Flavoxate

There are no or limited amount of data from the use of flavoxate in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of flavoxate during pregnancy.

It is unknown whether flavoxate (metabolites) is excreted in human milk. A risk to the suckling child cannot be excluded. Flavoxate should not be used during breast-feeding.

Fertility

There are no data on the effect of flavoxate on human fertility. Flavoxate has no effect on animal fertility.

Patients should be informed that if somnolence or blurred vision occur they should not drive or use machines.

The source of the below ADRs frequencies is represented by data collected through clinical trials, observational studies, and spontaneous reporting.

In the list below, adverse reactions are reported and listed by MedDRA system organ class and frequency: 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 available data). Within each frequency grouping the observed adverse reactions are presented in order of decreasing seriousness.

Immune system disorders

Not known: Hypersensitivity, anaphylactic reaction, anaphylactic shock

Psychiatric disorders

Not known: Confusional state

Nervous system disorders

Uncommon: Somnolence

Eye disorders

Uncommon: Visual impairment

Not known: Glaucoma

Cardiac disorders

Not known: Palpitations

Gastrointestinal disorders

Uncommon: Vomiting, dry mouth, dyspepsia

Common: Nausea

Hepatobiliary disorders

Not known: Jaundice, liver disorder, hepatic enzyme abnormal

Skin and subcutaneous tissue disorders

Uncommon: Rash

Rare: Urticaria, pruritus

Not known: Erythema

Renal and urinary disorders

Rare: Urinary retention

General disorders and administration site conditions

Rare: Fatigue