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)
Liver function test abnormal13.03.01.013--Not Available
Loss of consciousness17.02.04.0040.033678%Not Available
Lower respiratory tract infection22.07.01.002; 11.01.09.0020.001365%Not Available
Lung disorder22.02.07.0010.002731%Not Available
Lymphadenopathy01.09.01.002--Not Available
Malaise08.01.01.0030.037319%
Mania19.16.02.0020.009102%
Memory impairment19.20.01.003; 17.03.02.0030.011833%
Meniere's disease04.04.02.003; 17.02.12.003; 07.01.07.007--Not Available
Menopausal symptoms21.02.02.002--Not Available
Menorrhagia21.01.03.002--
Menstrual disorder21.01.01.004--Not Available
Mental disability26.01.01.001--Not Available
Mental impairment19.21.02.003; 17.03.03.0020.001820%Not Available
Middle insomnia19.02.01.003; 17.15.03.0030.001820%Not Available
Migraine24.03.05.003; 17.14.02.0010.005461%Not Available
Mood altered19.04.02.0070.017749%Not Available
Mood swings19.04.03.0010.025486%Not Available
Mouth haemorrhage24.07.02.014; 07.05.02.0010.001820%
Mouth ulceration07.05.06.0040.002276%Not Available
Movement disorder17.01.02.0100.001820%Not Available
Multiple sclerosis17.16.01.001; 10.04.10.0080.001365%Not Available
Muscle atrophy17.05.03.004; 15.05.03.0030.000910%Not Available
Muscle spasms15.05.03.004--
Muscle twitching15.05.03.0050.001820%Not Available
Muscular weakness17.05.03.005; 15.05.06.001--
Musculoskeletal pain15.03.04.007--
Myalgia15.05.02.001--
Mydriasis17.02.11.003; 06.05.03.004--Not Available
Myocardial infarction24.04.04.009; 02.02.02.007--
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