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)
Euphoric mood19.04.02.0060.000910%
Extrapyramidal disorder17.01.02.007--
Eye disorder06.08.03.001--Not Available
Eye irritation06.04.05.003--Not Available
Eye pain06.08.03.002--
Eye swelling06.08.03.0030.001820%Not Available
Facial paralysis17.04.03.0080.001365%Not Available
Fatigue08.01.01.002--
Fear19.06.03.0010.004096%Not Available
Feeling abnormal08.01.09.0140.043691%Not Available
Flat affect19.04.01.0040.000910%Not Available
Flatulence07.01.04.0020.003186%
Fluid retention20.01.02.003; 14.05.06.002--Not Available
Foot fracture15.08.03.012; 12.04.01.0120.000910%Not Available
Formication19.10.02.010; 17.02.06.0180.000910%Not Available
Fracture15.08.02.001; 12.04.02.001--
Frequent bowel movements07.02.04.002--Not Available
Fungal infection11.03.05.001--Not Available
Gait disturbance17.02.05.016; 08.01.02.002--
Gallbladder disorder09.03.02.0010.001820%Not Available
Gastric ulcer07.04.03.002--
Gastritis07.08.02.001--
Gastrooesophageal reflux disease07.02.02.003--
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Gastrointestinal pain07.01.05.005--
Generalised anxiety disorder19.06.01.0040.000910%Not Available
Generalised tonic-clonic seizure17.12.01.0020.002731%Not Available
Gingival bleeding24.07.02.010; 07.09.07.0010.002276%Not Available
Gingival pain07.09.04.001--
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