Pred-G Side Effects

Please note - some side effects for Pred-G may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Pred-G - for the Consumer

Pred-G S.O.P.

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 Pred-G S.O.P.:

Mild burning or stinging; temporary blurred vision.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; eye pain, itching, redness, swelling, irritation, or sores not present when you began using Pred-G S.O.P. .

Pred-G

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 Pred-G:

Mild burning or stinging.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; eye pain, itching, redness, swelling, irritation, or sores not present when you began using Pred-G .

Pred-G Side Effects - for the Professional

Pred-G Ophthalmic ointment

Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available.

The most frequent reactions observed include ocular discomfort, irritation upon instillation of the medication and punctate keratitis. These reactions have resolved upon discontinuation of the medication.

Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitizations. The reactions due to the steroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.

Secondary Infection: The development of secondary ocular infection has occurred after use of combinations containing steroids and antimicrobials. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs.

Side Effects by Body System

Hypersensitivity

Hypersensitivity reactions due to allergic sensitization to the gentamicin component have been reported.

Ocular

Ocular side effects have included burning and stinging upon instillation. Superficial punctate keratitis has been reported occasionally. Less frequent ocular side effects include elevation of intraocular pressure with possible development of glaucoma, delayed wound healing, posterior subcapsular cataract formation, and optic nerve damage.

Corticosteroid containing preparations have also been reported to cause acute anterior uveitis, perforation of the globe, keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation, and ptosis.

Other

Other side effects have included secondary bacterial or fungal infections.

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