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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 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.
  • 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-FDA-1088. You may also report side effects at http://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]

References

1. "Product Information. Prednisolone Na Phosphate-Na Sulfacetamide (prednisolone-sulfacetamide sodium ophthalmic)." Bausch and Lomb, Rochester, NY.

2. "Product Information. Pred Forte (prednisolone ophthalmic)." Allergan Inc, Irvine, CA.

3. "Product Information. Sulamyd Ophthalmic Solution (sodium sulfacetamide ophthalmic)." Schering Corporation, Kenilworth, NJ.

Some side effects of prednisolone / sulfacetamide sodium ophthalmic may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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