Over-the-counter medication · Vitamin B3 (Lipid-Modifying)
niacin
Also sold as Niaspan, Slo-Niacin. This medicine is for children ages 4 and up who don't get enough fluoride in their drinking water.
Data updated 2026-05-15
- 11,382
- FDA reportsModerately reported
- 21
- InteractionsSeveral interactions
- 3
- Recall records
What the data shows
niacin (Niaspan) is an over-the-counter Vitamin B3 (Lipid-Modifying), reported less often than most tracked drugs (11,382 FDA reports), with 21 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
niacin (Niaspan) is an over-the-counter Vitamin B3 (Lipid-Modifying). This medicine is for children ages 4 and up who don't get enough fluoride in their drinking water.
This medicine is a multivitamin with fluoride. It helps prevent tooth decay and provides essential vitamins.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from niacin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
This is a plain-language summary of niacin's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
This medication is for children. Consult a doctor for information about vitamin and fluoride supplements during pregnancy or breastfeeding.
This is a plain-language summary of niacin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
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.
This is a plain-language summary of niacin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at room temperature and keep the bottle tightly closed.
Side Effects (from patient reports)
Based on 11,382 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for niacin, by number of reports
- Feeling tired
Feeling tired
749 reports
- Feeling sick to your stomach
Feeling sick to your stomach
671 reports
- Loose stools
Loose stools
630 reports
- Feeling lightheaded
Feeling lightheaded
546 reports
- Difficulty breathing
Difficulty breathing
529 reports
- Allergic reaction to the medicine
Allergic reaction to the medicine
495 reports
- Aches
Aches
489 reports
- Headache
Headache
472 reports
- Weakness
Weakness
440 reports
- Fall
Fall
380 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for niacin each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where niacin sits
niacin has more FDA adverse-event reports than 42% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is niacin; the line is the median (50th percentile).
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
Reports Mentioning Death
745
6.5% of reports — not proof of cause
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 |
| 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 |
| 16 | PRURITUS | 341 |
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...
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.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
Golden State Medical Supply Inc.
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Lannett Company Inc.
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 11,382 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 3 recall records 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.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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