Adverse reactions : תופעות לוואי

4.8     Undesirable effects

Summary of the safety profile
The safety of fesoterodine was evaluated in placebo-controlled clinical studies in a total of 2859 patients with overactive bladder, of which 780 received placebo.

Due to the pharmacological properties of fesoterodine, treatment may cause mild to moderate antimuscarinic effects like dry mouth, dry eye, dyspepsia and constipation. Urinary retention may occur uncommonly.

Dry mouth, the only very common adverse reactions, occurred with a frequency of 28.8% in the fesoterodine group compared to 8.5% in the placebo group. The majority of adverse reactions occurred during the first month of treatment with the exception of cases classified as urinary retention or post void residual urine greater than 200 ml, which could occur after long term treatment and was more common in male than female subjects.

Tabulated list of adverse reactions
The table below gives the frequency of treatment emergent adverse reactions from placebo-controlled clinical trials and from post-marketing experience. The adverse reactions are reported in this table with the following frequency 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).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

System organ class      Very common           Common            Uncommon                Rare Infections and                                                     Urinary tract infestations                                                       infection 
Psychiatric disorders                          Insomnia                                Confusional state
System organ class        Very common            Common            Uncommon                Rare Nervous system                                 Dizziness;          Dysgeusia; disorders                                      Headache            Somnolence 
Eye disorders                                  Dry eye             Blurred vision Ear and labyrinth                                                  Vertigo disorders
Cardiac disorders                                              Tachycardia; Palpitations
Respiratory, thoracic                          Dry throat      Pharyngolaryng and mediastinal                                                eal pain; Cough; disorders                                                      Nasal dryness Gastrointestinal           Dry mouth           Abdominal pain; Abdominal               Hypoaesthesia disorders                                      Diarrhoea;      discomfort;             oral Dyspepsia;      Flatulence,
Constipation;   Gastroesophage
Nausea          al reflux
Hepatobiliary disorders                                        ALT increased; GGT increased
Skin and subcutaneous                                          Rash; Dry skin;         Angioedema; tissue disorders                                               Pruritus                Urticaria Renal and urinary                              Dysuria         Urinary disorders                                                      retention (including feeling of residual urine;
micturition disorder);
Urinary hesitation
General disorders and                                          Fatigue administration site conditions


Description of selected adverse reactions
In clinical trials of fesoterodine, cases of markedly elevated liver enzymes were reported with the occurrence frequency no different from the placebo group. The relation to fesoterodine treatment is unclear.

Electrocardiograms were obtained from 782 patients treated with 4 mg, 785 treated with 8 mg, 222 treated with 12 mg fesoterodine and 780 with placebo. The heart rate corrected QT interval in fesoterodine treated patients did not differ from that seen in placebo treated patients. The incidence rates of QTc ≥500 ms post baseline or QTc increase of ≥60 ms is 1.9%, 1.3%, 1.4% and 1.5%, for fesoterodine 4 mg, 8 mg, 12 mg and placebo, respectively. The clinical relevance of these findings will depend on individual patient risk factors and susceptibilities present (see section 4.4).

Post-marketing cases of urinary retention requiring catheterisation have been described, generally within the first week of treatment with fesoterodine. They have mainly involved elderly (≥ 65 years) male patients with a history consistent with benign prostatic hyperplasia (see section 4.4).

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 event should be reported to the Ministry of Health according to the National form 
    https://sideeffects.health.gov.il/