Drug · FAERS side-effect profile with label screen
Nicotinamide side effects: what 2,495 FDA adverse event reports show
Drug class
Copper-containing Intrauterine Device, Standardized Chemical Allergen
FDA label (Established Pharmacologic Class)
Who reports
2,495 reports · 94% serious · 758 with death outcome · 70% female
openFDA FAERS counts, all years, deduplication not applied
Used for
—
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
Reporting / coding artifact 4No label text to screen 36
What the badges mean
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 240 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 |
|---|---|---|---|---|---|---|
| Hypercholesterolaemia | 282 | 255.2 228.2–285.4ROR 287.5 · χ² 69,048 / p <1e-300 | 243.5 EB05 220.6 · IC025 +7.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 161.7 · ♀ 93% (drug 70%) | no trial data cached |
| Pemphigus | 358 | 249.1 226.0–274.6ROR 290.7 · χ² 85,701 / p <1e-300 | 238.8 EB05 218.8 · IC025 +7.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 149.1 · ♀ 98% (drug 70%) · 93% clinician | no trial data cached |
| Helicobacter infection | 266 | 225.1 200.6–252.6ROR 251.8 · χ² 57,584 / p <1e-300 | 215.8 EB05 194.9 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 142.4 · ♀ 100% (drug 70%) · 91% clinician | no trial data cached |
| Folliculitis | 253 | 210.9 187.4–237.5ROR 234.6 · χ² 51,373 / p <1e-300 | 202.6 EB05 182.5 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 148.6 · ♀ 100% (drug 70%) | no trial data cached |
| Hand deformity | 299 | 196.5 176.4–218.8ROR 223.1 · χ² 56,652 / p <1e-300 | 189.6 EB05 172.3 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 128.3 · ♀ 100% (drug 70%) · 92% clinician | no trial data cached |
| Joint range of motion decreased | 295 | 189.6 170.1–211.3ROR 214.9 · χ² 53,958 / p <1e-300 | 183.2 EB05 166.3 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 145.3 · ♀ 100% (drug 70%) | no trial data cached |
| Bursitis | 246 | 174.9 155.1–197.2ROR 193.9 · χ² 41,499 / p <1e-300 | 169.0 EB05 152.0 · IC025 +6.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 123.9 · ♀ 100% (drug 70%) · 91% clinician | no trial data cached |
| Back injury | 217 | 171.8 151.1–195.4ROR 188.1 · χ² 35,955 / p <1e-300 | 165.9 EB05 148.2 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 137.0 · ♀ 100% (drug 70%) | no trial data cached |
| Wound infection | 212 | 167.1 146.7–190.4ROR 182.5 · χ² 34,171 / p <1e-300 | 161.5 EB05 144.0 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 108.0 · ♀ 100% (drug 70%) | no trial data cached |
| Synovitis | 302 | 143.0 128.5–159.1ROR 162.5 · χ² 41,749 / p <1e-300 | 139.3 EB05 126.6 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 90.5 · ♀ 100% (drug 70%) · 92% clinician | no trial data cached |
| Macular degeneration | 199 | 142.7 124.7–163.2ROR 154.9 · χ² 27,398 / p <1e-300 | 138.4 EB05 123.0 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 93.0 · ♀ 100% (drug 70%) | no trial data cached |
| Pericarditis | 272 | 139.4 124.5–156.1ROR 156.3 · χ² 36,648 / p <1e-300 | 135.8 EB05 122.8 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 84.9 · ♀ 100% (drug 70%) · 92% clinician | no trial data cached |
| Obesity | 250 | 133.7 118.8–150.6ROR 148.5 · χ² 32,304 / p <1e-300 | 130.3 EB05 117.3 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 93.9 · ♀ 100% (drug 70%) · 91% clinician | no trial data cached |
| Coeliac disease | 151 | 131.2 112.3–153.4ROR 139.6 · χ² 19,094 / p <1e-300 | 127.2 EB05 111.0 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 98.9 · ♀ 100% (drug 70%) | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 326 | 124.3 112.2–137.7ROR 142.8 · χ² 39,208 / p <1e-300 | 121.6 EB05 110.9 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 109.0 · ♀ 100% (drug 70%) | no trial data cached |
| Vaginal discharge | 137 | 116.2 98.6–136.9ROR 122.8 · χ² 15,318 / p <1e-300 | 112.8 EB05 97.8 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=137 · ♀ 100% (drug 70%) · 91% clinician | no trial data cached |
| Irritable bowel syndrome | 290 | 115.6 103.6–128.9ROR 130.7 · χ² 32,410 / p <1e-300 | 113.2 EB05 102.7 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 88.7 · ♀ 100% (drug 70%) · 92% clinician | no trial data cached |
