Drug · FAERS side-effect profile with label screen
Niacin side effects: what 11,543 FDA adverse event reports show
Drug class
Nicotinic Acid
FDA label (Established Pharmacologic Class)
Who reports
11,543 reports · 56% serious · 757 with death outcome · 43% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Therapy 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. 1.
FDA label, Indications and Usage
What it is
Niacin extended-release tablet, USP contains niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline po.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled (related wording) 5Likely indication confounding 7Lab value / disease marker 3Not in label — unassessed 25
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,058 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Urticaria thermal | 20 | 293.6 183.0–470.9ROR 294.1 · χ² 4,762 / p <1e-300 | 203.5 EB05 139.1 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=20 · ♀ 100% (drug 43%) | no trial data cached |
| Administration site erythema | 14 | 95.3 55.7–163.1ROR 95.4 · χ² 1,153 / p 6e-253 | 80.9 EB05 51.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Discoloured vomit | 23 | 45.2 29.9–68.4ROR 45.3 · χ² 927 / p 6e-204 | 42.7 EB05 30.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 100% (drug 43%) | no trial data cached |
| Chronic kidney disease-mineral and bone disorder | 16 | 27.4 16.7–44.9ROR 27.4 · χ² 375 / p 7e-84 | 26.2 EB05 17.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Venous insufficiency | 10 | 25.2 13.5–46.9ROR 25.2 · χ² 205 / p 7e-47 | 23.6 EB05 13.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Nephrogenic anaemia | 51 | 20.0 15.2–26.4ROR 20.1 · χ² 893 / p 2e-196 | 19.7 EB05 15.5 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=51 | no trial data cached |
| High density lipoprotein decreased | 36 | 19.8 14.2–27.5ROR 19.8 · χ² 616 / p 2e-136 | 19.4 EB05 14.6 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious n=18 · ♀ 12% (drug 43%) | no trial data cached |
| Hyperparathyroidism secondary | 22 | 15.9 10.5–24.2ROR 15.9 · χ² 290 / p 2e-65 | 15.3 EB05 10.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=22 | no trial data cached |
| Recalled product administered | 74 | 15.4 12.2–19.3ROR 15.5 · χ² 972 / p 9e-214 | 15.2 EB05 12.4 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | 100% consumer | no trial data cached |
| Rebound acid hypersecretion | 24 | 14.3 9.6–21.4ROR 14.3 · χ² 282 / p 2e-63 | 13.7 EB05 9.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=24 | no trial data cached |
| Haemorrhagic anaemia | 31 | 12.7 8.9–18.1ROR 12.7 · χ² 320 / p 6e-72 | 12.2 EB05 8.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=31 · 79% consumer | no trial data cached |
| Excoriation | 17 | 12.1 7.5–19.4ROR 12.1 · χ² 160 / p 4e-37 | 10.9 EB05 6.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Colonic polyp | 11 | 12.0 6.6–21.7ROR 12.0 · χ² 99 / p 1e-23 | 10.1 EB05 5.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Vitamin b12 deficiency | 25 | 11.4 7.7–16.8ROR 11.4 · χ² 225 / p 5e-51 | 10.6 EB05 7.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 100% (drug 43%) | no trial data cached |
| Essential hypertension | 16 | 11.3 6.9–18.4ROR 11.3 · χ² 139 / p 2e-32 | 10.0 EB05 6.0 · IC025 +2.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=15 | no trial data cached |
