Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Glycopyrronium
Drug ID BADD_D02432
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
DrugBank ID DB00986
KEGG ID D10938
MeSH ID D006024
PubChem ID 9933193
TTD Drug ID D0M0AM
NDC Product Code 69489-411
UNII A14FB57V1D
Synonyms Glycopyrrolate | Glycopyrronium Bromide | Bromide, Glycopyrronium | Pyrrolidinium, 3-((cyclopentylhydroxyphenylacetyl)oxy)-1,1-dimethyl-, bromide | Glycopyrronium | NVA237 | NVA 237 | NVA-237
Chemical Information
Molecular Formula C19H28NO3+
CAS Registry Number 746600-85-1
SMILES C[N+]1(CCC(C1)OC(=O)C(C2CCCC2)(C3=CC=CC=C3)O)C
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)
Myalgia15.05.02.001--
Mydriasis17.02.11.003; 06.05.03.0040.233202%Not Available
Nasal congestion22.04.04.001--
Nasal dryness22.04.03.0020.009646%Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Paralysis17.01.04.0040.001891%Not Available
Pharyngeal haemorrhage24.07.02.017; 22.04.05.0020.004161%
Photophobia06.01.01.004; 17.17.02.0060.013807%
Premature baby18.04.02.001--Not Available
Productive cough22.02.03.0050.002837%
Pruritus23.03.12.001--
Pulmonary oedema22.01.03.003; 02.05.02.0030.001891%
Rash23.03.13.0010.024398%Not Available
Rash erythematous23.03.13.0290.006431%Not Available
Respiratory arrest22.02.01.0090.002837%Not Available
Respiratory disorder22.02.07.0020.001891%Not Available
Respiratory distress22.02.01.0120.001891%Not Available
Rhinorrhoea22.12.03.021--
Seizure17.12.03.0010.009457%
Sinus tachycardia02.03.03.0100.001891%
Skin exfoliation23.03.07.0030.006431%Not Available
Skin irritation23.03.04.0090.006431%Not Available
Speech disorder22.12.03.027; 19.19.02.002; 17.02.08.0030.004161%Not Available
Swollen tongue23.04.01.014; 10.01.05.015; 07.14.02.0030.001891%Not Available
Syncope02.11.04.015; 24.06.02.012; 17.02.04.0080.001891%
Tachycardia02.03.02.0070.014185%Not Available
Tachypnoea22.02.01.0140.004728%Not Available
Therapeutic response decreased08.06.01.0160.006431%Not Available
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