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)
Eyelid rash06.04.04.017; 23.03.13.0200.003406%-
Pharyngeal paraesthesia17.02.06.035; 22.04.05.0180.001362%-
Allergic reaction to excipient10.01.01.0350.001362%-
Eyelash changes06.06.04.0250.002043%-
Floppy eyelid syndrome06.06.04.026; 23.07.04.0400.001362%-
Illness08.01.03.0910.003806%-
Instillation site burn08.02.01.057; 12.07.01.057; 23.03.11.0370.008173%-
Instillation site coldness08.02.01.058; 12.07.01.0580.001362%-
Instillation site discharge08.02.01.059; 12.07.01.059; 23.03.03.0890.019953%-
Instillation site dryness08.02.01.060; 12.07.01.0600.008854%-
Instillation site erythema08.02.01.061; 12.07.01.061; 23.03.06.0250.050803%-
Instillation site foreign body sensation08.02.01.062; 12.07.01.0620.009055%-
Instillation site hypersensitivity08.02.01.063; 10.01.03.060; 12.07.01.0630.005449%-
Instillation site inflammation08.02.01.064; 12.07.01.0640.010898%-
Instillation site lacrimation08.02.01.065; 12.07.01.0650.037661%-
Instillation site odour08.02.01.066; 12.07.01.0660.001362%-
Instillation site paraesthesia08.02.01.067; 12.07.01.067; 17.02.06.0520.002925%-
Instillation site pruritus08.02.01.068; 12.07.01.068; 23.03.12.0140.044192%-
Instillation site rash08.02.01.069; 12.07.01.069; 23.03.13.0270.001362%-
Instillation site swelling08.02.01.070; 12.07.01.0700.019953%-
Instillation site vesicles08.02.01.071; 12.07.01.071; 23.03.01.0370.001362%-
Periorbital swelling06.08.03.032; 10.01.05.025; 23.04.01.0250.005168%-
Pharyngeal swelling22.04.05.0280.002444%-
Sinus pain22.12.03.0230.004087%
Swelling of eyelid06.04.04.018; 10.01.05.026; 23.04.01.0260.011298%-
Taste disorder07.14.03.004; 17.02.07.0290.022877%-
Therapeutic response shortened08.06.01.0620.001362%-
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