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ATC Codes: None found

Side effects

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MedDRA Preferred Term Side effect Data for drug Placebo Labels
1 2
Hypertension Hypertension 0.5% - 11.3% 7.6% x
Dry mouth Dry mouth 2.8% - 8.6% x
Urinary tract infection Urinary tract infection 0.4% - 6.4% 1.8% x x
Nasopharyngitis Nasopharyngitis 3.1% - 3.9% 2.5% x
Influenza Influenza 2.6% - 3.4% x
Dizziness Dizziness 0.5% - 2.7% x
Headache Headache 0.6% - 4.1% 3% x
Back pain Back pain 1.6% - 2.8% x
Cystitis Cystitis 2.1% - 2.3% x x
Bladder pain Cystitis 2.1% - 2.3% x x
Bladder pain x
Cystitis noninfective Cystitis 2.1% - 2.3% x x
Sinusitis Sinusitis 1.5% - 2.7% x
Arthralgia Arthralgia 1.3% - 2.1% 1.1% x
Musculoskeletal discomfort Arthralgia 1.3% - 2.1% 1.1% x
Upper respiratory tract infection Upper respiratory tract infection 1.5% - 2.1% 1.7% x
Constipation Constipation 0.9% - 2.8% 1.4% x
Tachycardia Tachycardia 1.2% - 1.6% 0.6% x x
Diarrhoea Diarrhoea 1.2% - 1.5% 1.3% x
Asthenia Fatigue 1.2% - 1.4% 1% x
Fatigue Fatigue 1.2% - 1.4% 1% x
Abdominal pain Abdominal pain 0.6% - 1.4% 0.7% x
Gastrointestinal pain Abdominal pain 0.6% - 1.4% 0.7% x
Nausea Nausea 0.4% x
Cerebrovascular accident Cerebrovascular accident 0.4% x
Dry eye Dry eye 0.4% x
Vision blurred Vision blurred 0.4% x
Atrial fibrillation Atrial fibrillation 0.2% x x
Osteoarthritis Osteoarthritis 0.2% x
Prostate cancer Prostate cancer 0.1% x
Urinary retention Urinary retention postmarketing x
Abdominal distension Abdominal distension x
Breast cancer Breast cancer x
Breast disorder Breast disorder x x
Infection Infection x x
Connective tissue disorder Connective tissue disorder x
Dyspepsia Dyspepsia x x
Dermatitis Rash x x
Rash Rash x x
Eye disorder Eye disorder x x
Gastritis Gastritis x x
Gastrointestinal disorder Gastrointestinal disorder x x
Glaucoma Glaucoma x
Cardiac disorder Cardiac disorder x x
Neoplasm Neoplasm x
Palpitations Palpitations x x
Pruritus Pruritus x x
Purpura Purpura x x
Vascular purpura Purpura x x
Rhinitis Rhinitis x
Erythema multiforme Stevens-Johnson syndrome x
Stevens-Johnson syndrome Stevens-Johnson syndrome x
Urethral disorder Urinary tract disorder x
Urinary tract disorder Urinary tract disorder x
Urticaria Urticaria x x
Gamma-glutamyltransferase increased Gamma-glutamyltransferase increased x x
Blood lactate dehydrogenase increased Lactic dehydrogenase activity increased x
Aspartate aminotransferase increased Aspartate aminotransferase increased x x
Alanine aminotransferase increased Alanine aminotransferase increased x x
Joint swelling Joint swelling x
Eyelid oedema Eyelid oedema x
Skin disorder Unspecified disorder of skin and subcutaneous tissue x x
Rash macular Rash macular x
Lung neoplasm malignant Lung neoplasm malignant x
Nephrolithiasis Nephrolithiasis x
Lipoedema Lipoedema x x
Vaginal infection Vaginal infection x x
Blood pressure increased Blood pressure increased x x
Lip oedema Lip oedema x x
Infestation Infestation NOS x x
Vulvovaginal pruritus Vulvovaginal pruritus x x
Rash papular Rash papular x
Leukocytoclastic vasculitis Leukocytoclastic vasculitis x x


Information about indications was extracted from the indications and usage sections of the labels.

mirabegron / mirabegron

Side effects:32


Side effects:59
Source:FDA Structured Product Label

Color scheme:


    frequent (1% to 100%)
    infrequent (0.1% to 1%)
    rare (<0.1%)
    no frequency information
    not found on label