Evidence review: safety

Adverse effects of oral glycopyrronium bromide in case series

Bajaj and Langtry (2007) reported that 15 of the 19 people who completed follow-up (79%) experienced adverse effects with oral glycopyrronium bromide. Dry mouth was the most common and affected 12 people. Five of the 19 people stopped treatment because of adverse effects: 3 because of dry mouth, 1 because of erectile dysfunction, and 1 because of headaches and urinary retention.

Lee et al. (2012) reported that 36% of 36 people experienced adverse effects with oral glycopyrronium bromide treatment, the most common of which was dry mouth (affecting 10 people [28%]). Other adverse effects reported were palpitations (n=4), headache (n=1) and 'other' (n=3).

Walling (2012) reported that 9 out of 45 people treated with oral glycopyrronium bromide (20%) stopped treatment because of adverse effects. Reasons for stopping were dry mouth (n=4), gastrointestinal disturbance (n=2), headache (n=1), rash (n=1) and mental health effects (n=1).

Paller et al. (2012) reported that adverse effects were experienced by 9 out of 31 children or young people (29%). The most common adverse effect was dry mouth, which was experienced by 8 people, 3 of whom also had dry eyes, and 1 of whom had blurred vision. Dryness was dose related and improved when the dosage was reduced. One other person experienced palpitations and stopped treatment because of this adverse effect.

Gong and Kim (2013) reported that 8 out of 19 people (42%) who received oral glycopyrronium bromide to treat compensatory hyperhidrosis and had complete follow-up experienced adverse effects. These included dry mouth (n=3), palpitations (n=3), headache (n=1) and constipation (n=1). No participants stopped medication because of adverse effects.

Additional safety information from US products

Oral glycopyrronium bromide products are available in the USA (glycopyrrolate tablets, USP, Robinul and Robinul Forte; and glycopyrrolate oral solution, Cuvposa). Neither of these products is licensed for hyperhidrosis but their labelling provides useful safety information.

Robinul and Robinul Forte are contraindicated in medical conditions that preclude antimuscarinic therapy, such as glaucoma, obstructive uropathy, obstructive disease of the gastrointestinal tract, paralytic ileus, unstable cardiovascular status in acute haemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis and myasthenia gravis. There are also warnings about fever and heat stroke as a result of decreased sweating in high environmental temperatures, and diarrhoea, which may be an early symptom of incomplete intestinal obstruction. Listed adverse effects include dry mouth, decreased sweating, urinary hesitancy and retention, blurred vision, tachycardia, palpitations, headaches, nervousness, mental confusion, drowsiness, weakness, dizziness, insomnia, nausea, vomiting, constipation, and impotence.