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)
Pneumonia11.01.09.003; 22.07.01.003--Not Available
Pollakiuria20.02.02.0070.002897%
Pruritus23.03.12.001--
Purpura24.07.06.005; 23.06.01.004; 01.01.04.003--
Pyrexia08.05.02.003--
Rash23.03.13.0010.004553%Not Available
Rash generalised23.03.13.0020.000828%Not Available
Rash macular23.03.13.003--Not Available
Rash papular23.03.13.017--Not Available
Rhinitis22.07.03.006; 11.01.13.0040.000828%
Rhinorrhoea22.02.05.0100.003725%
Seizure17.12.03.001--
Sinusitis22.07.03.007; 11.01.13.0050.000828%
Skin disorder23.03.03.007--Not Available
Sleep apnoea syndrome22.02.01.013; 19.02.05.002; 17.15.05.0010.000828%
Sleep disorder19.02.04.0010.001242%Not Available
Somnolence19.02.05.003; 17.02.04.006--
Stevens-Johnson syndrome12.03.01.014; 11.07.01.005; 10.01.03.020; 23.03.01.007--
Stomatitis07.05.06.0050.000828%
Swelling face10.01.05.018; 23.04.01.0180.001242%Not Available
Syncope24.06.02.012; 17.02.04.008; 02.01.02.0080.001242%
Tachycardia02.03.02.0070.004139%Not Available
Testicular swelling21.13.01.0030.000828%Not Available
Thirst14.03.02.007; 08.01.09.0210.000828%Not Available
Throat irritation07.05.03.004; 22.02.05.0130.000828%Not Available
Tinnitus17.04.07.004; 04.04.01.0020.001242%
Transient ischaemic attack24.04.06.005; 17.08.04.0010.001656%
Tremor17.01.06.002--
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urethral disorder20.07.01.002--Not Available
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