| Adverse reaction | 173 | 111.0 96.0–128.3ROR 119.2 · χ² 18,510 / p <1e-300 | 108.3 EB05 95.4 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious n=173 · ♀ 100% (drug 70%) | no trial data cached |
| Wound | 325 | 99.4 89.7–110.0ROR 114.1 · χ² 31,215 / p <1e-300 | 97.6 EB05 89.1 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 71.7 · ♀ 99% (drug 70%) | no trial data cached |
| Liver injury | 272 | 95.6 85.4–107.0ROR 107.1 · χ² 25,098 / p <1e-300 | 93.9 EB05 84.9 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 60.0 · ♀ 100% (drug 70%) · 92% clinician | no trial data cached |
| Paraesthesia oral | 158 | 93.4 80.2–108.7ROR 99.6 · χ² 14,197 / p <1e-300 | 91.4 EB05 80.0 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 100.7 · ♀ 100% (drug 70%) · 90% clinician | no trial data cached |
| Oral candidiasis (oral thrush) | 143 | 93.4 79.5–109.6ROR 99.0 · χ² 12,837 / p <1e-300 | 91.2 EB05 79.4 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 79.5 · ♀ 99% (drug 70%) · 92% clinician | no trial data cached |
| Taste disorder | 215 | 91.1 80.1–103.6ROR 99.6 · χ² 18,881 / p <1e-300 | 89.4 EB05 79.8 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 111.3 · ♀ 99% (drug 70%) | no trial data cached |
| Fibromyalgia | 259 | 90.5 80.6–101.7ROR 100.9 · χ² 22,627 / p <1e-300 | 89.0 EB05 80.3 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 72.4 · ♀ 100% (drug 70%) | no trial data cached |
| Liver function test increased | 213 | 84.7 74.5–96.4ROR 92.6 · χ² 17,383 / p <1e-300 | 83.3 EB05 74.3 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 80.5 · ♀ 98% (drug 70%) | no trial data cached |
| Night sweats | 286 | 75.3 67.5–84.0ROR 84.9 · χ² 20,733 / p <1e-300 | 74.3 EB05 67.3 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 78.8 · ♀ 99% (drug 70%) | no trial data cached |
| Osteoarthritis | 376 | 75.0 68.3–82.4ROR 88.2 · χ² 27,200 / p <1e-300 | 74.1 EB05 68.0 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 51.3 · ♀ 100% (drug 70%) | no trial data cached |
| Systemic lupus erythematosus | 298 | 71.4 64.1–79.4ROR 80.9 · χ² 20,463 / p <1e-300 | 70.5 EB05 64.0 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 44.6 · ♀ 100% (drug 70%) · 92% clinician | no trial data cached |
| Contraindicated product administered | 250 | 70.2 62.4–79.0ROR 77.9 · χ² 16,867 / p <1e-300 | 69.3 EB05 62.4 · IC025 +5.7 3/3 methods agree | Reporting / coding artifact | serious PRR 53.3 · ♀ 100% (drug 70%) | no trial data cached |
| Impaired healing | 262 | 67.6 60.2–75.8ROR 75.4 · χ² 17,003 / p <1e-300 | 66.7 EB05 60.2 · IC025 +5.7 3/3 methods agree | Reporting / coding artifact | serious PRR 49.8 · ♀ 100% (drug 70%) | no trial data cached |
| Gait inability | 252 | 64.4 57.3–72.5ROR 71.6 · χ² 15,580 / p <1e-300 | 63.7 EB05 57.3 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 48.5 · ♀ 99% (drug 70%) | no trial data cached |
| Type 2 diabetes mellitus | 244 | 61.1 54.2–68.9ROR 67.6 · χ² 14,289 / p <1e-300 | 60.4 EB05 54.3 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 39.3 · ♀ 100% (drug 70%) · 91% clinician | no trial data cached |
| Lower respiratory tract infection | 322 | 60.1 54.3–66.6ROR 68.9 · χ² 18,566 / p <1e-300 | 59.5 EB05 54.2 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 38.8 · ♀ 94% (drug 70%) · 91% clinician | no trial data cached |
| Infusion related reaction (reaction during infusion) | 465 | 59.6 54.8–64.7ROR 73.0 · χ² 26,606 / p <1e-300 | 59.0 EB05 54.6 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 45.9 · ♀ 100% (drug 70%) · 91% clinician | no trial data cached |
| Epilepsy | 211 | 58.5 51.4–66.6ROR 63.8 · χ² 11,799 / p <1e-300 | 57.8 EB05 51.5 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.9 · ♀ 99% (drug 70%) · 90% clinician | no trial data cached |
| Incorrect route of product administration | 115 | 57.9 48.4–69.2ROR 60.6 · χ² 6,332 / p <1e-300 | 57.0 EB05 48.8 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious PRR 70.6 · 94% clinician | no trial data cached |
| Pulmonary fibrosis | 130 | 57.5 48.6–68.1ROR 60.6 · χ² 7,122 / p <1e-300 | 56.7 EB05 49.0 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.5 · 94% clinician | no trial data cached |
