Nicotine side effects: what 40,197 FDA adverse event reports show

Nicotine · 1,201 reaction terms · 131,132 drug–reaction co-reports · data 2026-09-14

Drug class

Cholinergic Nicotinic Agonist

FDA label (Established Pharmacologic Class) · compare the class

Who reports

40,197 reports · 36% serious · 1,858 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

Likely indication confounding 2Reporting / coding artifact 1Not in label — unassessed 37

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). 1,161 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	186	823.5 653.2–1,038.2ROR 827.3 · calibrated p 5e-16 ✓	306.9 EB05 271.6 · IC025 +7.2 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.8 (4.9–6.8)	Not in label — unassessed	serious n=186 · ♀ 100% (drug 62%)	no trial arm names this drug
Plethysmography	16	821.7 372.9–1,810.7ROR 822.1 · calibrated p 7e-13 ✓	230.0 EB05 150.1 · IC025 +4.1 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 6.3 (3.5–11.2)	Not in label — unassessed	serious n=16	no trial arm names this drug
Rhesus incompatibility	68	658.9 460.2–943.5ROR 660.1 · calibrated p 2e-14 ✓	267.5 EB05 218.2 · IC025 +6.1 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
Application site bruising	33	605.3 365.9–1,001.5ROR 605.8 · calibrated p 2e-13 ✓	239.8 EB05 178.7 · IC025 +5.2 3/3 methods agree vs other Cholinergic Nicotinic Agonists: only this drug	Not in label — unassessed	♀ 100% (drug 62%) · 100% consumer	no trial arm names this drug
Tobacco poisoning	58	595.8 408.2–869.5ROR 596.6 · calibrated p 6e-14 ✓	253.3 EB05 203.2 · IC025 +5.9 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 8.9 (6.5–12.2)	Not in label — unassessed	serious n=46	no trial arm names this drug
Truncus arteriosus persistent	77	324.2 243.7–431.1ROR 324.8 · calibrated p 1e-11 ✓	189.8 EB05 156.8 · IC025 +6.1 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.7 (4.4–7.4)	Not in label — unassessed	serious n=77 · ♀ 100% (drug 62%) · 100% clinician	no trial arm names this drug
Nicotine dependence	2,751	281.8 269.3–294.9ROR 302.4 · calibrated p 9e-12 ✓	182.1 EB05 176.4 · IC025 +7.4 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 8.2 (7.8–8.5)	Likely indication confounding shares a disease stem with the indications wording	serious n=428 · 95% consumer	no trial arm names this drug
Application site hyperaesthesia	28	202.5 130.8–313.6ROR 202.7 · calibrated p 2e-9 ✓	132.6 EB05 96.3 · IC025 +4.7 3/3 methods agree vs other Cholinergic Nicotinic Agonists: only this drug	Not in label — unassessed	100% consumer	no trial arm names this drug
Application site dermatitis	248	187.3 162.0–216.6ROR 188.5 · calibrated p 8e-10 ✓	136.1 EB05 122.5 · IC025 +6.5 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 111.0 (78.6–156.7)	Not in label — unassessed	serious n=20 · 96% consumer	no trial arm names this drug
Application site urticaria	445	127.7 115.1–141.6ROR 129.1 · calibrated p 2e-8 ✓	102.0 EB05 94.3 · IC025 +6.4 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 59.4 (48.7–72.5)	Not in label — unassessed	serious n=20 · 98% consumer	no trial arm names this drug
Myocardial stunning	25	118.9 77.0–183.7ROR 119.0 · calibrated p 1e-7 ✓	90.2 EB05 64.3 · IC025 +4.4 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.7 (3.6–9.1)	Not in label — unassessed	serious n=25 · ♀ 100% (drug 62%) · 100% clinician	no trial arm names this drug
Application site papules	183	109.5 93.4–128.5ROR 110.0 · calibrated p 6e-8 ✓	89.6 EB05 79.3 · IC025 +5.9 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 104.5 (70.6–154.5)	Not in label — unassessed	♀ 84% (drug 62%) · 100% consumer	no trial arm names this drug
Rib deformity	44	108.1 78.1–149.6ROR 108.2 · calibrated p 1e-7 ✓	86.2 EB05 66.9 · IC025 +5.0 3/3 methods agree vs other Cholinergic Nicotinic Agonists: only this drug	Not in label — unassessed	serious n=44 · ♀ 100% (drug 62%)	no trial arm names this drug
