Drug · FAERS side-effect profile with label screen
Nicotine Polacrilex Gum side effects: what 6,195 FDA adverse event reports show
Drug class
Cholinergic Nicotinic Agonist
FDA label (Established Pharmacologic Class) of the closest related product
Label matched
Nicotine Polacrilex (Nicotine Polacrilex Coated Ice Mint)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
6,195 reports · 17% serious · 33 with death outcome · 62% female
openFDA FAERS counts, all years, deduplication not applied
Used for
reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
FDA label, Indications and Usage
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 10No label text to screen 30
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. 75 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 |
|---|---|---|---|---|---|---|
| Macular degeneration | 567 | 168.9 155.9–183.1ROR 185.8 · χ² 89,990 / p <1e-300 | 160.0 EB05 149.2 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 578.6 · ♀ 100% (drug 62%) | no trial data cached |
| Oral discomfort | 329 | 81.9 73.6–91.1ROR 86.4 · χ² 25,585 / p <1e-300 | 79.6 EB05 72.6 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=6 · 100% consumer | no trial data cached |
| Intentional drug misuse | 333 | 53.9 48.5–59.9ROR 56.9 · χ² 16,986 / p <1e-300 | 52.9 EB05 48.3 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious PRR 107.4 · 99% consumer | no trial data cached |
| Paraesthesia oral | 165 | 39.3 33.7–45.7ROR 40.3 · χ² 6,046 / p <1e-300 | 38.7 EB05 34.0 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 175.1 · ♀ 94% (drug 62%) | no trial data cached |
| Vaginal discharge | 82 | 27.8 22.4–34.5ROR 28.2 · χ² 2,077 / p <1e-300 | 27.4 EB05 22.8 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=82 · ♀ 100% (drug 62%) | no trial data cached |
| Oral candidiasis (oral thrush) | 84 | 22.0 17.7–27.2ROR 22.3 · χ² 1,650 / p <1e-300 | 21.7 EB05 18.1 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 99.5 · ♀ 97% (drug 62%) | no trial data cached |
| Drug administration error | 199 | 21.8 19.0–24.9ROR 22.4 · χ² 3,899 / p <1e-300 | 21.6 EB05 19.2 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 49.0 · 99% consumer | no trial data cached |
| Expired product administered | 209 | 21.4 18.7–24.5ROR 22.1 · χ² 4,030 / p <1e-300 | 21.3 EB05 18.9 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious n=1 · 100% consumer | no trial data cached |
| Incorrect route of product administration | 94 | 19.0 15.5–23.2ROR 19.3 · χ² 1,578 / p <1e-300 | 18.8 EB05 15.9 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | 100% consumer | no trial data cached |
| Dental caries | 58 | 17.8 13.8–23.1ROR 18.0 · χ² 901 / p 4e-198 | 17.6 EB05 14.1 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 · ♀ 35% (drug 62%) · 95% consumer | no trial data cached |
| Throat irritation | 234 | 17.8 15.7–20.2ROR 18.4 · χ² 3,678 / p <1e-300 | 17.7 EB05 15.8 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.5 · 98% consumer | no trial data cached |
| Procedural pain | 125 | 15.3 12.9–18.3ROR 15.6 · χ² 1,657 / p <1e-300 | 15.2 EB05 13.1 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 87.8 · ♀ 100% (drug 62%) | no trial data cached |
| Product taste abnormal | 49 | 12.4 9.3–16.3ROR 12.4 · χ² 499 / p 9e-111 | 12.1 EB05 9.3 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious n=2 · 96% consumer | no trial data cached |
| Drug effect less than expected | 48 | 11.5 8.7–15.3ROR 11.6 · χ² 451 / p 3e-100 | 11.2 EB05 8.6 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | 100% consumer | no trial data cached |
| Frequent bowel movements | 87 | 11.0 8.9–13.5ROR 11.1 · χ² 776 / p 4e-171 | 10.7 EB05 8.9 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 53.6 · ♀ 96% (drug 62%) | no trial data cached |
| Dyspepsia (indigestion) | 314 | 10.9 9.7–12.1ROR 11.4 · χ² 2,803 / p <1e-300 | 10.8 EB05 9.8 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.1 | no trial data cached |
