Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Varenicline tartrate
Drug ID BADD_D02338
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. Varenicline as a nasal spray is indicated for the symptomatic treatment of dry eye disease.[L38954]
Marketing Status approved; investigational
ATC Code S01XA28; N07BA03
DrugBank ID DB01273
KEGG ID D06282
MeSH ID D000068580
PubChem ID 46783232
TTD Drug ID D0LM4A
NDC Product Code 53296-0093; 65015-758; 65085-0073; 65977-0120; 10829-1469; 15894-0024; 0069-0468; 49884-155; 0069-0469; 0069-0471; 42413-0179; 63539-473; 75945-040; 49884-944; 63187-618; 60687-648; 71205-381; 43353-899; 49884-156; 10829-1468
UNII 82269ASB48
Synonyms Varenicline | 6,7,8,9-Tetrahydro-6,10-methano-6H-pyrazino(2,3-h)benzazepine | Chantix | Varenicline Tartrate | Champix
Chemical Information
Molecular Formula C17H19N3O6
CAS Registry Number 375815-87-5
SMILES C1C2CNCC1C3=CC4=NC=CN=C4C=C23.C(C(C(=O)O)O)(C(=O)O)O
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)
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Hallucination19.10.04.003--
Headache17.14.01.001--
Hostility19.05.01.003--Not Available
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypersensitivity10.01.03.003--
Hypoglycaemia14.06.03.001; 05.06.03.001--
Hypokalaemia14.05.03.002--
Increased appetite14.03.01.003; 08.01.09.027--Not Available
Influenza like illness08.01.03.010--
Insomnia17.15.03.002; 19.02.01.002--
Intestinal obstruction07.13.01.002--Not Available
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.008--
Leukocytosis01.02.01.002--
Libido decreased21.03.02.005; 19.08.03.001--
Liver function test abnormal13.03.04.030--Not Available
Lymphadenopathy01.09.01.002--Not Available
Malaise08.01.01.003--
Mania19.16.02.002--
Meniere's disease17.02.12.003; 07.01.07.007; 04.04.02.003--Not Available
Menstrual disorder21.01.01.004--Not Available
Mental impairment17.03.03.002; 19.21.02.003--Not Available
Migraine24.03.05.003; 17.14.02.001--Not Available
Mood swings19.04.03.001--Not Available
Mouth ulceration07.05.06.004--Not Available
Multiple sclerosis17.16.01.001; 10.04.10.008--Not Available
Muscle spasms15.05.03.004--
Musculoskeletal pain15.03.04.007--
Myalgia15.05.02.001--
Myocardial infarction24.04.04.009; 02.02.02.007--
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