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 Prescription
ATC Code D07AC19
DrugBank ID DB06781
KEGG ID D01266
MeSH ID C015808
PubChem ID 443936
TTD Drug ID D01ZOG
NDC Product Code 49803-002; 46439-8738; 26251-0003; 46439-8739; 69097-341; 76282-708
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
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Application site irritation08.02.01.003; 12.07.01.003--Not Available
Blepharitis06.04.04.001; 23.03.04.012--Not Available
Blindness06.02.02.001; 17.17.01.0030.000965%Not Available
Cataract06.06.01.0010.001447%
Cataract subcapsular06.06.01.002--Not Available
Cerebrovascular accident17.08.01.007; 24.03.05.0010.000965%
Chromatopsia06.02.05.0010.000965%Not Available
Cleft palate03.04.02.001; 07.05.08.001--Not Available
Conjunctival oedema06.04.01.001--Not Available
Corneal abrasion06.11.03.001; 12.01.04.0010.000965%Not Available
Corneal dystrophy03.01.06.001; 06.13.03.0010.000965%Not Available
Corneal epithelium defect06.06.03.0120.001447%Not Available
Corneal oedema06.04.02.0010.002412%Not Available
Corneal pigmentation06.06.03.013--Not Available
Dry eye06.08.02.0010.000965%
Endophthalmitis06.04.05.009; 11.01.06.003--
Episcleritis06.04.07.001; 10.02.01.024--Not Available
Eye disorder06.08.03.0010.001447%Not Available
Eye infection06.04.05.007; 11.01.06.001--
Eye inflammation06.04.05.0020.002894%Not Available
Eye irritation06.04.05.0030.007718%Not Available
Eye pain06.08.03.0020.009165%
Eye swelling06.08.03.0030.001447%Not Available
Eyelid oedema06.04.04.004; 10.01.05.001; 23.04.01.0030.001447%Not Available
Eyelid ptosis06.05.01.002; 17.17.02.0040.000965%Not Available
Fatigue08.01.01.002--
Gastrointestinal haemorrhage07.12.02.001; 24.07.02.0090.000965%Not Available
Glaucoma06.03.01.0020.001447%
Headache17.14.01.0010.001930%
Herpes simplex11.05.02.001; 23.09.03.001--Not Available
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