Drug · FAERS side-effect profile with label screen
Nicotine Polacrilex Mini side effects: what 14,919 FDA adverse event reports show
Drug class
FDA label (Established Pharmacologic Class) · compare the class
Who reports
14,919 reports · 70% serious · 1,563 with death outcome · 57% 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 2Lab value / disease marker 1No label text to screen 37
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.
- 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.
- 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. 1,093 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 |
|---|---|---|---|---|---|---|
| Vaginal flatulence | 177 | 1,962.7 1,561.9–2,466.4ROR 1,986.3 · χ² 142,836 / p <1e-300 | 746.8 EB05 659.0 · IC025 +7.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=177 · ♀ 100% (drug 57%) | no trial arm names this drug |
| Rhesus incompatibility | 68 | 1,778.4 1,242.3–2,545.9ROR 1,786.5 · χ² 52,134 / p <1e-300 | 638.5 EB05 521.0 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=68 | no trial arm names this drug |
| Plethysmography | 14 | 1,617.1 748.1–3,495.7ROR 1,618.6 · χ² 9,703 / p <1e-300 | 369.2 EB05 233.8 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | no trial arm names this drug |
| Truncus arteriosus persistent | 74 | 820.6 615.8–1,093.4ROR 824.7 · χ² 37,536 / p <1e-300 | 454.9 EB05 374.3 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=74 · 92% clinician | no trial arm names this drug |
| Tobacco poisoning | 30 | 533.1 350.0–812.0ROR 534.2 · χ² 11,126 / p <1e-300 | 309.3 EB05 227.1 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=30 | no trial arm names this drug |
| Myocardial stunning | 24 | 305.2 196.2–474.7ROR 305.7 · χ² 5,717 / p <1e-300 | 208.9 EB05 147.7 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=24 · ♀ 100% (drug 57%) · 100% clinician | no trial arm names this drug |
| Tobacco interaction | 16 | 233.4 137.5–396.4ROR 233.7 · χ² 2,973 / p <1e-300 | 161.7 EB05 105.5 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=15 | no trial arm names this drug |
| Lung diffusion disorder | 18 | 180.8 110.7–295.4ROR 181.0 · χ² 2,690 / p <1e-300 | 137.1 EB05 91.7 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=18 | no trial arm names this drug |
| Female genital tract fistula | 181 | 165.3 141.8–192.7ROR 167.3 · χ² 26,260 / p <1e-300 | 145.5 EB05 128.6 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=181 · ♀ 100% (drug 57%) | no trial arm names this drug |
| Tobacco abuse | 50 | 143.2 107.1–191.5ROR 143.7 · χ² 6,271 / p <1e-300 | 123.8 EB05 97.6 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious n=47 | no trial arm names this drug |
| Nicotine dependence | 715 | 140.6 130.4–151.6ROR 147.6 · χ² 89,870 / p <1e-300 | 127.3 EB05 119.7 · IC025 +6.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=260 · 83% consumer | no trial arm names this drug |
| Cardiac septal defect | 54 | 113.2 85.8–149.4ROR 113.6 · χ² 5,450 / p <1e-300 | 101.1 EB05 80.4 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=54 · 92% clinician | no trial arm names this drug |
| Tremor neonatal | 32 | 107.7 75.2–154.2ROR 107.9 · χ² 3,039 / p <1e-300 | 94.5 EB05 70.1 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=32 · ♀ 0% (drug 57%) | no trial arm names this drug |
| Multiple drug overdose accidental | 32 | 104.1 72.7–149.1ROR 104.3 · χ² 2,945 / p <1e-300 | 91.8 EB05 68.0 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=32 · ♀ 31% (drug 57%) · 100% clinician | no trial arm names this drug |
| Radiculopathy | 180 | 103.0 88.6–119.7ROR 104.2 · χ² 16,827 / p <1e-300 | 95.0 EB05 83.9 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=180 · ♀ 100% (drug 57%) | no trial arm names this drug |
| Congenital cardiovascular anomaly | 57 | 101.0 77.2–132.1ROR 101.4 · χ² 5,169 / p <1e-300 | 91.4 EB05 73.2 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=57 · 93% clinician | no trial arm names this drug |
| Weight decrease neonatal | 13 | 100.1 57.0–175.7ROR 100.2 · χ² 1,099 / p 3e-241 | 82.5 EB05 51.3 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial arm names this drug |
| Neutropenia neonatal | 15 | 100.0 59.2–168.8ROR 100.1 · χ² 1,280 / p 1e-280 | 83.7 EB05 53.8 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=15 | no trial arm names this drug |
