DIFLUPREDNATE: 1,681 Adverse Event Reports & Safety Profile
Boost Your Natural Energy & Metabolism
Mitolyn — 6 exotic plants to unlock your body's fat-burning power. 90-day guarantee.
Route: OPHTHALMIC · Manufacturer: Amneal Pharmaceuticals NY LLC · FDA Application: 022212 · HUMAN PRESCRIPTION DRUG · FDA Label: Available
First Report: 20110315 · Latest Report: 20250920
What Are the Most Common DIFLUPREDNATE Side Effects?
All DIFLUPREDNATE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Intraocular pressure increased | 478 | 28.4% | 0 | 4 |
| Drug ineffective | 139 | 8.3% | 0 | 5 |
| Therapy partial responder | 100 | 6.0% | 0 | 0 |
| Vision blurred | 94 | 5.6% | 0 | 8 |
| Eye irritation | 92 | 5.5% | 0 | 3 |
| Eye pain | 87 | 5.2% | 0 | 4 |
| Visual impairment | 84 | 5.0% | 0 | 3 |
| Treatment failure | 58 | 3.5% | 0 | 0 |
| Blindness | 49 | 2.9% | 0 | 3 |
| Cataract | 48 | 2.9% | 0 | 10 |
| Eye inflammation | 46 | 2.7% | 0 | 1 |
| No adverse event | 44 | 2.6% | 0 | 0 |
| Headache | 40 | 2.4% | 1 | 6 |
| Product availability issue | 40 | 2.4% | 0 | 3 |
| Glaucoma | 35 | 2.1% | 0 | 1 |
| Ocular hyperaemia | 35 | 2.1% | 0 | 0 |
| Condition aggravated | 33 | 2.0% | 0 | 1 |
| Uveitis | 31 | 1.8% | 0 | 6 |
| Blindness unilateral | 30 | 1.8% | 0 | 2 |
| Eye swelling | 30 | 1.8% | 0 | 0 |
Who Reports DIFLUPREDNATE Side Effects? Age & Gender Data
Gender: 62.8% female, 37.2% male. Average age: 61.2 years. Most reports from: US. View detailed demographics →
Is DIFLUPREDNATE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 3 | 0 | 3 |
| 2013 | 7 | 0 | 0 |
| 2014 | 17 | 0 | 3 |
| 2015 | 34 | 2 | 4 |
| 2016 | 43 | 0 | 1 |
| 2017 | 49 | 0 | 1 |
| 2018 | 10 | 0 | 5 |
| 2019 | 11 | 0 | 0 |
| 2020 | 12 | 0 | 0 |
| 2021 | 15 | 1 | 2 |
| 2022 | 26 | 0 | 1 |
| 2023 | 9 | 0 | 0 |
| 2024 | 6 | 0 | 0 |
| 2025 | 2 | 0 | 0 |
What Is DIFLUPREDNATE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 1,028 |
| Posterior capsule opacification | 157 |
| Postoperative care | 110 |
| Cataract operation | 58 |
| Uveitis | 35 |
| Eye inflammation | 29 |
| Iritis | 17 |
| Inflammation | 14 |
| Preoperative care | 12 |
| Glaucoma | 10 |
DIFLUPREDNATE vs Alternatives: Which Is Safer?
Official FDA Label for DIFLUPREDNATE
Official prescribing information from the FDA-approved drug label.
Drug Description
Difluprednate ophthalmic emulsion, 0.05% is a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. The chemical name is (6α,11β)-21-(Acetyloxy)-6,9-difluoro-11-hydroxy-17-(1-oxobutoxy)pregna-1,4-diene-3,20-dione. Difluprednate is represented by the following structural formula: Difluprednate has a molecular weight of 508.55, and the molecular formula is C 27 H 34 F 2 O 7 . Difluprednate (micronized) is a white to creamy-white crystalline powder. It is freely soluble in acetonitrile and in chloroform, soluble in methanol, in ethanol and in dioxane; slightly soluble in ether; practically insoluble in water. Each mL contains: Active : difluprednate 0.5 mg (0.05%) Inactive : boric acid, castor oil, glycerin, polysorbate 80, water for injection, sodium acetate, edetate disodium, sodium hydroxide (to adjust the pH to 5.2 to 5.8). The emulsion is essentially isotonic with a tonicity of 304 to 411 mOsmol/kg Preservative : sorbic acid 0.1% 1
FDA Approved Uses (Indications)
AND USAGE Difluprednate ophthalmic emulsion is a topical corticosteroid that is indicated for: The treatment of inflammation and pain associated with ocular surgery (1.1) The treatment of endogenous anterior uveitis (1.2)
1.1 Ocular Surgery Difluprednate ophthalmic emulsion 0.05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery.
1.2 Endogenous Anterior Uveitis Difluprednate ophthalmic emulsion is also indicated for the treatment of endogenous anterior uveitis.
