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)
Aspartate aminotransferase increased13.03.01.006--
Aspiration22.02.07.007--
Asthenia08.01.01.001--Not Available
Asthenopia06.01.01.0020.001158%Not Available
Asthma22.03.01.002; 10.01.03.0100.037634%Not Available
Atrial fibrillation02.03.03.002--
Atrioventricular block02.03.01.002--Not Available
Atrioventricular block complete02.03.01.003--
Atrophy08.03.04.0010.001158%Not Available
Atypical pneumonia22.07.01.010; 11.01.09.0120.002895%Not Available
Autoimmune hepatitis10.04.09.001; 09.01.07.019--Not Available
Autonomic nervous system imbalance24.06.01.005; 17.05.01.011; 08.01.01.0100.001158%Not Available
B-cell lymphoma16.28.01.001; 01.15.01.0010.000755%Not Available
Back disorder15.03.01.0140.015054%Not Available
Back pain15.03.04.0050.287759%
Bacteraemia11.01.11.001--
Basal cell carcinoma23.08.02.001; 16.03.02.001--Not Available
Basedow's disease10.04.08.004; 06.09.04.003; 05.02.02.0030.001158%Not Available
Bile duct cancer16.07.01.001; 09.04.02.0010.000302%Not Available
Bile duct stone09.02.02.0030.001158%Not Available
Bladder cancer20.03.04.001; 16.08.01.001--Not Available
Bladder pain20.02.02.0010.001737%Not Available
Bleeding time prolonged13.01.02.0020.001158%Not Available
Blepharospasm17.17.02.001; 06.05.01.001--Not Available
Blindness17.17.01.003; 06.02.02.001--Not Available
Blindness unilateral17.17.01.016; 06.02.02.009--Not Available
Blister23.03.01.001; 12.01.06.0020.033003%Not Available
Blood albumin decreased13.09.01.001--Not Available
Blood bilirubin increased13.03.01.008--
Blood cholesterol abnormal13.12.01.0090.002316%Not Available
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