Prednisolone / sulfacetamide sodium ophthalmic Side Effects
For the Consumer
Applies to prednisolone/sulfacetamide sodium ophthalmic: ophthalmic ointment, ophthalmic solution, ophthalmic suspension
What are some side effects that I need to call my doctor about right away?
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.
What are some other side effects of this drug?
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.
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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
For Healthcare Professionals
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]
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
-Frequency not reported: Intraocular pressure increased, glaucoma developed, optic nerve damage, posterior subcapsular cataract formation[Ref]
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
-Frequency not reported: Allergic sensitization[Ref]
Frequency not reported: Rash, pruritus, urticaria[Ref]
-Frequency not reported: Local irritation[Ref]
-Frequency not reported: Wound healing delayed[Ref]
Frequency not reported: Dizziness[Ref]
Frequency not reported: Systemic hypercorticoidism[Ref]
1. "Product Information. Pred Forte (prednisolone ophthalmic)." Allergan Inc, Irvine, CA.
2. "Product Information. Prednisolone Na Phosphate-Na Sulfacetamide (prednisolone-sulfacetamide sodium ophthalmic)." Bausch and Lomb, Rochester, NY.
3. "Product Information. Sulamyd Ophthalmic Solution (sodium sulfacetamide ophthalmic)." Schering Corporation, Kenilworth, NJ.
Some side effects may not be reported. You may report them to the FDA.
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