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 indicated for the treatment of overactive bladder (OAB) - with symptoms of urge urinary incontinence, urgency, and urinary frequency - either alone or in combination with [solifenacin].[L32853] It is also indicated for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 3 years of age and older and weighing 35kg or more.[L32853]
Marketing Status approved
ATC Code G04BD12
DrugBank ID DB08893
KEGG ID D09535
MeSH ID C520025
PubChem ID 9865528
TTD Drug ID D0X5UN
NDC Product Code 55111-971; 55154-8712; 55111-961; 59285-004; 66039-902; 59651-015; 65727-048; 65977-0112; 14501-0031; 42765-047; 65977-0133; 76072-1013; 0469-2603; 0469-2601; 0469-5020; 55154-8713; 70518-2435; 64552-4077; 65372-1202; 68259-1315; 70518-3158; 14501-0092; 0469-2602; 64552-4084; 65085-0067; 66639-022
UNII MVR3JL3B2V
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
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Eye disorder06.08.03.0010.000355%-
Eye swelling06.08.03.0030.000629%-
Eyelid oedema06.04.04.004; 10.01.05.001; 23.04.01.003---
Faeces discoloured07.01.03.0020.000355%-
Fatigue08.01.01.002--
Feeling cold08.01.09.008---
Flushing08.01.03.025; 23.06.05.003; 24.03.01.0020.000904%
Frequent bowel movements07.02.04.002---
Gait disturbance08.01.02.002; 15.03.05.013; 17.02.05.0160.001339%
Gamma-glutamyltransferase increased13.03.04.024--
Gastritis07.08.02.001--
Gastrooesophageal reflux disease07.02.02.0030.001097%
Gastrointestinal disorder07.11.01.001---
Gastrointestinal pain07.01.05.005--
Glaucoma06.03.01.0020.000403%
Glossodynia07.14.02.0010.000549%-
Haematuria20.02.01.006; 21.10.01.018; 24.07.01.0470.000984%
Hallucination19.10.04.0030.001501%
Hallucination, visual19.10.04.0070.000242%-
Headache17.14.01.0010.016651%
Hemiparesis17.01.04.001--
Hepatic steatosis09.01.07.003; 14.08.04.0050.000161%-
Hypersensitivity10.01.03.003--
Hypersensitivity vasculitis01.01.04.008; 10.02.02.017; 23.06.02.005; 24.12.04.013---
Hypertension24.08.02.0010.012456%
Hypertensive crisis24.08.01.0010.000597%-
Hypertonic bladder17.10.01.003; 20.03.03.0030.000823%-
Hypoaesthesia17.02.06.023; 23.03.03.081---
Ileus07.13.01.0010.000323%
Ileus paralytic07.02.05.0010.000161%-
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