Scopolamine topical Side Effects

Please note - some side effects for Scopolamine topical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects by Body System - for Healthcare Professionals

General

Most adverse effects of scopolamine are extensions of its pharmacologic activity and are anticholinergic in nature. Scopolamine delivered transdermally is associated with considerably less side effects than when administered by other routes.

Gastrointestinal

The most common adverse effect of topical scopolamine is dry mouth, which occurs in approximately two-thirds of the patients using the transdermal patch.

Nervous system

Recurrent classic migraine attacks developed in a 20-year-old naval crew member who had been treated continuously with transdermal scopolamine for 5 months. The initial attack occurred within 24 hours of diagnosis of scopolamine intoxication. The patient had no self or family history of migraines. The attacks, presenting with prodrome and aura, followed by severe throbbing left headache, nausea, photophobia and sonophobia lasting 6 to 8 hours, recurred every 10 to 14 days for more than a year. Common triggers of migraines and other precipitating factors could not be identified in this case.

Drowsiness occurs quite frequently and is reported by about 17% of patients administered the scopolamine transdermal patch. Other nervous system side effects are sporadic, including dizziness, restlessness, insomnia, disorientation, memory disturbances, hallucinations, paranoia, and confusion. Most reports of scopolamine-induced psychosis and delirium have involved the elderly, although some behavioral and mental irregularities may also be seen in young children. Concomitant use of antihistamines and other anticholinergics may be predisposing factors.

Recurrent migraine attacks have been described in one individual following an apparent scopolamine intoxication characterized by weakness, blurred vision, drowsiness, confusion, motor incoordination, and a stuporous state lasting 2 hours.

Ocular

Transient mydriasis and cycloplegia may occur, resulting in blurred vision. Symptoms generally resolve within 2 days following removal of the patch but may take longer depending on the cumulative dose received. Unilateral dilation of the pupil and anisocoria have been reported, suggesting that some ocular events may be due to inadvertent contamination of the eye when there is failure to wash the hands after drug application. Narrow angle glaucoma resulting from bilateral mydriasis has been reported rarely but, in one case, required surgery. Esotropia has also occurred in a pediatric patient with neurodevelopmental disabilities but resolved several days after removal of the patch.

Cardiovascular

Cardiovascular side effects are limited when scopolamine is delivered transdermally. Occasionally, there may be some clinically insignificant reductions in heart rate or blood pressure.

Dermatologic

Rashes and erythema have been observed rarely. Dermatitis may occur at the site of application, in some cases due to the scopolamine itself.

Other

Withdrawal symptoms may seldomly develop within 2 or 3 days following removal of the patch, usually in patients who have used it for more than 3 days. These symptoms are consistent with rebound cholinesterase activity and include dizziness, nausea, vomiting, paresthesias of the hands and feet, dysphoria, and hypotension.

Genitourinary

Urinary retention has been reported infrequently with the transdermal patch.

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