Drug · FAERS side-effect profile with label screen
Nicotine Transdermal System Patch side effects: what 4,583 FDA adverse event reports show
Drug class
FDA label (Established Pharmacologic Class) · compare the class
Who reports
4,583 reports · 12% serious · 31 with death outcome · 65% 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
Labeled (related wording) 1Reporting / coding artifact 17Not in label — unassessed 22
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.
- 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. 35 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 |
|---|---|---|---|---|---|---|
| Product adhesion issue | 1,196 | 159.8 152.0–167.9ROR 215.8 · χ² 182,402 / p <1e-300 | 154.0 EB05 146.8 · IC025 +7.1 3/3 methods agree | Reporting / coding artifact | serious n=9 · 94% consumer | no trial data cached |
| Treatment noncompliance | 887 | 75.9 71.5–80.6ROR 93.9 · χ² 64,596 / p <1e-300 | 74.6 EB05 70.5 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious PRR 35.7 · 96% consumer | no trial data cached |
| Macular degeneration | 170 | 66.2 57.1–76.8ROR 68.7 · χ² 10,702 / p <1e-300 | 64.8 EB05 57.0 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 336.0 · ♀ 100% (drug 65%) | no trial data cached |
| Application site pruritus | 207 | 42.1 36.8–48.1ROR 44.0 · χ² 8,198 / p <1e-300 | 41.6 EB05 37.0 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=4 · 96% consumer | no trial data cached |
| Application site rash | 122 | 40.8 34.2–48.7ROR 41.9 · χ² 4,659 / p <1e-300 | 40.2 EB05 34.6 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=7 · 93% consumer | no trial data cached |
| Vaginal discharge | 86 | 39.5 32.0–48.7ROR 40.2 · χ² 3,163 / p <1e-300 | 38.9 EB05 32.4 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=86 · ♀ 100% (drug 65%) · 91% clinician | no trial data cached |
| Product quality issue | 944 | 32.3 30.5–34.2ROR 40.4 · χ² 28,545 / p <1e-300 | 32.0 EB05 30.3 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 25.1 · 97% consumer | no trial data cached |
| Paraesthesia oral | 96 | 30.8 25.2–37.5ROR 31.4 · χ² 2,718 / p <1e-300 | 30.4 EB05 25.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 257.7 · ♀ 100% (drug 65%) | no trial data cached |
| Oral candidiasis (oral thrush) | 86 | 30.4 24.7–37.6ROR 31.0 · χ² 2,404 / p <1e-300 | 30.1 EB05 25.1 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 202.2 · ♀ 100% (drug 65%) · 91% clinician | no trial data cached |
| Application site erythema | 167 | 29.2 25.2–33.9ROR 30.3 · χ² 4,499 / p <1e-300 | 28.9 EB05 25.4 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=8 · 95% consumer | no trial data cached |
| Abnormal dreams | 162 | 26.8 23.0–31.2ROR 27.8 · χ² 3,982 / p <1e-300 | 26.6 EB05 23.3 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 30.2 · 96% consumer | no trial data cached |
| Application site irritation | 60 | 22.2 17.2–28.5ROR 22.4 · χ² 1,186 / p 3e-260 | 21.9 EB05 17.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=2 · 95% consumer | no trial data cached |
| Expired product administered | 142 | 19.7 16.7–23.1ROR 20.3 · χ² 2,490 / p <1e-300 | 19.5 EB05 17.0 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious n=2 · 99% consumer | no trial data cached |
| Incorrect drug administration duration | 106 | 17.1 14.1–20.6ROR 17.4 · χ² 1,583 / p <1e-300 | 16.9 EB05 14.4 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 23.7 · 95% consumer | no trial data cached |
| Application site pain | 80 | 16.7 13.4–20.7ROR 17.0 · χ² 1,161 / p 1e-254 | 16.5 EB05 13.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=3 · 95% consumer | no trial data cached |
| Procedural pain | 94 | 15.6 12.8–19.1ROR 15.9 · χ² 1,267 / p 8e-278 | 15.5 EB05 13.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 127.8 · ♀ 100% (drug 65%) | no trial data cached |
| Frequent bowel movements | 86 | 14.7 11.9–18.1ROR 14.9 · χ² 1,080 / p 4e-237 | 14.5 EB05 12.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 107.6 · ♀ 100% (drug 65%) · 91% clinician | no trial data cached |
