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)
Keratoconus06.06.03.0170.000401%Not Available
Lacrimation decreased06.08.02.0070.002043%Not Available
Lacrimation increased06.08.02.0040.076044%
Lip swelling23.04.01.007; 10.01.05.005; 07.05.04.0050.004007%Not Available
Macular degeneration06.09.03.0010.001202%Not Available
Migraine24.03.05.003; 17.14.02.0010.006130%Not Available
Mydriasis17.02.11.003; 06.05.03.0040.002043%Not Available
Myopia06.02.04.0020.001362%Not Available
Nasal congestion22.04.04.0010.004968%
Nasal dryness22.04.03.0020.001362%Not Available
Nasal oedema22.04.03.0120.001563%Not Available
Ocular hyperaemia06.04.05.0040.058535%Not Available
Oral discomfort07.05.05.0010.001362%Not Available
Parosmia22.04.03.007; 17.04.04.0020.001763%Not Available
Pharyngeal oedema10.01.05.016; 23.04.01.016; 22.04.05.0030.000881%Not Available
Pharyngeal ulceration22.04.05.0040.000881%Not Available
Photophobia17.17.02.006; 06.01.01.0040.009936%
Photopsia17.17.01.006; 06.02.06.0040.001763%
Photosensitivity reaction23.03.09.0030.001563%
Productive cough22.02.03.0050.001563%
Punctate keratitis06.04.02.0030.000801%Not Available
Rhinorrhoea22.12.03.0210.009255%
Scab23.03.03.0040.000881%Not Available
Screaming19.04.02.020; 08.01.03.0990.001362%Not Available
Sinus congestion22.04.06.0010.003606%Not Available
Sinusitis22.07.03.007; 11.01.13.005--
Sjogren's syndrome06.08.02.011; 15.06.01.015; 10.04.04.009; 07.06.01.0100.001002%Not Available
Skin irritation23.03.04.0090.001563%Not Available
Skin reaction23.03.03.013; 10.01.03.0190.001362%Not Available
Sneezing22.12.03.0240.003406%
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