niacin
Brand names: Niaspan, Slo-Niacin
This medicine is a multivitamin with fluoride. It helps prevent tooth decay and provides essential vitamins.
Drug Pricing (NADAC)
Generic Price
$0.22/unit
Generic Available
Yes (9 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine is for children ages 4 and up who don't get enough fluoride in their drinking water.
Common side effects
No common side effects listed.
Key warnings
There are no serious warnings listed for this medication.
How It Works
The fluoride in this medicine strengthens your teeth to protect them from decay. The vitamins help your body work properly and stay healthy.
How to Take It
Take one tablet each day. You can dissolve it in your mouth or chew it before swallowing. Do not give this chewable tablet to children under 4 years old. Regular brushing and good oral hygiene are also important.
Pregnancy & Breastfeeding
This medication is for children. Consult a doctor for information about vitamin and fluoride supplements during pregnancy or breastfeeding.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
Storage
Store at room temperature and keep the bottle tightly closed.
Side Effects (from patient reports)
Based on 5,756 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 11,382 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
11,382
Death-Related Reports
745
Hospitalization Reports
3,202
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | FATIGUE | 750 |
| 2 | DRUG INEFFECTIVE | 735 |
| 3 | NAUSEA | 671 |
| 4 | DIARRHOEA | 630 |
| 5 | DIZZINESS | 546 |
| 6 | DYSPNOEA | 530 |
| 7 | DRUG HYPERSENSITIVITY | 495 |
| 8 | PAIN | 489 |
| 9 | HEADACHE | 473 |
| 10 | ASTHENIA | 441 |
| 11 | FALL | 380 |
| 12 | PAIN IN EXTREMITY | 375 |
| 13 | ARTHRALGIA | 373 |
| 14 | RASH | 348 |
| 15 | VOMITING | 346 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
There are no serious warnings listed for this medication.
Known Drug Interactions
Niacin Clinical Impact: Cases of myopathy and rhabdomyolysis have been observed with concomitant use of lipid modifying dosages of niacin ( > 1 gram/day niacin) with atorvastatin. Intervention: Consider if the benefit of using lipid modifying dosages of niacin concomitantly with atorvastatin outweighs the increased risk of myopathy and rhabdomyolysis.
Mechanism: Taking high doses of niacin along with atorvastatin can increase your risk of developing severe muscle pain or damage.
What to do: Your doctor will decide if the benefits of taking both drugs are worth the increased risk to your muscles.
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 ezetimibe and simvastatin. In a clinical trial (median follow-up 3.9 years) of patients at high risk of CVD and with well-controlled LDL-C levels on simvastatin 40 mg/day with or without ezetimibe 10 mg/day, there was no incremental benefit on cardiovascular outcomes with the addition of lipid-modifying doses of niacin Intervention: Concomitant use of ezetimibe and simvastatin with lipid-modifying dosages of n...
Mechanism: Combining these drugs increases the chance of developing serious muscle problems. Research also shows that adding niacin to this treatment might not provide extra heart health benefits for some patients.
What to do: Your doctor will decide if you need both medications based on your risk of muscle injury. Be sure to tell your healthcare provider if you experience any muscle pain or weakness.
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 VYTORIN. In a clinical trial (median follow-up 3.9 years) of patients at high risk of CVD and with well-controlled LDL-C levels on simvastatin 40 mg/day with or without ezetimibe 10 mg/day, there was no incremental benefit on cardiovascular outcomes with the addition of lipid-modifying doses of niacin Intervention: Concomitant use of VYTORIN with lipid-modifying dosages of niacin is not recommended in Chinese ...
Mechanism: Taking high doses of niacin with this drug increases the risk of muscle damage and may not provide extra heart benefits.
What to do: This combination is generally not recommended, particularly for Chinese patients, due to the risk of muscle problems.
Limit fluvastatin dose to 20 mg ( 2.5 , 7.2 ) Concomitant lipid-lowering therapies: Use with fibrates or lipid-modifying doses (≥ 1 g/day) of niacin increases the risk of adverse skeletal muscle effects. 7.5 Niacin The risk of skeletal muscle effects may be enhanced when fluvastatin sodium is used in combination with lipid-modifying doses (≥ 1 g/day) of niacin; a reduction in fluvastatin sodium dosage should be considered in this setting [see Warnings and Precautions ( 5.1 )].
Mechanism: Combining these drugs increases the chance of experiencing muscle pain or damage.
What to do: Your doctor may need to lower your dose of fluvastatin if you are taking high doses of niacin.
Gemfibrozil Other fibrates Niacin (nicotinic acid) (≥ 1 g/day) Other Drug Interactions Cyclosporine The risk of myopathy/rhabdomyolysis is increased by concomitant administration of cyclosporine (see WARNINGS , Myopathy/Rhabdomyolysis ).
Mechanism: Using niacin along with lovastatin increases the risk of serious muscle breakdown and pain.
What to do: If you take more than one gram of niacin a day, your doctor should monitor you closely for muscle issues.
Common Questions
What age is this medicine for?
How often should my child see the dentist?
What if my child's water has some fluoride?
Can I give this to my baby?
Does this replace brushing?
What vitamins are in this medicine?
Is this medicine over-the-counter?
What do the tablets look like?
How many tablets are in a bottle?
What should I do if my child swallows too many tablets?
Does niacin interact with other medications?
What drug class is niacin?
Is niacin safe during pregnancy?
Has niacin been recalled?
Active Recalls
Failed Dissolution Specifications
Lannett Company Inc.
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What the FDA Data Shows for niacin
The FDA label for niacin (sold under brand names such as Niaspan, Slo-Niacin) classifies it as an over-the-counter product in the Vitamin B3 (Lipid-Modifying) class. This medicine is for children ages 4 and up who don't get enough fluoride in their drinking water. Labeling covers dosing, contraindications, and monitoring requirements derived from clinical trials.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 5,756 voluntary reports. The database also lists 21 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.22.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: September 30, 2024
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages