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---
Hypotension24.06.03.0020.000463%
Intraocular pressure increased13.07.04.002---
Iridocyclitis06.04.03.001---
Iritis06.04.03.002; 10.02.01.022---
Keratitis06.04.02.0020.000463%
Keratopathy06.06.03.0070.000421%-
Lacrimation increased06.08.02.0040.000463%
Macular oedema06.04.06.005---
Ocular hyperaemia06.04.05.0040.002968%-
Optic nerve injury06.11.02.001; 12.01.16.001; 17.04.05.008---
Palpitations02.11.04.0120.000716%
Panophthalmitis06.04.05.005---
Photophobia06.01.01.004; 17.17.02.0060.000210%
Posterior capsule opacification06.06.05.001; 12.02.02.002---
Pregnancy18.08.02.004---
Pruritus23.03.12.001--
Punctate keratitis06.04.02.0030.000421%-
Rash23.03.13.0010.001789%-
Retinal tear06.09.03.010; 12.01.04.0140.000210%
Scab23.03.03.004---
Skin striae23.01.05.002---
Teratogenicity03.02.01.004; 12.03.01.032---
Uveitis06.04.03.003; 10.02.01.0230.000421%
Vision blurred06.02.06.007; 17.17.01.0100.005641%
Visual acuity reduced06.02.10.012; 17.17.01.0110.001284%
Visual field defect06.02.07.003; 17.17.01.0010.000926%-
Visual impairment06.02.10.0130.002063%-
Weight increased13.15.01.006--
Hypoacusis04.02.01.0060.001179%
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