Loteprednol/tobramycin Side Effects

Please note - some side effects for Loteprednol/tobramycin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Loteprednol/tobramycin - for the Consumer

Loteprednol/tobramycin Drops

Applies to: eye drops

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Loteprednol/tobramycin Drops:

Burning or stinging upon using loteprednol/tobramycin drops; mild itching, discomfort, or redness of the eye.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; sensitivity to light; severe or worsening pain or inflammation, redness, swelling, or discharge from the eye or eyelid; unusual tearing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

Applies to: ophthalmic suspension

Ocular

Randomized studies involving patients treated with loteprednol etabonate therapy for 28 days or longer revealed the incidence of significant elevation in intraocular pressure (>= 10 mmHg) was 2% (15/901) with loteprednol etabonate, 7% (11/164) with 1% prednisolone acetate and 0.5% (3/583) with placebo.

Ocular side effects have been reported the most frequently. They have included injection (20%), superficial punctate keratitis (15%), increased intraocular pressure (10%), and burning and stinging upon instillation (9%). Vision disorders, discharge, itching, lacrimation disorder, photophobia, corneal deposits, ocular discomfort, eyelid disorder and other unspecified eye disorders have been reported in less than 4% of patients.

Ocular side effects associated with loteprednol have included abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, injection, and photophobia in 5% to 15% of patients. Conjunctivitis, corneal abnormalities, eyelid erythema, keratoconjunctivitis, ocular irritation/pain/discomfort, papillae, and uveitis have been reported in <5% of patients.

Corticosteroids have also been reported to cause elevated intraocular pressure, optic nerve damage, visual acuity and field defects, cataracts, secondary infections, acute anterior uveitis, perforation of the globe, keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation, and ptosis.

Ocular side effects associated with tobramycin ophthalmic have included eyelid itching and swelling, and conjunctival erythema (<4%).

Nervous system

Nervous system side effects have included headache (14%).

Respiratory

Respiratory side effects associated with loteprednol ophthalmic have included rhinitis and pharyngitis (<15%).

Hypersensitivity

Hypersensitivity side effects associated with tobramycin ophthalmic have included allergic conjunctivitis and blepharitis.

A case of allergic conjunctivitis and blepharitis associated with tobramycin ophthalmic ointment has been reported. Hypersensitivity was confirmed by patch testing.

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