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)
Abdominal discomfort07.01.06.0010.203805%Not Available
Abdominal distension07.01.04.0010.053267%
Abdominal pain07.01.05.0020.152275%
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.0030.188751%
Abdominal tenderness07.01.05.004--Not Available
Abnormal dreams19.02.03.001; 17.15.02.001--Not Available
Abnormal faeces07.01.03.0010.003474%Not Available
Abortion spontaneous18.01.04.001--Not Available
Abscess11.01.08.0010.008106%Not Available
Acne23.02.01.0010.075269%Not Available
Acne pustular23.02.01.007; 11.01.12.0160.002316%Not Available
Acrochordon23.10.01.005; 16.26.01.0050.001737%Not Available
Actinic keratosis23.01.06.001--Not Available
Acute leukaemia01.10.02.001; 16.01.02.0010.000453%Not Available
Acute myeloid leukaemia01.10.05.001; 16.01.05.001--Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.001--Not Available
Acute pulmonary oedema22.01.03.005; 02.05.02.004--Not Available
Acute respiratory distress syndrome22.01.03.001--
Acute respiratory failure22.02.06.001; 14.01.04.004--Not Available
Adenocarcinoma16.16.01.0040.000302%Not Available
Adrenal disorder05.01.03.0010.001737%Not Available
Affective disorder19.04.04.001--Not Available
Ageusia17.02.07.001; 07.14.03.003--Not Available
Aggression19.05.01.001--Not Available
Agitation19.06.02.001; 17.02.05.012--
Alanine aminotransferase decreased13.03.01.0020.001737%Not Available
Alanine aminotransferase increased13.03.01.003--
Alopecia23.02.02.0010.170803%
Alopecia totalis23.02.02.0060.001158%Not Available
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