Simvastatin — $0 on Listed Strengths

Related medications

Other medications associated with the same conditions in this catalog.

Also listed for Hyperlipidemia

• Atorvastatin
• Ezetimibe
• Fenofibrate
• Gemfibrozil
• Lovastatin
• Pravastatin
• Rosuvastatin

Other medications in Heart & Cardiovascular

• Sotalol
• Tadalafil (PAH)
• Telmisartan
• Ticagrelor
• Torsemide
• Trandolapril
• Treprostinil
• Triamterene

What Simvastatin is approved for (FDA label)

Simvastatin tablets USP are indicated: • To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. • As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). • As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH).

Source: Read the full FDA label on DailyMed. Label effective date: August 31, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Simvastatin (FDA label)

• Simvastatin tablets 5 mg are tan colored, round, biconvex, film-coated tablets debossed with 'LL' on one side and 'C01' on the other side. • Simvastatin tablets 10 mg are peach colored, oval shaped, biconvex, film-coated tablets debossed with 'LL' on one side and 'C02' on the other side. • Simvastatin tablets 20 mg are tan colored, oval shaped, biconvex, film-coated tablets debossed with 'LL' on one side and 'C03' on the other side. • Simvastatin tablets 40 mg are brick red colored, round shaped, biconvex, film-coated tablets debossed with 'LL' on one side and 'C04' on the other side.

Source: FDA prescribing information (DailyMed). Set ID: 3f6fad0b-0278-433f-86db-761b673a5803. SPL document ID: 6607bc0b-d728-46ed-9186-425d1b0405b2. Label effective date: August 31, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Simvastatin (FDA label)

The following important adverse reactions are described below and elsewhere in the labeling: • Myopathy and Rhabdomyolysis [see WARNINGS AND PRECAUTIONS ( 5.1 )] • Immune-Mediated Necrotizing Myopathy [see WARNINGS AND PRECAUTIONS ( 5.2 )] • Hepatic Dysfunction [see WARNINGS AND PRECAUTIONS ( 5.3 )] • Increases in HbA1c and Fasting Serum Glucose Levels [see WARNINGS AND PRECAUTIONS ( 5.4 )] Most common adverse reactions (incidence ≥5%) are: upper respiratory infection, headache, abdominal pain, constipation, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Source: FDA prescribing information (DailyMed). Set ID: 3f6fad0b-0278-433f-86db-761b673a5803. SPL document ID: 6607bc0b-d728-46ed-9186-425d1b0405b2. Label effective date: August 31, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Simvastatin (FDA label)

Simvastatin is contraindicated in the following conditions: • Concomitant use of strong CYP3A4 inhibitors (select azole anti-fungals, macrolide antibiotics, anti-viral medications, and nefazodone) [see DRUG INTERACTIONS ( 7.1 )]. • Concomitant use of cyclosporine, danazol or gemfibrozil [see DRUG INTERACTIONS ( 7.1 )]. • Acute liver failure or decompensated cirrhosis [see WARNINGS AND PRECAUTIONS ( 5.3 )] • Hypersensitivity to simvastatin or any excipients in simvastatin tablets USP. Hypersensitivity reactions, including anaphylaxis, angioedema and Stevens-Johnson syndrome, have been reported [see ADVERSE REACTIONS ( 6.2 )] • Concomitant use of strong CYP3A4 inhibitors (select azole anti-fungals, macrolide antibiotics, anti-viral medications, and nefazodone) (, 7.1 ) • Concomitant use of cyclosporine, danazol or gemfibrozil (, 7.1 ) • Acute liver failure or decompensated cirrhosis (, 5.3 ) • Hypersensitivity to simvastatin or any excipient in simvastatin tablets USP (, 6.2 )

Source: FDA prescribing information (DailyMed). Set ID: 3f6fad0b-0278-433f-86db-761b673a5803. SPL document ID: 6607bc0b-d728-46ed-9186-425d1b0405b2. Label effective date: August 31, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Simvastatin (FDA label)

• Myopathy and Rhabdomyolysis: Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher simvastatin dosage. Chinese patients may be at higher risk for myopathy. Discontinue simvastatin if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue simvastatin in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing simvastatin dosage. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. ( 5.1 , 7.1 , 8.5 , 8.6 , 8.8 ) • Immune-Mediated Necrotizing Myopathy (IMNM): Rare reports of IMNM, an autoimmune myopathy, have been reported. Discontinue simvastatin if IMNM is suspected. ( 5.2 ) • Hepatic Dysfunction: Increases in serum transaminases have occurred, some persistent.

Source: FDA prescribing information (DailyMed). Set ID: 3f6fad0b-0278-433f-86db-761b673a5803. SPL document ID: 6607bc0b-d728-46ed-9186-425d1b0405b2. Label effective date: August 31, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Simvastatin (FDA label)

• See full prescribing information for details regarding concomitant use of simvastatin with other drugs or grapefruit juice that increase the risk of myopathy and rhabdomyolysis. ( 2.5 , 7.1 ) • Coumarin Anticoagulants: Obtain INR before simvastatin initiation and monitor INR during simvastatin dosage initiation or adjustment. ( 7.2 ) • Digoxin: During simvastatin initiation, monitor digoxin levels. ( 7.2 ) 7.1 Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Simvastatin Simvastatin is a substrate of CYP3A4 and of the transport protein OATP1B1. Simvastatin exposure can be significantly increased with concomitant administration of inhibitors of CYP3A4 and OATP1B1. Table 2 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when used concomitantly with simvastatin and instructions for preventing or managing them [see WARNINGS AND PRECAUTIONS ( 5.1 ) AND CLINICAL PHARMACOLOGY ( 12.3 )] . Table 2: Drug Interactions that Increase the

Source: FDA prescribing information (DailyMed). Set ID: 3f6fad0b-0278-433f-86db-761b673a5803. SPL document ID: 6607bc0b-d728-46ed-9186-425d1b0405b2. Label effective date: August 31, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.