Nicotine Transdermal System side effects: what 1,433 FDA adverse event reports show

Nicotine Transdermal System · 33 reaction terms · 777 drug–reaction co-reports · data 2026-09-14

Drug class

Cholinergic Nicotinic Agonist

FDA label (Established Pharmacologic Class) · compare the class

Who reports

1,433 reports · 28% serious · 42 with death outcome · 60% 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 18 strongest signals

Labeled (related wording) 1Likely indication confounding 1Reporting / coding artifact 7Not in label — unassessed 9

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 15 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
Product adhesion issue	199	82.3 72.3–93.7ROR 95.4 · χ² 15,839 / p <1e-300	81.2 EB05 72.2 · IC025 +5.9 3/3 methods agree	Reporting / coding artifact	serious n=3 · 97% consumer	no trial data cached
Application site pruritus	79	50.9 41.1–63.1ROR 53.8 · χ² 3,808 / p <1e-300	50.2 EB05 41.6 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious n=2 · 97% consumer	no trial data cached
Application site rash	40	42.4 31.2–57.6ROR 43.6 · χ² 1,572 / p <1e-300	41.5 EB05 31.8 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=2 · 92% consumer	no trial data cached
Application site pain	43	28.5 21.2–38.3ROR 29.4 · χ² 1,114 / p 2e-244	28.2 EB05 21.8 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=2 · 100% consumer	no trial data cached
Application site erythema	41	22.8 16.8–30.8ROR 23.4 · χ² 831 / p 6e-183	22.5 EB05 17.3 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	100% consumer	no trial data cached
Application site irritation	14	16.4 9.7–27.7ROR 16.6 · χ² 188 / p 6e-43	15.6 EB05 9.2 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Nightmare	32	13.4 9.5–18.9ROR 13.7 · χ² 356 / p 9e-80	13.1 EB05 9.4 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	97% consumer	no trial data cached
Economic problem	12	11.4 6.5–20.0ROR 11.4 · χ² 103 / p 1e-24	9.6 EB05 5.3 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 25.4	no trial data cached
Anhedonia	18	9.9 6.3–15.7ROR 10.0 · χ² 136 / p 1e-31	8.8 EB05 5.6 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 22.5	no trial data cached
Expired product administered	20	8.8 5.7–13.6ROR 8.9 · χ² 131 / p 2e-30	7.8 EB05 5.1 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	95% consumer	no trial data cached
Intentional product misuse	48	8.1 6.1–10.6ROR 8.3 · χ² 291 / p 2e-65	7.6 EB05 5.9 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 2.3 · 98% consumer	no trial data cached
Abnormal dreams	15	7.9 4.8–13.0ROR 7.9 · χ² 83 / p 4e-20	6.6 EB05 4.2 · IC025 +1.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.2	no trial data cached
Product substitution issue	28	7.1 4.9–10.2ROR 7.2 · χ² 141 / p 8e-33	6.5 EB05 4.6 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	96% consumer	no trial data cached
Skin irritation	22	7.0 4.6–10.6ROR 7.1 · χ² 107 / p 2e-25	6.2 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	100% consumer	no trial data cached
Product complaint	10	5.8 3.2–10.8ROR 5.9 · χ² 35 / p 1e-9	4.7 EB05 2.8 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Nervousness	21	5.8 3.8–8.9ROR 5.9 · χ² 79 / p 2e-19	5.2 EB05 3.6 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 2.3 · 95% consumer	no trial data cached
Withdrawal syndrome	11	3.8 2.1–6.8ROR 3.8 · χ² 20 / p 4e-6	3.4 EB05 2.0 · IC025 +0.7 3/3 methods agree	Likely indication confounding term in indications	serious PRR 3.1	no trial data cached
Wrong technique in product usage process	46	3.3 2.5–4.4ROR 3.4 · χ² 73 / p 6e-18	3.2 EB05 2.5 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 4.5 · 96% consumer	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
Product adhesion issue	199	82.3 72.3–93.7ROR 95.4 · χ² 15,839 / p <1e-300	81.2 EB05 72.2 · IC025 +5.9 3/3 methods agree	Reporting / coding artifact	serious n=3 · 97% consumer	no trial data cached
Application site pruritus	79	50.9 41.1–63.1ROR 53.8 · χ² 3,808 / p <1e-300	50.2 EB05 41.6 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious n=2 · 97% consumer	no trial data cached
Intentional product misuse	48	8.1 6.1–10.6ROR 8.3 · χ² 291 / p 2e-65	7.6 EB05 5.9 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 2.3 · 98% consumer	no trial data cached
Wrong technique in product usage process	46	3.3 2.5–4.4ROR 3.4 · χ² 73 / p 6e-18	3.2 EB05 2.5 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 4.5 · 96% consumer	no trial data cached
Application site pain	43	28.5 21.2–38.3ROR 29.4 · χ² 1,114 / p 2e-244	28.2 EB05 21.8 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=2 · 100% consumer	no trial data cached
Application site erythema	41	22.8 16.8–30.8ROR 23.4 · χ² 831 / p 6e-183	22.5 EB05 17.3 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	100% consumer	no trial data cached
Application site rash	40	42.4 31.2–57.6ROR 43.6 · χ² 1,572 / p <1e-300	41.5 EB05 31.8 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=2 · 92% consumer	no trial data cached
Nightmare	32	13.4 9.5–18.9ROR 13.7 · χ² 356 / p 9e-80	13.1 EB05 9.4 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	97% consumer	no trial data cached
Product substitution issue	28	7.1 4.9–10.2ROR 7.2 · χ² 141 / p 8e-33	6.5 EB05 4.6 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	96% consumer	no trial data cached
Skin irritation	22	7.0 4.6–10.6ROR 7.1 · χ² 107 / p 2e-25	6.2 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	100% consumer	no trial data cached
Nervousness	21	5.8 3.8–8.9ROR 5.9 · χ² 79 / p 2e-19	5.2 EB05 3.6 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 2.3 · 95% consumer	no trial data cached
Expired product administered	20	8.8 5.7–13.6ROR 8.9 · χ² 131 / p 2e-30	7.8 EB05 5.1 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	95% consumer	no trial data cached
Anhedonia	18	9.9 6.3–15.7ROR 10.0 · χ² 136 / p 1e-31	8.8 EB05 5.6 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 22.5	no trial data cached
Abnormal dreams	15	7.9 4.8–13.0ROR 7.9 · χ² 83 / p 4e-20	6.6 EB05 4.2 · IC025 +1.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.2	no trial data cached
Application site irritation	14	16.4 9.7–27.7ROR 16.6 · χ² 188 / p 6e-43	15.6 EB05 9.2 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	–	no trial data cached

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.

Application site pruritus — n=79, PRR 50.9
Application site rash — n=40, PRR 42.4
Application site pain — n=43, PRR 28.5
Application site erythema — n=41, PRR 22.8
Nightmare — n=32, PRR 13.4
Skin irritation — n=22, PRR 7.0
Nervousness — n=21, PRR 5.8

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 Transdermal System?

In FDA FAERS, the most frequently co-reported reaction terms for Nicotine Transdermal System are application site pruritus, application site pain, application site erythema, application site rash, nightmare, skin 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 Transdermal System have an FDA boxed warning?

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

Do FAERS signals prove that Nicotine Transdermal System 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 7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe, effective 20250730; matched on openfda.generic_name.exact:"NICOTINE TRANSDERMAL SYSTEM")
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, 33 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.