Applies to brimonidine/brinzolamide ophthalmic: ophthalmic suspension.

Serious side effects

Along with its needed effects, brimonidine/brinzolamide ophthalmic may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking brimonidine / brinzolamide ophthalmic:

More common

• Blurred vision
• discoloration of the white part of the eye
• eye irritation or redness

Less common

• Decreased vision
• eye pain
• eyes sensitive to light
• red, sore eyes

Rare

• Burning, dry, or itching eyes
• discharge or excessive tearing
• hives or welts
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• skin rash

Incidence not known

• Chest pain, discomfort, or tightness
• constricted, pinpoint, or small pupils (black part of the eye)
• fast, pounding, or irregular heartbeat or pulse
• fever
• hoarseness
• irritation
• itching
• joint pain, stiffness, or swelling
• lightheadedness, dizziness, or fainting
• redness of the skin
• slow or irregular heartbeat
• swelling of the eyelids, face, lips, hands, or feet
• tearing
• throbbing pain
• trouble breathing or swallowing
• unusual tiredness

Incidence not known

• Blistering, peeling, or loosening of the skin
• chills
• cough
• diarrhea
• muscle pain
• red irritated eyes
• red skin lesions, often with a purple center
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips

Get emergency help immediately if any of the following symptoms of overdose occur while taking brimonidine / brinzolamide ophthalmic:

Symptoms of overdose

• Confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• muscle cramps or pain
• numbness, tingling, pain, or weakness in the hands or feet
• seizures
• sweating
• trembling
• weakness and heaviness of the legs

Other side effects

Some side effects of brimonidine / brinzolamide ophthalmic may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Burning and stinging sensation
• change in color vision
• change in taste
• difficulty seeing at night
• drowsiness
• feeling of having something in the eye
• headache
• increase in blood flow to the whites of the eyes
• increased sensitivity of the eyes to sunlight
• lack or loss of strength
• loss of taste
• paleness of the eye or inner lining of the eyelid
• redness and tiny bumps on the lining of the eyelid

Less common

• Dry eyes
• dry mouth
• muscle pain
• sneezing
• stuffy or runny nose
• trouble sleeping

Rare

• Acid or sour stomach
• belching
• body aches or pain
• cough
• crusting in the corner of the eye
• double vision
• dryness or soreness of the throat
• excessive muscle tone
• hair loss or thinning of the hair
• heartburn
• hoarseness
• indigestion
• muscle stiffness, tension, or tightness
• nausea
• stomach discomfort, upset, or pain
• tender, swollen glands in the neck
• voice changes

For Healthcare Professionals

Applies to brimonidine / brinzolamide ophthalmic: ophthalmic suspension.

Cardiovascular

Uncommon (0.1% to 1%): Cardio-respiratory distress, angina pectoris, arrhythmia, palpitations, irregular heart rate, bradycardia, tachycardia, hypotension, chest discomfort

Very rare (less than 0.01%): Hypertension

Frequency not reported: Chest pain

Postmarketing reports: Pallor^[Ref]

Dermatologic

Uncommon (0.1% to 1%): Contact dermatitis, urticaria, rash, maculo-papular rash, generalized pruritus, alopecia, skin tightness

Frequency not reported: Dermatitis, erythema^[Ref]

Gastrointestinal

Common (1% to 10%): Dry mouth

Uncommon (0.1% to 1%): Dyspepsia, esophagitis, abdominal discomfort, diarrhea, vomiting, nausea, frequent bowel movements, flatulence, oral hypoesthesia, oral paresthesia^[Ref]

General

The most commonly reported side effects were blurred vision, ocular hyperemia, eye allergy, dry mouth, and dysgeusia.^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity^[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Back pain, muscle spasms, myalgia

Frequency not reported: Arthralgia, pain in extremity^[Ref]

Nervous system

Common (1% to 10%): Somnolence, dizziness, dysgeusia

Uncommon (0.1% to 1%): Headache, motor dysfunction, amnesia, memory impairment, paresthesia, vertigo, tinnitus, feeling jittery

Very rare (less than 0.01%): Syncope

Frequency not reported: Tremor, hypoesthesia, ageusia

Postmarketing reports: Coma, lethargy^[Ref]

Ocular

Common (1% to 10%): Eye allergy, keratitis, eye pain, ocular discomfort, blurred vision, abnormal vision, ocular hyperemia, conjunctival blanching

Uncommon (0.1% to 1%): Corneal erosion, corneal edema, blepharitis, corneal deposits (keratic precipitates), conjunctival disorder (papilla) , photophobia, photopsia, eye swelling, eyelid edema, conjunctival edema, dry eye, eye discharge, reduced visual acuity, increased lacrimation, pterygium, erythema of eyelid, meibomianitis, diplopia, glare, eye hypoesthesia, scleral pigmentation, subconjunctival cyst, abnormal sensation in eye, asthenopia

Very rare (less than 0.01%): Uveitis, miosis

Frequency not reported: Visual disturbances, madarosis

Postmarketing reports: Iritis, keratoconjunctivitis sicca^[Ref]

Other

Uncommon (0.1% to 1%): Pain, feeling abnormal, irritability

Frequency not reported: Face edema, peripheral edema

Postmarketing reports: Hypothermia^[Ref]

Psychiatric

Uncommon (0.1% to 1%): Apathy, depression, insomnia, nightmare, nervousness^[Ref]

Renal

Uncommon (0.1% to 1%): Renal pain

Frequency not reported: Pollakiuria^[Ref]

Respiratory

Uncommon (0.1% to 1%): Nasopharyngitis, pharyngitis, sinusitis, dyspnea, bronchial hyperactivity, pharyngolaryngeal pain, dry throat, cough, epistaxis, upper respiratory tract congestion, nasal congestion, rhinorrhea, throat irritation, nasal dryness, postnasal drip, sneezing

Frequency not reported: Rhinitis, asthma

Postmarketing reports: Apnea, respiratory depression^[Ref]

Genitourinary

Uncommon (0.1% to 1%): Decreased libido, erectile dysfunction^[Ref]

Hematologic

Uncommon (0.1% to 1%): Decreased red blood cell, increased blood chloride^[Ref]

Hepatic

Frequency not reported: Abnormal liver function^[Ref]