What the label lists and what reports show
Scopolamine side effects
Scopolamine's FDA label: “Most common adverse reactions are: • Motion Sickness (>15%): dry mouth, drowsiness, blurred vision and dilation of the pupils.” FAERS holds 5,895 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dizziness (484 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the scopolamine FDA label on DailyMed (effective June 10, 2025, Baxter Healthcare Corporation); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of TRANSDERM SCŌP?TRANSDERM SCŌP may cause serious side effects, including: • angle closure glaucoma. If you have open angle glaucoma and use TRANSDERM SCŌP, remove TRANSDERM SCŌP and call a doctor right away if you feel pain or discomfort, have blurred vision, or see halos or colored images around lights and reddening of your eyes. • worsening of seizures. Tell your doctor about any worsening of seizures while using TRANSDERM SCŌP. • an unusual reaction called acute psychosis. Tell your doctor if you have any of these symptoms: o confusion o agitation o rambling speech o hallucinations (seeing or hearing things that are not there) o paranoid behaviors and delusions (false belief in something) If you experience any of the above symptoms, your doctor may stop your treatment with TRANSDERM SCŌP. If your symptoms continue and they are severe, get medical help. […]
Source: FDA drug label, Baxter Healthcare Corporation, effective June 10, 2025 (SPL set b877a694-a1d0-4280-937a-a06820b12a88), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions are: • Motion Sickness (>15%): dry mouth, drowsiness, blurred vision and dilation of the pupils.
Table 1 Common Adverse Reactions* in Surgical Patients for the Prevention of PONV
| Reaction | TRANSDERM SCŌP % (N = 461) | Placebo % (N = 457) |
|---|---|---|
| Dry mouth | 29 | 16 |
| Dizziness | 12 | 7 |
| Somnolence | 8 | 4 |
| Agitation | 6 | 4 |
| Visual Impairment | 5 | 3 |
| Confusion | 4 | 3 |
| Mydriasis | 4 | 0 |
| Pharyngitis | 3 | 2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are described elsewhere in labeling: • Acute Angle Closure Glaucoma [see Warnings and Precautions ( 5.1 )] • Neuropsychiatric Adverse Reactions [see Warnings and Precautions ( 5.2 )] • Eclamptic Seizures in Pregnant Women [see Warnings and Precautions ( 5.3 )] • Gastrointestinal and Urinary Disorders [see Warnings and Precautions ( 5.4 )] • Hyperthermia [see Warnings and Precautions ( 5.5 )] • Drug Withdrawal/Post-Removal Symptoms [see Warnings and Precautions ( 5.6 )] • Blurred Vision [see Warnings and Precautions ( 5.7 )] • MRI Skin Burns [see Warnings and Precautions ( 5.8 )] Most common adverse reactions are: • Motion Sickness (>15%): dry mouth, drowsiness, blurred vision and dilation of the pupils. ( 6.1 ) • PONV (≥ 3%): dry mouth, dizziness, somnolence, agitation, visual impairment, confusion, mydriasis and pharyngitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, Baxter Healthcare Corporation, effective June 10, 2025 (SPL set b877a694-a1d0-4280-937a-a06820b12a88), via openFDA; the full label on DailyMed
What do FAERS reports show?
5,895 reports list scopolamine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 753 are coded as a death and 1,924 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 17 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Scopolamine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions