Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Difluprednate
Drug ID BADD_D00667
Description Difluprednate is a topical corticosteroid indicated for the treatment of infammation and pain associated with ocular surgery. It is a butyrate ester of 6(α), 9(α)-difluoro prednisolone acetate. Difluprednate is abbreviated DFBA, or difluoroprednisolone butyrate acetate. It is indicated for treatment of endogenous anterior uveiti.
Indications and Usage For the treatment of inflammation and pain associated with ocular surgery.
Marketing Status approved
ATC Code D07AC19
DrugBank ID DB06781
KEGG ID D01266
MeSH ID C015808
PubChem ID 443936
TTD Drug ID D01ZOG
NDC Product Code 26251-0003; 69097-341; 0078-0862; 46439-8738; 76282-708; 46439-8739; 49803-002
UNII S8A06QG2QE
Synonyms difluprednate | ENV905 | C.M.9155 | Epitopic
Chemical Information
Molecular Formula C27H34F2O7
CAS Registry Number 23674-86-4
SMILES CCCC(=O)OC1(CCC2C1(CC(C3(C2CC(C4=CC(=O)C=CC43C)F)F)O)C)C(=O)COC(=O)C
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)
Anxiety19.06.02.0020.001074%
Application site irritation12.07.01.003; 08.02.01.003--Not Available
Blepharitis23.03.04.012; 06.04.04.001--Not Available
Blindness06.02.10.003; 17.17.01.0030.000316%Not Available
Cataract06.06.01.0010.000631%
Cataract subcapsular06.06.01.002--Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.0070.000210%
Cleft palate07.05.08.001; 03.04.02.001--Not Available
Condition aggravated08.01.03.0040.000568%Not Available
Conjunctival oedema06.04.01.001--Not Available
Corneal epithelium defect06.06.03.0120.000316%Not Available
Corneal oedema06.04.02.0010.001389%Not Available
Corneal pigmentation06.06.03.013--Not Available
Dementia19.20.02.001; 17.03.01.0010.000210%Not Available
Discomfort08.01.08.0030.000716%Not Available
Dry eye06.08.02.0010.000716%
Endophthalmitis11.01.06.003; 06.04.05.009--
Episcleritis10.02.01.024; 06.04.07.001--Not Available
Eye disorder06.08.03.0010.001284%Not Available
Eye infection06.04.05.007; 11.01.06.001--
Eye inflammation06.04.05.0020.002358%Not Available
Eye irritation06.04.05.0030.006757%Not Available
Eye pain06.08.03.0020.005894%
Eye swelling06.08.03.0030.000821%Not Available
Eyelid oedema23.04.01.003; 10.01.05.001; 06.04.04.0040.000716%Not Available
Eyelid ptosis17.17.02.004; 06.05.01.0020.000463%Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.0010.000210%Not Available
Glaucoma06.03.01.0020.000526%
Headache17.14.01.0010.001537%
Herpes simplex23.11.05.004; 11.05.02.001--Not Available
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