In clinical trials the use of BETAGAN has been associated with transient ocular burning and stinging in up to 1 in 3 patients, and with blepharoconjunctivitis in up to 1 in 20 patients. Decreases in heart rate and blood pressure have been reported (see CONTRAINDICATIONS and WARNINGS).

The following adverse reactions have been reported rarely with the use of BETAGAN: iridocyclitis, headache, transient ataxia, dizziness, lethargy, urticaria, and pruritus. Decreased corneal sensitivity has been noted in a small number of patients. Although levobunolol has minimal membrane-stabilizing activity, there remains a possibility of decreased corneal sensitivity after prolonged use. The following additional adverse reactions have been reported either with BETAGAN or ophthalmic use of other beta-adrenergic receptor blocking agents:

Body as a Whole: Headache, asthenia, chest pain.

Cardiovascular: Bradycardia, arrhythmia, hypotension, syncope, heart block, cerebral vascular accident, cerebral ischemia, congestive heart failure, palpitation, cardiac arrest.

Digestive: Nausea, diarrhea.

Psychiatric: Depression, confusion, increase in signs and symptoms of myasthenia gravis, paresthesia.

Skin: Hypersensitivity, including localized and generalized rash, alopecia, Stevens-Johnson Syndrome.

Respiratory: Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), respiratory failure, dyspnea, nasal congestion.

Urogenital: Impotence.

Endocrine: Masked symptoms of hypoglycemia in insulin dependent diabetics (see WARNINGS).

Special Senses: Signs and symptoms of keratitis, blepharoptosis, visual disturbances including refractive changes (due to withdrawal of miotic therapy in some cases), diplopia, ptosis.

Other reactions associated with the oral use of non-selective adrenergic receptor blocking agents should be considered potential effects with ophthalmic use of these agents.

Although BETAGAN used alone has little or no effect on pupil size, mydriasis resulting from concomitant therapy with BETAGAN and epinephrine may occur.

Close observation of the patient is recommended when a beta-blocker is administered to patients receiving catecholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or marked bradycardia, which may produce vertigo, syncope or postural hypotension.

Patients receiving beta-adrenergic blocking agents along with either oral or intravenous calcium antagonists should be monitored for possible atrioventricular conduction disturbances, left ventricular failure and hypotension. In patients with impaired cardiac function, simultaneous use should be avoided altogether.

The concomitant use of beta-adrenergic blocking agents with digitalis and calcium antagonists may have additive effects on prolonging atrioventricular conduction time.

Phenothiazine-related compounds and beta-adrenergic blocking agents may have additive hypotensite effects due to the inhibition of each other's metabolism.

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