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%-
Ageusia17.02.07.001; 07.14.03.0030.007492%-
Anosmia22.04.03.006; 17.04.04.0010.004087%
Aphonia22.12.03.001; 19.19.01.002; 17.02.08.0090.001563%
Arthritis15.01.01.0010.007412%
Asthenopia06.01.01.0020.008854%-
Blepharitis23.03.04.012; 06.04.04.0010.003606%-
Blindness06.02.10.003; 17.17.01.0030.002003%-
Blindness unilateral17.17.01.016; 06.02.10.0070.000401%-
Bronchospasm22.03.01.004; 10.01.03.0120.002244%
Burning sensation17.02.06.001; 08.01.09.0290.018390%-
Cataract06.06.01.0010.002284%
Condition aggravated08.01.03.0040.025522%-
Conjunctival haemorrhage24.07.05.001; 06.07.01.0010.000401%-
Conjunctival oedema06.04.01.0010.002724%-
Conjunctivitis allergic10.01.04.002; 06.04.01.0030.002244%-
Corneal erosion06.06.03.0030.002043%-
Corneal lesion06.06.03.0040.000601%-
Cyst08.03.05.001; 16.02.02.0020.001362%-
Depressed mood19.15.02.0010.004087%-
Dermatitis allergic23.03.04.003; 10.01.03.0140.004087%-
Dermatitis contact10.01.01.003; 23.03.04.004; 12.03.01.0400.001763%-
Diplopia17.17.01.005; 06.02.06.0020.002925%-
Drug ineffective08.06.01.0060.121598%-
Dry eye06.08.02.0010.083055%
Dry mouth07.06.01.0020.007693%
Dry throat22.12.03.005; 07.06.01.0050.002043%-
Dysgeusia17.02.07.003; 07.14.03.0010.162866%
Dysphonia19.19.03.002; 17.02.08.004; 22.12.03.0060.005168%
Ectropion23.07.05.001; 06.06.04.0010.001362%-
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