TIMOPTOL-XE is usually well tolerated. The most frequent drug-related complaint in the original clinical trials for TIMOPTOL-XE was transient blurred vision (6.0%), lasting from 30 seconds to 5 minutes, following instillation.
The following possibly, probably, or definitely drug-related adverse reactions occurred with a frequency of at least 1% in active treatment controlled clinical trials: Ocular: Burning and stinging, conjunctival redness, discharge, foreign body sensation, itching.
The following additional adverse reactions have been reported with ocular administration of this or other timolol maleate formulations, either in clinical trials or since the drug has been marketed: Special Senses: Signs and symptoms of ocular irritation, including conjunctivitis, blepharitis, keratitis, decreased corneal sensitivity, and dry eyes. Visual disturbances, including refractive changes (due to withdrawal of miotic therapy in some cases), diplopia, ptosis, choroidal detachment following filtration surgery (see PRECAUTIONS), tinnitus.
Cardiovascular: Bradycardia, arrhythmia, hypotension, syncope, heart block, cerebrovascular accident, cerebral ischemia, congestive heart failure, palpitation, cardiac arrest, edema, claudication, Raynaud's phenomenon, cold hands and feet.
Respiratory: Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), respiratory failure, dyspnea, cough.
Body as a Whole: Headache, asthenia, fatigue, chest pain.
Integumentary: Alopecia, psoriasiform rash or exacerbation of psoriasis.
Hypersensitivity: Signs and symptoms of allergic reactions including anaphylaxis, angioedema, urticaria, localized and generalized rash.
Nervous System/Psychiatric: Dizziness, depression, insomnia, nightmares, memory loss, paresthesia.
Neuromuscular: Increase in signs and symptoms of myasthenia gravis.
Digestive: Nausea, diarrhea, dyspepsia, dry mouth, abdominal pain.
Urogenital: Decreased libido, Peyronie's disease, sexual dysfunction.
Immunologic: Systemic lupus erythematosus.
Potential Side Effects: Side effects reported in clinical experience with systemic timolol maleate may be considered potential side effects of ophthalmic timolol maleate.