Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Tofacitinib
Drug ID BADD_D02236
Description Tofacitinib is an inhibitor of Janus kinases, a group of intracellular enzymes involved in signalling pathways that affect hematopoiesis and immune cell function. It is approved by the FDA for treatment of moderate to severe rheumatoid arthritis that responds inadequately to methotrexate or in those who are intolerant to methotrexate. Besides rheumatoid arthritis, tofacitinib has also been studied in clinical trials for the prevention of organ transplant rejection, and is currently under investigation for the treatment of psoriasis. Known adverse effects include nausea and headache as well as more serious immunologic and hematological adverse effects. Tofacitinib is marketed under the brand name Xeljanz by Pfizer.
Indications and Usage It is not to be initiated in patients with a history of chronic or recurrent infections, or in the presence of active infection, even if localized, due to reports of serious and sometimes fatal infections (commonly pneumonia, herpes zoster and urinary tract infections). Use of tofacitinib is also discouraged in those who have been, or are likely to be, exposed to TB. An increased likelihood of exposure may be encountered by traveling to certain areas. In addition, tofacitinib is not to be used in patients with severe hepatic impairment, or low hemoglobin (less than 9g/dL). Cautioned is advised when using tofacitinib in patients at risk of gastrointestinal perforation, and in the elderly who are more susceptible to infection.
Marketing Status Prescription
ATC Code L04AA29
DrugBank ID DB08895
KEGG ID D09970
MeSH ID C479163
PubChem ID 9926791
TTD Drug ID D0EG1I
NDC Product Code 63539-012; 63539-016; 63539-502; 63539-501; 0069-1029; 0069-1002; 0069-1001; 0069-0502; 0069-0501
Synonyms tofacitinib | tasocitinib | tofacitinib citrate | Xeljanz | CP 690,550 | CP690550 | CP-690550 | CP 690550 | CP-690,550
Chemical Information
Molecular Formula C16H20N6O
CAS Registry Number 477600-75-2
SMILES CC1CCN(CC1N(C)C2=NC=NC3=C2C=CN3)C(=O)CC#N
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)
Diverticulitis11.01.07.003; 07.10.02.0010.048635%Not Available
Diverticulum07.10.01.0010.003474%Not Available
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Dizziness postural24.06.02.008; 17.02.05.004; 02.01.02.005--Not Available
Drooling17.02.05.005--Not Available
Drug dependence19.07.02.009--Not Available
Drug eruption23.03.05.001; 10.01.01.005; 08.01.06.015--Not Available
Drug hypersensitivity10.01.01.001--Not Available
Dry eye06.08.02.0010.101903%
Dry mouth07.06.01.0020.123325%
Dry skin23.03.03.0010.037055%
Dry throat22.02.05.004; 07.06.01.0050.009264%Not Available
Duodenal perforation07.04.02.0010.001158%
Duodenal ulcer07.04.02.002--
Dupuytren's contracture15.03.03.0030.001737%Not Available
Dysaesthesia17.02.06.003--
Dysarthria19.19.03.001; 17.02.08.001--
Dysgeusia17.02.07.003; 07.14.03.001--
Dyskinesia17.01.02.006--
Dyslexia19.21.01.003; 17.02.03.0090.002316%Not Available
Dysmenorrhoea21.01.01.002--
Dyspepsia07.01.02.0010.107692%
Dysphagia07.01.06.003--
Dysphonia22.02.05.005; 19.19.03.002; 17.02.08.0040.026055%
Dyspnoea22.02.01.004; 02.01.03.002--
Dyspnoea exertional02.01.03.003; 22.02.01.005--Not Available
Dysuria20.02.02.0020.023160%
Ear disorder04.03.01.0010.004632%Not Available
Ear infection11.01.05.001; 04.03.01.0060.046898%Not Available
Ear pain04.03.01.0030.015054%
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