Dorzolamide Side Effects

Please note - some side effects for Dorzolamide 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 Dorzolamide - 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.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain or discomfort; chills; confusion; dark urine; eye irritation, swelling, pain, or discharge; eyelid pain, redness, scaling, drooping, or swelling; fainting; fever; pain, numbness, weakness, or tingling of an arm or leg; red, swollen, blistered, or peeling skin; severe or persistent headache or dizziness; slow or irregular heartbeat; swelling of the hands, ankles, or feet; unusual tiredness or weakness; vision changes; yellowing of the skin or eyes.

Dorzolamide 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 Drops:

Bitter taste in mouth; blurred vision; burning and stinging upon instillation; dryness of eyes; eye sensitivity to sunlight; redness of the eyes; tearing.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); irritated eyelids.

Dorzolamide Side Effects - for the Professional

Dorzolamide

Controlled clinical trials:

The most frequent adverse events associated with Dorzolamide Hydrochloride Ophthalmic Solution were ocular burning, stinging, or discomfort immediately following ocular administration (approximately one-third of patients). Approximately one-quarter of patients noted a bitter taste following administration. Superficial punctate keratitis occurred in 10-15% of patients and signs and symptoms of ocular allergic reaction in approximately 10%. Events occurring in approximately 1-5% of patients were conjunctivitis and lid reactions, blurred vision, eye redness, tearing, dryness, and photophobia. Other ocular events and systemic events were reported infrequently, including headache, nausea, asthenia/fatigue; and, rarely, skin rashes, urolithiasis, and iridocyclitis.

In a 3-month, double-masked, active-treatment-controlled, multicenter study in pediatric patients, the adverse experience profile of Dorzolamide Hydrochloride Ophthalmic Solution was comparable to that seen in adult patients.

Clinical practice: The following adverse events have occurred either at low incidence (<1%) during clinical trials or have been reported during the use of Dorzolamide Hydrochloride Ophthalmic Solution in clinical practice where these events were reported voluntarily from a population of unknown size and frequency of occurrence cannot be determined precisely. They have been chosen for inclusion based on factors such as seriousness, frequency of reporting, possible causal connection to Dorzolamide Hydrochloride Ophthalmic Solution, or a combination of these factors: signs and symptoms of systemic allergic reactions including angioedema, bronchospasm, pruritus, and urticaria; dizziness, paresthesia; ocular pain, transient myopia, choroidal detachment following filtration surgery, eyelid crusting; dyspnea; contact dermatitis, epistaxis, dry mouth and throat irritation.

Side Effects by Body System

Ocular

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.

A 76-year-old woman with a 7-year history of open-angle glaucoma developed an abrupt choroidal detachment in the surgically untreated eye following 2 doses of dorzolamide. Systemic medications included verapamil and hydrochlorothiazide. Ocular medications consisted of timolol 0.5% twice daily to both eyes for the past 7 years. This reaction may have been a result of hypotony or an idiosyncratic reaction to the sulfa-containing agent, dorzolamide.

Ocular side effects have included burning and stinging upon instillation which has been reported in approximately 33% of patients receiving dorzolamide ophthalmic drops. Superficial punctate epithelial erosions occurred in approximately 15% of patients. Evidence of local allergic reaction to dorzolamide was present in approximately 10% of patients. Other ocular events seen in 1% to 5% of patients were conjunctivitis, lid reactions, dryness, photophobia, tearing, and blurred vision. Transient myopia, ocular pain, iridocyclitis, and eyelid crusting have been reported rarely. Slight increases in central corneal thickness have been reported in patients with cornea guttata after short-term (1 day) use of dorzolamide. A single case of abrupt choroidal detachment in a surgically untreated eye has been reported.

Other

Approximately 25% of patients have reported a bitter taste following administration.

Hypersensitivity

Hypersensitivity has occurred in approximately 10% of patients. Reactions reported include local ocular reaction, angioedema, pruritus, urticaria, and bronchospasm. Skin rashes and contact dermatitis have also been reported.

Dermatologic

Dermatologic side effects have included skin rashes and throat irritation.

Nervous system

Nervous system side effects have included headache, asthenia, paresthesia and dizziness.

Gastrointestinal

Gastrointestinal side effects have included bitter taste (25%), nausea (infrequent), throat irritation (<1%), and dry mouth (<1%).

Genitourinary

Genitourinary side effects have included urolithiasis.

Respiratory

Respiratory side effects have included rare reports of bronchospasm, which may be a symptom of hypersensitivity.

Hematologic

Hematologic side effects have included epistaxis.

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