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)
Abnormal sensation in eye06.01.01.0010.007011%Not Available
Ageusia17.02.07.001; 07.14.03.0030.007492%Not Available
Anosmia22.04.03.006; 17.04.04.0010.004087%
Aphonia19.19.01.002; 17.02.08.009; 22.12.03.0010.001563%
Arthritis15.01.01.0010.007412%
Asthenopia06.01.01.0020.008854%Not Available
Blepharitis23.03.04.012; 06.04.04.0010.003606%Not Available
Blindness06.02.10.003; 17.17.01.0030.002003%Not Available
Blindness unilateral06.02.10.007; 17.17.01.0160.000401%Not Available
Bronchospasm22.03.01.004; 10.01.03.0120.002244%
Burning sensation17.02.06.001; 08.01.09.0290.018390%Not Available
Cataract06.06.01.0010.002284%
Condition aggravated08.01.03.0040.025522%Not Available
Conjunctival haemorrhage24.07.05.001; 06.07.01.0010.000401%Not Available
Conjunctival oedema06.04.01.0010.002724%Not Available
Conjunctivitis allergic10.01.04.002; 06.04.01.0030.002244%Not Available
Corneal erosion06.06.03.0030.002043%Not Available
Corneal lesion06.06.03.0040.000601%Not Available
Cyst16.02.02.002; 08.03.05.0010.001362%Not Available
Depressed mood19.15.02.0010.004087%Not Available
Dermatitis allergic23.03.04.003; 10.01.03.0140.004087%Not Available
Dermatitis contact12.03.01.040; 10.01.01.003; 23.03.04.0040.001763%Not Available
Diplopia17.17.01.005; 06.02.06.0020.002925%Not Available
Drug ineffective08.06.01.0060.121598%Not Available
Dry eye06.08.02.0010.083055%
Dry mouth07.06.01.0020.007693%
Dry throat07.06.01.005; 22.12.03.0050.002043%Not Available
Dysgeusia17.02.07.003; 07.14.03.0010.162866%
Dysphonia22.12.03.006; 19.19.03.002; 17.02.08.0040.005168%
Ectropion06.06.04.001; 23.07.05.0010.001362%Not Available
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