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 irritation08.02.01.012; 12.07.01.0130.039424%-
Hypoaesthesia oral07.05.05.003; 17.02.06.0210.001362%-
Paraesthesia oral07.05.05.035; 17.02.06.0080.002043%-
Eyelid irritation06.04.04.007; 23.03.04.0230.003606%-
Brain neoplasm16.30.01.003; 17.20.01.0030.000401%-
Eyelid disorder06.08.03.010; 23.03.03.0280.004007%-
Eyelid function disorder06.05.01.0030.001362%
Corneal disorder06.08.01.0040.002724%-
Ill-defined disorder08.01.03.0490.004087%-
Lacrimal disorder06.08.02.0050.002043%-
Autoimmune disorder10.04.04.0030.000801%
Drug intolerance08.06.01.0130.013141%-
Sinus disorder22.04.06.0020.007011%
Unevaluable event08.01.03.0510.013141%-
Metamorphopsia06.02.06.014; 17.17.01.0200.002043%-
Instillation site reaction08.02.01.046; 12.07.01.0460.213148%-
Eyelid exfoliation06.06.04.004; 23.03.07.0040.001362%-
Dark circles under eyes06.08.03.019; 08.01.03.0540.001362%-
Ulcerative keratitis06.04.02.004; 10.02.01.0210.003005%
Instillation site discomfort08.02.01.035; 12.07.01.0350.013141%-
Treatment failure08.06.01.0170.008374%-
Adverse reaction08.06.01.0180.003406%-
Oropharyngeal blistering07.05.05.006; 22.12.03.0140.000401%-
Oropharyngeal discomfort07.05.05.008; 22.12.03.0150.002043%-
Oropharyngeal pain07.05.05.004; 22.12.03.0160.013141%
Eye complication associated with device06.08.03.020; 08.07.03.0010.001563%-
Upper-airway cough syndrome22.12.03.0360.005850%
Mouth swelling07.05.04.007; 10.01.05.020; 23.04.01.0200.002043%-
Frustration tolerance decreased19.04.02.0160.007011%-
Reading disorder19.21.05.0030.001362%-
The 5th Page    First    Pre   5 6    Next   Last    Total 6 Pages