ADVERSE REACTIONS
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 the rates in the clinical studies of another drug and may not reflect the rates observed in practice.
In clinical studies of AZOPT® (brinzolamide ophthalmic suspension) 1%, the most frequently reported adverse events reported in 5-10% of patients were blurred vision and bitter, sour or unusual taste. Adverse events occurring in 1-5% of patients were blepharitis, dermatitis, dry eye, foreign body sensation, headache, hyperemia, ocular discharge, ocular discomfort, ocular keratitis, ocular pain, ocular pruritus and rhinitis.
The following adverse reactions were reported at an incidence below 1%: allergic reactions, alopecia, chest pain, conjunctivitis, diarrhea, diplopia, dizziness, dry mouth, dyspnea, dyspepsia, eye fatigue, hypertonia, keratoconjunctivitis, keratopathy, kidney pain, lid margin crusting or sticky sensation, nausea, pharyngitis, tearing and urticaria.
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REPORTS OF SUSPECTED AZOPT SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Azopt. The information is not vetted and should not be considered as verified clinical evidence.
Possible Azopt side effects / adverse reactions in 84 year old female
Reported by a consumer/non-health professional from Belgium on 2011-10-25
Patient: 84 year old female
Reactions: Fatigue, Dyspnoea, Gait Disturbance
Suspect drug(s):
Azopt
Other drugs received by patient: Diphantoine; Zantac; Magnesium; Inderal; Montelukast Sodium; Fenofibrate; Asaflow; Persantine
Possible Azopt side effects / adverse reactions in 84 year old female
Reported by a consumer/non-health professional from Belgium on 2011-11-08
Patient: 84 year old female
Reactions: Dyspnoea, Fatigue
Suspect drug(s):
Azopt
Other drugs received by patient: Fenofibrate; Asaflow; Inderal; Zantac; Diphantoine; Magnesium; Persantine; Montelukast Sodium
Possible Azopt side effects / adverse reactions in 64 year old male
Reported by a individual with unspecified qualification from United Kingdom on 2011-11-17
Patient: 64 year old male
Reactions: Dyspnoea, Rash, Erythema, Feeling Cold, Fatigue, Scrotal Oedema, Joint Swelling, Oedema Peripheral, Adverse Event
Adverse event resulted in: hospitalization
Suspect drug(s):
Azopt
Other drugs received by patient: Warfarin Sodium; Lumigan; Sotalol HCL
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