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. Varenicline as a nasal spray is indicated for the symptomatic treatment of dry eye disease.[L38954]
Marketing Status approved; investigational
ATC Code N07BA03; S01XA28
DrugBank ID DB01273
KEGG ID D08669
MeSH ID D000068580
PubChem ID 170361
TTD Drug ID D0LM4A
NDC Product Code 60505-3614; 60505-4765; 70771-1774; 73521-030; 70710-1613; 70710-1614; 70600-015; 51407-755; 60505-3613; 50090-6446; 50090-6447; 60505-4766; 65427-010; 51407-756; 70771-1773
UNII W6HS99O8ZO
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
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)
Rhinorrhoea22.12.03.021--
Rotator cuff syndrome12.01.07.018; 15.01.08.0020.000195%
Salivary hypersecretion07.06.01.0090.000662%Not Available
Schizophrenia19.03.04.001--Not Available
Scleral discolouration06.09.06.001--Not Available
Screaming08.01.03.099; 19.04.02.0200.001285%Not Available
Sedation17.02.04.005--Not Available
Seizure17.12.03.0010.007631%
Sensory disturbance17.02.07.006--Not Available
Sexual dysfunction21.03.02.003; 19.08.05.002--Not Available
Shock24.06.02.002--Not Available
Sinus congestion22.04.06.001--Not Available
Sinusitis22.07.03.007; 11.01.13.005--
Skin disorder23.03.03.007--Not Available
Skin exfoliation23.03.07.0030.002375%Not Available
Skin reaction10.01.03.019; 23.03.03.0130.000857%Not Available
Sleep apnoea syndrome22.02.01.013; 19.02.05.002; 17.15.05.0010.000584%
Sleep disorder19.02.04.0010.005626%Not Available
Sleep talking19.02.03.005; 17.15.02.0030.000428%Not Available
Sleep terror19.02.03.008; 17.15.02.0060.001285%Not Available
Sluggishness08.01.01.0040.000662%Not Available
Sneezing22.12.03.0240.006950%
Snoring22.12.03.025--Not Available
Social avoidant behaviour19.05.01.0070.000389%Not Available
Somnambulism19.02.03.006; 17.15.02.0040.004380%Not Available
Somnolence19.02.05.003; 17.02.04.006--
Speech disorder22.12.03.027; 19.19.02.002; 17.02.08.0030.002239%Not Available
Splenomegaly01.09.02.001--Not Available
Stevens-Johnson syndrome10.01.01.045; 23.03.01.007; 12.03.01.014; 11.07.01.005--
Stomatitis07.05.06.005--
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ADReCS-Target
Drug Name ADR Term Target
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