| Proctitis | 183 | 98.1 84.5–113.9ROR 99.3 · χ² 16,341 / p <1e-300 | 90.9 EB05 80.3 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=183 · ♀ 100% (drug 57%) | no trial arm names this drug |
| Poor feeding infant | 69 | 97.0 76.0–123.7ROR 97.4 · χ² 6,038 / p <1e-300 | 88.6 EB05 72.4 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=69 · ♀ 35% (drug 57%) | no trial arm names this drug |
| Chronic sinusitis | 239 | 95.8 84.1–109.1ROR 97.3 · χ² 20,881 / p <1e-300 | 89.0 EB05 79.9 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=238 · ♀ 100% (drug 57%) | no trial arm names this drug |
| Idiopathic interstitial pneumonia | 18 | 77.5 48.2–124.5ROR 77.6 · χ² 1,216 / p 1e-266 | 68.3 EB05 45.7 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=18 | no trial arm names this drug |
| Congenital tricuspid valve incompetence | 10 | 77.0 40.7–145.5ROR 77.1 · χ² 640 / p 1e-141 | 64.4 EB05 37.4 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial arm names this drug |
| Jaundice neonatal | 96 | 74.9 61.0–91.9ROR 75.4 · χ² 6,570 / p <1e-300 | 70.1 EB05 59.1 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=96 | no trial arm names this drug |
| Mediastinal mass | 18 | 70.3 43.8–112.8ROR 70.4 · χ² 1,105 / p 1e-242 | 62.7 EB05 42.0 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=18 | no trial arm names this drug |
| Macular degeneration | 563 | 69.7 64.1–75.7ROR 72.4 · χ² 36,247 / p <1e-300 | 66.3 EB05 61.8 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 58.6 · ♀ 100% (drug 57%) | no trial arm names this drug |
| Adenoidectomy | 18 | 68.9 42.9–110.6ROR 69.0 · χ² 1,084 / p 5e-238 | 61.6 EB05 41.2 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=18 | no trial arm names this drug |
| Necrosis ischaemic | 20 | 63.4 40.5–99.3ROR 63.5 · χ² 1,116 / p 5e-245 | 57.5 EB05 39.3 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=20 · ♀ 100% (drug 57%) | no trial arm names this drug |
| Pulmonary eosinophilia | 19 | 60.3 38.1–95.4ROR 60.3 · χ² 1,005 / p 7e-221 | 54.8 EB05 37.1 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=18 | no trial arm names this drug |
| Neonatal aspiration | 13 | 57.2 32.9–99.6ROR 57.3 · χ² 636 / p 1e-140 | 51.1 EB05 31.8 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | no trial arm names this drug |
| Breech presentation | 49 | 56.9 42.8–75.7ROR 57.1 · χ² 2,533 / p <1e-300 | 53.6 EB05 42.2 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=49 · ♀ 35% (drug 57%) | no trial arm names this drug |
| Postmortem blood drug level increased | 14 | 56.4 33.1–96.2ROR 56.5 · χ² 680 / p 4e-150 | 50.7 EB05 32.1 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious n=14 | no trial arm names this drug |
| Respiratory gas exchange disorder | 14 | 55.1 32.3–94.0ROR 55.2 · χ² 664 / p 8e-147 | 49.7 EB05 31.5 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | no trial arm names this drug |
| Substance dependence | 25 | 54.5 36.5–81.2ROR 54.6 · χ² 1,212 / p 8e-266 | 50.6 EB05 36.0 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=24 · ♀ 21% (drug 57%) | no trial arm names this drug |
| Sputum purulent | 24 | 52.8 35.1–79.4ROR 52.9 · χ² 1,126 / p 4e-247 | 49.0 EB05 34.7 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=24 · ♀ 100% (drug 57%) · 100% clinician | no trial arm names this drug |
| Tooth erosion | 40 | 51.1 37.3–70.0ROR 51.2 · χ² 1,847 / p <1e-300 | 48.3 EB05 37.0 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=34 | no trial arm names this drug |
| Exposure during breast feeding | 114 | 49.3 41.0–59.4ROR 49.7 · χ² 5,167 / p <1e-300 | 47.3 EB05 40.5 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=110 | no trial arm names this drug |
| Loss of proprioception | 11 | 49.2 27.0–89.7ROR 49.2 · χ² 456 / p 2e-101 | 44.2 EB05 26.3 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | no trial arm names this drug |
| Exposure via breast milk | 126 | 46.7 39.2–55.8ROR 47.1 · χ² 5,412 / p <1e-300 | 45.0 EB05 38.7 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious n=126 · ♀ 25% (drug 57%) | no trial arm names this drug |
| Foetal disorder | 27 | 46.4 31.6–68.0ROR 46.5 · χ² 1,116 / p 4e-245 | 43.6 EB05 31.5 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=26 | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Nicotine Polacrilex Mini only as a background or rescue medication (NCT01544153, NCT02721082); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.
