Scopolamine Transdermal System side effects: what 253 FDA adverse event reports show
Who reports
253 reports · 14% serious · 7 with death outcome · 70% female
Used for
Scopolamine transdermal system is indicated in adults for the prevention of: • nausea and vomiting associated with motion sickness. • post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery. Scopolamine transdermal system is an anticholinergic indicated in adults for the prevention of: • nausea and vomiting associated with motion sickness.
What it is
Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.0 2,4 ]nonan-7-yl) 3-hydroxy-2-phenylpropanoate.
Boxed warning
None in the current label
Causality screen of the 4 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- 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. 3 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Product adhesion issue | 158 | 369.6 335.6–407.0ROR 976.1 · χ² 57,543 / p <1e-300 | 352.2 EB05 308.4 · IC025 +7.2 3/3 methods agree | Reporting / coding artifact | serious n=5 · 87% consumer | no trial data cached |
| Mydriasis | 8 | 51.5 26.1–102.0ROR 53.2 · χ² 348 / p 7e-78 | 46.2 EB05 25.1 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 69.6 | no trial data cached |
| Wrong technique in product usage process | 51 | 20.9 16.3–26.6ROR 25.8 · χ² 953 / p 1e-209 | 20.7 EB05 16.3 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | 84% consumer | no trial data cached |
| Application site erythema | 5 | 15.7 6.6–37.4ROR 16.0 · χ² 55 / p 6e-14 | 11.2 EB05 3.8 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 | 158 | 369.6 335.6–407.0ROR 976.1 · χ² 57,543 / p <1e-300 | 352.2 EB05 308.4 · IC025 +7.2 3/3 methods agree | Reporting / coding artifact | serious n=5 · 87% consumer | no trial data cached |
| Wrong technique in product usage process | 51 | 20.9 16.3–26.6ROR 25.8 · χ² 953 / p 1e-209 | 20.7 EB05 16.3 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | 84% consumer | no trial data cached |
| Mydriasis | 8 | 51.5 26.1–102.0ROR 53.2 · χ² 348 / p 7e-78 | 46.2 EB05 25.1 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 69.6 | no trial data cached |
| Application site erythema | 5 | 15.7 6.6–37.4ROR 16.0 · χ² 55 / p 6e-14 | 11.2 EB05 3.8 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Application site pruritus | 4 | 14.6 5.5–38.5ROR 14.8 · χ² 38 / p 4e-10 | 9.0 EB05 2.9 · IC025 +0.8 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Application site rash | 4 | 23.9 9.1–63.3ROR 24.3 · χ² 66 / p 2e-16 | 17.8 EB05 4.6 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Application site irritation | 4 | 26.5 10.0–70.2ROR 27.0 · χ² 74 / p 3e-18 | 20.4 EB05 5.3 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Scopolamine Transdermal System?
In FDA FAERS, the most frequently co-reported reaction terms for Scopolamine Transdermal System are mydriasis, application site erythema, application site pruritus, application site rash, application site 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 Scopolamine Transdermal System have an FDA boxed warning?
No. The FDA label retrieved for Scopolamine Transdermal System has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Scopolamine 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 8455ce88-1270-440b-b62e-fe5fef1415ac, effective 20250731; matched on
openfda.generic_name.exact:"SCOPOLAMINE 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, fieldpatient.drug.openfda.generic_name.exact, 7 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.