| Underdose | 198 | 12.4 10.8–14.2ROR 12.9 · χ² 2,071 / p <1e-300 | 12.3 EB05 11.0 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 · 99% consumer | no trial data cached |
| Nightmare | 86 | 11.3 9.2–14.0ROR 11.5 · χ² 800 / p 2e-176 | 11.1 EB05 9.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 · 95% consumer | no trial data cached |
| Colitis | 87 | 10.6 8.6–13.0ROR 10.8 · χ² 746 / p 2e-164 | 10.4 EB05 8.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 54.3 · ♀ 100% (drug 65%) | no trial data cached |
| Rectal haemorrhage | 86 | 9.1 7.4–11.3ROR 9.3 · χ² 616 / p 3e-136 | 8.9 EB05 7.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 46.7 · ♀ 100% (drug 65%) · 91% clinician | no trial data cached |
| Colitis ulcerative | 85 | 8.7 7.1–10.8ROR 8.9 · χ² 575 / p 3e-127 | 8.5 EB05 7.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 44.7 · ♀ 99% (drug 65%) · 91% clinician | no trial data cached |
| Overdose | 357 | 7.6 6.8–8.3ROR 8.1 · χ² 2,040 / p <1e-300 | 7.5 EB05 6.9 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 4.8 · 95% consumer | no trial data cached |
| Haematochezia (blood in stool) | 89 | 7.4 6.0–9.1ROR 7.5 · χ² 487 / p 4e-108 | 7.2 EB05 6.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 38.8 · ♀ 99% (drug 65%) | no trial data cached |
| Infusion related reaction (reaction during infusion) | 96 | 6.7 5.5–8.1ROR 6.8 · χ² 457 / p 1e-101 | 6.5 EB05 5.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 40.0 · ♀ 100% (drug 65%) | no trial data cached |
| Therapeutic product effect incomplete | 98 | 6.3 5.2–7.7ROR 6.5 · χ² 437 / p 2e-97 | 6.2 EB05 5.2 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 56.3 · ♀ 100% (drug 65%) | no trial data cached |
| Drug dose omission | 230 | 6.3 5.5–7.1ROR 6.6 · χ² 1,023 / p 8e-225 | 6.2 EB05 5.6 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 · 93% consumer | no trial data cached |
| Wrong technique in product usage process | 272 | 6.2 5.5–6.9ROR 6.5 · χ² 1,183 / p 2e-259 | 6.1 EB05 5.5 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 · 95% consumer | no trial data cached |
| Product dose omission | 82 | 5.7 4.6–7.0ROR 5.8 · χ² 311 / p 5e-70 | 5.5 EB05 4.6 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | 94% consumer | no trial data cached |
| Dyspepsia (indigestion) | 106 | 4.9 4.1–6.0ROR 5.0 · χ² 331 / p 3e-74 | 4.8 EB05 4.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 44.2 · ♀ 96% (drug 65%) | no trial data cached |
| Initial insomnia | 11 | 4.9 2.7–8.9ROR 4.9 · χ² 31 / p 1e-8 | 4.2 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious n=1 | no trial data cached |
| Product administered at inappropriate site | 19 | 4.8 3.1–7.5ROR 4.8 · χ² 53 / p 1e-13 | 4.3 EB05 2.9 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Product use issue | 191 | 4.7 4.1–5.4ROR 4.8 · χ² 553 / p 1e-122 | 4.6 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 1.8 · 96% consumer | no trial data cached |
| Incorrect product administration duration | 20 | 4.5 2.9–7.0ROR 4.5 · χ² 51 / p 4e-13 | 4.1 EB05 2.8 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | 100% consumer | no trial data cached |
| Inappropriate schedule of drug administration | 65 | 4.1 3.2–5.3ROR 4.2 · χ² 151 / p 5e-35 | 4.0 EB05 3.3 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 7.4 · 92% consumer | no trial data cached |
| Nervousness | 44 | 3.8 2.9–5.1ROR 3.9 · χ² 90 / p 1e-21 | 3.7 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · 98% consumer | no trial data cached |
| Drug prescribing error | 15 | 3.5 2.1–5.8ROR 3.5 · χ² 25 / p 3e-7 | 3.2 EB05 2.1 · IC025 +0.8 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Irritability | 43 | 3.3 2.4–4.4ROR 3.3 · χ² 66 / p 3e-16 | 3.2 EB05 2.5 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · 98% consumer | no trial data cached |
| Feeling jittery | 13 | 3.1 1.8–5.4ROR 3.1 · χ² 17 / p 2e-5 | 2.9 EB05 1.8 · IC025 +0.6 | Not in label — unassessed | serious n=3 | no trial data cached |
| Incorrect dose administered | 140 | 2.8 2.4–3.4ROR 2.9 · χ² 168 / p 1e-38 | 2.8 EB05 2.5 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 1.8 · 97% 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 | 1,196 | 159.8 152.0–167.9ROR 215.8 · χ² 182,402 / p <1e-300 | 154.0 EB05 146.8 · IC025 +7.1 3/3 methods agree | Reporting / coding artifact | serious n=9 · 94% consumer | no trial data cached |
