Nicotine Polacrilex side effects: what 38,030 FDA adverse event reports show

Nicotine Polacrilex · Nicotine · 1,194 reaction terms · 112,634 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

38,030 reports · 37% serious · 1,709 with death outcome · 58% 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 2Reporting / coding artifact 3Not in label — unassessed 35

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.
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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,154 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	180	801.0 636.7–1,007.8ROR 804.8 · calibrated p 7e-16 ✓	313.4 EB05 276.8 · IC025 +7.2 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.5 (4.7–6.5)	Not in label — unassessed	serious n=180 · ♀ 100% (drug 58%)	no trial arm names this drug
Rhesus incompatibility	68	696.6 486.5–997.4ROR 697.8 · calibrated p 1e-14 ✓	281.5 EB05 229.7 · IC025 +6.2 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.5 (4.2–7.3)	Not in label — unassessed	serious n=68	no trial arm names this drug
Plethysmography	14	633.4 293.0–1,369.4ROR 633.6 · calibrated p 5e-12 ✓	209.5 EB05 132.6 · IC025 +3.8 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.3 (2.9–9.6)	Not in label — unassessed	serious n=14	no trial arm names this drug
Nicotine dependence	4,155	624.9 598.3–652.6ROR 701.4 · calibrated p 1e-15 ✓	290.7 EB05 283.3 · IC025 +8.1 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 16.5 (15.8–17.1)	Likely indication confounding shares a disease stem with the indications wording	serious n=766 · 95% consumer	no trial arm names this drug
Tobacco poisoning	48	434.3 297.2–634.8ROR 434.9 · calibrated p 1e-12 ✓	220.6 EB05 173.0 · IC025 +5.6 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 6.7 (4.8–9.4)	Not in label — unassessed	serious n=42	no trial arm names this drug
Truncus arteriosus persistent	74	321.4 241.2–428.4ROR 322.0 · calibrated p 1e-11 ✓	192.3 EB05 158.2 · IC025 +6.0 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.4 (4.2–7.1)	Not in label — unassessed	serious n=74 · 92% clinician	no trial arm names this drug
Myocardial stunning	24	119.5 76.9–186.0ROR 119.6 · calibrated p 1e-7 ✓	91.2 EB05 64.5 · IC025 +4.4 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.4 (3.4–8.6)	Not in label — unassessed	serious n=24 · ♀ 100% (drug 58%) · 100% clinician	no trial arm names this drug
Intentional drug misuse	3,482	108.3 104.6–112.2ROR 119.2 · calibrated p 3e-8 ✓	90.4 EB05 87.9 · IC025 +6.4 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 46.6 (43.8–49.7)	Reporting / coding artifact	serious PRR 43.2 · 96% consumer	no trial arm names this drug
Tobacco interaction	16	91.4 53.8–155.3ROR 91.5 · calibrated p 1e-6 ✓	71.9 EB05 47.0 · IC025 +3.7 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.4 (3.1–9.5)	Not in label — unassessed	serious n=15	no trial arm names this drug
Tobacco abuse	64	73.9 57.0–96.0ROR 74.1 · calibrated p 1e-6 ✓	64.0 EB05 51.9 · IC025 +5.0 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 6.3 (4.8–8.5)	Reporting / coding artifact	serious n=56	no trial arm names this drug
Lung diffusion disorder	18	70.8 43.3–115.7ROR 70.8 · calibrated p 5e-6 ✓	59.0 EB05 39.5 · IC025 +3.8 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.4 (3.2–9.2)	Not in label — unassessed	serious n=18	no trial arm names this drug
Female genital tract fistula	184	65.9 56.6–76.8ROR 66.3 · calibrated p 2e-6 ✓	58.6 EB05 51.8 · IC025 +5.4 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.5 (4.7–6.5)	Not in label — unassessed	serious n=184 · ♀ 100% (drug 58%)	no trial arm names this drug
Oral mucosal discolouration	64	59.1 45.7–76.5ROR 59.2 · calibrated p 6e-6 ✓	52.6 EB05 42.6 · IC025 +4.8 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 20.4 (14.1–29.4)	Not in label — unassessed	100% consumer	no trial arm names this drug
