Combigan Side Effects

Please note - some side effects for Combigan 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 Combigan - for the Consumer

Combigan 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 Combigan Drops:

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

Seek medical attention right away if any of these SEVERE side effects occur when using Combigan Drops:

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; mental or mood changes; muscle weakness; pain, numbness, weakness, or tingling of an arm or leg; severe or persistent headache or dizziness; severely cold, numb, or blue fingers or toes; shortness of breath; slow or irregular heartbeat; slurred speech; sudden unusual weight gain; swelling of the hands, ankles, or feet; vision changes.

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.

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Combigan Side Effects - for the Professional

Combigan

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Combigan®

In clinical trials of 12 months duration with Combigan®, the most frequent reactions associated with its use occurring in approximately 5% to 15% of the patients included: allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, ocular burning, and stinging. The following adverse reactions were reported in 1% to 5% of patients: asthenia, blepharitis, corneal erosion, depression, epiphora, eye discharge, eye dryness, eye irritation, eye pain, eyelid edema, eyelid erythema, eyelid pruritus, foreign body sensation, headache, hypertension, oral dryness, somnolence, superficial punctate keratitis, and visual disturbance.

Other adverse reactions that have been reported with the individual components are listed below.

Brimonidine Tartrate (0.1%-0.2%)

Abnormal taste, allergic reaction, blepharoconjunctivitis, blurred vision, bronchitis, cataract, conjunctival edema, conjunctival hemorrhage, conjunctivitis, cough, dizziness, dyspepsia, dyspnea, fatigue, flu syndrome, follicular conjunctivitis, gastrointestinal disorder, hypercholesterolemia, hypotension, infection (primarily colds and respiratory infections), hordeolum, insomnia, keratitis, lid disorder, nasal dryness, ocular allergic reaction, pharyngitis, photophobia, rash, rhinitis, sinus infection, sinusitis, taste perversion, tearing, visual field defect, vitreous detachment, vitreous disorder, vitreous floaters, and worsened visual acuity.

Timolol (Ocular Administration)

Body as a whole: chest pain; Cardiovascular: Arrhythmia, bradycardia, cardiac arrest, cardiac failure, cerebral ischemia, cerebral vascular accident, claudication, cold hands and feet, edema, heart block, palpitation, pulmonary edema, Raynaud's phenomenon, syncope, and worsening of angina pectoris; Digestive: Anorexia, diarrhea, nausea; Immunologic: Systemic lupus erythematosus; Nervous System/Psychiatric: Increase in signs and symptoms of myasthenia gravis, insomnia, nightmares, paresthesia, behavioral changes and psychic disturbances including confusion, hallucinations, anxiety, disorientation, nervousness, and memory loss; Skin: Alopecia, psoriasiform rash or exacerbation of psoriasis; Hypersensitivity: Signs and symptoms of systemic allergic reactions, including anaphylaxis, angioedema, urticaria, and generalized and localized rash; Respiratory: Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), dyspnea, nasal congestion, respiratory failure; Endocrine: Masked symptoms of hypoglycemia in diabetes patients; Special Senses: diplopia, choroidal detachment following filtration surgery, cystoid macular edema, decreased corneal sensitivity, pseudopemphigoid, ptosis, refractive changes, tinnitus; Urogenital: Decreased libido, impotence, Peyronie's disease, retroperitoneal fibrosis.

Postmarketing Experience

Brimonidine

The following reactions have been identified during post-marketing use of brimonidine tartrate ophthalmic solutions in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to brimonidine tartrate ophthalmic solutions, or a combination of these factors, include: bradycardia, depression, iritis, keratoconjunctivitis sicca, miosis, nausea, skin reactions (including erythema, eyelid pruritus, rash, and vasodilation), and tachycardia. Apnea, bradycardia, hypotension, hypothermia, hypotonia, and somnolence have been reported in infants receiving brimonidine tartrate ophthalmic solutions.

