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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Accommodation disorder06.02.04.001--Not Available
Ageusia17.02.07.001; 07.14.03.003--Not Available
Aggression19.05.01.001--Not Available
Agitation19.06.02.001; 17.02.05.012--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Asthenia08.01.01.001--Not Available
Atrial fibrillation02.03.03.002--
Atrioventricular block02.03.01.002--Not Available
Bladder pain20.02.02.001--Not Available
Body temperature increased13.15.01.001--Not Available
Bradycardia02.03.02.002--Not Available
Cardiac arrest02.03.04.001--
Confusional state19.13.01.001; 17.02.03.005--
Constipation07.02.02.001--
Cycloplegia17.17.02.003; 06.05.03.002--Not Available
Cystitis20.03.02.002; 11.01.14.001--
Dehydration14.05.05.001--
Dental caries07.09.01.001--
Dermatitis23.03.04.002--Not Available
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dry mouth07.06.01.002--
Dry skin23.03.03.001--
Dysgeusia17.02.07.003; 07.14.03.001--
Dyspepsia07.01.02.001--
Dysuria20.02.02.002--
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