| Lung disorder | 320 | 55.3 49.9–61.2ROR 63.2 · χ² 16,922 / p <1e-300 | 54.7 EB05 49.9 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 38.0 · 91% clinician | no trial data cached |
| Hepatitis (liver inflammation) | 166 | 54.8 47.3–63.6ROR 58.7 · χ² 8,673 / p <1e-300 | 54.2 EB05 47.6 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 34.1 · ♀ 100% (drug 70%) | no trial data cached |
| Psoriatic arthropathy | 240 | 50.4 44.7–56.9ROR 55.7 · χ² 11,531 / p <1e-300 | 49.9 EB05 44.9 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 38.6 · ♀ 100% (drug 70%) · 90% clinician | 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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 742 | 7.2 6.8–7.6ROR 9.8 · χ² 4,114 / p <1e-300 | 7.2 EB05 6.7 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 8.1 | no trial data cached |
| Drug ineffective (drug did not work) | 676 | 4.3 4.0–4.6ROR 5.5 · χ² 1,833 / p <1e-300 | 4.3 EB05 4.0 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 7.3 | no trial data cached |
| Pain | 641 | 8.8 8.2–9.4ROR 11.4 · χ² 4,527 / p <1e-300 | 8.7 EB05 8.2 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.4 · ♀ 91% (drug 70%) | no trial data cached |
| Nausea | 627 | 6.7 6.2–7.1ROR 8.6 · χ² 3,139 / p <1e-300 | 6.6 EB05 6.2 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.8 · ♀ 96% (drug 70%) | no trial data cached |
| Malaise (feeling unwell) | 476 | 9.1 8.4–9.9ROR 11.0 · χ² 3,496 / p <1e-300 | 9.1 EB05 8.4 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.3 · ♀ 96% (drug 70%) | no trial data cached |
| Infusion related reaction (reaction during infusion) | 465 | 59.6 54.8–64.7ROR 73.0 · χ² 26,606 / p <1e-300 | 59.0 EB05 54.6 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 45.9 · ♀ 100% (drug 70%) · 91% clinician | no trial data cached |
| Dyspepsia (indigestion) | 439 | 37.8 34.7–41.1ROR 45.6 · χ² 15,675 / p <1e-300 | 37.5 EB05 34.7 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 45.4 · ♀ 95% (drug 70%) | no trial data cached |
| Headache | 417 | 5.6 5.1–6.1ROR 6.5 · χ² 1,618 / p <1e-300 | 5.6 EB05 5.1 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.0 · ♀ 92% (drug 70%) | no trial data cached |
| Condition aggravated | 410 | 11.4 10.5–12.5ROR 13.5 · χ² 3,940 / p <1e-300 | 11.4 EB05 10.5 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 10.7 | no trial data cached |
| Dyspnoea (shortness of breath) | 402 | 6.0 5.5–6.5ROR 6.9 · χ² 1,705 / p <1e-300 | 5.9 EB05 5.5 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.1 | no trial data cached |
| Drug intolerance | 389 | 34.1 31.1–37.4ROR 40.2 · χ² 12,467 / p <1e-300 | 33.9 EB05 31.2 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 33.8 · ♀ 91% (drug 70%) | no trial data cached |
| Fatigue (tiredness) | 382 | 4.1 3.8–4.5ROR 4.7 · χ² 938 / p 2e-206 | 4.1 EB05 3.8 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.6 | no trial data cached |
| Osteoarthritis | 376 | 75.0 68.3–82.4ROR 88.2 · χ² 27,200 / p <1e-300 | 74.1 EB05 68.0 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 51.3 · ♀ 100% (drug 70%) | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 374 | 39.4 35.8–43.2ROR 46.1 · χ² 13,932 / p <1e-300 | 39.1 EB05 35.9 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 38.4 · ♀ 99% (drug 70%) | no trial data cached |
| Drug hypersensitivity | 367 | 15.9 14.5–17.5ROR 18.5 · χ² 5,149 / p <1e-300 | 15.9 EB05 14.5 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.1 | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Nicotinamide?
In FDA FAERS, the most frequently co-reported reaction terms for Nicotinamide are pain, nausea, malaise, infusion related reaction, dyspepsia, headache. 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 Nicotinamide have an FDA boxed warning?
No. The FDA label retrieved for Nicotinamide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Nicotinamide 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 05813526-41d0-4451-8543-f4288ba7eb95, effective 20250213; matched on
openfda.generic_name.exact:"NICOTINAMIDE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - 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, 280 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.