| Oral pain | 71 | 10.7 8.5–13.5ROR 10.8 · χ² 614 / p 6e-136 | 10.4 EB05 8.5 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.7 · 99% consumer | no trial data cached |
| Salivary hypersecretion | 30 | 10.2 7.1–14.6ROR 10.2 · χ² 239 / p 4e-54 | 9.5 EB05 6.8 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 1.5 · 97% consumer | no trial data cached |
| Therapeutic product effect incomplete | 175 | 8.4 7.2–9.7ROR 8.6 · χ² 1,132 / p 2e-248 | 8.2 EB05 7.3 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 37.8 · ♀ 92% (drug 62%) | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 52 | 7.9 6.0–10.3ROR 7.9 · χ² 305 / p 1e-68 | 7.5 EB05 5.9 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Retching | 49 | 7.8 5.9–10.3ROR 7.9 · χ² 284 / p 6e-64 | 7.4 EB05 5.8 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.1 · 98% consumer | no trial data cached |
| Stomatitis (mouth sores) | 139 | 7.8 6.6–9.2ROR 7.9 · χ² 813 / p 5e-179 | 7.6 EB05 6.6 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 0.8 · 97% consumer | no trial data cached |
| Colitis | 83 | 7.5 6.0–9.2ROR 7.6 · χ² 458 / p 7e-102 | 7.2 EB05 6.0 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.4 · ♀ 99% (drug 62%) | no trial data cached |
| Wrong technique in product usage process | 419 | 7.0 6.4–7.7ROR 7.5 · χ² 2,176 / p <1e-300 | 7.0 EB05 6.4 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 2.0 · 99% consumer | no trial data cached |
| Rectal haemorrhage | 87 | 6.8 5.5–8.4ROR 6.9 · χ² 427 / p 3e-95 | 6.6 EB05 5.5 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.4 · ♀ 97% (drug 62%) | no trial data cached |
| Pharyngeal oedema | 31 | 6.7 4.7–9.6ROR 6.8 · χ² 145 / p 9e-34 | 6.2 EB05 4.5 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 1.9 · 97% consumer | no trial data cached |
| Infusion related reaction (reaction during infusion) | 125 | 6.4 5.4–7.6ROR 6.5 · χ² 566 / p 2e-125 | 6.3 EB05 5.4 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.9 · ♀ 100% (drug 62%) | no trial data cached |
| Colitis ulcerative | 84 | 6.4 5.2–7.9ROR 6.5 · χ² 376 / p 6e-84 | 6.2 EB05 5.1 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.8 · ♀ 99% (drug 62%) | no trial data cached |
| Pharyngeal swelling | 18 | 6.4 4.0–10.1ROR 6.4 · χ² 76 / p 1e-18 | 5.5 EB05 3.7 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Throat tightness | 50 | 6.3 4.8–8.3ROR 6.3 · χ² 216 / p 3e-49 | 5.9 EB05 4.7 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 0.6 · 100% consumer | no trial data cached |
| Tooth fracture | 20 | 6.1 4.0–9.5ROR 6.2 · χ² 81 / p 1e-19 | 5.4 EB05 3.7 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Incorrect drug administration duration | 49 | 5.8 4.4–7.7ROR 5.9 · χ² 191 / p 1e-43 | 5.5 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 10.0 · 96% consumer | no trial data cached |
| Toothache | 31 | 5.8 4.1–8.2ROR 5.8 · χ² 118 / p 7e-28 | 5.4 EB05 4.0 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.1 · 97% consumer | no trial data cached |
| Haematochezia (blood in stool) | 85 | 5.2 4.2–6.5ROR 5.3 · χ² 286 / p 2e-64 | 5.1 EB05 4.2 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.7 · ♀ 97% (drug 62%) | no trial data cached |
| Incorrect route of drug administration | 55 | 5.1 3.9–6.7ROR 5.2 · χ² 179 / p 4e-41 | 4.9 EB05 3.9 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | 100% consumer | no trial data cached |
| Dysgeusia (altered taste) | 107 | 4.8 4.0–5.9ROR 4.9 · χ² 324 / p 1e-72 | 4.7 EB05 4.0 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 1.3 · 98% consumer | no trial data cached |
| Flatulence (gas) | 65 | 3.9 3.1–4.9ROR 3.9 · χ² 137 / p 7e-32 | 3.8 EB05 3.1 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.1 · 97% consumer | no trial data cached |
| Hypoaesthesia oral | 17 | 3.8 2.4–6.1ROR 3.8 · χ² 33 / p 6e-9 | 3.5 EB05 2.3 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 1.4 | no trial data cached |