Application site perspiration	30	107.7 72.7–159.7ROR 107.8 · calibrated p 2e-7 ✓	84.6 EB05 62.1 · IC025 +4.6 3/3 methods agree vs other Cholinergic Nicotinic Agonists: only this drug	Not in label — unassessed	100% consumer	no trial arm names this drug
Tobacco interaction	17	92.9 55.4–155.7ROR 92.9 · calibrated p 1e-6 ✓	72.6 EB05 48.0 · IC025 +3.8 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.9 (3.4–10.2)	Not in label — unassessed	serious n=16	no trial arm names this drug
Application site pruritus	3,069	81.5 78.6–84.6ROR 88.2 · calibrated p 3e-7 ✓	70.5 EB05 68.4 · IC025 +6.1 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 40.9 (38.3–43.6)	Not in label — unassessed	serious n=87 · 99% consumer	no trial arm names this drug
Application site swelling	659	79.2 73.0–86.0ROR 80.5 · calibrated p 6e-7 ✓	68.7 EB05 64.4 · IC025 +5.9 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 58.0 (49.4–68.2)	Not in label — unassessed	serious n=19 · 99% consumer	no trial arm names this drug
Application site reaction	903	76.0 70.9–81.5ROR 77.8 · calibrated p 7e-7 ✓	66.3 EB05 62.7 · IC025 +5.9 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 63.9 (55.4–73.7)	Not in label — unassessed	serious n=46 · 98% consumer	no trial arm names this drug
Application site warmth	162	75.5 64.0–89.0ROR 75.8 · calibrated p 1e-6 ✓	65.5 EB05 57.4 · IC025 +5.5 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 49.7 (36.5–67.6)	Not in label — unassessed	♀ 85% (drug 62%) · 100% consumer	no trial arm names this drug
Tobacco abuse	67	73.7 57.0–95.2ROR 73.8 · calibrated p 1e-6 ✓	63.5 EB05 51.7 · IC025 +5.1 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 6.8 (5.1–9.0)	Reporting / coding artifact	serious n=61	no trial arm names this drug
Lung diffusion disorder	19	71.2 44.1–115.1ROR 71.3 · calibrated p 4e-6 ✓	59.1 EB05 40.0 · IC025 +3.8 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.8 (3.5–9.8)	Not in label — unassessed	serious n=19	no trial arm names this drug
Application site erythema	3,142	70.7 68.2–73.3ROR 76.6 · calibrated p 8e-7 ✓	62.2 EB05 60.4 · IC025 +5.9 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 41.3 (38.8–44.1)	Not in label — unassessed	serious n=117 · 99% consumer	no trial arm names this drug
Tobacco withdrawal symptoms	21	70.0 44.4–110.5ROR 70.1 · calibrated p 4e-6 ✓	58.6 EB05 40.5 · IC025 +3.9 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 24.8 (12.6–48.8)	Likely indication confounding shares a disease stem with the indications wording	–	no trial arm names this drug
Female genital tract fistula	190	64.7 55.6–75.2ROR 65.0 · calibrated p 3e-6 ✓	57.2 EB05 50.7 · IC025 +5.4 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.8 (4.9–6.8)	Not in label — unassessed	serious n=190 · ♀ 100% (drug 62%)	no trial arm names this drug
Application site paraesthesia	118	51.6 42.7–62.3ROR 51.7 · calibrated p 1e-5 ✓	46.6 EB05 40.0 · IC025 +5.0 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 114.9 (69.1–191.0)	Not in label — unassessed	100% consumer	no trial arm names this drug
Application site irritation	1,108	50.9 47.9–54.1ROR 52.3 · calibrated p 1e-5 ✓	46.4 EB05 44.1 · IC025 +5.4 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 47.2 (42.0–52.9)	Not in label — unassessed	serious n=39 · 98% consumer	no trial arm names this drug
Reversible airways obstruction	43	47.5 34.8–64.9ROR 47.5 · calibrated p 3e-5 ✓	42.8 EB05 33.1 · IC025 +4.4 3/3 methods agree vs other Cholinergic Nicotinic Agonists: only this drug	Not in label — unassessed	serious n=43 · ♀ 100% (drug 62%)	no trial arm names this drug
Oral mucosal discolouration	52	44.5 33.5–59.1ROR 44.6 · calibrated p 4e-5 ✓	40.5 EB05 32.1 · IC025 +4.4 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 13.5 (9.3–19.4)	Not in label — unassessed	100% consumer	no trial arm names this drug
Cardiac septal defect	57	44.5 33.9–58.3ROR 44.6 · calibrated p 4e-5 ✓	40.5 EB05 32.4 · IC025 +4.5 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.8 (4.3–7.9)	Not in label — unassessed	serious n=57 · 100% clinician	no trial arm names this drug
