Applies to dexamethasone/neomycin/polymyxin b ophthalmic: ophthalmic ointment, 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:

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

For Healthcare Professionals

Applies to dexamethasone/neomycin/polymyxin b ophthalmic: ophthalmic ointment, ophthalmic suspension.

General

The most frequently reported side effects were ocular discomfort, keratitis, eye irritation, and allergic sensitization.^[Ref]

Ocular

Uncommon (0.1% to 1%): Keratitis, intraocular pressure increased, vision blurred, photophobia, mydriasis, eyelid ptosis, eye pain, eye swelling, eye pruritus, ocular discomfort, foreign body sensation, eye irritation, ocular hyperemia, lacrimation increased

Frequency not reported: Corneal thinning, ulcerative keratitis

Dexamethasone:

Frequency not reported: Intraocular pressure increased, glaucoma, visual acuity reduced, visual field defect, posterior subcapsular cataract formation, globe perforation, keratitis, conjunctivitis, corneal ulcer, conjunctival hyperemia, optic nerve damage, wound healing delayed^[Ref]

Immunologic

Uncommon (0.1% to 1%): Hypersensitivity

Frequency not reported: Allergic sensitization^[Ref]

Nervous system

Frequency not reported: Headache^[Ref]

Other

Frequency not reported: Secondary ocular infection developed, fungal infection developed^[Ref]

Dermatologic

Frequency not reported: Stevens-Johnson syndrome