Note: This document contains side effect information about scopolamine. Some dosage forms listed on this page may not apply to the brand name Transderm-Scop.

Applies to scopolamine: transdermal patch extended release.

Serious side effects of Transderm-Scop

Along with its needed effects, scopolamine (the active ingredient contained in Transderm-Scop) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking scopolamine:

More common

• Agitation

Less common

• Bigger, dilated, or enlarged pupils (black part of the eye)
• blurred vision or other changes in vision
• confusion
• increased sensitivity of the eyes to light

Incidence not known

• Burning feeling while urinating
• delusions of persecution, mistrust, suspiciousness, or combativeness
• difficulty in speaking
• disturbance in attention
• dry, itchy eyes
• eyelid irritation
• headache
• loss of memory
• poor coordination
• problems with memory
• restlessness
• seeing, hearing, or feeling things that are not there

Get emergency help immediately if any of the following symptoms of overdose occur while taking scopolamine:

Symptoms of overdose

• Anxiety
• blurred or loss of vision
• change in consciousness
• decrease in frequency of urination
• decrease in urine volume
• deep or fast breathing with dizziness
• difficulty in passing urine (dribbling)
• disturbed color perception
• double vision
• dry mouth
• dry, flushed skin
• fast, pounding, or irregular heartbeat or pulse
• halos around lights
• headache
• irritability
• loss of consciousness
• nervousness
• night blindness
• numbness of the feet, hands, and around the mouth
• overbright appearance of lights
• painful urination
• pounding in the ears
• seizures
• shaking
• sleepiness
• trouble with sleeping
• tunnel vision
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Other side effects of Transderm-Scop

Some side effects of scopolamine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Dizziness
• dry mouth
• sleepiness or unusual drowsiness

Less common

• Body aches or pain
• congestion
• cough
• dryness or soreness of the throat
• fever
• hoarseness
• runny nose
• tender, swollen glands in the neck
• trouble in swallowing
• voice changes

More common

• Burning feeling at the application site
• feeling of constant movement of self or surroundings
• itching, skin rash
• lightheadedness
• sensation of spinning

For Healthcare Professionals

Applies to scopolamine: compounding powder, injectable solution, oral tablet, transdermal film extended release.

General

The most commonly reported side effects included dry mouth, dizziness, and somnolence.^[Ref]

Gastrointestinal

Very common (10% or more): Dry mouth (up to 66.7%)

Rare (0.01% to 0.1%): Nausea, vomiting

Frequency not reported: Constipation, gastrointestinal disorders, mild to moderate gastrointestinal tract symptoms, swallowing difficulty^[Ref]

Nervous system

Very common (10% or more): Dizziness (up to 16.7%)

Common (1% to 10%): Drowsiness, sedation, somnolence

Uncommon (0.1% to 1%): Central nervous system simulation

Rare (0.01% to 0.1%): Attention disturbance, balance disturbances, headache, increased seizure frequency, memory impairment

Frequency not reported: Anticholinergic effects, coma, dystonia, eclamptic seizures, loss of consciousness, neuroleptic malignant syndrome

Postmarketing reports: Coordination abnormalities, speech disorder, vertigo^[Ref]

Increased seizure frequency occurred in patients with epilepsy.

Eclamptic seizures occurred in pregnant patients.^[Ref]

Psychiatric

Common (1% to 10%): Agitation, confusion

Uncommon (0.1% to 1%): Hallucinations, restlessness

Rare (0.01% to 0.1%): Disorientation, visual hallucinations

Frequency not reported: Delirium, mental confusion, mental excitement, neuropsychiatric adverse reactions, psychiatric disorders, psychotic disorder

Postmarketing reports: Acute psychosis, paranoia^[Ref]

Ocular

Common (1% to 10%): Accommodation disorder, blurred vision, cycloplegia, eyelid irritation, mydriasis/unilateral mydriasis, myopia, pupil dilation, visual accommodation disorder, visual impairment

Very rare (less than 0.01%): Acute glaucoma precipitation, closed angle glaucoma, narrow angle glaucoma

Frequency not reported: Acute angle closure glaucoma, angle closure glaucoma, increased intraocular pressure, loss of accommodation, periorbital swelling, photophobia

Postmarketing reports: Amblyopia, dry eyes, eye pruritus^[Ref]

Dermatologic

Common (1% to 10%): Skin irritation

Uncommon (0.1% to 1%): Abnormal sweating, pruritus, skin reactions, urticaria

Very rare (less than 0.01%): Generalized rash

Frequency not reported: Decreased sweating, dyshidrosis, dry skin, erythema, mild to moderate skin reactions, rash^[Ref]

Cardiovascular

Common (1% to 10%): Tachycardia

Frequency not reported: Arrhythmias, cardiorespiratory distress, decreased blood pressure, edema, flushing, mild to moderate cardiovascular system symptoms, palpitations, transient bradycardia^[Ref]

Respiratory

Common (1% to 10%): Pharyngitis

Frequency not reported: Asthma syndrome, dyspnea, mild to moderate respiratory tract reactions, reduced bronchial secretions^[Ref]

Genitourinary

Rare (0.01% to 0.1%): Urinary retention

Frequency not reported: Impaired micturition, micturition difficulty, urinary disorders, urinary disturbances, urinary emergency

Postmarketing reports: Dysuria^[Ref]

Hypersensitivity

Frequency not reported: Allergic reaction, anaphylactic reactions, anaphylactic shock/fatal anaphylactic shock, anaphylactoid reactions, hypersensitivity reactions with respective clinical/laboratory manifestations, other hypersensitivity^[Ref]

Other

Frequency not reported: Drug withdrawal symptoms/post-removal symptoms, hyperthermia at high temperatures (decreased sweating), idiosyncratic reactions^[Ref]

Local

Frequency not reported: Injection site pain, MRI skin burns/application site burning (patch)^[Ref]

Immunologic

Frequency not reported: Facial swelling^[Ref]

Metabolic

Frequency not reported: Thirst^[Ref]