Application site rash	1,047	42.8 40.2–45.5ROR 43.9 · calibrated p 3e-5 ✓	39.5 EB05 37.6 · IC025 +5.2 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 22.6 (20.6–24.8)	Not in label — unassessed	serious n=41 · 97% consumer	no trial arm names this drug
Neutropenia neonatal	17	42.4 25.8–69.5ROR 42.4 · calibrated p 1e-4 ✓	37.7 EB05 24.9 · IC025 +3.4 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 6.1 (3.5–10.7)	Not in label — unassessed	serious n=17	no trial arm names this drug
Tremor neonatal	33	41.2 28.9–58.8ROR 41.3 · calibrated p 7e-5 ✓	37.5 EB05 27.9 · IC025 +4.0 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.7 (3.8–8.5)	Not in label — unassessed	serious n=33 · ♀ 0% (drug 62%)	no trial arm names this drug
Radiculopathy	189	40.2 34.7–46.6ROR 40.4 · calibrated p 5e-5 ✓	37.2 EB05 33.0 · IC025 +4.9 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.8 (4.9–6.8)	Not in label — unassessed	serious n=189 · ♀ 100% (drug 62%)	no trial arm names this drug
Application site bleeding	18	40.2 24.9–64.9ROR 40.2 · calibrated p 1e-4 ✓	36.1 EB05 24.1 · IC025 +3.4 3/3 methods agree vs other Cholinergic Nicotinic Agonists: only this drug	Not in label — unassessed	–	no trial arm names this drug
Congenital cardiovascular anomaly	60	39.6 30.4–51.4ROR 39.6 · calibrated p 7e-5 ✓	36.4 EB05 29.3 · IC025 +4.4 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.8 (4.3–7.8)	Not in label — unassessed	serious n=60 · ♀ 100% (drug 62%) · 100% clinician	no trial arm names this drug
Chronic sinusitis	261	39.0 34.4–44.2ROR 39.2 · calibrated p 6e-5 ✓	36.2 EB05 32.7 · IC025 +4.9 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.9 (5.1–6.8)	Not in label — unassessed	serious n=260 · ♀ 100% (drug 62%)	no trial arm names this drug
Macular degeneration	828	38.9 36.3–41.7ROR 39.7 · calibrated p 6e-5 ✓	36.2 EB05 34.2 · IC025 +5.0 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 6.5 (6.0–7.1)	Not in label — unassessed	serious PRR 63.1 · ♀ 100% (drug 62%)	no trial arm names this drug
Multiple drug overdose accidental	32	38.6 26.9–55.2ROR 38.6 · calibrated p 1e-4 ✓	35.3 EB05 26.2 · 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 62%) · 100% clinician	no trial arm names this drug
Proctitis	191	38.1 32.9–44.1ROR 38.2 · calibrated p 7e-5 ✓	35.4 EB05 31.4 · IC025 +4.8 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.7 (4.9–6.8)	Not in label — unassessed	serious n=191 · ♀ 100% (drug 62%)	no trial arm names this drug
Poor feeding infant	70	36.5 28.6–46.5ROR 36.6 · calibrated p 1e-4 ✓	33.9 EB05 27.7 · IC025 +4.4 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.4 (4.1–7.1)	Not in label — unassessed	serious n=70 · ♀ 36% (drug 62%)	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Nicotine only as a background or rescue medication (NCT00461630, NCT06177795); 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)	5,266	2.1 2.0–2.1ROR 2.3 · calibrated p 0.925	2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 10.1 (9.8–10.4)	Reporting / coding artifact	serious PRR 2.5 · 83% consumer	no trial arm names this drug
Nausea	3,270	2.2 2.1–2.2ROR 2.3 · calibrated p 0.918	2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 10.9 (10.4–11.3)	Labeled adverse reaction exact term	serious PRR 2.2 · 80% consumer	no trial arm names this drug
Application site erythema	3,142	70.7 68.2–73.3ROR 76.6 · calibrated p 8e-7 ✓	62.2 EB05 60.4 · IC025 +5.9 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 41.3 (38.8–44.1)	Not in label — unassessed	serious n=117 · 99% consumer	no trial arm names this drug
Application site pruritus	3,069	81.5 78.6–84.6ROR 88.2 · calibrated p 3e-7 ✓	70.5 EB05 68.4 · IC025 +6.1 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 40.9 (38.3–43.6)	Not in label — unassessed	serious n=87 · 99% consumer	no trial arm names this drug
