Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Lifitegrast
Drug ID BADD_D01290
Description Lifitegrast is a FDA approved drug for the treatment of keratoconjunctivitis sicca (dry eye syndrome). It is a tetrahydroisoquinoline derivative and lymphocyte function-associated antigen-1 ( LFA-1) antagonist that was discovered through the rational design process. The ophthalmic solution was approved in July, 2016 under the trade name Xiidra. It has shown to protect the corneal surface and alleviate the symptoms of dry eye syndrome with fast onset of action and well tolerated profile in both local and systemic setting [A18805].
Indications and Usage For the treatment of signs and symptoms of keratoconjunctivitis sicca (dry eye syndrome).
Marketing Status approved
ATC Code S01XA25
DrugBank ID DB11611
KEGG ID D10374
MeSH ID C575157
PubChem ID 11965427
TTD Drug ID D0Q9EV
NDC Product Code 65392-2803; 17337-0431; 59116-5170; 63592-3385; 66005-0049; 59651-445; 64552-4088; 64552-4089; 71796-011; 58159-054; 65129-1428; 69766-074; 66039-948; 0078-0911
UNII 038E5L962W
Synonyms lifitegrast | L-phenylalanine, n-((2-(6-benzofuranylcarbonyl)-5,7-dichloro-1,2,3,4-tetrahydro-6-isoquinolinyl)carbonyl)-3-(methylsulfonyl)- | (2S)-2-(((2-(benzofuran-6-ylcarbonyl)-5,7-dichloro-1,2,3,4-tetrahydroisoquinolin-6- yl)carbonyl)amino)-3-(3-(methylsulfonyl)phenyl)propanoic acid | Xiidra | SHP-606 | SHP606 | lifitegrast ophthalmic solution | SAR 1118 | SAR-1118
Chemical Information
Molecular Formula C29H24Cl2N2O7S
CAS Registry Number 1025967-78-5
SMILES CS(=O)(=O)C1=CC=CC(=C1)CC(C(=O)O)NC(=O)C2=C(C=C3CN(CCC3=C2Cl)C(=O)C4=CC5=C(C=C4) C=CO5)Cl
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)
Eczema23.03.04.0060.002043%
Epistaxis22.04.03.001; 24.07.01.0050.010417%
Erythema23.03.06.0010.011980%Not Available
Erythema of eyelid23.03.06.006; 06.04.04.0030.003125%Not Available
Eye allergy10.01.03.028; 06.04.05.0100.003606%Not Available
Eye discharge06.04.05.0010.040306%Not Available
Eye disorder06.08.03.0010.028647%Not Available
Eye haemorrhage12.02.02.012; 24.07.05.002; 06.07.02.0010.001202%Not Available
Eye inflammation06.04.05.0020.002925%Not Available
Eye irritation06.04.05.0030.256098%Not Available
Eye pain06.08.03.0020.088344%
Eye swelling06.08.03.0030.024159%Not Available
Eyelid oedema23.04.01.003; 10.01.05.001; 06.04.04.0040.003406%Not Available
Facial pain08.01.08.0120.002724%
Fear19.06.03.0010.002724%Not Available
Feeling abnormal08.01.09.0140.015225%Not Available
Feeling jittery08.01.09.0160.001362%Not Available
Gastrooesophageal reflux disease07.02.02.0030.006130%
Gingival pain07.09.13.0100.001362%
Glaucoma06.03.01.0020.001202%
Glossodynia07.14.02.0010.001362%Not Available
Halo vision06.02.06.0030.003406%Not Available
Headache17.14.01.0010.055611%
Hyperacusis17.04.03.003; 04.02.02.0010.000881%Not Available
Hyperaemia24.03.02.0020.001362%Not Available
Hypersensitivity10.01.03.0030.046957%
Hypogeusia17.02.07.004; 07.14.03.0020.000881%Not Available
Instillation site pain12.07.01.008; 08.02.01.0080.255657%Not Available
Iridocyclitis06.04.03.0010.000401%Not Available
Keratitis06.04.02.0020.002444%
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