Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Undesirable effects observed with oxybutynin hydrochloride such as dry mouth, somnolence, and constipation mainly reflect the typical anticholinergic properties of the active ingredient.

Table 4 includes adverse reactions from clinical trials with intravesical use of oxybutynin hydrochloride. The adverse reactions are classified by System Organ Class and frequency, using the following convention: Very common (1/10), Common (1/100 to < 1/10), Uncommon ( 1/1,000 to < 1/100), Rare (1/10,000 to < 1/1,000), Very rare (< 1/10,000), Not known (cannot be estimated from the available data).

Table 4: Adverse reactions from clinical trials with intravesical use of oxybutynin hydrochloride 
System Organ Class          Adverse reaction                                            Frequency Infections and              Urinary tract infection, asymptomatic bacteriuria           unknown infestations
Endocrine disorders         Hyperprolactinaemia, prolactin increase                     unknown 


System Organ Class          Adverse reaction                                            Frequency Psychiatric disorders       Listless, hallucinations, cognitive disorders, hyperactivity, unknown insomnia, agoraphobia, disorientation
Nervous system              Disturbance in attention, dizziness, headache, somnolence, unknown disorders                   fatigue, dysgeusia, depressed level of consciousness, loss of consciousness, anticholinergic syndrome, seizure
Ear and labyrinth           Vertigo                                                     unknown disorders
Eye disorders               Dry eye, abnormal sensation in eye, accommodation           unknown disorder
Cardiac disorders           Supraventricular tachycardia                                unknown Vascular disorders          Hypotension, facial flushing                                unknown Gastrointestinal            Constipation, dry mouth, abdominal discomfort,              unknown Disorders                   abdominal pain lower, abdominal pain upper, nausea, dyspepsia, diarrhoea

Skin and subcutaneous        Hypohidrosis, rash, nocturnal sweating                           unknown tissue disorders
Renal and urinary            Micturition urgency, proteinuria, haematuria, micturition        unknown disorders                    disorder
General disorders            Instillation site pain, thirst, chest discomfort, feeling cold   unknown and administration site conditions

One patient experienced decreased oxygen saturation during home oxygen therapy (see section 4.3).

Paediatric population
Children may be more sensitive to the effects of the product, particularly the CNS and psychiatric adverse reactions.

Adverse reactions known to be associated with anticholinergic therapy, but not observed with intravesical use of oxybutynin during clinical studies are vomiting, anorexia, decreased appetite, dysphagia, gastroesophageal reflux disease, pseudo-obstruction in patients at risk (elderly or patients with constipation and treated with other drugs that decrease intestinal motility), confusional state, agitation, anxiety, nightmares, paranoia, symptoms of depression, dependence to oxybutynin (in patients with history of drug or substance abuse), arrhythmia, heat stroke, angle closure glaucoma, ocular hypertension, dry skin, angioedema, urticaria, photosensitivity, hypersensitivity.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il