Tobacco withdrawal symptoms	14	47.2 27.3–81.5ROR 47.2 · calibrated p 7e-5 ✓	41.3 EB05 26.1 · IC025 +3.2 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 11.0 (5.6–21.7)	Likely indication confounding shares a disease stem with the indications wording	–	no trial arm names this drug
Hiccups	615	44.9 41.4–48.7ROR 45.6 · calibrated p 2e-5 ✓	41.5 EB05 38.8 · IC025 +5.2 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 27.2 (23.9–30.9)	Not in label — unassessed	serious n=35 · 98% consumer	no trial arm names this drug
Cardiac septal defect	54	44.4 33.6–58.5ROR 44.4 · calibrated p 4e-5 ✓	40.5 EB05 32.2 · IC025 +4.5 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.4 (4.0–7.4)	Not in label — unassessed	serious n=54 · 100% clinician	no trial arm names this drug
Poor feeding infant	77	42.7 33.9–53.9ROR 42.8 · calibrated p 4e-5 ✓	39.3 EB05 32.5 · IC025 +4.6 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 6.1 (4.7–8.0)	Not in label — unassessed	serious n=77	no trial arm names this drug
Tremor neonatal	32	42.2 29.4–60.4ROR 42.2 · calibrated p 6e-5 ✓	38.4 EB05 28.5 · IC025 +4.0 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.5 (3.7–8.1)	Not in label — unassessed	serious n=32 · ♀ 0% (drug 58%)	no trial arm names this drug
Neutropenia neonatal	16	42.0 25.2–69.8ROR 42.0 · calibrated p 1e-4 ✓	37.4 EB05 24.4 · IC025 +3.3 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.6 (3.2–9.9)	Not in label — unassessed	serious n=16	no trial arm names this drug
Radiculopathy	183	41.1 35.3–47.7ROR 41.2 · calibrated p 5e-5 ✓	38.1 EB05 33.7 · IC025 +4.9 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.5 (4.7–6.5)	Not in label — unassessed	serious n=183 · ♀ 100% (drug 58%)	no trial arm names this drug
Multiple drug overdose accidental	32	40.8 28.5–58.4ROR 40.8 · calibrated p 8e-5 ✓	37.2 EB05 27.6 · IC025 +4.0 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.5 (3.7–8.2)	Not in label — unassessed	serious n=32 · ♀ 31% (drug 58%) · 100% clinician	no trial arm names this drug
Chronic sinusitis	252	39.7 35.0–45.1ROR 40.0 · calibrated p 6e-5 ✓	37.0 EB05 33.3 · IC025 +4.9 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.6 (4.9–6.5)	Not in label — unassessed	serious n=251 · ♀ 100% (drug 58%)	no trial arm names this drug
Congenital cardiovascular anomaly	57	39.6 30.2–51.8ROR 39.6 · calibrated p 7e-5 ✓	36.5 EB05 29.3 · IC025 +4.4 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.4 (4.0–7.3)	Not in label — unassessed	serious n=57 · 100% clinician	no trial arm names this drug
Macular degeneration	797	39.5 36.8–42.4ROR 40.3 · calibrated p 5e-5 ✓	36.8 EB05 34.7 · IC025 +5.1 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 6.2 (5.7–6.7)	Not in label — unassessed	serious PRR 61.7 · ♀ 100% (drug 58%)	no trial arm names this drug
Proctitis	185	38.9 33.5–45.1ROR 39.1 · calibrated p 7e-5 ✓	36.2 EB05 32.1 · IC025 +4.8 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.5 (4.7–6.5)	Not in label — unassessed	serious n=185 · ♀ 100% (drug 58%)	no trial arm names this drug
Saliva discolouration	21	37.4 24.0–58.2ROR 37.4 · calibrated p 2e-4 ✓	34.1 EB05 23.5 · IC025 +3.6 3/3 methods agree vs other Cholinergic Nicotinic Agonists: only this drug	Not in label — unassessed	–	no trial arm names this drug
Tooth erosion	62	31.7 24.5–40.9ROR 31.7 · calibrated p 2e-4 ✓	29.7 EB05 24.0 · IC025 +4.2 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 8.0 (5.9–10.8)	Not in label — unassessed	serious n=43	no trial arm names this drug
Oral discomfort	744	31.1 28.9–33.5ROR 31.7 · calibrated p 2e-4 ✓	29.4 EB05 27.7 · IC025 +4.7 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 25.8 (23.0–28.9)	Not in label — unassessed	serious n=36 · 100% consumer	no trial arm names this drug
Idiopathic interstitial pneumonia	18	30.4 18.9–48.8ROR 30.4 · calibrated p 5e-4 ✓	28.0 EB05 18.7 · IC025 +3.2 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.4 (3.2–9.2)	Not in label — unassessed	serious n=18	no trial arm names this drug
