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)
Urine analysis abnormal13.13.02.008--Not Available
Sinus disorder22.04.06.0020.000910%
Unevaluable event08.01.03.051--Not Available
Self injurious behaviour19.12.01.0050.001820%Not Available
Hypophagia19.09.01.004; 14.03.01.006; 07.01.06.0100.002276%Not Available
Suicidal behaviour19.12.01.0060.015474%Not Available
Type 1 diabetes mellitus14.06.01.010; 10.04.08.007; 05.06.01.0100.000910%Not Available
Type 2 diabetes mellitus14.06.01.003; 05.06.01.003--Not Available
Brain injury17.11.01.003; 19.07.03.0070.000831%Not Available
Intellectual disability17.03.07.001; 19.21.06.001--Not Available
Oropharyngeal pain22.02.05.022; 07.05.05.004--
Semen analysis abnormal13.20.01.004--Not Available
Terminal insomnia19.02.01.004; 17.15.03.004--Not Available
Acute kidney injury20.01.03.016--
Upper-airway cough syndrome22.02.05.030--
Craniocerebral injury17.11.01.007; 12.01.10.0120.000910%Not Available
Neuropsychiatric syndrome19.07.03.009; 17.02.10.0140.001820%Not Available
Mouth swelling07.05.04.007; 23.04.01.020; 10.01.05.0200.000910%Not Available
Frustration tolerance decreased19.04.02.0160.002731%Not Available
Gambling disorder19.07.02.014--Not Available
Agitated depression19.15.01.007; 17.02.05.0500.000910%Not Available
Alcohol interaction08.06.03.0030.001365%Not Available
Borderline personality disorder19.05.03.0030.001820%Not Available
Cervical spinal stenosis17.10.02.006; 15.10.04.0060.000910%Not Available
Coeliac disease14.02.01.007; 10.04.04.012; 07.17.01.0080.000910%Not Available
Flashback19.10.02.0090.000910%Not Available
Gallbladder pain09.03.02.0080.000910%
Impulsive behaviour19.18.01.0010.000910%Not Available
Maternal drugs affecting foetus18.03.03.009; 12.03.03.0060.000910%Not Available
Patella fracture15.08.03.015; 12.04.01.0150.000910%Not Available
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