 10%): Constipation, nausea, flatulence, diarrhea, dyspepsia, abdominal pain, gastritis
Frequency not reported: Anorexia
Postmarketing reports: Pancreatitis, vomiting
Frequency not reported: Hemolytic anemia, thrombocytopenia, leucopenia, thrombotic thrombocytopenic purpura (TTP)
Postmarketing reports: Anemia
Common (1% to 10%): Headache, vertigo
Frequency not reported: Cognitive impairment, cranial nerve dysfunction, tremor, vertigo, memory loss, paraesthesias, peripheral neuropathy, peripheral nerve palsy
Postmarketing reports: Dizziness, paresthesia, peripheral neuropathy, cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion)
Frequency not reported: Myoglobinuria, acute renal failure secondary to rhabdomyolysis
Common (1% to 10%): Angina, edema, atrial fibrillation
Common (1% to 10%): Eczema
Frequency not reported: Pruritic rash, erythema multiform including Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity, purpura
Postmarketing reports: Pruritus, alopecia, a variety of skin changes (e.g., nodules, discoloration, dryness of skin/mucous membranes, changes to hair/nails)
Frequency not reported: Anaphylaxis, angioedema, urticaria, fever, chills, flushing, malaise, dyspnea
Postmarketing reports: Hypersensitivity syndrome which has included some of the follow features: anaphylaxis, angioedema, lupus erythematous-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive ANA, ESR increase, eosinophilia, arthritis, arthralgia, urticaria, asthenia, photosensitivity, fever, chills, flushing, malaise, dyspnea, toxic epidermal necrolysis, erythema multiforme including Stevens-Johnson syndrome
Postmarketing reports: Immune-mediated necrotizing myopathy
Frequency not reported: Progression of cataracts, ophthalmoplegia
Common (1%to 10%): Insomnia
Postmarketing reports: Depression
Common (1% to 10%): Urinary tract infection
Frequency not reported: Impotence, testicular pain, proteinuria
Postmarketing reports: Erectile dysfunction
Frequency not reported: Tumor growth, liver, thyroid, lung adenomas, carcinomas
Common (1% to 10%): Diabetes mellitus
Frequency not reported: HbA1c and fasting serum glucose levels elevations
Common (1% to 10%): Respiratory tract infection, bronchitis, sinusitis
Postmarketing reports: Interstitial lung disease
Frequency not reported: Asthenia
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Simvastatin (www.drugs.com/simvastatin.html).
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