Two medicines, side by side
Simvastatin vs niacin
Simvastatin and niacin are both labeled for heart attack and coronary artery disease, high cholesterol and high triglycerides. Drugs@FDA records approvals of simvastatin since 1991 and of niacin since 1957. Pharmacies paid $0.0321 per simvastatin 20 mg tablet and $0.193 per niacin ER 500 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, simvastatin is a hmg-coa reductase inhibitor and niacin a nicotinic acid.
Check it at the source: the simvastatin FDA label on DailyMed (effective March 28, 2025); the niacin FDA label on DailyMed (effective February 14, 2023).
Highlights of the simvastatin record
Simvastatin (Zocor) · label of March 28, 2025
Used for
From the label: indicationsZOCOR ® is 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. […]
On the market
- Earliest approval on file
- December 23, 1991
- Generic labelers
- 27 labelers
- Pharmacy cost
- $0.0321 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 26
Highlights of the niacin record
Niacin (Niacor) · label of February 14, 2023
Used for
From the label: indicationsTherapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. […]
On the market
- Earliest approval on file
- July 24, 1957
- Generic labelers
- 13 labelers
- Pharmacy cost
- $0.193 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 7
Source: FDA drug labels via openFDA (Simvastatin label of March 28, 2025, Niacin label of February 14, 2023); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do simvastatin and niacin differ on the record?
In FDA's classes, simvastatin is a hmg-coa reductase inhibitor and niacin a nicotinic acid.
How each works, in its label's words: Simvastatin, “Simvastatin is a prodrug and is hydrolyzed to its active β-hydroxyacid form, simvastatin acid, after administration.”; Niacin, “The mechanism by which niacin alters lipid profiles has not been well defined.”
Generics: simvastatin since 2006; niacin since 1972 (Drugs@FDA).
| Simvastatin | Niacin | |
|---|---|---|
| Labeled for | Heart attack and coronary artery disease, High cholesterol, High triglycerides | High cholesterol, Heart attack and coronary artery disease, High triglycerides |
| Pharmacologic class | HMG-CoA Reductase Inhibitor | Nicotinic Acid |
| How it works (label) | Simvastatin is a prodrug and is hydrolyzed to its active β-hydroxyacid form, simvastatin acid, after administration. | The mechanism by which niacin alters lipid profiles has not been well defined. |
| Half-life (label) | n/a | n/a |
| Earliest approval on file (Drugs@FDA) | December 23, 1991 | July 24, 1957 |
| First generic approved | June 23, 2006 | September 15, 1972 |
| Generic labelers (NDC) | 27 labelers | 13 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.0321 per tablet (Simvastatin 20 mg tablet) | $0.193 per tablet (Niacin ER 500 mg tablet) |
| 12-month price change | +5% | +17% |
| Boxed warning | No | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 26 | 7 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 248,728 | 11,548 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
Do their labels mention each other?
Simvastatin label, drug interactionsNiacin Clinical Impact: Cases of myopathy and rhabdomyolysis have been observed with concomitant use of lipid modifying dosages of niacin-containing products (≥1 gram/day niacin) with ZOCOR. The risk of myopathy is greater in Chinese patients. … Intervention: Concomitant use of ZOCOR with lipid-modifying dosages of niacin is not recommended in Chinese patients [see ]. For non-Chinese patients, consider if the benefit of using lipid-modifying doses of niacin …
Simvastatin label, warnings and precautionsLipid modifying doses (≥1 gram/day) of niacin, fibrates, colchicine, and grapefruit juice may also increase the risk of myopathy and rhabdomyolysis [see Drug Interactions (7.1) ].
Niacin label, warnings and precautionsAll participants received simvastatin, 40 to 80 mg per day, plus ezetimibe 10 mg per day if needed, to maintain an LDL-C level of 40 to 80 mg/dL, and were randomized to receive niacin extended-release tablets 1,500 to 2,000 mg/day (n=1718) or matching placebo (IR Niacin, 100 to 150 mg, n=1696).
Source: FDA drug labels via openFDA
What next?
- Alternatives to simvastatin
- every medicine labeled for the same conditions