Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Varenicline
Drug ID BADD_D02337
Description Varenicline is a prescription medication used to treat smoking addiction. This medication is the first approved nicotinic receptor partial agonist. Specifically, varenicline is a partial agonist of the alpha4/beta2 subtype of the nicotinic acetylcholine receptor. In addition it acts on alpha3/beta4 and weakly on alpha3beta2 and alpha6-containing receptors. A full agonism was displayed on alpha7-receptors. On March 9, 2015, the U.S. Food and Drug Administration warned that Varenicline, in the form of Pfizer Inc's quit-smoking drug, Chantix, has been associated with seizures and that some patients who drink while taking the drug may become aggressive or black out. Pfizer is conducting an additional safety study of the drug, results of which are expected in late 2015. The FDA said it is keeping the black box in place at least until the results of the trial are announced.
Indications and Usage For use as an aid in smoking cessation.
Marketing Status Prescription
ATC Code N07BA03
DrugBank ID DB01273
KEGG ID D08669
MeSH ID D000068580
PubChem ID 170361
TTD Drug ID D0LM4A
NDC Product Code 73521-030; 70600-015; 65427-010; 60505-4766; 60505-4765
Synonyms Varenicline | 6,7,8,9-Tetrahydro-6,10-methano-6H-pyrazino(2,3-h)benzazepine | Chantix | Varenicline Tartrate | Champix
Chemical Information
Molecular Formula C13H13N3
CAS Registry Number 249296-44-4
SMILES C1C2CNCC1C3=CC4=NC=CN=C4C=C23
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)
Drug eruption10.01.01.005; 23.03.05.001; 08.01.06.015--Not Available
Drug hypersensitivity10.01.01.0010.134258%Not Available
Drug withdrawal syndrome19.07.02.011; 08.06.02.004--Not Available
Dry eye06.08.02.001--
Dry mouth07.06.01.0020.003641%
Dry skin23.03.03.001--
Dysarthria19.19.03.001; 17.02.08.001--
Dysgeusia17.02.07.003; 07.14.03.0010.011378%
Dyskinesia17.01.02.0060.003641%
Dyspepsia07.01.02.0010.005006%
Dysphagia07.01.06.003--
Dysphonia22.02.05.005; 19.19.03.002; 17.02.08.0040.002731%
Dysphoria19.04.02.004--Not Available
Dyspnoea22.02.01.004; 02.01.03.002--
Dysuria20.02.02.0020.001820%
Ear disorder04.03.01.001--Not Available
Eating disorder19.09.01.008; 14.03.01.0080.003186%Not Available
Eczema23.03.04.006--
Electrocardiogram abnormal13.14.05.0010.001365%Not Available
Electrocardiogram ST segment depression13.14.05.005--Not Available
Electrocardiogram T wave amplitude decreased13.14.05.006--Not Available
Emotional disorder19.04.02.0050.008192%Not Available
Emphysema22.01.02.0020.000950%Not Available
Endocrine disorder05.09.01.001--Not Available
Enterocolitis07.08.03.003--
Epilepsy17.12.03.002--Not Available
Epistaxis24.07.01.005; 22.04.03.001--
Eructation07.01.02.003--
Erythema23.03.06.001--Not Available
Erythema multiforme23.03.01.003; 10.01.03.015--
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