Applies to gentamicin/prednisolone ophthalmic: 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.

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:

• Burning.
• Stinging.
• Eye irritation.
• More tears.
• Blurred eyesight.
• Feeling that something is in the eye.
• Change in taste.

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 gentamicin/prednisolone ophthalmic: ophthalmic ointment, ophthalmic suspension.

General

The most frequently reported side effects were ocular discomfort, irritation following instillation, and punctate keratitis.^[Ref]

Ocular

Frequency not reported: Superficial punctate keratitis, ocular discomfort

Prednisolone:

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

Local

Frequency not reported: Burning, stinging, irritation^[Ref]

Other

Frequency not reported: Secondary ocular infection developed

Prednisolone:

Frequency not reported: Wound healing delayed^[Ref]

Immunologic

Gentamicin:

Frequency not reported: Allergic sensitization^[Ref]