| Oropharyngeal pain (sore throat) | 104 | 3.8 3.1–4.6ROR 3.8 · χ² 213 / p 2e-48 | 3.7 EB05 3.2 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.2 · 93% consumer | no trial data cached |
| Dry throat | 11 | 3.7 2.0–6.6ROR 3.7 · χ² 19 / p 8e-6 | 3.3 EB05 2.0 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | – | 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 1,401 | 3.6 3.4–3.8ROR 4.4 · χ² 2,802 / p <1e-300 | 3.6 EB05 3.4 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 14.3 · 72% consumer | no trial data cached |
| Nausea | 701 | 3.0 2.8–3.2ROR 3.3 · χ² 972 / p 1e-213 | 3.0 EB05 2.8 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.5 · 83% consumer | no trial data cached |
| Macular degeneration | 567 | 168.9 155.9–183.1ROR 185.8 · χ² 89,990 / p <1e-300 | 160.0 EB05 149.2 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 578.6 · ♀ 100% (drug 62%) | no trial data cached |
| Wrong technique in product usage process | 419 | 7.0 6.4–7.7ROR 7.5 · χ² 2,176 / p <1e-300 | 7.0 EB05 6.4 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 2.0 · 99% consumer | no trial data cached |
| Intentional drug misuse | 333 | 53.9 48.5–59.9ROR 56.9 · χ² 16,986 / p <1e-300 | 52.9 EB05 48.3 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious PRR 107.4 · 99% consumer | no trial data cached |
| Oral discomfort | 329 | 81.9 73.6–91.1ROR 86.4 · χ² 25,585 / p <1e-300 | 79.6 EB05 72.6 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=6 · 100% consumer | no trial data cached |
| Dyspepsia (indigestion) | 314 | 10.9 9.7–12.1ROR 11.4 · χ² 2,803 / p <1e-300 | 10.8 EB05 9.8 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.1 | no trial data cached |
| Malaise (feeling unwell) | 288 | 2.2 2.0–2.5ROR 2.3 · χ² 195 / p 1e-44 | 2.2 EB05 2.0 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.1 | no trial data cached |
| Throat irritation | 234 | 17.8 15.7–20.2ROR 18.4 · χ² 3,678 / p <1e-300 | 17.7 EB05 15.8 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.5 · 98% consumer | no trial data cached |
| Expired product administered | 209 | 21.4 18.7–24.5ROR 22.1 · χ² 4,030 / p <1e-300 | 21.3 EB05 18.9 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious n=1 · 100% consumer | no trial data cached |
| Drug administration error | 199 | 21.8 19.0–24.9ROR 22.4 · χ² 3,899 / p <1e-300 | 21.6 EB05 19.2 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 49.0 · 99% consumer | no trial data cached |
| Therapeutic product effect incomplete | 175 | 8.4 7.2–9.7ROR 8.6 · χ² 1,132 / p 2e-248 | 8.2 EB05 7.3 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 37.8 · ♀ 92% (drug 62%) | no trial data cached |
| Abdominal discomfort | 168 | 3.4 2.9–3.9ROR 3.5 · χ² 284 / p 4e-64 | 3.4 EB05 3.0 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 1.1 · 98% consumer | no trial data cached |
| Paraesthesia oral | 165 | 39.3 33.7–45.7ROR 40.3 · χ² 6,046 / p <1e-300 | 38.7 EB05 34.0 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 175.1 · ♀ 94% (drug 62%) | no trial data cached |
| Incorrect dose administered | 150 | 2.3 1.9–2.6ROR 2.3 · χ² 105 / p 7e-25 | 2.2 EB05 2.0 · IC025 +0.9 | Reporting / coding artifact | serious PRR 0.4 · 97% consumer | 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 Nicotine Polacrilex Gum?
In FDA FAERS, the most frequently co-reported reaction terms for Nicotine Polacrilex Gum are nausea, macular degeneration, oral discomfort, dyspepsia, malaise, throat irritation. 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 Nicotine Polacrilex Gum have an FDA boxed warning?
No. The FDA label retrieved for Nicotine Polacrilex Gum has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Nicotine Polacrilex Gum 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 e4e3fd5f-1ed1-4a18-9c31-7224cae77ded, effective 20241003; matched on
openfda.generic_name.exact:"NICOTINE POLACRILEX GUM") - 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, 115 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.