Applies to prednisolone/sulfacetamide sodium ophthalmic: ophthalmic solution, ophthalmic suspension.

Serious side effects

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Change in eyesight, eye pain, or very bad eye irritation.
• Eye is bothered by bright light.
• Rarely, very bad effects have happened with sulfa drugs. Sometimes, these have been deadly. These effects have included liver problems, blood problems, and very bad skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis). Call your doctor right away if you have a rash; red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, or eyes; fever, chills, or sore throat; cough that is new or worse; feeling very tired or weak; any bruising or bleeding; or signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

Other side effects

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Eye irritation.
• Dizziness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to prednisolone/sulfacetamide sodium ophthalmic: ophthalmic ointment, ophthalmic solution, ophthalmic suspension.

General

The frequency of the reported side effects is unknown. Reactions occurring from the combination product include cataract, dizziness, eye discharge, eyelid edema, eyelid erythema, eye irritation, eye pain, eye pruritus, and hypersensitivity including rash, skin pruritus, urticaria, ocular hyperemia, and visual disturbance/blurred vision.^[Ref]

Ocular

Frequency not reported: Cataract, eye discharge, eyelid edema, eyelid erythema, eye irritation, eye pain, eye pruritus, ocular hyperemia, vision blurred, intraocular pressure increased, glaucoma developed, optic nerve damage, posterior subcapsular cataract formation, secondary bacterial ocular infection, fungal infection of cornea, viral infection of cornea, vision disturbed, mydriasis, loss of accommodation, ptosis, acute anterior uveitis, perforation of the globe

Prednisolone:

-Frequency not reported: Intraocular pressure increased, glaucoma developed, optic nerve damage, posterior subcapsular cataract formation^[Ref]

Immunologic

Rarely, fatalities have occurred due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias.^[Ref]

Frequency not reported: Hypersensitivity, allergic sensitization

Sulfacetamide sodium:

-Frequency not reported: Allergic sensitization^[Ref]

Dermatologic

Frequency not reported: Rash, pruritus, urticaria^[Ref]

Local

Sulfacetamide sodium:

-Frequency not reported: Local irritation^[Ref]

Other

Prednisolone:

-Frequency not reported: Wound healing delayed^[Ref]

Nervous system

Frequency not reported: Dizziness^[Ref]

Endocrine

Frequency not reported: Systemic hypercorticoidism^[Ref]