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 Not Available
ATC Code L04AA37
DrugBank ID DB11817
KEGG ID D10308
MeSH ID C000596027
PubChem ID 44205240
TTD Drug ID D0Y7IC
NDC Product Code 59651-639; 0110-4732; 0110-4182; 14501-0104; 0110-4479; 0002-6885; 63419-0552; 0002-4182; 0002-4732; 52076-6225
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
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)
Nausea07.01.07.0010.006369%
Neuropathy peripheral17.09.03.0030.001158%Not Available
Oedema peripheral02.05.04.007; 14.05.06.011; 08.01.07.0070.001158%
Pain08.01.08.0040.003474%
Pain in extremity15.03.04.0100.006948%
Palpitations02.01.02.0030.001158%
Paraesthesia17.02.06.0050.001737%
Pneumonia22.07.01.003; 11.01.09.0030.002895%Not Available
Pneumonia legionella22.07.06.009; 11.02.16.0020.001158%Not Available
Productive cough22.02.03.0050.001158%
Psoriasis10.02.01.036; 23.03.14.0020.001158%Not Available
Pulmonary congestion24.03.08.001; 22.01.03.002; 02.05.02.0020.000302%Not Available
Pulmonary embolism24.01.06.001; 22.06.02.0010.002316%Not Available
Pyrexia08.05.02.0030.002316%
Restlessness17.02.05.021; 19.11.02.0020.001158%
Rheumatoid arthritis15.01.03.001; 10.04.06.0010.005211%Not Available
Rhinorrhoea22.02.05.0100.001158%
Sepsis11.01.11.0030.000453%
Sinusitis22.07.03.007; 11.01.13.0050.006369%
Skin disorder23.03.03.0070.001158%Not Available
Skin lesion23.03.03.0100.001158%Not Available
Somnolence19.02.05.003; 17.02.04.006--
Squamous cell carcinoma16.16.01.0020.001158%Not Available
Swelling08.01.03.0150.001158%Not Available
Thrombosis24.01.01.0060.001158%Not Available
Ulcer08.03.06.0010.001158%Not Available
Upper respiratory tract infection22.07.03.011; 11.01.13.0090.001158%
Urinary tract infection20.08.02.001; 11.01.14.0040.004632%
Urticaria10.01.06.001; 23.04.02.0010.001158%
Visual impairment06.02.06.0080.002895%Not Available
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