Transderm Scop (Scopolamine Transdermal) - Side Effects and Adverse Reactions

ADVERSE DRUG EXPERIENCES

The adverse reactions for Transderm Scóp are provided separately for patients with motion sickness and with post-operative nausea and vomiting.

Motion Sickness: In motion sickness clinical studies of Transderm Scóp, the most frequent adverse reaction was dryness of the mouth. This occurred in about two thirds of patients on drug. A less frequent adverse drug reaction was drowsiness, which occurred in less than one sixth of patients on drug. Transient impairment of eye accommodation, including blurred vision and dilation of the pupils, was also observed.

Post-operative Nausea and Vomiting: In a total of five clinical studies in which Transderm Scóp was administered perioperatively to a total of 461 patients and safety was assessed, dry mouth was the most frequently reported adverse drug experience, which occurred in approximately 29% of patients on drug. Dizziness was reported by approximately 12% of patients on drug⁶.

Postmarketing and Other Experience: In addition to the adverse experiences reported during clinical testing of Transderm Scóp, the following are spontaneously reported adverse events from postmarketing experience. Because the reports cite events reported spontaneously from worldwide postmarketing experience, frequency of events and the role of Transderm Scóp in their causation cannot be reliably determined: acute angle-closure (narrow-angle) glaucoma; confusion; difficulty urinating; dry, itchy, or conjunctival injection of eyes; restlessness; hallucinations; memory disturbances; rashes and erythema; and transient changes in heart rate.

Drug Withdrawal/Post-Removal Symptoms: Symptoms such as dizziness, nausea, vomiting, and headache occur following abrupt discontinuation of antimuscarinics. Similar symptoms, including disturbances of equilibrium, have been reported in some patients following discontinuation of use of the Transderm Scóp system. These symptoms usually do not appear until 24 hours or more after the patch has been removed. Some symptoms may be related to adaptation from a motion environment to a motion-free environment. More serious symptoms including muscle weakness, bradycardia and hypotension may occur following discontinuation of Transderm Scóp.

REPORTS OF SUSPECTED TRANSDERM SCOP SIDE EFFECTS / ADVERSE REACTIONS

Possible Transderm Scop side effects / adverse reactions in 42 year old female

Reported by a consumer/non-health professional from United States on 2011-10-07

Patient: 42 year old female weighing 79.4 kg (174.6 pounds)

Reactions: Fatigue, Nausea, Dysuria, Disturbance in Attention, Dizziness, Memory Impairment, Disorientation

Suspect drug(s):
Transderm Scop

Possible Transderm Scop side effects / adverse reactions in 32 year old female

Reported by a consumer/non-health professional from United States on 2011-10-14

Patient: 32 year old female

Reactions: Confusional State, Vomiting, Mydriasis, Hallucination, Visual, Nausea, Heart Rate Increased, Formication, Blindness, Tremor

Suspect drug(s):
Transderm Scop
    Dosage: 1 df, once/single
    Start date: 2011-10-08
    End date: 2011-10-08

Transderm Scop
    Dosage: 1 df, once/single
    Start date: 2011-10-08
    End date: 2011-10-09

Transderm Scop
    Dosage: 1 df, once/single
    Indication: Motion Sickness
    Start date: 2011-10-06
    End date: 2011-10-08

Possible Transderm Scop side effects / adverse reactions in 86 year old female

Reported by a consumer/non-health professional from United States on 2011-10-18

Patient: 86 year old female

Reactions: OFF Label USE, Vomiting, DRY Mouth, Condition Aggravated, Disorientation, Amnesia

Suspect drug(s):
Transderm Scop
    Dosage: 1 df, q72h
    Indication: Dizziness
    Start date: 2011-01-01

Transderm Scop
    Indication: Balance Disorder

Other drugs received by patient: Vitamin B-12; Atacand; Labetalol HCL; Levothyroxine Sodium