Nicotine dependence	2,751	281.8 269.3–294.9ROR 302.4 · calibrated p 9e-12 ✓	182.1 EB05 176.4 · IC025 +7.4 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 8.2 (7.8–8.5)	Likely indication confounding shares a disease stem with the indications wording	serious n=428 · 95% consumer	no trial arm names this drug
Dizziness	1,910	2.0 1.9–2.1ROR 2.1 · calibrated p 0.974	2.0 EB05 1.9 · IC025 +0.9 vs other Cholinergic Nicotinic Agonists: PRR 13.0 (12.2–13.7)	Labeled adverse reaction exact term	serious PRR 1.9 · 87% consumer	no trial arm names this drug
Headache	1,645	1.4 1.3–1.4ROR 1.4 · calibrated p 0.567	1.4 EB05 1.3 · IC025 +0.4 vs other Cholinergic Nicotinic Agonists: PRR 10.1 (9.5–10.7)	Not in label — unassessed	serious PRR 2.0 · 75% consumer	no trial arm names this drug
Malaise (feeling unwell)	1,636	1.9 1.9–2.0ROR 2.0 · calibrated p 0.936	1.9 EB05 1.9 · IC025 +0.9 vs other Cholinergic Nicotinic Agonists: PRR 10.1 (9.5–10.7)	Not in label — unassessed	serious PRR 2.1 · 76% consumer	no trial arm names this drug
Wrong technique in product usage process	1,257	3.3 3.1–3.4ROR 3.3 · calibrated p 0.528	3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 11.3 (10.6–12.2)	Reporting / coding artifact	serious PRR 1.9 · 97% consumer	no trial arm names this drug
Vomiting	1,256	1.4 1.3–1.5ROR 1.4 · calibrated p 0.583	1.4 EB05 1.3 · IC025 +0.4 vs other Cholinergic Nicotinic Agonists: PRR 10.5 (9.8–11.3)	Labeled adverse reaction exact term	serious PRR 1.4 · 77% consumer	no trial arm names this drug
Dyspnoea (shortness of breath)	1,158	1.1 1.0–1.1ROR 1.1 · calibrated p 0.353	1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC vs other Cholinergic Nicotinic Agonists: PRR 8.9 (8.3–9.5)	Not in label — unassessed	serious PRR 1.7	no trial arm names this drug
Insomnia (trouble sleeping)	1,115	2.2 2.1–2.3ROR 2.2 · calibrated p 0.942	2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 13.5 (12.5–14.6)	Labeled (related wording) related wording	serious PRR 2.3 · 84% consumer	no trial arm names this drug
Application site irritation	1,108	50.9 47.9–54.1ROR 52.3 · calibrated p 1e-5 ✓	46.4 EB05 44.1 · IC025 +5.4 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 47.2 (42.0–52.9)	Not in label — unassessed	serious n=39 · 98% consumer	no trial arm names this drug
Overdose	1,083	2.6 2.5–2.8ROR 2.7 · calibrated p 0.748	2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree vs other Cholinergic Nicotinic Agonists: PRR 5.9 (5.5–6.3)	Reporting / coding artifact	serious PRR 3.0	no trial arm names this drug
Anxiety	1,080	2.0 1.9–2.1ROR 2.0 · calibrated p 0.947	2.0 EB05 1.9 · IC025 +0.9 vs other Cholinergic Nicotinic Agonists: PRR 9.9 (9.2–10.6)	Not in label — unassessed	serious PRR 2.8 · 76% 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=186, PRR 823.5
Rhesus incompatibility — n=68, PRR 658.9
Application site bruising — n=33, PRR 605.3
Tobacco poisoning — n=58, PRR 595.8
Truncus arteriosus persistent — n=77, PRR 324.2
Application site hyperaesthesia — n=28, PRR 202.5
Application site dermatitis — n=248, PRR 187.3
Application site urticaria — n=445, PRR 127.7
Myocardial stunning — n=25, PRR 118.9
Application site papules — n=183, PRR 109.5

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?

In FDA FAERS, the most frequently co-reported reaction terms for Nicotine are nausea, application site erythema, application site pruritus, nicotine dependence, dizziness, 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 Nicotine have an FDA boxed warning?

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

Do FAERS signals prove that Nicotine 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 13cdd780-4196-685b-3cab-f9694a327618, effective 20240725; matched on openfda.generic_name.exact:"NICOTINE")
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, 1,201 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, 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.