| Product quality issue | 944 | 32.3 30.5–34.2ROR 40.4 · χ² 28,545 / p <1e-300 | 32.0 EB05 30.3 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 25.1 · 97% consumer | no trial data cached |
| Treatment noncompliance | 887 | 75.9 71.5–80.6ROR 93.9 · χ² 64,596 / p <1e-300 | 74.6 EB05 70.5 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious PRR 35.7 · 96% consumer | no trial data cached |
| Drug ineffective (drug did not work) | 606 | 2.1 2.0–2.3ROR 2.3 · χ² 374 / p 1e-83 | 2.1 EB05 2.0 · IC025 +0.9 | Reporting / coding artifact | serious PRR 8.7 · 79% consumer | no trial data cached |
| Overdose | 357 | 7.6 6.8–8.3ROR 8.1 · χ² 2,040 / p <1e-300 | 7.5 EB05 6.9 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 4.8 · 95% consumer | no trial data cached |
| Wrong technique in product usage process | 272 | 6.2 5.5–6.9ROR 6.5 · χ² 1,183 / p 2e-259 | 6.1 EB05 5.5 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 · 95% consumer | no trial data cached |
| Drug dose omission | 230 | 6.3 5.5–7.1ROR 6.6 · χ² 1,023 / p 8e-225 | 6.2 EB05 5.6 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 · 93% consumer | no trial data cached |
| Application site pruritus | 207 | 42.1 36.8–48.1ROR 44.0 · χ² 8,198 / p <1e-300 | 41.6 EB05 37.0 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=4 · 96% consumer | no trial data cached |
| Underdose | 198 | 12.4 10.8–14.2ROR 12.9 · χ² 2,071 / p <1e-300 | 12.3 EB05 11.0 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 · 99% consumer | no trial data cached |
| Product use issue | 191 | 4.7 4.1–5.4ROR 4.8 · χ² 553 / p 1e-122 | 4.6 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 1.8 · 96% consumer | no trial data cached |
| Macular degeneration | 170 | 66.2 57.1–76.8ROR 68.7 · χ² 10,702 / p <1e-300 | 64.8 EB05 57.0 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 336.0 · ♀ 100% (drug 65%) | no trial data cached |
| Application site erythema | 167 | 29.2 25.2–33.9ROR 30.3 · χ² 4,499 / p <1e-300 | 28.9 EB05 25.4 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=8 · 95% consumer | no trial data cached |
| Abnormal dreams | 162 | 26.8 23.0–31.2ROR 27.8 · χ² 3,982 / p <1e-300 | 26.6 EB05 23.3 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 30.2 · 96% consumer | no trial data cached |
| Expired product administered | 142 | 19.7 16.7–23.1ROR 20.3 · χ² 2,490 / p <1e-300 | 19.5 EB05 17.0 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious n=2 · 99% consumer | no trial data cached |
| Incorrect dose administered | 140 | 2.8 2.4–3.4ROR 2.9 · χ² 168 / p 1e-38 | 2.8 EB05 2.5 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 1.8 · 97% consumer | 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.
- Macular degeneration — n=170, PRR 66.2
- Application site pruritus — n=207, PRR 42.1
- Application site rash — n=122, PRR 40.8
- Vaginal discharge — n=86, PRR 39.5
- Paraesthesia oral — n=96, PRR 30.8
- Oral candidiasis — n=86, PRR 30.4
- Application site erythema — n=167, PRR 29.2
- Application site irritation — n=60, PRR 22.2
- Application site pain — n=80, PRR 16.7
- Procedural pain — n=94, PRR 15.6
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 Patch?
In FDA FAERS, the most frequently co-reported reaction terms for Nicotine Transdermal System Patch are application site pruritus, macular degeneration, application site erythema, abnormal dreams. 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 Patch have an FDA boxed warning?
No. The FDA label retrieved for Nicotine Transdermal System Patch has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Nicotine Transdermal System Patch 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 4856e99a-badc-b957-e063-6294a90a8606, effective 20260710; matched on
openfda.generic_name.exact:"NICOTINE TRANSDERMAL SYSTEM PATCH") - 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, 75 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.