Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Glycopyrrolate
Drug ID BADD_D01034
Description Glycopyrronium, also known as NVA237 or glycopyrrolate, is a racemic mixture of two enantiomers.[L33110] They are both quaternary ammonium compounds and long acting muscarinic antagonists.[L33110] It is one of the most commonly prescribed anticholinergic medications.[A233535,A233540] Early research into glycopyrronium use was for its indication as an adjunct therapy in the treatment of peptic ulcers.[A233570,L33090] Later research, taking advantage of the systemic distribution of muscarinic receptors through the body, found that glycopyrronium could also be used for reducing sweat gland,[L4755] oral,[L33140] airway, and gastric secretions;[L33120] as well as reducing cardiac inhibitory reflexes;[L33120] and reducing bronchoconstriction in COPD.[L33105] Glycopyrronium is commonly prescribed as a first line treatment for a wide variety indications and is considered to have a wider therapeutic window than [tiotropium].[A233565] Glycopyrronium was originally granted FDA approval on 11 August 1961.[L33090]
Indications and Usage Glycopyrronium formulated as a topical cloth is indicated to treat primary axillary hyperhidrosis in patients ≥9 years,[L4755] and an inhalational solution is indicated for long term maintenance of airflow obstruction in COPD.[L33105] A glycopyrronium intravenous and intramuscular injection is indicated in adults and pediatric patients to reduce the volume and acidity of gastric secretions, reduce airway secretions, and block cardiac inhibitory reflexes during the induction of anesthesia and intubation; to treat surgically-induced, drug-induced, or vagal reflex associated arrhythmias intraoperatively; and to prevent peripheral muscarinic effects of cholinergic drugs.[L33120] The same injection is indicated in adults as an adjunct therapy in the treatment of peptic ulcers.[L33120] An oral solution is indicated to treat excessive drooling associated with neurologic conditions in patients aged 3-16 years.[L33140] Glycopyrronium and [budesonide][L33145] can be formulated with [formoterol] fumarate for the maintenance of COPD.[L33150]
Marketing Status approved; investigational; vet_approved
ATC Code D11AA01; A03AB02; R03BB06
DrugBank ID DB00986
KEGG ID D00540
MeSH ID D006024
PubChem ID 11693
TTD Drug ID D0M0AM
NDC Product Code 72887-160; 75834-195; 76045-208; 16571-743; 16714-620; 16729-471; 0143-9584; 0143-9586; 0143-9587; 43547-639; 50090-6113; 51754-6013; 52584-396; 62332-627; 63323-578; 0404-9870; 70069-012; 70121-1699; 70700-165; 71872-7227; 71872-7289; 75834-196; 76045-206; 0781-3825; 64567-0018; 68022-7048; 16729-474; 43547-543; 51662-1487; 55154-8225; 66794-203; 0404-9869; 70199-008; 71335-2119; 71839-123; 71839-124; 71839-126; 71872-7093; 71872-7175; 71872-7196; 71872-7292; 75834-194; 0904-6709; 51927-1575; 16729-472; 23155-607; 43547-640; 49884-066; 51662-1554; 55111-648; 55150-293; 65145-105; 0517-4602; 0517-4605; 70199-007; 71335-9652; 71872-7174; 55150-294; 55150-295; 63629-9287; 65145-103; 66794-204; 68083-379; 68788-8279; 69315-139; 70700-168; 70700-902; 70771-1616; 70771-1617; 71872-7012; 71872-7094; 79739-7097; 49452-3358; 51552-0042; 59115-809; 50268-363; 51662-1425; 55154-7475; 60505-6180; 63629-9592; 66794-205; 0517-4620; 70069-011; 70121-1396; 70518-3152; 70756-634; 70771-1618; 76045-203; 80056-160; 51014-7146; 54239-012; 62991-2886; 13107-014; 16571-744; 16714-536; 23155-606; 0143-9585; 51754-6015; 62332-628; 65145-104; 66794-202; 68083-377; 69076-475; 70121-1395; 70700-903; 70756-631; 71288-415; 71335-2075; 71872-7013; 71872-7181; 71872-7208; 72572-225; 76045-023; 0781-3829; 59651-737; 0143-9682; 51662-1601; 51754-6001; 52584-682; 63629-2207; 65145-102; 0404-9867; 68083-376; 70069-616; 70700-166; 70710-1645; 70756-633; 71288-408; 71335-1225; 71872-7179; 71872-7224; 71872-7237; 72572-226; 75834-193; 66064-3100; 13107-015; 16714-906; 0143-9681; 43547-544; 49884-042; 51662-1431; 51662-1484; 51754-6000; 52584-681; 60505-6179; 60505-6181; 60505-6182; 62332-629; 68083-378; 69076-476; 0517-4601; 70069-014; 70121-1394; 70710-1646; 70710-1648; 70756-632; 70860-781; 0781-3827; 14335-250; 17373-1036; 62938-0042; 0259-0501; 0259-0502; 55150-292; 60429-666; 62332-607; 63629-2206; 63629-7207; 0404-9868; 69315-140; 70069-013; 70518-3031; 70700-167; 71288-407; 71288-414; 71839-125; 59651-738; 16714-998; 0143-9680; 49884-065; 55111-649; 60429-665; 70121-1397; 70121-1698; 70710-1647; 70771-1619; 71872-7148; 71872-7238; 0781-3831; 38779-2087; 15955-305; 15955-318; 16729-473; 31722-016; 0143-9679
UNII V92SO9WP2I
Synonyms Glycopyrrolate | Glycopyrronium Bromide | Bromide, Glycopyrronium | Pyrrolidinium, 3-((cyclopentylhydroxyphenylacetyl)oxy)-1,1-dimethyl-, bromide | Glycopyrronium | NVA237 | NVA 237 | NVA-237
Chemical Information
Molecular Formula C19H28BrNO3
CAS Registry Number 596-51-0
SMILES C[N+]1(CCC(C1)OC(=O)C(C2CCCC2)(C3=CC=CC=C3)O)C.[Br-]
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)
Urinary hesitation20.02.02.009--Not Available
Urinary retention20.02.02.011--
Urinary tract disorder20.08.01.001--Not Available
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001--
Ventricular fibrillation02.03.04.008--
Ventricular tachycardia02.03.04.010--
Vision blurred17.17.01.010; 06.02.06.007--
Vomiting07.01.07.003--
Chapped lips07.05.01.004--Not Available
Tongue dry07.14.02.009--Not Available
Idiosyncratic drug reaction08.06.01.002--Not Available
Musculoskeletal chest pain15.03.04.012; 22.09.01.001--
Gastrointestinal hypomotility07.02.02.005--Not Available
Affect lability19.04.01.001--Not Available
Increased viscosity of bronchial secretion22.12.01.003--Not Available
Cardiac disorder02.11.01.003--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Impulse-control disorder19.18.01.002--Not Available
Infestation11.09.01.001; 23.11.01.002--Not Available
Malnutrition14.03.02.004--Not Available
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.002--Not Available
Abnormal behaviour19.01.01.001--Not Available
Erectile dysfunction21.03.01.007; 19.08.04.001--
Urinary tract obstruction20.08.01.004--
Cystitis noninfective20.03.02.001--
Tracheostomy infection12.02.07.007; 11.01.13.017--Not Available
Lactation insufficiency18.06.02.006; 21.05.02.006--Not Available
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