Applies to ofloxacin ophthalmic: ophthalmic solution.

Serious side effects

Along with its needed effects, ofloxacin 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 ofloxacin ophthalmic:

Rare

• Puffiness or swelling of eyes
• signs of an allergic reaction, such as hives, itching, rash, swelling of face or lips, tightness in chest, troubled breathing, or wheezing

Check with your doctor as soon as possible if any of the following side effects occur while taking ofloxacin ophthalmic:

Rare

• Dizziness

Other side effects

Some side effects of ofloxacin 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 of eye

Less common

• Blurred vision
• eye pain
• feeling of something in the eye
• increased sensitivity of eye to light
• redness, irritation, or itching of eye, eyelid, or inner lining of eyelid
• stinging, tearing, or dryness of eye

For Healthcare Professionals

Applies to ofloxacin ophthalmic: ophthalmic solution.

Ocular

Burning/stinging, tearing, and eye pain were reported in up to 14%, up to 11%, and up to 5% of treated eyes, respectively.

Burning/stinging, tearing, photophobia, and foreign body sensation were reported more often in patients treated for corneal ulcer.^[Ref]

Common (1% to 10%): Eye irritation, ocular discomfort

Frequency not reported: Transient ocular burning/discomfort, keratitis, conjunctivitis, eye edema, periorbital edema, foreign body sensation in eyes, dry eyes, ocular hyperemia, eye pruritus, eyelid pruritus, burning/stinging, redness, itching, chemical conjunctivitis/keratitis, ocular/periocular/facial edema, eye pain, photophobia, tearing, blurred vision, dryness

Postmarketing reports: Hypersensitivity, increased lacrimation^[Ref]

Hypersensitivity

Very rare (less than 0.01%)/Postmarketing reports: Hypersensitivity (including angioedema, dyspnea, anaphylactic reaction/shock, oropharyngeal swelling, swollen tongue)

Systemic ofloxacin:

-Frequency not reported: Hypersensitivity (anaphylactic/anaphylactoid) reactions

Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid) reactions (some after first dose) have been reported with systemic ofloxacin.

Cardiovascular

Ventricular arrhythmia and torsades de pointes were reported mainly in patients with risk factors for QT prolongation.

Frequency not reported: Ventricular arrhythmia, torsades de pointes, prolonged ECG QT

Nervous system

Frequency not reported: Dizziness^[Ref]

Gastrointestinal

Frequency not reported: Nausea^[Ref]

Other

Frequency not reported: Facial edema