Applies to moxifloxacin ophthalmic: ophthalmic solution.

Serious side effects

Along with its needed effects, moxifloxacin ophthalmic may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking moxifloxacin ophthalmic:

Incidence not known

• Blurred or decreased vision
• change in vision
• chest tightness
• cough
• difficulty swallowing
• dizziness
• fast heartbeat
• hives, itching, skin rash
• loss of consciousness
• pooling of whitish fluid visible on the colored part of the eye
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seeing floating spots before the eyes
• swelling of the eye
• trouble breathing
• unusual tiredness or weakness

Other side effects

Some side effects of moxifloxacin ophthalmic may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Burning, dry, or itching eyes
• dry eye
• discharge, excessive tearing
• itching of the eye
• pain in the eye
• red, sore eyes

Less common

• Body aches or pain
• congestion
• fever or chills
• general body discomfort
• lower back or side pain
• painful or difficult urination
• runny nose
• sore throat
• tender, swollen glands in the neck
• trouble with swallowing
• voice changes

For Healthcare Professionals

Applies to moxifloxacin ophthalmic: intraocular solution, ophthalmic solution.

General

The most common side effects were eye irritation and eye pain.

Ocular

Common (1% to 10%): Conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, tearing, eye irritation, eye pain

Uncommon (0.1% to 1%): Punctuate keratitis, eye pruritus, conjunctival hemorrhage, eyelid edema

Rare (less than 0.1%): Corneal epithelium defect, corneal disorder, blepharitis, eye swelling, conjunctival edema, blurred vision, asthenopia, erythema of eyelid

Frequency not reported: Endophthalmitis, ulcerative keratitis, corneal erosion, corneal abrasion, intraocular pressure increased, corneal opacity, corneal infiltrates, corneal deposits, eye allergy, corneal edema, photophobia, lacrimation increased, eye discharge, foreign body sensation in eyes, corneal staining, eyelid disorder, abnormal sensation in eye^[Ref]

Respiratory

Common (1% to 10%): Increased cough, pharyngitis, rhinitis

Rare (less than 0.1%): Nasal discomfort, pharyngolaryngeal pain, sensation of foreign body (throat)

Frequency not reported: Dyspnea^[Ref]

Dermatologic

Common (1% to 10%): Rash

Frequency not reported: Erythema, pruritus, urticaria^[Ref]

Other

Common (1% to 10%): Otitis media, fever/pyrexia, infection^[Ref]

Nervous system

Uncommon (0.1% to 1%): Dysgeusia, headache

Rare (less than 0.1%): Paresthesia

Frequency not reported: Dizziness^[Ref]

Gastrointestinal

Rare (less than 0.1%): Vomiting

Frequency not reported: Nausea^[Ref]

Hematologic

Rare (less than 0.1%): Decreased hemoglobin^[Ref]

Hepatic

Rare (less than 0.1%): Increased ALT, increased GGT^[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity

Systemic quinolones:

-Frequency not reported: Hypersensitivity (anaphylactic) reactions^[Ref]

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions (some after first dose) have been reported with systemic quinolones.^[Ref]

Cardiovascular

Frequency not reported: Palpitations^[Ref]

Musculoskeletal

Systemic fluoroquinolones:

-Frequency not reported: Tendon ruptures^[Ref]

Ruptures of the shoulder, hand, Achilles, or other tendons (requiring surgical repair or resulting in prolonged disability) have been reported with systemic fluoroquinolones. Risk of such ruptures may be increased in patients using concomitant corticosteroids, especially geriatric patients and in tendons under high stress (including the Achilles tendon).^[Ref]