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) | 1,517 | 1.6 1.5–1.7ROR 1.7 · χ² 383 / p 1e-85 | 1.6 EB05 1.6 · IC025 +0.6 | Reporting / coding artifact | serious PRR 2.1 | no trial arm names this drug |
| Nausea | 1,020 | 1.8 1.7–1.9ROR 1.9 · χ² 389 / p 7e-87 | 1.8 EB05 1.7 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | no trial arm names this drug |
| Overdose | 762 | 5.0 4.6–5.3ROR 5.2 · χ² 2,421 / p <1e-300 | 4.9 EB05 4.6 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 | no trial arm names this drug |
| Foetal exposure during pregnancy | 744 | 13.0 12.1–13.9ROR 13.6 · χ² 8,172 / p <1e-300 | 12.9 EB05 12.1 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 10.6 | no trial arm names this drug |
| Product adhesion issue | 727 | 29.4 27.4–31.6ROR 30.9 · χ² 19,544 / p <1e-300 | 28.8 EB05 27.1 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious n=21 · 96% consumer | no trial arm names this drug |
| Nicotine dependence | 715 | 140.6 130.4–151.6ROR 147.6 · χ² 89,870 / p <1e-300 | 127.3 EB05 119.7 · IC025 +6.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=260 · 83% consumer | no trial arm names this drug |
| Headache | 702 | 1.6 1.5–1.7ROR 1.6 · χ² 152 / p 3e-35 | 1.6 EB05 1.5 · IC025 +0.5 | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | no trial arm names this drug |
| Treatment noncompliance | 664 | 17.4 16.1–18.7ROR 18.1 · χ² 10,134 / p <1e-300 | 17.2 EB05 16.1 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 · 91% consumer | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 607 | 1.5 1.4–1.6ROR 1.5 · χ² 107 / p 3e-25 | 1.5 EB05 1.4 · IC025 +0.5 | No label text to screen label has no adverse-reaction text | serious PRR 1.5 | no trial arm names this drug |
| Toxicity to various agents | 596 | 5.0 4.6–5.4ROR 5.2 · χ² 1,915 / p <1e-300 | 5.0 EB05 4.6 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.2 · ♀ 34% (drug 57%) | no trial arm names this drug |
| Pain | 580 | 1.3 1.2–1.4ROR 1.3 · χ² 47 / p 3e-12 | 1.3 EB05 1.2 · IC025 +0.3 | No label text to screen label has no adverse-reaction text | serious PRR 1.5 | no trial arm names this drug |
| Malaise (feeling unwell) | 579 | 1.9 1.7–2.0ROR 1.9 · χ² 231 / p 2e-52 | 1.9 EB05 1.7 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 2.1 · ♀ 80% (drug 57%) | no trial arm names this drug |
| Macular degeneration | 563 | 69.7 64.1–75.7ROR 72.4 · χ² 36,247 / p <1e-300 | 66.3 EB05 61.8 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 58.6 · ♀ 100% (drug 57%) | no trial arm names this drug |
| Off label use (used outside approved label) | 553 | 0.9 0.8–1.0ROR 0.9 · χ² 7 / p 0.004 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.1 | no trial arm names this drug |
| Dizziness | 550 | 1.6 1.4–1.7ROR 1.6 · χ² 110 / p 4e-26 | 1.6 EB05 1.4 · IC025 +0.5 | No label text to screen label has no adverse-reaction text | serious PRR 1.7 | no trial arm names this drug |
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 Mini?
In FDA FAERS, the most frequently co-reported reaction terms for Nicotine Polacrilex Mini are nausea, nicotine dependence, headache, dyspnoea, toxicity to various agents, pain. 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 Mini have an FDA boxed warning?
No. The FDA label retrieved for Nicotine Polacrilex Mini has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Nicotine Polacrilex Mini 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 10ee6816-8155-d590-e063-6394a90a9dea, effective 20250502; matched on
openfda.generic_name.exact:"NICOTINE POLACRILEX MINI") - 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, 1,133 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 - ClinicalTrials.gov API v2 (query
NICOTINE POLACRILEX MINI, results-bearing studies sorted by enrollment)
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.