Levobunolol ophthalmic Side Effects

Some side effects of levobunolol ophthalmic may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to levobunolol ophthalmic: ophthalmic solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking levobunolol ophthalmic: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• severe swelling, itching, burning, redness, pain, or discomfort in or around your eye;

• drainage, crusting, or oozing of your eyes or eyelids;

• bronchospasm (wheezing, chest tightness, trouble breathing);

• slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);

• feeling short of breath, even with mild exertion;

• swelling, rapid weight gain; or

• severe blistering, peeling, and red skin rash.

Less serious side effects of levobunolol ophthalmic may include:

• mild burning, stinging, itching, or discomfort of your eyes;

• blurred vision;

• mildly swollen or puffy eyes;

• headache, dizziness, spinning sensation;

• depression, confusion, tired feeling;

• muscle weakness;

• mild skin rash or itching; or

• nausea, diarrhea.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to levobunolol ophthalmic: ophthalmic solution

General

The safety of levobunolol in over 2,000 patients has been reported in a multicenter trial. Eighty-five percent of the patients completed 3 months of therapy with well-controlled intraocular pressure. Treatment was discontinued in 7% due to adverse drug events.

Ocular

There is a possibility of decreased corneal sensitivity after prolonged use despite the minimal activity levobunolol has on membrane-stabilizing.

Ocular side effects have frequently included transient ocular discomfort, stinging, or burning in up to 33% of patients. Blepharoconjunctivitis has been reported in 5%, and blepharitis, decreased visual acuity, conjunctivitis, band keratopathy, erythema, tearing, and pruritus have each been reported in approximately 4% of patients. Iridocyclitis and corneal sensitivity have been reported rarely.

Ocular side effects associated with levobunolol and/or other ophthalmic beta blockers have included signs and symptoms of keratitis, blepharoptosis, visual disturbances (including refractive changes), diplopia, and ptosis.

Respiratory

Levobunolol and timolol appear more likely to produce clinically important decreases in airflow than betaxolol when administered to patients with reactive airways disease.

Respiratory side effects associated with levobunolol and/or other ophthalmic beta blockers have included bronchospasm, respiratory failure, dyspnea, and nasal congestion.

Cardiovascular

Cardiovascular side effects have included decreased heart rate and blood pressure.

Cardiovascular side effects associated with levobunolol and/or other ophthalmic beta blockers have included bradycardia, arrhythmia, hypotension, syncope, heart block, cerebral vascular accident, cerebral ischemia, congestive heart failure, palpitation, and cardiac arrest.

In one case, an 82-year-old man with glaucoma, first degree AV heart block, and peptic ulcer disease developed episodes of dizziness at rest and one episode of syncope associated with sinus bradycardia (42 beats/min) with first degree AV heart block soon after levobunolol eyedrops were added to his medical regimen. He responded to atropine, but reverted to sinus bradycardia (in the 40's) during his subsequent hospitalization. An electrophysiologic study revealed a prolonged AH interval at 240 msec and a slightly prolonged HV interval at 60 msec and intermittent left bundle branch block with atrial pacing. Neither supraventricular nor ventricular tachycardia could be induced. Pilocarpine was substituted, and the patient's ambulatory ECG revealed fewer episodes of bradycardia and AV heart block. The patient had no further episodes of syncope or dizziness.

Heart rate and blood pressure changes are rarely clinically relevant, and usually consist of reductions of resting heart rate of 2 to 10 beats/min and decreased systolic and diastolic blood pressures of 3 to 20 and 1 to 10 mm Hg, respectively.

Levobunolol can blunt the heart rate response to exercise.

Hypersensitivity

Hypersensitivity side effects have included urticaria, pruritus, contact dermatitis, alopecia, and Stevens-Johnson syndrome.

Hypersensitivity side effects associated with levobunolol and/or other ophthalmic beta blockers have included localized and generalized rash.

Nervous system

Nervous system side effects have included headache, transient ataxia, dizziness, depression, and lethargy,

Nervous system side effects associated with levobunolol and/or other ophthalmic beta blockers have included paresthesia, headache, and asthenia.

Gastrointestinal

Gastrointestinal side effects associated with levobunolol and/or other ophthalmic beta blockers have included nausea and diarrhea.

Endocrine

Endocrine side effects associated with levobunolol and/or other ophthalmic beta blockers have included masking of the signs of hyperthyroidism/thyroid storm or hypoglycemia.

Genitourinary

Genitourinary side effects have included impotence.

Musculoskeletal

Musculoskeletal side effects have included ataxia.

Musculoskeletal side effects associated with levobunolol and/or other ophthalmic beta blockers have included exacerbation of myasthenia gravis.

Psychiatric

Psychiatric side effects have included depression and confusion.

Other

Other side effects associated with levobunolol and/or other ophthalmic beta blockers have included chest pain.

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