Istalol Side Effects

Generic Name: timolol ophthalmic

Please note - some side effects for Istalol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Istalol - for the Consumer

Istalol Drops

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Istalol Drops:

Blurred vision; dizziness; dry eyes; feeling that something is in your eye; headache; increased tear production; minor burning, itching, or stinging of the eye; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain or discomfort; confusion; eye irritation, swelling, pain, or discharge; eyelid pain, redness, scaling, drooping, or swelling; fainting; pain, numbness, weakness, or tingling of an arm or leg; severe or persistent headache or dizziness; shortness of breath; slow or irregular heartbeat; swelling of the hands, ankles, or feet; vision changes.

Istalol Side Effects - for the Professional

Istalol

The most frequently reported adverse experiences have been burning and stinging upon instillation in 38% of patients treated with Istalol. Additional events reported with Istalol at a frequency of 4 to 10% include: blurred vision, cataract, conjunctival injection, headache, hypertension, infection, itching and decreased visual acuity.

The following additional adverse experiences have been reported less frequently with ocular administration of this or other timolol maleate formulations:

BODY AS A WHOLE
Asthenia/fatigue and chest pain.

CARDIOVASCULAR
Bradycardia, arrhythmia, hypotension, syncope, heart block, cerebral vascular accident, cerebral ischemia, cardiac failure, worsening of angina pectoris, palpitation, cardiac arrest, pulmonary edema, edema, claudication, Raynaud's phenomenon, and cold hands and feet.

DIGESTIVE
Nausea, diarrhea, dyspepsia, anorexia, and dry mouth.

IMMUNOLOGIC
Systemic lupus erythematosus.

NERVOUS SYSTEM/PSYCHIATRIC
Dizziness, increase in signs and symptoms of myasthenia gravis, paresthesia, somnolence, insomnia, nightmares, behavioral changes and psychic disturbances including depression, confusion, hallucinations, anxiety, disorientation, nervousness, and memory loss.

SKIN
Alopecia and psoriasiform rash or exacerbation of psoriasis.

HYPERSENSITIVITY
Signs and symptoms of systemic allergic reactions, including angioedema, urticaria, and localized and generalized rash.

RESPIRATORY
Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), respiratory failure, dyspnea, nasal congestion, cough and upper respiratory infections.

ENDOCRINE
Masked symptoms of hypoglycemia in diabetic patients.

SPECIAL SENSES
Signs and symptoms of ocular irritation including conjunctivitis, blepharitis, keratitis, ocular pain, discharge (e.g., crusting), foreign body sensation, itching and tearing, and dry eyes; ptosis; decreased corneal sensitivity; cystoid macular edema; visual disturbances including refractive changes and diplopia; pseudopemphigoid; choroidal detachment following filtration surgery; and tinnitus.

UROGENITAL
Retroperitoneal fibrosis, decreased libido, impotence, and Peyronie's disease.

The following additional adverse effects have been reported in clinical experience with ORAL timolol maleate or other ORAL beta-blocking agents and may be considered potential effects of ophthalmic timolol maleate: Allergic: Erythematous rash, fever combined with aching and sore throat, laryngospasm with respiratory distress; Body as a Whole: Extremity pain, decreased exercise tolerance, weight loss; Cardiovascular: Worsening of arterial insufficiency, vasodilatation; Digestive: Gastrointestinal pain, hepatomegaly, vomiting, mesenteric arterial thrombosis, ischemic colitis; Hematologic: Nonthrombocytopenic purpura; thrombocytopenic purpura, agranulocytosis; Endocrine: Hyperglycemia, hypoglycemia; Skin: Pruritus, skin irritation, increased pigmentation, sweating; Musculoskeletal: Arthralgia; Nervous System/Psychiatric: Vertigo, local weakness, diminished concentration, reversible mental depression progressing to catatonia, an acute reversible syndrome characterized by disorientation for time and place, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics; Respiratory: Rales, bronchial obstruction; Urogenital: Urination difficulties.

Side Effects by Body System

General

Topically applied timolol ophthalmic drops may be absorbed systemically and side effects similar to systemically administered timolol or other beta-blockers such as severe respiratory or cardiac reactions may be experienced.

In clinical trials, timolol ophthalmic solution and gel forming solution had a similar incidence of side effects.

Ocular

The results of a comparative trial suggest that timolol maleate may be more irritating than timolol hemihydrate.

Blurred vision upon instillation lasting from 30 seconds to 5 minutes has been reported in 33% of patients receiving the sustained release gel forming solution.

Ocular side effects have included burning and stinging upon instillation, which has been reported in approximately 12% of patients receiving timolol ophthalmic drops. Signs of ocular irritation including but not limited to conjunctivitis, blepharitis, keratitis, ocular pain, discharge/crusting, foreign body sensation, itching, tearing, and dry eyes. Ptosis, decreased corneal sensitivity, cystoid macular edema, visual disturbances (including refractive changes and diplopia), pseudopemphigoid, impairment of tear production and turnover, and choroidal detachment following filtration surgery have also been reported. In addition, cases of bacterial keratitis have been reported as a result of inadvertent contamination by patients.

