The most frequent adverse events (AEs) with the use of the drug were dry mouth (20.2% for 7.5 mg and 35.0% for 15 mg) and constipation (14.8% for 7.5 mg and 21.0% for 15 mg). The withdrawal of drug therapy due to the development of AE data was low: for dry mouth 0% (for 7.5 mg) and 0.9% (for 15 mg), for constipation 0.6% and 1.2%, respectively .
In most cases, AEs were mild or moderate and did not require discontinuation of therapy. The incidence of serious adverse events with darifenacin at doses of 7.5 mg and 15 mg once daily was similar to that of placebo. When Enablex was used for 6 months, there was a decrease in the incidence of AE and the cases of withdrawal of drug therapy.
The frequency of AEs, possibly associated with the use of the drug, was estimated as follows: very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10000, <1/1000), very rarely (<1/10000). Within each group, the frequency of AH is presented in order of decreasing frequency of development of AE, if the frequency of development is similar, then in order of decreasing importance.
Infections and infestations: infrequently - urinary tract infection.
Disorders of the psyche: infrequently - insomnia, pathological thinking.
From the nervous system: often - headache, infrequently - dizziness, dysgeusia, drowsiness.
From the side of the organ of vision: often - dry eye syndrome, infrequently - impaired vision.
From the cardiovascular system: infrequently - rise blood pressure.
From the respiratory system, chest and mediastinum: often - dryness in the nose, infrequently - shortness of breath, cough, rhinitis.
From the gastrointestinal tract: very often - constipation, dry mouth; often - abdominal pain, nausea, dyspepsia; infrequently - flatulence, diarrhea, ulcerative stomatitis.
From the skin and subcutaneous tissues: infrequently - rash, dry skin, itching, hyperhidrosis.
From the urinary system: infrequently - retention of urine, disorders of the urinary tract, pain in the bladder.
On the part of the reproductive system and mammary glands: infrequently - erectile dysfunction, vaginitis.
General disorders and disorders at the site of administration: infrequently - peripheral edema, asthenia, edema of the face, other swelling.
Laboratory data: infrequently - increasing the concentration of ASAT in the blood plasma, increasing the concentration of AlAT in blood plasma.
Injuries, poisoning and complications of the procedure of administration: infrequently - accidental injury.
Undesirable phenomena according to post-marketing reports
The following undesirable phenomena were identified according to individual post-marketing reports: generalized reactions hypersensitivity, angioedema with / without airway obstruction. Since the reports of these reactions were voluntary and the population size in which they occurred is not exactly known, the frequency of their occurrence is difficult to estimate (the frequency is unknown).