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)
Abdominal discomfort07.01.06.0010.002316%Not Available
Abdominal pain upper07.01.05.0030.001158%
Alanine aminotransferase increased13.03.01.0030.001158%
Alopecia23.02.02.0010.001737%
Anaemia01.03.02.0010.002316%
Anxiety19.06.02.002--
Arthralgia15.01.02.0010.002895%
Asthma22.03.01.002; 10.01.03.0100.001158%Not Available
Blister23.03.01.001; 12.01.06.0020.002316%Not Available
Breast cancer21.05.01.003; 16.10.01.0010.001737%Not Available
Bronchitis22.07.01.001; 11.01.09.0010.001737%
Cardiac arrest02.03.04.0010.000302%
Cerebral infarction24.04.06.002; 17.08.01.0040.001158%Not Available
Chest discomfort22.02.08.001; 08.01.08.019; 02.02.02.0090.000453%Not Available
Chest pain22.02.08.003; 08.01.08.002; 02.02.02.0110.003474%Not Available
Confusional state19.13.01.001; 17.02.03.005--
Constipation07.02.02.0010.002316%
Cough22.02.03.0010.005211%
Death08.04.01.001--
Depression19.15.01.001--
Diarrhoea07.02.01.0010.006948%
Diplopia17.17.01.005; 06.02.06.0020.001158%Not Available
Diverticulitis11.01.07.003; 07.10.02.0010.001737%Not Available
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.0040.004632%
Dyspnoea02.01.03.002; 22.02.01.0040.003474%
Fatigue08.01.01.002--
Feeling abnormal08.01.09.0140.001737%Not Available
Fracture15.08.02.001; 12.04.02.0010.001158%
Fungal infection11.03.05.0010.001158%Not Available
Gait disturbance17.02.05.016; 08.01.02.0020.001737%
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