Cardiovascular

Cardiovascular side effects have included bradycardia, arrhythmia, hypotension, hypertension, syncope, heart block, cerebral vascular accident, cerebral ischemia, exacerbation of angina, palpitation, cardiac arrest, pulmonary edema, edema, claudication, Raynaud's phenomenon, and cold hands and feet. It should be noted that death due to cardiac failure has been reported following use of ophthalmic timolol.

Cardiovascular side effects associated with oral timolol or other oral beta-blockers have included worsening of arterial insufficiency and vasodilatation.

Respiratory

Respiratory side effects have included respiratory failure, dyspnea, nasal congestion, cough, and upper respiratory infections. It should be noted that death due to bronchospasm, in patients with asthma, has been reported following use of ophthalmic timolol.

Respiratory side effects associated with timolol, as with other beta-antagonists, have included bronchial constriction in susceptible patients. Alternative therapy should be considered in patients with reactive airways disease.

Respiratory side effects associated with oral timolol or other oral beta-blockers have included rales and bronchial obstruction.

A case of refractory rhinitis is reported. The rhinitis may have been due to timolol-induced vasomotor changes.

The results of one study show that in otherwise healthy patients with glaucoma, long-term (3 yrs) treatment with ophthalmic timolol 0.5% can result in a significant reduction from baseline in FEV1 and a subclinical increase in bronchial reactivity which may not be completely reversible upon discontinuation of therapy.

Endocrine

Alternative therapy should be considered in patients with diabetes mellitus who are prone to hypoglycemia.

Endocrinologic side effects have included masking the signs and symptoms and blunting the normal physiologic response to hypoglycemia.

Endocrinologic side effects associated with timolol have included an increase in serum triglycerides, LDL cholesterol, and VLDL cholesterol, a decrease in HDL cholesterol, hyperglycemia, and hypoglycemia.

Nervous system

A case of amaurosis fugax is associated with timolol. However, the patient involved had underlying cerebrovascular disease, autonomic dysfunction, and an arrhythmia.

Nervous system side effects have included dizziness, headache, paresthesia, anxiety, somnolence, insomnia, nightmares, nervousness, memory loss, and disorientation. Timolol may worsen myasthenia gravis.

Nervous system side effects associated with oral timolol or other oral beta-blockers have included vertigo, local weakness, diminished concentration, an acute reversible syndrome characterized by disorientation for time and place, and slightly clouded sensorium.

Psychiatric

Sexual dysfunction is reported from questionnaires, although the questions may have biased the data since the responses were not spontaneous.

Psychiatric side effects such as depression, confusion, hallucinations, and psychosis have been reported in rare cases. These effects may occur suddenly and are typically reversible upon discontinuation.

Psychiatric side effects associated with oral timolol or other oral beta-blockers have included reversible mental depression progressing to catatonia, emotional lability, and decreased performance on neuropsychometrics.

Dermatologic

Dermatologic side effects have included contact dermatitis, urticaria and alopecia. Rare cases of psoriasis, prurigo and hyperpigmented nail beds have been reported.

Dermatologic side effects associated with oral timolol or other oral beta-blockers have included pruritus, skin irritation, and increased pigmentation.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, diarrhea, dyspepsia, anorexia, and dry mouth.

Gastrointestinal side effects associated with oral timolol or other oral beta-blockers have included gastrointestinal pain, hepatomegaly, vomiting, mesenteric arterial thrombosis, and ischemic colitis.

Immunologic

An 86-year-old male with a 10 year history of chronic open angle glaucoma developed fever, malaise, pleurisy and recurrent sterile pleural effusions while taking only topical ophthalmic timolol. Antinuclear antibodies were present and the patient was felt to have timolol induced systemic lupus erythematosus. The patient improved upon the discontinuation of timolol and was not rechallenged.

Immunologic side effects have rarely included systemic lupus erythematosus and arthropathies.

Hypersensitivity

Hypersensitivity reactions have included allergic conjunctivitis, anaphylaxis, angioedema, urticaria, and localized/generalized rash.

Hypersensitivity side effects associated with oral timolol and other oral beta-blockers have included erythematous rash, fever combined with aching and sore throat, and laryngospasm with respiratory distress.

Genitourinary

Genitourinary side effects have rarely included complaints of impotence, retroperitoneal fibrosis, decreased libido, and Peyronie's disease.

Genitourinary side effects associated with oral timolol or other oral beta-blockers have included urination difficulties.

Other

Other side effects have included asthenia/fatigue, chest pain, and tinnitus.

Other side effects associated with oral timolol or other oral beta-blockers have included extremity pain, decreased exercise tolerance, sweating, and weight loss.

Hematologic

Hematologic side effects associated with oral timolol or other oral beta-blockers have included nonthrombocytopenic purpura, thrombocytopenic purpura, and agranulocytosis.

Musculoskeletal

Musculoskeletal side effects associated with oral timolol or other oral beta blockers have included arthralgia.

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