Drug abuser	321	29.9 26.7–33.5ROR 30.2 · calibrated p 3e-4 ✓	28.4 EB05 25.9 · IC025 +4.6 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 31.8 (26.4–38.3)	Not in label — unassessed	serious n=216 · 88% consumer	no trial arm names this drug
Tooth discolouration	152	29.8 25.3–35.0ROR 29.9 · calibrated p 3e-4 ✓	28.2 EB05 24.6 · IC025 +4.4 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 23.3 (18.2–29.8)	Not in label — unassessed	100% consumer	no trial arm names this drug
Jaundice neonatal	96	29.3 23.9–36.0ROR 29.4 · calibrated p 3e-4 ✓	27.7 EB05 23.4 · IC025 +4.3 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.5 (4.4–6.9)	Not in label — unassessed	serious n=96	no trial arm names this drug
Mediastinal mass	18	27.5 17.1–44.2ROR 27.5 · calibrated p 8e-4 ✓	25.6 EB05 17.1 · IC025 +3.2 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.3 (3.1–9.0)	Not in label — unassessed	serious n=18	no trial arm names this drug
Adenoidectomy	18	27.0 16.8–43.3ROR 27.0 · calibrated p 9e-4 ✓	25.1 EB05 16.8 · IC025 +3.2 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.4 (3.2–9.2)	Not in label — unassessed	serious n=18	no trial arm names this drug
Gingival blister	20	26.0 16.6–40.7ROR 26.0 · calibrated p 1e-3 ✓	24.3 EB05 16.6 · IC025 +3.2 3/3 methods agree vs other Cholinergic Nicotinic Agonists: only this drug	Not in label — unassessed	100% consumer	no trial arm names this drug
Necrosis ischaemic	20	24.8 15.9–38.9ROR 24.9 · calibrated p 0.001 ✓	23.3 EB05 15.9 · IC025 +3.2 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.5 (3.3–9.2)	Not in label — unassessed	serious n=20 · ♀ 100% (drug 58%)	no trial arm names this drug
Gingival discomfort	27	23.7 16.1–34.8ROR 23.7 · calibrated p 0.001 ✓	22.4 EB05 16.1 · IC025 +3.4 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 26.3 (14.3–48.2)	Not in label — unassessed	100% consumer	no trial arm names this drug
Pulmonary eosinophilia	19	23.6 14.9–37.4ROR 23.6 · calibrated p 0.002 ✓	22.2 EB05 14.9 · IC025 +3.1 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.4 (3.2–9.1)	Not in label — unassessed	serious n=18	no trial arm names this drug
Breech presentation	49	22.3 16.8–29.7ROR 22.3 · calibrated p 0.001 ✓	21.3 EB05 16.7 · IC025 +3.7 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.5 (4.0–7.6)	Not in label — unassessed	serious n=49 · ♀ 35% (drug 58%)	no trial arm names this drug
Drug administration error	1,202	22.1 20.9–23.4ROR 22.8 · calibrated p 0.001 ✓	21.3 EB05 20.3 · IC025 +4.3 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 26.9 (24.6–29.4)	Reporting / coding artifact	serious PRR 10.7 · 97% consumer	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Nicotine Polacrilex only as a background or rescue medication (NCT01456936); 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)	5,020	2.1 2.1–2.2ROR 2.3 · calibrated p 0.915	2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 9.3 (9.0–9.6)	Reporting / coding artifact	serious PRR 2.3 · 85% consumer	no trial arm names this drug
Nicotine dependence	4,155	624.9 598.3–652.6ROR 701.4 · calibrated p 1e-15 ✓	290.7 EB05 283.3 · IC025 +8.1 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 16.5 (15.8–17.1)	Likely indication confounding shares a disease stem with the indications wording	serious n=766 · 95% consumer	no trial arm names this drug
Intentional drug misuse	3,482	108.3 104.6–112.2ROR 119.2 · calibrated p 3e-8 ✓	90.4 EB05 87.9 · IC025 +6.4 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 46.6 (43.8–49.7)	Reporting / coding artifact	serious PRR 43.2 · 96% consumer	no trial arm names this drug
Nausea	2,945	2.1 2.0–2.1ROR 2.2 · calibrated p 0.976	2.1 EB05 2.0 · IC025 +1.0 vs other Cholinergic Nicotinic Agonists: PRR 9.2 (8.8–9.6)	Labeled adverse reaction exact term	serious PRR 2.0 · 80% consumer	no trial arm names this drug
