In clinical trials involving more than 2,732 patients who received brenzolamide as monotherapy or additional therapy with timolol maleate 5 mg / ml, the most frequently reported adverse reactions were: dysgeusia (6.0%) (bitter or unusual taste) and temporary blurring of vision (5.4%) after instillation over several seconds to several minutes.
The frequency of adverse reactions given below is determined by the following frequency categories: very often (≥1 / 10); often (≥1 / 100 and <1/10); infrequently (≥1 / 1000 and <1/100); rarely (≥1 / 10000 and <1/1000); rarely (<1/10000); with an unknown frequency (which can not be estimated on the basis of available data). In each group of frequencies, adverse reactions are presented in order of frequency of occurrence. Adverse reactions were obtained from clinical studies and from post-marketing spontaneous reports.
Infections and infections:
Infrequently: nasopharyngitis, pharyngitis, sinusitis.
With unknown frequency: rhinitis.
On the part of the hematopoiesis system:
Infrequently: Reducing the number of red blood cells, increasing the chlorine content in the plasma.
From the immune system:
With unknown frequency: hypersensitivity.
From the side of metabolism and nutrition:
With unknown frequency: decreased appetite.
Mental disorders:
Infrequently: apathy, depression, depressed mood, decreased libido, nightmares, nervousness;
Rarely: Insomnia.
From the nervous system:
Infrequently: motor dysfunction, amnesia, dizziness, paresthesia, headache;
Rarely: memory impairment, drowsiness;
With unknown frequency: tremor, hypoesthesia, agevia.
From the side of the organ of vision:
Often: blurred vision, eye irritation, eye pain, foreign body sensation in the eyes, eye hyperemia.
Infrequently: corneal erosion, keratitis, spot keratitis, keratopathy, accumulation in the eye, staining the cornea, defective corneal epithelium, breach of the integrity of the corneal epithelium, blepharitis, itching of the eyes, conjunctivitis, conjunctival edema, meibomite, photophobia, allergic conjunctivitis, pigment accumulation in the cornea during diagnostic tests to confirm corneal epithelial integrity disorder, pterygium, scleral pigmentation, asthenopia, discomfort in the eyes, unusual sensation in the eye,dry eye syndrome, subconjunctival cysts, conjunctival injection, itchy eyelids, discharge from the eyes, crust on the edges of the eyelids, lacrimation.
Rarely: corneal edema, diplopia, decreased visual acuity, photopsy, hypoesthesia, periorbital edema, increased intraocular pressure, changes in the ratio of excavation diameters to the diameter of the optic disc;
With unknown frequency: violations of the cornea, visual impairment, allergic manifestations of the eyes, madarose, violations of the eyelids, erythema century.
From the side of the organ of hearing and labyrinth:
Rarely: ringing in the ears.
With unknown frequency: dizziness.
From the side of the cardiovascular system:
Infrequently: cardiorespiratory distress syndrome, bradycardia, heart palpitations.
Rarely: stenocardia, a violation of the rhythm of heartbeats.
With unknown frequency: arrhythmia, tachycardia, hypertension, increased blood pressure, lower blood pressure, increased heart rate.
Disorders from the respiratory, thoracic and mediastinal organs:
Infrequently: shortness of breath, nosebleeds, oropharyngeal pain, pharyngeal pain, irritation in the throat, cough syndrome of the upper respiratory tract, runny nose, sneezing.
Rarely: bronchial hyperactivity, a feeling of congestion in the upper respiratory tract, edema of the mucous membrane of the paranasal sinuses, congestion of the nose, coughing, dryness in the nose.
With unknown frequency: bronchial asthma.
From the gastrointestinal tract:
Often: dysgeusia.
Infrequently: esophagitis, diarrhea, nausea, vomiting, dyspepsia, pain in the upper abdomen, abdominal discomfort, stomach discomfort, flatulence, frequent bowel movement, gastrointestinal disorders, decreased sensitivity in the mouth, paresthesia in the mouth, dry mouth .
From the hepatobiliary system:
With unknown frequency: change in the results of analysis of the functional state of the liver.
From the skin and subcutaneous fat:
Infrequently: a rash, maculopapular rash, a feeling of tightness of the skin.
Rarely: urticaria, hair loss, generalized itching.
With unknown frequency: dermatitis, erythema.
From the musculoskeletal system and connective tissue:
Infrequently: back pain, muscle spasms, myalgia.
With unknown frequency: arthralgia, pain in the extremities.
On the part of the kidneys and urinary tract:
Infrequently: pain in the kidney area.
With unknown frequency: pollakiuria.
On the part of the reproductive system:
Infrequently: erectile disfunction.
Common violations:
Infrequently: pain, discomfort in the chest, increased fatigue, unusual sensations.
Rarely: pain in the chest, a sense of anxiety, asthenia, irritability.
With unknown frequency: peripheral edema, malaise.
Injuries, poisoning and complications during instillation
Infrequently: the sensation of a foreign body in the eye.
Description of individual adverse reactions
Dysgeusia (a bitter or unusual taste in the mouth after instillation) is the most common systemic adverse reaction noted during clinical studies of brenzolamide. Most likely, it is associated with the passage of eye drops into the nasopharynx through the nasolacrimal canal. Nasolacrimal occlusion or easy eyelid closure after instillation can help in reducing the frequency of this effect.
Brinzopt is an inhibitor of carbonic anhydrase with a sulfonamide structure, its excretion into the systemic circulation is noted. Side effects with regard to the gastrointestinal tract, nervous system, hematologic indices, kidneys, as well as metabolic abnormalities were mainly noted in systemic use of carbonic anhydrase inhibitors.Side effects noted with oral administration of carbonic anhydrase inhibitors may also occur after topical application in ophthalmology.
No unexpected side effects were observed with the use of Brinzolamide as an additional therapy for travoprost. The observed adverse reactions with additional therapy were seen after each active ingredient alone.
Pediatric Use
In small-scale short-term clinical trials, about 12.5% of pediatric patients experienced adverse reactions, most of which were local, non-serious eye reactions, such as conjunctival injection, eye irritation, discharge from the eyes and lacrimation.