Dorzolamide/timolol Side Effects

Please note - some side effects for Dorzolamide/timolol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Dorzolamide/timolol - for the Consumer

Dorzolamide/timolol 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 Dorzolamide/timolol Drops:

Back pain; bloodshot eyes; blurred vision; cough; dizziness; dry eyes; eyelid discomfort; feeling that something is in your eye; headache; increased tear production; minor burning, itching, or stinging of the eye; nausea; sore throat; stomach pain or upset; taste changes (eg, bitter, sour, or unusual taste).

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); chest, jaw, or arm pain; cold hands or feet; confusion; difficult or painful urination; eye irritation, swelling, pain, or discharge; eyelid pain, redness, scaling, drooping, or swelling; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; one-sided weakness; red, swollen, blistered, or peeling skin; severe or persistent headache or dizziness; shortness of breath; slurred speech; sudden, unexplained weight gain; sudden, unusual sweating; swelling of the hands, ankles, or feet; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe stomach pain, yellowing of the skin or eyes); unusual tiredness or weakness; vision changes (eg, double vision, loss of vision); wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

Applies to: ophthalmic solution

General

The most common side effects have included taste perversion and ocular burning and stinging (up to 30%). 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.

Ocular

Ocular side effects have included burning and stinging upon instillation in up to 30% of patients. Conjunctival hyperemia, superficial punctate keratitis, blurred vision, and eye itching have been reported in 5% to 5% of patients. Blepharitis, cloudy vision, conjunctival discharge, conjunctival edema, conjunctival follicles, conjunctival injection, conjunctivitis, corneal erosion, corneal staining, cortical lens opacity, eye dryness, eye debris, eye discharge, eye pain, eye tearing, eyelid edema, eyelid erythema, eyelid tearing, eyelid exudate/scales, eyelid pain or discomfort, foreign body sensation, glaucomatous cupping, lens nucleus coloration, lens opacity, nuclear lens opacity, post-subcapsular cataract, visual field defect, and vitreous detachment have been reported in 1% to 5% of patients. Iridocyclitis and photophobia have been reported in less than 1% of patients.

Ocular side effects associated with dorzolamide have included eyelid crusting, transient myopia, and ocular allergic reactions.

Ocular side effects associated with timolol ocular have included ptosis, decreased corneal sensitivity, cystoid macular edema, refractive changes, diplopia, pseudopemphigoid, and choroidal detachment following filtration surgery.

Foreign body sensation has been reported due to formation of precipitate on the tip of the dropper bottle, which entered the eye during instillation of the eye drops.

Respiratory

Respiratory side effects have included bronchitis, sinusitis, pharyngitis, cough, and upper respiratory tract infection in 1% to 5% of patients. Dyspnea, nasal congestion, and respiratory failure have been reported in less than 1% of patients.

Respiratory side effects associated with timolol ocular have included pulmonary edema, respiratory failure, dyspnea, nasal congestion, cough, and upper respiratory infections.

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. Cases of fatal respiratory arrest have been reported in patients with asthma, even after topically-administered timolol.

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

Cardiovascular

Cardiovascular side effects have included hypertension in 1% to 5% of patients. Bradycardia, cardiac failure, cerebral vascular accident, chest pain, heart block, and myocardial infarction have been reported in less than 1% of patients.

Cardiovascular side effects associated with timolol ocular 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.

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

Nervous system

Nervous system side effects have included headache in 1% to 5% of patients. Depression and paresthesia have been reported in less than 1% of patients.

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.

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

Hypersensitivity

Hypersensitivity reactions associated with dorzolamide or timolol ocular have included angioedema, bronchospasm, pruritus, urticaria, local ocular reaction, contact dermatitis, anaphylaxis, local and generalized skin rash, and allergic conjunctivitis.

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.

Dermatologic

Dermatologic side effects have included skin rashes (less than 1%).

Dermatologic side effects associated with dorzolamide have included contact dermatitis, throat irritation, alopecia, pruritus, and urticaria. Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported rarely.

Dermatologic side effects associated with timolol ocular have included contact dermatitis, psoriasiform rash, exacerbation of psoriasis, 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 and increased pigmentation. Oral timolol has been associated with hyperpigmented nail beds and skin irritation and these may potentially occur with ocular administration, also.

Endocrine

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

Endocrine side effects of timolol ocular have included masking the signs and symptoms of and blunting the normal physiologic response to hypoglycemia in patients with diabetes, and increases in serum triglycerides, LDL cholesterol, and VLDL cholesterol, and decreases in HDL cholesterol.

Endocrine side effects associated with oral timolol have included hyperglycemia, hypoglycemia, and increased sweating. These effects may potentially occur with ocular administration, also.

Psychiatric

Psychiatric side effects have included rare cases of depression in less than 1% of patients.

Psychiatric side effects associated with timolol ocular have rarely included depression, confusion, hallucinations, and psychosis. 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.

Gastrointestinal

Gastrointestinal side effects have most commonly included taste perversion in 30% of patients (bitter, sour or unusual taste). Nausea and abdominal pain has been reported in 1% to 5% of patients. Diarrhea, dyspepsia, dry mouth, and vomiting have been reported in less than 1% of patients.

Dorzolamide has been associated with throat irritation.

Timolol ocular has been associated with anorexia.

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

Genitourinary

Genitourinary side effects have included urinary tract infection (1% to 5%) and urolithiasis (less than 1%).

Genitourinary side effects associated with timolol ocular have included retroperitoneal fibrosis, decreased libido, impotence, and Peyronie's disease.

Genitourinary side effects associated with oral timolol or other oral beta-blockers have included urination difficulties. This may potentially occur with ocular administration, also.

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

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 associated with timolol ocular have included rare cases of systemic lupus erythematosus.

Hematologic

Hematologic side effects associated with dorzolamide have included epistaxis.

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

Other

Other side effects have included back pain (1 to 5%).

Other side effects associated with timolol ocular 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.

Hepatic

Hepatic side effects have included hepatomegaly associated with oral timolol. This may potentially occur with ocular administration also.

Metabolic

Metabolic side effects associated with oral timolol have included weight loss, and this may potentially occur with ocular administration, also.

Musculoskeletal

Musculoskeletal side effects associated with oral timolol have included extremity pain and this may potentially occur with ocular administration, also.

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