Malaise (feeling unwell)	1,522	1.9 1.8–2.0ROR 1.9 · calibrated p 0.916	1.9 EB05 1.8 · IC025 +0.8 vs other Cholinergic Nicotinic Agonists: PRR 9.0 (8.5–9.6)	Not in label — unassessed	serious PRR 2.0 · 76% consumer	no trial arm names this drug
Dizziness	1,339	1.5 1.4–1.6ROR 1.5 · calibrated p 0.643	1.5 EB05 1.4 · IC025 +0.5 vs other Cholinergic Nicotinic Agonists: PRR 7.4 (6.9–7.8)	Labeled adverse reaction exact term	serious PRR 1.7 · 82% consumer	no trial arm names this drug
Headache	1,303	1.1 1.1–1.2ROR 1.2 · calibrated p 0.408	1.1 EB05 1.1 · IC025 +0.1 vs other Cholinergic Nicotinic Agonists: PRR 7.1 (6.6–7.5)	Not in label — unassessed	serious PRR 1.8 · 72% consumer	no trial arm names this drug
Drug administration error	1,202	22.1 20.9–23.4ROR 22.8 · calibrated p 0.001 ✓	21.3 EB05 20.3 · IC025 +4.3 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 26.9 (24.6–29.4)	Reporting / coding artifact	serious PRR 10.7 · 97% consumer	no trial arm names this drug
Overdose	1,144	2.9 2.8–3.1ROR 3.0 · calibrated p 0.633	2.9 EB05 2.8 · IC025 +1.4 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 6.4 (6.0–6.8)	Reporting / coding artifact	serious PRR 3.6	no trial arm names this drug
Vomiting	1,110	1.3 1.2–1.4ROR 1.3 · calibrated p 0.518	1.3 EB05 1.2 · IC025 +0.3 vs other Cholinergic Nicotinic Agonists: PRR 8.6 (8.0–9.3)	Labeled adverse reaction exact term	serious PRR 1.2 · 77% consumer	no trial arm names this drug
Product quality issue	1,109	4.6 4.3–4.8ROR 4.7 · calibrated p 0.274	4.5 EB05 4.3 · IC025 +2.1 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 6.7 (6.2–7.2)	Reporting / coding artifact	serious PRR 2.5 · 97% consumer	no trial arm names this drug
Wrong technique in product usage process	959	2.6 2.5–2.8ROR 2.7 · calibrated p 0.745	2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 7.4 (6.9–8.0)	Reporting / coding artifact	serious PRR 2.2 · 96% consumer	no trial arm names this drug
Dyspnoea (shortness of breath)	942	0.9 0.9–1.0ROR 0.9 · calibrated p 0.253	0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC vs other Cholinergic Nicotinic Agonists: PRR 6.6 (6.1–7.1)	Not in label — unassessed	serious PRR 1.4	no trial arm names this drug
Drug dependence	891	3.0 2.8–3.2ROR 3.1 · calibrated p 0.601	3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 9.9 (9.2–10.8)	Reporting / coding artifact	serious PRR 4.7	no trial arm names this drug
Dyspepsia (indigestion)	844	4.8 4.5–5.1ROR 4.9 · calibrated p 0.251	4.7 EB05 4.5 · IC025 +2.1 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 10.5 (9.6–11.4)	Not in label — unassessed	serious PRR 5.7 · 73% consumer	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=180, PRR 801.0
Rhesus incompatibility — n=68, PRR 696.6
Tobacco poisoning — n=48, PRR 434.3
Truncus arteriosus persistent — n=74, PRR 321.4
Myocardial stunning — n=24, PRR 119.5
Female genital tract fistula — n=184, PRR 65.9
Oral mucosal discolouration — n=64, PRR 59.1
Hiccups — n=615, PRR 44.9
Cardiac septal defect — n=54, PRR 44.4
Poor feeding infant — n=77, PRR 42.7

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?

In FDA FAERS, the most frequently co-reported reaction terms for Nicotine Polacrilex are nicotine dependence, nausea, malaise, dizziness, headache, vomiting. 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 have an FDA boxed warning?

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

Do FAERS signals prove that Nicotine Polacrilex 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 00b40bb3-3785-4a53-804e-633795e87f71, effective 20260720; matched on openfda.generic_name.exact:"NICOTINE POLACRILEX")
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, 1,194 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, results-bearing studies sorted by enrollment)

Page generated 2026-10-14. 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.