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 For the treatment of moderate to severe rheumatoid arthritis which is resistant or intolerant to methotrexate therapy. It may also be used as an adjunct to methotrexate therapy, or other non-biologic disease-modifying antirheumatic drugs (DMARDS), when methotrexate alone is not sufficient. Tofacitinib has also been investigated as a preventative therapy for kidney transplant rejections, and as a treatment for psoriasis, ulcerative colitis, and ankylosing spondylitis. 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 approved; investigational
ATC Code L04AA29
DrugBank ID DB08895
KEGG ID D09970
MeSH ID C479163
PubChem ID 9926791
TTD Drug ID D0EG1I
NDC Product Code 0069-1002; 63539-012; 0069-0502; 42816-0501; 63539-501; 0069-0501; 0069-1001; 0069-1029; 63539-016; 63539-502; 71796-050
UNII 87LA6FU830
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
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)
Abdominal discomfort07.01.06.0010.264669%Not Available
Abdominal distension07.01.04.0010.052707%
Abdominal pain07.01.05.0020.133142%
Abdominal pain upper07.01.05.0030.219412%
Abdominal rigidity07.01.05.0110.001640%Not Available
Abdominal tenderness07.01.05.004--Not Available
Abnormal faeces07.01.03.0010.009765%Not Available
Acne23.02.01.0010.104354%Not Available
Acne cystic23.02.01.0050.002170%Not Available
Acrochordon23.10.01.005; 16.26.01.0050.001881%Not Available
Acute leukaemia16.01.02.001; 01.10.02.0010.000362%Not Available
Adenoma benign16.02.02.0010.000530%Not Available
Adrenal disorder05.01.03.0010.001181%Not Available
Alopecia23.02.02.0010.183824%
Alopecia totalis23.02.02.0060.000820%Not Available
Amaurosis06.02.10.0010.000241%Not Available
Amyotrophic lateral sclerosis17.05.05.0040.000362%Not Available
Anaemia01.03.02.001--
Anal fistula07.11.05.002--
Aneurysm24.02.01.0010.002363%Not Available
Angina pectoris24.04.04.002; 02.02.02.002--
Angular cheilitis23.03.03.054; 07.05.07.0130.000530%Not Available
Ankylosing spondylitis15.01.09.001; 10.04.04.0040.002580%Not Available
Anorectal disorder07.03.01.0010.000892%Not Available
Anosmia22.04.03.006; 17.04.04.0010.004605%
Aortic aneurysm24.02.03.0010.001567%Not Available
Aortic aneurysm rupture24.02.03.0030.000241%Not Available
Aortic valve stenosis02.07.03.0040.000362%Not Available
Aphasia19.21.01.001; 17.02.03.001--
Aphonia22.12.03.001; 19.19.01.002; 17.02.08.0090.012586%
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