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Cosopt (Dorzolamide Hydrochloride / Timolol Maleate Ophthalmic) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

COSOPT was evaluated for safety in 1035 patients with elevated intraocular pressure treated for open-angle glaucoma or ocular hypertension. Approximately 5% of all patients discontinued therapy with COSOPT because of adverse reactions. The most frequently reported adverse events were taste perversion (bitter, sour, or unusual taste) or ocular burning and/or stinging in up to 30% of patients. Conjunctival hyperemia, blurred vision, superficial punctate keratitis or eye itching were reported between 5-15% of patients. The following adverse events were reported in 1-5% of patients: abdominal pain, back pain, blepharitis, bronchitis, cloudy vision, conjunctival discharge, conjunctival edema, conjunctival follicles, conjunctival injection, conjunctivitis, corneal erosion, corneal staining, cortical lens opacity, cough, dizziness, dryness of eyes, dyspepsia, eye debris, eye discharge, eye pain, eye tearing, eyelid edema, eyelid erythema, eyelid exudate/scales, eyelid pain or discomfort, foreign body sensation, glaucomatous cupping, headache, hypertension, influenza, lens nucleus coloration, lens opacity, nausea, nuclear lens opacity, pharyngitis, post-subcapsular cataract, sinusitis, upper respiratory infection, urinary tract infection, visual field defect, vitreous detachment.

The following adverse events have occurred either at low incidence (<1%) during clinical trials or have been reported during the use of COSOPT 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 COSOPT, or a combination of these factors: bradycardia, cardiac failure, cerebral vascular accident, chest pain, choroidal detachment following filtration surgery (see PRECAUTIONS, General ), depression, diarrhea, dry mouth, dyspnea, heart block, hypotension, iridocyclitis, myocardial infarction, nasal congestion, Stevens-Johnson syndrome, toxic epidermal necrolysis, paresthesia, photophobia, respiratory failure, skin rashes, urolithiasis, and vomiting.

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

DorzolamideAllergic/Hypersensitivity: Signs and symptoms of local reactions including palpebral reactions and systemic allergic reactions including angioedema, bronchospasm, pruritus, urticaria; Body as a Whole: Asthenia/fatigue; Skin/Mucous Membranes: Contact dermatitis, epistaxis, throat irritation; Special Senses: Eyelid crusting, signs and symptoms of ocular allergic reaction, and transient myopia.

Timolol (ocular administration) — Body as a Whole: Asthenia/fatigue; Cardiovascular: Arrhythmia, syncope, cerebral ischemia, worsening of angina pectoris, palpitation, cardiac arrest, pulmonary edema, edema, claudication, Raynaud's phenomenon, and cold hands and feet; Digestive: Anorexia, abdominal pain; Immunologic: Systemic lupus erythematosus; Nervous System/Psychiatric: Increase in signs and symptoms of myasthenia gravis, somnolence, insomnia, nightmares, 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 localized and generalized rash; Respiratory: Bronchospasm (predominantly in patients with pre-existing bronchospastic disease); Endocrine: Masked symptoms of hypoglycemia in diabetic patients (see WARNINGS); Special Senses: Ptosis, decreased corneal sensitivity, cystoid macular edema, visual disturbances including refractive changes and diplopia, pseudopemphigoid, and tinnitus; Urogenital: Retroperitoneal fibrosis, decreased libido, impotence, sexual dysfunction, and Peyronie's disease; Musculoskeletal: Myalgia.

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, 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.



REPORTS OF SUSPECTED COSOPT SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Cosopt. The information is not vetted and should not be considered as verified clinical evidence.

Possible Cosopt side effects / adverse reactions in 85 year old female

Reported by a consumer/non-health professional from United States on 2011-11-21

Patient: 85 year old female

Reactions: Deposit Eye, Abasia, Heart Rate Irregular

Adverse event resulted in: hospitalization

Suspect drug(s):
Cosopt

Other drugs received by patient: Ocupress



Possible Cosopt side effects / adverse reactions in 81 year old male

Reported by a consumer/non-health professional from Canada on 2011-11-23

Patient: 81 year old male

Reactions: Intraocular Pressure Increased, Visual Acuity Reduced

Suspect drug(s):
Xalatan
    Dosage: 1 gtt in both eyes, 1x/day at night 15 min to 30 min after cosopt
    Indication: Glaucoma
    Start date: 2011-05-01

Cosopt
    Dosage: 1 drop in right eye twice a day
    Indication: Glaucoma
    Start date: 2011-05-01



Possible Cosopt side effects / adverse reactions in 84 year old male

Reported by a consumer/non-health professional from Switzerland on 2011-11-28

Patient: 84 year old male

Reactions: Rash, Spinal Disorder

Suspect drug(s):
Cosopt

Other drugs received by patient: Cozaar



See index of all Cosopt side effect reports >>

Drug label data at the top of this Page last updated: 2014-04-28

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