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)
Hyperaemia24.03.02.002--Not Available
Hypotension24.06.03.0020.000463%
Intraocular pressure increased13.07.04.002--Not Available
Iridocyclitis06.04.03.001--Not Available
Iritis10.02.01.022; 06.04.03.002--Not Available
Keratitis06.04.02.0020.000463%
Keratopathy06.06.03.0070.000421%Not Available
Lacrimation increased06.08.02.0040.000463%
Macular oedema06.04.06.005--Not Available
Ocular hyperaemia06.04.05.0040.002968%Not Available
Optic nerve injury17.04.05.008; 12.01.16.001; 06.11.02.001--Not Available
Palpitations02.11.04.0120.000716%
Panophthalmitis06.04.05.005--Not Available
Photophobia17.17.02.006; 06.01.01.0040.000210%
Posterior capsule opacification12.02.02.002; 06.06.05.001--Not Available
Pregnancy18.08.02.004--Not Available
Pruritus23.03.12.001--
Punctate keratitis06.04.02.0030.000421%Not Available
Rash23.03.13.0010.001789%Not Available
Retinal tear12.01.04.014; 06.09.03.0100.000210%
Scab23.03.03.004--Not Available
Skin striae23.01.05.002--Not Available
Teratogenicity12.03.01.032; 03.02.01.004--Not Available
Uveitis06.04.03.003; 10.02.01.0230.000421%
Vision blurred17.17.01.010; 06.02.06.0070.005641%
Visual acuity reduced06.02.10.012; 17.17.01.0110.001284%
Visual field defect17.17.01.001; 06.02.07.0030.000926%Not Available
Visual impairment06.02.10.0130.002063%Not Available
Weight increased13.15.01.006--
Hypoacusis04.02.01.0060.001179%
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