| Muscle cramp | 11 | 11.2 6.2–20.2ROR 11.2 · χ² 91 / p 6e-22 | 9.2 EB05 4.9 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Lipids increased | 12 | 10.9 6.2–19.3ROR 10.9 · χ² 98 / p 2e-23 | 9.1 EB05 5.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Pericardial haemorrhage | 12 | 10.0 5.7–17.6ROR 10.0 · χ² 88 / p 4e-21 | 8.2 EB05 4.7 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Blood cholesterol decreased | 10 | 9.8 5.3–18.2ROR 9.8 · χ² 70 / p 3e-17 | 7.7 EB05 4.1 · IC025 +1.7 3/3 methods agree | Likely indication confounding term in indications | – | no trial data cached |
| Orthopnoea | 16 | 9.1 5.6–14.9ROR 9.2 · χ² 107 / p 2e-25 | 7.8 EB05 4.9 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Renal failure chronic | 39 | 9.1 6.7–12.5ROR 9.1 · χ² 273 / p 2e-61 | 8.5 EB05 6.4 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.2 | no trial data cached |
| Benign prostatic hyperplasia | 25 | 8.8 5.9–13.0ROR 8.8 · χ² 164 / p 6e-38 | 7.9 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 0% (drug 43%) | no trial data cached |
| Dizziness postural | 44 | 8.4 6.2–11.2ROR 8.4 · χ² 276 / p 2e-62 | 7.8 EB05 6.0 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious n=38 · ♀ 71% (drug 43%) | no trial data cached |
| Blood triglycerides increased | 79 | 8.1 6.5–10.1ROR 8.2 · χ² 485 / p 1e-107 | 7.8 EB05 6.5 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.1 | no trial data cached |
| Angina unstable | 29 | 8.1 5.6–11.6ROR 8.1 · χ² 172 / p 2e-39 | 7.3 EB05 5.3 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious n=29 | no trial data cached |
| Low density lipoprotein increased | 33 | 7.8 5.6–11.0ROR 7.8 · χ² 189 / p 3e-43 | 7.2 EB05 5.3 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious n=19 | no trial data cached |
| Urinary tract obstruction | 10 | 7.7 4.2–14.4ROR 7.7 · χ² 52 / p 3e-13 | 6.0 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Coronary artery disease | 129 | 7.7 6.5–9.1ROR 7.8 · χ² 744 / p 5e-164 | 7.5 EB05 6.5 · IC025 +2.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 7.7 | no trial data cached |
| Pancreatic carcinoma metastatic | 12 | 7.7 4.3–13.5ROR 7.7 · χ² 63 / p 1e-15 | 6.2 EB05 3.7 · IC025 +1.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=12 | no trial data cached |
| Tricuspid valve incompetence | 31 | 7.1 5.0–10.2ROR 7.2 · χ² 157 / p 2e-36 | 6.5 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Blood cholesterol abnormal | 18 | 7.1 4.5–11.3ROR 7.1 · χ² 88 / p 3e-21 | 6.1 EB05 4.1 · IC025 +1.8 3/3 methods agree | Likely indication confounding term in indications | serious n=14 | no trial data cached |
| Carotid artery occlusion | 14 | 7.0 4.1–11.8ROR 7.0 · χ² 65 / p 3e-16 | 5.8 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Radiculopathy | 10 | 6.9 3.7–12.8ROR 6.9 · χ² 45 / p 1e-11 | 5.4 EB05 3.1 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Blood testosterone decreased | 26 | 6.9 4.7–10.1ROR 6.9 · χ² 124 / p 5e-29 | 6.2 EB05 4.4 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious n=11 · ♀ 0% (drug 43%) | no trial data cached |
| Pigmentation disorder | 23 | 6.8 4.5–10.2ROR 6.8 · χ² 108 / p 2e-25 | 6.1 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=22 · ♀ 100% (drug 43%) | no trial data cached |
| Carotid artery stenosis | 13 | 6.7 3.9–11.6ROR 6.8 · χ² 58 / p 1e-14 | 5.6 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Hyperlipidaemia | 44 | 6.7 5.0–9.0ROR 6.7 · χ² 206 / p 4e-47 | 6.3 EB05 4.9 · IC025 +2.1 3/3 methods agree | Likely indication confounding term in indications | serious PRR 6.5 | no trial data cached |