1.1 Ocular Surgery Difluprednate ophthalmic emulsion 0.05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery.
1.2 Endogenous Anterior Uveitis Difluprednate ophthalmic emulsion is also indicated for the treatment of endogenous anterior uveitis.
Dosage & Administration
AND ADMINISTRATION
- For the treatment of inflammation and pain associated with ocular surgery, instill one drop into the conjunctival sac of the affected eye 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period, followed by 2 times daily for a week and then a taper based on the response. ( 2.1 )
- For the treatment of endogenous anterior uveitis, instill one drop into the conjunctival sac of the affected eye 4 times daily for 14 days followed by tapering as clinically indicated. ( 2.2 )
2.1 Ocular Surgery Instill one drop into the conjunctival sac of the affected eye 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period, followed by 2 times daily for a week and then a taper based on the response.
2.2 Endogenous Anterior Uveitis Instill one drop into the conjunctival sac of the affected eye 4 times daily for 14 days followed by tapering as clinically indicated.
2.3 Prescribing Guidelines The initial prescription and renewal of the medication order beyond one bottle should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be reevaluated. Not more than one bottle should be prescribed initially, and the prescription should not be refilled without further evaluation.
Contraindications
The use of difluprednate ophthalmic emulsion, as with other ophthalmic corticosteroids, is contraindicated in most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures. Difluprednate ophthalmic emulsion, as with other ophthalmic corticosteroids, is contraindicated in most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. ( 4 )
Known Adverse Reactions
REACTIONS The following serious reactions are found elsewhere in the labeling: lntraocular Pressure (IOP) Increase [see Warnings and Precautions ( 5. 1 )] Cataracts [see Warnings and Precautions ( 5.2 )]
Delayed
Healing [see Warnings and Precautions ( 5.3 )] Corneal and Scleral Melting [see Warnings and Precautions ( 5.4 )]
Bacterial
Infections [see Warnings and Precautions ( 5.5 )]
Viral
Infections [see Warnings and Precautions ( 5.6 )]
Fungal
Infections [see Warnings and Precautions ( 5. 7 )] For treatment of inflammation and pain associated with ocular surgery, most common adverse reactions (incidence 5% to 15%) are corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacificalion, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharilis. For treatment of endogenous anterior uveilis, most common adverse reactions (incidence 5% to 10%) are blurred vision, eye irritation, eye pain, headache, increased IOP, iritis, limbal and conjunctival hyperemia, punctate keratilis, and uveitis. To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Ocular Surgery Ocular adverse reactions occurring in 5% to 15% of subjects in clinical studies with difluprednate ophthalmic emulsion (0.05%) included corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharitis. Other ocular adverse reactions occurring in 1% to 5% of subjects included reduced visual acuity, punctate keratitis, eye inflammation, and iritis. Ocular adverse reactions occurring in less than 1% of subjects included application site discomfort or irritation, corneal pigmentation and striae, episcleritis, eye pruritis, eyelid irritation and crusting, foreign body sensation, increased lacrimation, macular edema, sclera hyperemia, and uveitis. Most of these reactions may have been the consequence of the surgical procedure.
6.2 Endogenous Anterior Uveitis A total of 200 subjects participated in the clinical trials for endogenous anterior uveitis, of which 106 were exposed to difluprednate ophthalmic emulsion (0.05%). The most common adverse reactions of those exposed to difluprednate ophthalmic emulsion (0.05%) occurring in 5% to 10 % of subjects included blurred vision, eye irritation, eye pain, headache, increased IOP, iritis, limbal and conjunctival hyperemia, punctate keratitis, and uveitis. Adverse reactions occurring in 2% to 5 % of subjects included anterior chamber flare, corneal edema, dry eye, iridocyclitis, photophobia, and reduced visual acuity.
6.1 Ocular Surgery Ocular adverse reactions occurring in 5% to 15% of subjects in clinical studies with difluprednate ophthalmic emulsion (0.05%) included corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharitis. Other ocular adverse reactions occurring in 1% to 5% of subjects included reduced visual acuity, punctate keratitis, eye inflammation, and iritis. Ocular adverse reactions occurring in less than 1% of subjects included application site discomfort or irritation, corneal pigmentation and striae, episcleritis, eye pruritis, eyelid irritation and crusting, foreign body sensation, increased lacrimation, macular edema, sclera hyperemia, and uveitis. Most of these reactions may have been the consequence of the surgical procedure.
Warnings
AND PRECAUTIONS Intraocular pressure (IOP) increase- Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve defects in visual acuity and fields of vision. If this product is used for 10 days or longer, IOP should be monitored. (5.1) Cataracts- Use of corticosteroids may result in posterior subcapsular cataract formation. (5.2) Delayed healing- The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order beyond 28 days should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. (5.3) Bacterial infections- Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated. (5.4) Viral infections- Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). (5.5) Fungal infections- Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. (5.6) To report SUSPECTED ADVERSE REACTIONS, contact LEADING PHARMA,LLC AT 1-844-740-7500,or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.