Loteprednol / tobramycin ophthalmic Side Effects

Not all side effects for loteprednol / tobramycin ophthalmic may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to loteprednol / tobramycin ophthalmic: ophthalmic suspension

In addition to its needed effects, some unwanted effects may be caused by loteprednol / tobramycin ophthalmic. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking loteprednol / tobramycin ophthalmic:

More common
  • Blurred vision
  • change in vision
  • feeling like something is in the eye
  • increased intraocular pressure
  • loss of vision
  • pain or irritation of the clear front part of the eye
  • sensitivity of the eyes to light
Less common
  • Blurred vision or seeing blue-green halos around objects
  • decreased vision
  • difficulty seeing at night
  • discharge from the eye
  • dry eyes
  • eyelid burning, redness, itching, pain, or tenderness
  • fast heartbeat
  • fever
  • hives
  • hoarseness
  • irritation and swelling of the eye
  • itching
  • joint pain
  • lid itching and swelling
  • pain in the eye
  • rash
  • redness of the eyelid
  • redness of the skin
  • shortness of breath
  • stiffness or swelling
  • swelling of the eyelids, face, lips, hands, or feet
  • tightness in the chest
  • troubled breathing or swallowing
  • wheezing
Incidence not known
  • Redness of the eye
  • tearing

Some of the side effects that can occur with loteprednol / tobramycin ophthalmic may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Burning of the eye
  • headache
  • increased sensitivity of the eyes to light
  • stinging of the eye

For Healthcare Professionals

Applies to loteprednol / tobramycin ophthalmic: 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 or greater) was 2% (15/901) with loteprednol etabonate, 7% (11/164) with 1% prednisolone acetate, and 0.5% (3/583) with placebo.[Ref]

Very common (10% or more): Injection (about 20%), superficial punctate keratitis (about 15%), increased intraocular pressure (10%); Loteprednol ophthalmic (5% to 15%): Abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, injection, photophobia
Common (1% to 10%): Burning and stinging upon instillation (9%); Less than 4%: Vision disorders, discharge, itching, lacrimation disorder, photophobia, corneal deposits, ocular discomfort, eyelid disorder, other unspecified eye disorders; Loteprednol ophthalmic (less than 5%): Conjunctivitis, corneal abnormalities, eyelid erythema, keratoconjunctivitis, ocular irritation/pain/discomfort, papillae, uveitis; Tobramycin ophthalmic (less than 4%): Localized ocular toxicity including eyelid itching and swelling, conjunctival erythema
Frequency not reported: Secondary infections (including fungal infections of the cornea, bacterial ocular infections); Ophthalmic steroids: Elevated intraocular pressure (may be associated with infrequent optic nerve damage), visual acuity and field defects, posterior subcapsular cataract formation, delayed wound healing and secondary ocular infections from pathogens including herpes simplex, perforation of the globe where there is thinning of the cornea or sclera, acute anterior uveitis, keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation, ptosis[Ref]

Nervous system

Very common (10% or more): Headache (about 14%)[Ref]

Other

Common (1% to 10%): Other (unspecified) non-ocular side effects (less than 5%)

Hypersensitivity

Common (1% to 10%): Tobramycin ophthalmic: Hypersensitivity (less than 4%)
Rare (less than 0.1%): Tobramycin ophthalmic: Allergic conjunctivitis and blepharitis (at least 1 case)[Ref]

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

Respiratory

Very common (10% or more): Loteprednol ophthalmic: Rhinitis (less than 15%), pharyngitis (less than 15%)[Ref]

References

1. "Product Information. Zylet (loteprednol-tobramycin ophthalmic)." Bausch and Lomb, Rochester, NY.

2. "Product Information. Lotemax (loteprednol ophthalmic)." Bausch and Lomb, Tampa, FL.

3. Caraffini S, Assalve D, Stingeni L, Lisi P "Allergic contact conjunctivitis and blepharitis from tobramycin." Contact Dermatitis 32 (1995): 186-7

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