Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Mirabegron
Drug ID BADD_D01475
Description Mirabegron is a sympathomimetic beta-3 adrenergic receptor agonist used to relax the smooth muscle of the bladder in the treatment of urinary frequency and incontinence. It is unique amongst overactive bladder treatment options in that, unlike other treatments such as [solifenacin] and [darifenacin], it lacks significant antimuscarinic activity,[A232553] which is responsible both for the therapeutic effects of these medications and their broad range of adverse effects. Mirabegron has a comparatively favorable adverse effect profile as compared to other available treatment options, and its complementary mechanism to the antimuscarinics that came before it allows for its use alongside solifenacin in refractory cases.[L32853] Mirabegron first received FDA approval in 2012, under the brand name Myrbetriq, for the treatment of adults with overactive bladder.[L32853] An extended-release granule formulation was subsequently granted approval in March 2021 for the treatment of pediatric patients with neurogenic detrusor overactivity.[L32853] Mirabegron is also used in other jurisdictions across the globe, including Canada,[L32925] the EU,[L32945] and Japan.[A7469]
Indications and Usage Mirabegron is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Marketing Status Prescription
ATC Code G04BD12
DrugBank ID DB08893
KEGG ID D09535
MeSH ID C520025
PubChem ID 9865528
TTD Drug ID D0X5UN
NDC Product Code 0469-2602; 70518-3158; 0469-5020; 65977-0133; 55111-971; 14501-0031; 64552-4077; 66639-022; 55154-8713; 59285-004; 76072-1013; 65727-048; 59651-015; 65372-1202; 64552-4084; 65977-0112; 55111-961; 42765-047; 65085-0067; 55154-8712; 0469-2603; 14501-0092; 70518-2435; 66039-902; 0469-2601; 68259-1315
Synonyms mirabegron | Betmiga | 2-(2-aminothiazol-4-yl)-4'-(2-((2-hydroxy-2-phenylethyl)amino)ethyl)acetanilide | Betanis | YM 178 | YM-178
Chemical Information
Molecular Formula C21H24N4O2S
CAS Registry Number 223673-61-8
SMILES C1=CC=C(C=C1)C(CNCCC2=CC=C(C=C2)NC(=O)CC3=CSC(=N3)N)O
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Electrocardiogram T wave amplitude decreased13.14.05.0060.000828%Not Available
Erythema multiforme23.03.01.003; 10.01.03.015--
Eye disorder06.08.03.001--Not Available
Eyelid oedema23.04.01.003; 10.01.05.001; 06.04.04.004--Not Available
Faeces discoloured07.01.03.0020.000828%Not Available
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014--Not Available
Gait disturbance17.02.05.016; 08.01.02.0020.001656%
Gamma-glutamyltransferase increased13.03.01.011--
Gastritis07.08.02.001--
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal pain07.01.05.005--
Glaucoma06.03.01.0020.000828%
Haematuria20.02.01.006; 24.07.01.0470.000828%
Blood urine present13.13.02.0020.000828%Not Available
Headache17.14.01.0010.016557%
Heart rate increased13.14.04.0020.001242%Not Available
Hepatic steatosis14.08.04.005; 09.01.07.0030.000828%Not Available
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypersensitivity10.01.03.003--
Hypersensitivity vasculitis24.05.02.012; 23.06.02.005; 10.02.02.017; 01.01.04.008--Not Available
Hypertension24.08.02.0010.010762%
Hypertensive crisis24.08.01.0010.002070%Not Available
Hypertonic bladder20.03.03.003; 17.10.01.0030.000828%Not Available
Hypoaesthesia17.02.06.023--Not Available
Hyponatraemia14.05.04.0020.000828%
Hypotension24.06.03.0020.002897%
Ileus07.13.01.0010.000828%
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
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