Nicotine Polarilex side effects: what 14,919 FDA adverse event reports show

Nicotine Polarilex · Nicotine · 1,133 reaction terms · 62,960 drug–reaction co-reports · data 2026-09-14

Drug class

Cholinergic Nicotinic Agonist

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Nicotine

openFDA label

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

Likely indication confounding 1Reporting / coding artifact 2Lab value / disease marker 1Not in label — unassessed 36

What the badges mean

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.
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.

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: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Likely indication confounding shares a disease stem with the indications wording	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	serious n=26	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Nicotine Polarilex (searched NICOTINE POLARILEX).

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	Labeled adverse reaction exact term	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	Likely indication confounding shares a disease stem with the indications wording	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Not in label — unassessed	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	Labeled adverse reaction exact term	serious PRR 1.7	no trial arm names this drug

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.

Vaginal flatulence — n=177, PRR 1,962.7
Rhesus incompatibility — n=68, PRR 1,778.4
Truncus arteriosus persistent — n=74, PRR 820.6
Tobacco poisoning — n=30, PRR 533.1
Myocardial stunning — n=24, PRR 305.2
Female genital tract fistula — n=181, PRR 165.3
Cardiac septal defect — n=54, PRR 113.2
Tremor neonatal — n=32, PRR 107.7
Multiple drug overdose accidental — n=32, PRR 104.1
Radiculopathy — n=180, PRR 103.0

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 Polarilex?

In FDA FAERS, the most frequently co-reported reaction terms for Nicotine Polarilex 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 Polarilex have an FDA boxed warning?

No. The FDA label retrieved for Nicotine Polarilex has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Nicotine Polarilex 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 9d9e95c7-f4c3-4a3b-9be5-43c1932f9f4d, effective 20260420; matched on openfda.generic_name.exact:"NICOTINE POLARILEX")
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, field patient.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 POLARILEX, 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.