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)
Instillation site irritation12.07.01.013; 08.02.01.0120.039424%Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.0030.001362%Not Available
Paraesthesia oral07.05.05.035; 17.02.06.0080.002043%Not Available
Eyelid irritation23.03.04.023; 06.04.04.0070.003606%Not Available
Brain neoplasm17.20.01.003; 16.30.01.0030.000401%Not Available
Eyelid disorder23.03.03.028; 06.08.03.0100.004007%Not Available
Eyelid function disorder06.05.01.0030.001362%
Corneal disorder06.08.01.0040.002724%Not Available
Ill-defined disorder08.01.03.0490.004087%Not Available
Lacrimal disorder06.08.02.0050.002043%Not Available
Autoimmune disorder10.04.04.0030.000801%
Drug intolerance08.06.01.0130.013141%Not Available
Sinus disorder22.04.06.0020.007011%
Unevaluable event08.01.03.0510.013141%Not Available
Metamorphopsia17.17.01.020; 06.02.06.0140.002043%Not Available
Instillation site reaction12.07.01.046; 08.02.01.0460.213148%Not Available
Eyelid exfoliation06.06.04.004; 23.03.07.0040.001362%Not Available
Dark circles under eyes08.01.03.054; 06.08.03.0190.001362%Not Available
Ulcerative keratitis10.02.01.021; 06.04.02.0040.003005%
Instillation site discomfort12.07.01.035; 08.02.01.0350.013141%Not Available
Treatment failure08.06.01.0170.008374%Not Available
Adverse reaction08.06.01.0180.003406%Not Available
Oropharyngeal blistering22.12.03.014; 07.05.05.0060.000401%Not Available
Oropharyngeal discomfort07.05.05.008; 22.12.03.0150.002043%Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.0040.013141%
Eye complication associated with device06.08.03.020; 08.07.03.0010.001563%Not Available
Upper-airway cough syndrome22.12.03.0360.005850%
Mouth swelling07.05.04.007; 23.04.01.020; 10.01.05.0200.002043%Not Available
Frustration tolerance decreased19.04.02.0160.007011%Not Available
Reading disorder19.21.05.0030.001362%Not Available
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