Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Baricitinib
Drug ID BADD_D02487
Description Baricitinib is a selective and reversible Janus kinase 1 (JAK1) and 2 (JAK2) inhibitor. Janus kinases belong to the tyrosine protein kinase family and play an important role in the proinflammatory pathway signalling that is frequently over-activated in autoimmune disorders such as rheumatoid arthritis. By blocking the actions of JAK1/2, baricitinib disrupts the activation of downstream signalling molecules and proinflammatory mediators. Rheumatoid arthritis is a progressive autoimmune disease commonly associated with discomfort, diasability, and joint damage. Throughout disease progression, the disease may further lead to joint erosions and deformities, causing premature mortality, functional impairment, and reduced quality of life [A31386]. While there are several disease modifying antirheumatic drugs (DMARDs) available for treatment, patients often experience inadequate threapeutic resposes to these drugs. In animal models of inflammatory arthritis, baricitinib was shown to have significant anti-inflammatory effects, but also led to preservation of cartilage and bone, with no detectable suppression of humoral immunity or adverse hematologic effects [A31382]. In the EU, baricitinib was approved in February of 2017 as a second-line orally administered treatment for moderate to severe active rheumatoid arthritis in adults, either as a monotherapy or when combined with methotrexate. It is marketed under the trade name Olumiant. Baricitinib in combination with [remdesivir] for the treatment of COVID-19, was granted an FDA Emergency Use Authorization on 19 November 2020.[L22619]
Indications and Usage Indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs as monotherapy or in combination with methotrexate.
Marketing Status approved; investigational
ATC Code L04AA37
DrugBank ID DB11817
KEGG ID D10308
MeSH ID C000596027
PubChem ID 44205240
TTD Drug ID D0Y7IC
NDC Product Code 0002-4182; 0110-4182; 14501-0104; 52076-6225; 0002-4479; 0002-6885; 0110-4732; 63419-0552; 59651-639; 0002-4732; 0110-4479
UNII ISP4442I3Y
Synonyms baricitinib | 3-azetidineacetonitrile, 1-(ethylsulfonyl)-3-(4-(7H-pyrrolo(2,3-d)pyrimidin-4-yl)-1H-pyrazol-1-yl)- | INCB-28050 | Olumiant | baricitinib phosphate | baricitinib phosphate salt | 3-azetidineacetonitrile, 1-(ethylsulfonyl)-3-(4-(7H-pyrrolo(2,3-d)pyrimidin-4-yl)-1H-pyrazol-1-yl)-, phosphate (1:1) | INCB028050 | INCB-028050 | LY3009104 | LY-3009104
Chemical Information
Molecular Formula C16H17N7O2S
CAS Registry Number 1187594-09-7
SMILES CCS(=O)(=O)N1CC(C1)(CC#N)N2C=C(C=N2)C3=C4C=CNC4=NC=N3
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 pain upper07.01.05.003--
Acute myocardial infarction24.04.04.001; 02.02.02.0010.000723%Not Available
Acute respiratory distress syndrome22.01.03.001; 24.03.02.034; 10.02.01.0670.000482%
Acute respiratory failure22.02.06.001; 14.01.04.0040.001447%Not Available
Altered state of consciousness19.07.01.003; 17.02.04.0010.000241%Not Available
Anaemia01.03.02.001--
Angina pectoris24.04.04.002; 02.02.02.0020.000241%
Aphthous ulcer07.05.06.0020.000530%Not Available
Arrhythmia02.03.02.0010.000362%Not Available
Arterial thrombosis24.01.01.0020.000241%Not Available
Arthralgia15.01.02.0010.005521%
Arthritis15.01.01.0010.000940%
Arthropathy15.01.01.0030.000530%Not Available
Asthenia08.01.01.001--Not Available
Asthma22.03.01.002; 10.01.03.0100.001640%Not Available
Atrial fibrillation02.03.03.0020.001543%
Back disorder15.03.05.003--Not Available
Back pain15.03.04.005--
Basal cell carcinoma23.08.02.001; 16.03.02.0010.000241%Not Available
Blister12.01.06.002; 23.03.01.0010.001760%Not Available
Blood pressure fluctuation24.06.01.0020.000530%Not Available
Bradycardia02.03.02.0020.000482%Not Available
Breast cancer21.05.01.003; 16.10.01.0010.000964%Not Available
Cardiac arrest02.03.04.0010.001688%
Cardiac failure02.05.01.0010.000723%
Cardio-respiratory arrest22.02.06.007; 02.03.04.0020.000964%Not Available
Cardiogenic shock24.06.02.006; 02.05.01.0030.000362%Not Available
Cerebral infarction17.08.01.004; 24.04.06.0020.001013%Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.0070.002098%
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.0110.002074%Not Available
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