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)
Pulmonary congestion22.01.03.002; 02.05.02.002; 24.03.08.0010.000530%Not Available
Pulmonary embolism24.01.06.001; 22.06.02.0010.013092%Not Available
Pulmonary fibrosis22.01.02.0060.000723%
Pyrexia08.05.02.0030.004726%
Renal cancer20.01.04.002; 16.08.02.001--Not Available
Renal failure20.01.03.0050.000844%Not Available
Renal infarct24.01.11.004; 20.01.07.0080.000241%Not Available
Respiratory depression22.02.01.010; 17.02.05.0470.001326%Not Available
Respiratory disorder22.02.07.0020.000892%Not Available
Respiratory distress22.02.01.0120.000241%Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.002942%
Restlessness19.11.02.002; 17.02.05.0210.000530%
Retinal vein occlusion24.01.07.006; 06.10.01.0100.000241%Not Available
Rhabdomyolysis15.05.05.0020.000603%
Rheumatoid arthritis15.01.03.001; 10.04.06.0010.006944%Not Available
Rhinorrhoea22.12.03.0210.000820%
Right ventricular failure02.05.03.0020.000482%Not Available
Sedation17.02.04.0050.000241%Not Available
Shock24.06.02.0020.000362%Not Available
Skin disorder23.03.03.0070.000940%Not Available
Skin lesion23.03.03.0100.000530%Not Available
Squamous cell carcinoma16.16.01.0020.000362%Not Available
Stress19.06.02.004--Not Available
Sudden death08.04.01.003; 02.03.04.0130.000241%
Swelling08.01.03.0150.001471%Not Available
Swelling face08.01.03.100; 23.04.01.018; 10.01.05.0180.000940%Not Available
Tachycardia02.03.02.0070.001374%Not Available
Tachypnoea22.02.01.0140.000362%Not Available
Throat tightness22.12.03.031; 19.01.02.005--Not Available
Thrombocytopenia01.08.01.0020.002194%Not Available
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