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)
Body temperature increased13.15.01.001--Not Available
Bone disorder15.02.04.0040.013896%Not Available
Bone pain15.02.01.0010.025476%
Bradycardia02.03.02.002--Not Available
Brain abscess17.06.07.001; 11.01.03.0030.001737%Not Available
Brain stem haemorrhage17.08.01.031; 24.07.04.0150.000302%Not Available
Breast cancer21.05.01.003; 16.10.01.0010.020844%Not Available
Breast cyst21.05.01.006; 16.14.01.0040.001158%Not Available
Breast enlargement21.05.04.001--Not Available
Breast inflammation21.05.03.0010.001158%Not Available
Breast mass21.05.04.0020.006369%Not Available
Breast pain21.05.05.003--
Breast tenderness21.05.05.004--Not Available
Bronchiectasis22.03.02.0050.002895%Not Available
Bronchiolitis22.03.02.004; 11.05.04.0080.001158%Not Available
Bronchitis11.01.09.001; 22.07.01.0010.152854%
Bronchitis chronic22.03.01.0190.001158%Not Available
Bronchospasm22.03.01.004; 10.01.03.012--
Bruxism19.11.03.001; 07.01.06.008--Not Available
Burning sensation17.02.06.001; 08.01.09.0290.031845%Not Available
Bursitis15.04.01.0010.015054%Not Available
C-reactive protein increased13.09.01.0070.036476%Not Available
Calcinosis08.03.04.0020.001158%Not Available
Calculus bladder20.04.02.0020.001158%Not Available
Carbon dioxide decreased13.02.01.0120.002316%Not Available
Cardiac arrest02.03.04.001--
Cardiac failure02.05.01.001--
Cardiac failure acute02.05.01.005--Not Available
Cardiac failure congestive02.05.01.002--Not Available
Cardiac murmur13.14.01.001--Not Available
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