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)
Swollen tongue23.04.01.014; 10.01.05.015; 07.14.02.0030.005168%Not Available
Therapeutic response unexpected08.06.01.0010.004087%Not Available
Throat irritation22.12.03.029; 07.05.05.0370.013342%Not Available
Throat tightness22.12.03.031; 19.01.02.0050.002925%Not Available
Tinnitus17.04.07.004; 04.04.01.0020.004087%
Toothache07.09.06.0010.004768%
Trichorrhexis23.02.06.0070.001362%Not Available
Ulcer08.03.06.0010.003406%Not Available
Vision blurred17.17.01.010; 06.02.06.0070.328656%
Visual acuity reduced06.02.10.012; 17.17.01.0110.007693%
Visual impairment06.02.10.0130.043070%Not Available
Vitreous floaters06.09.01.0050.001563%
Hypoacusis04.02.01.0060.006050%
Chapped lips07.05.01.0040.001362%Not Available
Muscle tightness15.05.03.0070.001563%Not Available
Hyposmia17.04.04.003; 22.04.03.0080.001362%Not Available
Foreign body sensation in eyes06.01.01.0060.015385%Not Available
Madarosis23.02.02.004; 06.06.04.0100.008374%Not Available
Conjunctival hyperaemia06.04.01.0040.003406%Not Available
Glare06.02.06.0130.001362%Not Available
Eyelid margin crusting23.03.03.029; 06.04.04.0050.006811%Not Available
Ear discomfort04.03.01.0050.001362%Not Available
Eye oedema06.08.03.0130.000881%Not Available
Eye pruritus06.04.05.0060.039424%Not Available
Ocular discomfort06.08.03.0080.022877%Not Available
Nasal discomfort22.12.03.0120.004768%Not Available
Paranasal sinus discomfort22.12.03.0180.001362%Not Available
Secretion discharge08.01.03.0190.004768%Not Available
Dacryostenosis acquired06.06.04.0030.004087%Not Available
Skin burning sensation23.03.03.021; 17.02.06.0090.001362%Not Available
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