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What the FDA labels say about taking them together

Niacin and simvastatin

Niacin's FDA label of February 14, 2023 names simvastatin in its warnings and precautions section, and simvastatin's label names niacin too. The simvastatin label: “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. …”

Check it at the source: the niacin FDA label on DailyMed (effective February 14, 2023, Aurobindo Pharma Limited); the simvastatin FDA label on DailyMed (effective March 28, 2025, Organon LLC).

What does the niacin label say about simvastatin?

Niacin label, warnings and precautions

All 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 label (Niacin), Aurobindo Pharma Limited, effective February 14, 2023 (SPL set 43233a21-3f90-4c69-bbeb-f50d5f2d35ae), via openFDA; the full label on DailyMed

What does the simvastatin label say about niacin?

Simvastatin label, drug interactions

Niacin 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 concomitantly with ZOCOR outweighs the increased risk of myopathy and rhabdomyolysis. …

Simvastatin label, warnings and precautions

Lipid 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) ].

Source: FDA drug label (ZOCOR), Organon LLC, effective March 28, 2025 (SPL set 8f55d5de-5a4f-4a39-8c84-c53976dd6af9), via openFDA; the full label on DailyMed

These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.

Both medicines on the record

13Niacin generic labelers
27Simvastatin generic labelers
NiacinSimvastatin
Labeled forHigh cholesterol, Heart attack and coronary artery disease, High triglyceridesHeart attack and coronary artery disease, High cholesterol, High triglycerides
Boxed warningNoNo
Pharmacy cost (NADAC)$0.193 per tablet 500 mg tablet$0.0321 per tablet 20 mg tablet
Shortage nowNo current entryNo current entry

Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)

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