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The following adverse reactions have been reported in clinical trials with Carteolol Hydrochloride (carteolol) Ophthalmic Solution.

Ocular

Transient eye irritation, burning, tearing, conjunctival hyperemia and edema occurred in about 1 of 4 patients. Ocular symptoms including blurred and cloudy vision, photophobia, decreased night vision, and ptosis and ocular signs including blepharoconjunctivitis, abnormal corneal staining, and corneal sensitivity occurred occasionally.

Systemic

As is characteristic of nonselective adrenergic blocking agents, Carteolol may cause bradycardia and decreased blood pressure (See WARNINGS). The following systemic events have occasionally been reported with the use of Carteolol Hydrochloride (carteolol) Ophthalmic Solution: cardiac arrhythmia, heart palpitation, dyspnea, asthenia, headache, dizziness, insomnia, sinusitis, and taste perversion. The following additional adverse reactions have been reported with ophthalmic use of beta1 and beta2 (nonselective) adrenergic receptor blocking agents:

Body As a Whole

Headache

Cardiovascular

Arrhythmia, syncope, heart block, cerebral vascular accident, cerebral ischemia, congestive heart failure, palpitation (see WARNINGS).

Digestive

Nausea

Psychiatric

Depression

Skin

Hypersensitivity, including localized and generalized rash

Respiratory

Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), respiratory failure (see WARNINGS)

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 nonselective adrenergic receptor blocking agents should be considered potential effects with ophthalmic use of these agents.