| Internal haemorrhage | 41 | 6.5 4.8–8.9ROR 6.5 · χ² 186 / p 1e-42 | 6.1 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · ♀ 66% (drug 43%) | no trial data cached |
| Coronary artery occlusion | 49 | 6.5 4.9–8.6ROR 6.5 · χ² 221 / p 3e-50 | 6.1 EB05 4.8 · IC025 +2.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.6 | no trial data cached |
| Muscle fatigue | 15 | 6.5 3.9–10.7ROR 6.5 · χ² 64 / p 7e-16 | 5.5 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 760 | 1.8 1.7–1.9ROR 1.8 · χ² 267 / p 2e-60 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled (related wording) related wording | serious PRR 1.9 | no trial data cached |
| Drug ineffective (drug did not work) | 747 | 1.0 1.0–1.1ROR 1.0 · χ² 1 / p 0.206 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.4 | no trial data cached |
| Nausea | 678 | 1.6 1.5–1.7ROR 1.6 · χ² 141 / p 7e-33 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Diarrhoea (diarrhea) | 643 | 1.8 1.7–2.0ROR 1.9 · χ² 242 / p 7e-55 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Dizziness | 552 | 2.0 1.9–2.2ROR 2.1 · χ² 287 / p 9e-65 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Dyspnoea (shortness of breath) | 533 | 1.7 1.6–1.9ROR 1.7 · χ² 161 / p 3e-37 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Drug hypersensitivity | 495 | 4.6 4.3–5.1ROR 4.8 · χ² 1,418 / p <1e-300 | 4.6 EB05 4.3 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.7 · ♀ 70% (drug 43%) | no trial data cached |
| Pain | 494 | 1.5 1.3–1.6ROR 1.5 · χ² 73 / p 7e-18 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Headache | 477 | 1.4 1.3–1.5ROR 1.4 · χ² 52 / p 3e-13 | 1.4 EB05 1.3 · IC025 +0.3 | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Asthenia (weakness) | 446 | 2.2 2.0–2.4ROR 2.2 · χ² 280 / p 5e-63 | 2.2 EB05 2.0 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Fall | 386 | 2.1 1.9–2.3ROR 2.1 · χ² 227 / p 1e-51 | 2.1 EB05 1.9 · IC025 +0.9 | Not in label — unassessed | serious PRR 2.3 | no trial data cached |
| Arthralgia (joint pain) | 381 | 1.7 1.5–1.8ROR 1.7 · χ² 104 / p 1e-24 | 1.7 EB05 1.5 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.7 | no trial data cached |
| Pain in extremity | 378 | 2.3 2.1–2.6ROR 2.4 · χ² 288 / p 6e-65 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Rash | 352 | 1.5 1.3–1.6ROR 1.5 · χ² 54 / p 8e-14 | 1.5 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.4 | no trial data cached |
| Pruritus (itching) | 349 | 1.7 1.5–1.9ROR 1.7 · χ² 96 / p 5e-23 | 1.7 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Urticaria thermal — n=20, PRR 293.6
- Discoloured vomit — n=23, PRR 45.2
- Nephrogenic anaemia — n=51, PRR 20.0
- Hyperparathyroidism secondary — n=22, PRR 15.9
- Rebound acid hypersecretion — n=24, PRR 14.3
- Haemorrhagic anaemia — n=31, PRR 12.7
- Vitamin b12 deficiency — n=25, PRR 11.4
- Benign prostatic hyperplasia — n=25, PRR 8.8
- Tricuspid valve incompetence — n=31, PRR 7.1
- Pigmentation disorder — n=23, PRR 6.8
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Niacin?
In FDA FAERS, the most frequently co-reported reaction terms for Niacin are fatigue, nausea, diarrhoea, dizziness, dyspnoea, drug hypersensitivity. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Niacin have an FDA boxed warning?
No. The FDA label retrieved for Niacin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Niacin causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e, effective 20250110; matched on
openfda.generic_name.exact:"NIACIN") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,098 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.