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)
Blood cholesterol increased13.12.01.0020.171961%
Blood creatine increased13.13.01.0010.004632%Not Available
Blood creatine phosphokinase increased13.04.01.001--
Blood creatinine abnormal13.13.01.0020.002316%Not Available
Blood creatinine decreased13.13.01.0030.001158%Not Available
Blood creatinine increased13.13.01.004--
Blood glucose abnormal13.02.02.0080.002895%Not Available
Blood glucose decreased13.02.02.0010.006369%Not Available
Blood glucose increased13.02.02.0020.031266%Not Available
Blood immunoglobulin G decreased13.06.05.0010.002316%Not Available
Blood immunoglobulin G increased13.06.05.0040.001158%Not Available
Blood iron decreased13.11.01.0060.008685%Not Available
Blood lactate dehydrogenase increased13.04.02.002--
Blood magnesium decreased13.11.01.008--Not Available
Blood potassium abnormal13.11.01.0240.001737%Not Available
Blood potassium decreased13.11.01.010--Not Available
Blood potassium increased13.11.01.011--Not Available
Blood pressure abnormal13.14.03.0010.010422%Not Available
Blood pressure decreased13.14.03.002--Not Available
Blood pressure diastolic increased13.14.03.0040.001737%Not Available
Blood pressure fluctuation24.06.01.002--Not Available
Blood pressure increased13.14.03.0050.143011%Not Available
Blood pressure systolic increased13.14.03.006--Not Available
Blood sodium decreased13.11.01.012--Not Available
Blood testosterone decreased13.10.05.004--Not Available
Blood triglycerides increased13.12.03.0010.028950%Not Available
Blood urea decreased13.13.01.0170.001158%Not Available
Blood urea increased13.13.01.006--Not Available
Blood uric acid increased13.02.04.001--Not Available
Body temperature decreased13.15.01.010--Not Available
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