Oral Timolol/Oral Beta-blockers

The following additional adverse reactions 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: Decreased exercise tolerance, extremity pain, weight loss; Cardiovascular: Vasodilatation, worsening of arterial insufficiency; Digestive: Gastrointestinal pain, hepatomegaly, ischemic colitis, mesenteric arterial thrombosis, vomiting; Hematologic: Agranulocytosis, nonthrombocytopenic purpura, thrombocytopenic purpura; Endocrine: Hyperglycemia, hypoglycemia; Skin: Increased pigmentation, pruritus, skin irritation, sweating; Musculoskeletal: Arthralgia; Nervous System/Psychiatric: An acute reversible syndrome characterized by disorientation for time and place, decreased performance on neuropsychometrics, diminished concentration, emotional lability, local weakness, reversible mental depression progressing to catatonia, slightly clouded sensorium, vertigo; Respiratory: Bronchial obstruction, rales; Urogenital: Urination difficulties.

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Side Effects by Body System - for Healthcare Professionals

Ocular

Ocular side effects have included allergic conjunctivitis, follicular conjunctivitis, conjunctival hyperemia, eye pruritis, ocular burning, and stinging. Also reported were diplopia, choroidal detachment following filtration surgery, cystoid macular edema, decreased corneal sensitivity, pseudophemphigoid ptosis, refractive changes, blepharitis, blepharoconjunctivitis, conjunctival edema, conjunctival hemorrhage, conjunctivitis, blurred vision, corneal erosion, epiphora, eye discharge, eye dryness, eye irritation, eye pain, eyelid edema, eyelid pruritis, lid disorder, tearing, visual field defect, vitreous detachment, vitreous disorder, vitreous floaters, worsened visual acuity, iritis, keratoconjunctivitis sicca, miosis, foreign body sensation, superficial punctate keratitis, and visual disturbance.

Cardiovascular

Cardiovascular side effects have included arrythmia, bradycardia, tachycardia, cardiac arrest, cardiac failure, cerebral ischemia, cerebral vascular accident, claudication, cold hands and feet, edema, heart block, palpitation, pulmonary edema, Raynaud's phenomena, syncope, and worsening of angina pectoris.

Gastrointestinal

Gastrointestinal side effects have included anorexia, diarrhea, gastrointestinal pain, gastrointestinal disorder, dyspepsia, hepatomegaly, ischemic colitis, mesenteric arterial thrombosis, diarrhea, vomiting, and nausea.

Immunologic

Immunologic side effects have included systemic lupus erythematosus.

Nervous system

Nervous system side effects have included increased signs and symptoms of myasthenia gravis, insomnia, nightmares, paresthesias, headache, asthenia, somnolence, dizziness, fatigue, photophobia, taste perversion, confusion, slightly clouded sensorium, and vertigo

Psychiatric

Psychiatric side effects have included hallucinations, anxiety, disorientation, nervousness, memory loss, behavorial changes and psychic disturbances, slightly clouded sensorium, decreased performance on neuropsychometrics, diminished concentration, emotional liability, an acute reversible syndrome characterized by disorientation for time and place, and reversible mental depression progressing to catatonia.

Respiratory

Respiratory side effects have included cough, oral dryness, dyspnea, bronchitis, bronchial obstruction, rales, bronchospasm, nasal dryness, dyspnea, nasal congestion, rhinitis, sinus infection, sinusitis, pharyngitis, colds, and respiratory infections.

Hematologic

Hematologic side effects have included agranulocytosis, nonthrombocytopenic purpura, and thrombocytopenic purpura,

Genitourinary

Genitourinary side effects have included urination difficulties, decreased libido, impotence, Peyronie's disease, and retroperitoneal fibrosis.

Hypersensitivity

Hypersensitivity side effects have included anaphylaxis, angioedema, urticaria, fever combined with aching and sore throat, laryngospasm with respiratory distress, erythematous rash and both generalized and localized rash.

Endocrine

Endocrine side effects have included masking of symptoms of hypoglycemia in diabetic patients, hypercholesterolemia, hyperglycemia, and hypoglycemia.

General

General side effects have included decreased exercise tolerance, extremity pain, local weakness, weight loss, tinnitus, flu syndrome, and abnormal taste.

Musculoskeletal

Musculoskeletal side effects have included arthralgia.

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