Adverse reactions : תופעות לוואי

4.8     Undesirable effects
Summary of the safety profile

The safety of Betmiga was evaluated in 8433 patients with OAB, of which 5648 received at least one dose of mirabegron in the phase 2/3 clinical program, and 622 patients received Betmiga for at least 1 year (365 days). In the three 12-week phase 3 double blind, placebo controlled studies, 88% of the patients completed treatment with this medicinal product, and 4% of the patients discontinued due to adverse events. Most adverse reactions were mild to moderate in severity.

The most common adverse reactions reported for patients treated with Betmiga 50 mg during the three 12-week phase 3 double blind, placebo controlled studies are tachycardia and urinary tract infections.
The frequency of tachycardia was 1.2% in patients receiving Betmiga 50 mg. Tachycardia led to discontinuation in 0.1% patients receiving Betmiga 50 mg. The frequency of urinary tract infections was 2.9% in patients receiving Betmiga 50 mg. Urinary tract infections led to discontinuation in none of the patients receiving Betmiga 50 mg. Serious adverse reactions included atrial fibrillation (0.2%).

Adverse reactions observed during the 1-year (long term) active controlled (muscarinic antagonist) study were similar in type and severity to those observed in the three 12-week phase 3 double blind, placebo controlled studies.

Tabulated list of adverse reactions

The table below reflects the adverse reactions observed with mirabegron in the three 12-week phase 3 double blind, placebo controlled studies.

The frequency of adverse reactions is defined as follows: 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) and not known (cannot be established from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.


MedDRA             Common             Uncommon           Rare               Very rare      Not known System organ class                                                                         (cannot be estimated from the available data)
Infections and       Urinary tract    Vaginal infestations         infection        infection
Cystitis
Psychiatric                                                                                Insomnia* disorders                                                                                  Confusional state*
Nervous system       Headache* disorders            Dizziness*
Eye disorders                                            Eyelid oedema Cardiac disorders    Tachycardia      Palpitation
Atrial fibrillation
Vascular                                                                    Hypertensive disorders                                                                   crisis* Gastrointestinal     Nausea*          Dyspepsia          Lip oedema disorders            Constipation*    Gastritis
Diarrhoea*
Skin and                              Urticaria          Leukocytoclastic subcutaneous                          Rash               vasculitis tissue disorders                      Rash macular       Purpura
Rash papular       Angioedema*
Pruritus
Musculoskeletal                       Joint swelling and connective tissue disorders
Renal and urinary                                        Urinary disorders                                                retention*
Reproductive                          Vulvovaginal system and breast                     pruritus disorders
Investigations                      Blood pressure increased
GGT increased
AST increased
ALT increased
*observed during post-marketing experience

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/ ) or by email (adr@MOH.HEALTH.GOV.IL).