Apraclonidine ophthalmic Side Effects

Some side effects of apraclonidine ophthalmic may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to apraclonidine ophthalmic: ophthalmic solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking apraclonidine ophthalmic: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• slow or uneven heart rate;

• pounding heartbeats or fluttering in your chest;

• shallow breathing, feeling like you might pass out;

• severe swelling, redness, or discomfort in or around your eye;

• eye pain or increased watering; or

• numbness or tingly feeling in your hands or feet.

Less serious side effects of apraclonidine ophthalmic may include:

• burning, itching, or dryness of your eyes;

• feeling like something is in your eye;

• blurred or dimmed vision;

• redness of the eye or eyelid;

• mildly swollen or puffy eyes;

• nausea, stomach pain, diarrhea;

• headache, sleep problems (insomnia);

• dry or stuffy nose, burning in your nose;

• a dry mouth; or

• unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to apraclonidine ophthalmic: ophthalmic solution

Ocular

Ocular side effects have included hyperemia and pruritus in 10% to 13% of patients. Ocular discomfort and tearing have been reported in 4% to 6% of patients. Lid edema, blurred vision, foreign body sensation, dry eye, conjunctivitis, discharge and blanching have been reported in 1% to 5% of patients. Lid margin crusting, conjunctival follicles, conjunctival edema, edema, abnormal vision, ocular pain, lid disorder, keratitis, blepharitis, photophobia, corneal staining, lid erythema, blepharoconjunctivitis, irritation, corneal erosion, corneal infiltrate, keratopathy, lid scales, and lid retraction have been reported in less than 1% of patients. Follicular conjunctivitis and hypotony have been reported rarely. Mydriasis has also been reported.

Many ocular side effects are transient and may not be observed until 5 to 7 hours after dosing.

A 66-year-old man with proliferative diabetic retinopathy and increased intraocular pressure (IOP) successfully underwent trabeculoplasty. He received one drop of apraclonidine 1% in the left eye one hour before and immediately after the procedure. At one and two hours postoperatively, the intraocular pressures in his left eye were 8 and 6 mm Hg, respectively. After examination, the patient was discharged. On postoperative days one and four, the intraocular pressures in his left eye were 10 and 28 mm Hg, respectively. The authors believed that the use of apraclonidine almost certainly contributed to low intraocular pressure in this patient, although trabeculoplasty itself can result in an acute decrease in intraocular pressure.

Hypersensitivity

Hypersensitivity side effects have been reported the most frequently in up to 20% of patients. They have included discomfort, hyperemia, pruritus, tearing, edema of the lids and conjunctiva, and foreign body sensation.

In one study in which approximately 40 patients received apraclonidine for 90 days, allergic reactions tended to occur 30 to 60 days after treatment began and resolved on discontinuation of the drug. Although up to 20% of patients developed allergic symptoms, only two patients elected to discontinue therapy for this reason.

In one double blind placebo controlled study (n=171) 12.9% of the 84 patients treated with apraclonidine 0.5% one to two drops in affected eye(s) 3 times a day discontinued treatment due to hypersensitivity side effects.

Gastrointestinal

Gastrointestinal side effects have included dry mouth (10%) and dysgeusia (3%). Abdominal pain, diarrhea, constipation, gastric discomfort, nausea, dyspepsia, and vomiting have also been reported.

Nervous system

Nervous system side effects have included lethargy (up to 14%). Abnormal coordination, asthenia, dizziness, headache, insomnia, malaise, nervousness, paresthesia, and somnolence have been reported in up to 3% of patients. Decreased libido, dream disturbances, fatigue, irritability, and numbness or pain of extremities have also been reported.

Lethargy has been reported in 14% of patients who have been on apraclonidine for up to four weeks.

Insomnia, dream disturbances, irritability, headache, dizziness, fatigue, paresthesia, numbness or pain of the extremities, and decreased libido have been reported in nonlaser patients using apraclonidine for up to 4 weeks.

Cardiovascular

Although long-term studies have not been done, systemic side effects from apraclonidine are expected to be relatively infrequent relative to clonidine since apraclonidine is far less lipophilic. The relative hydrophilia of apraclonidine markedly reduces the risk of central alpha-adrenergic stimulation. In one double-blinded, crossover study of 20 healthy female volunteers, the use of apraclonidine 0.25% or 0.5% did not produce any significant changes in resting or exercise heart rate or blood pressure relative to placebo. This study did not address chronic use of apraclonidine in the elderly or in patients with glaucoma.

A single case of syncope and chest tightness has been associated with apraclonidine. A 67-year-old woman with a history of hypertension, diabetes, and renal calculi was scheduled to undergo argon laser iridotomy. She had no known history of coronary artery disease or arrhythmias. Her native medications included insulin, furosemide, and metoprolol. Approximately ten minutes after the instillation of one drop of 1% apraclonidine to the right eye (to prevent elevated intraocular pressure), she complained of chest tightness. Her pulse was "strong and regular." Within one to two minutes, her pulse was undetectable and the patient lost consciousness. Her rhythm was sinus. She was successfully resuscitated after aggressive intravenous fluid therapy. Her blood glucose was 180 mg/dL, and her ECG was normal. The patient subsequently underwent successful argon laser iridotomy without the use of apraclonidine.

After topical application, apraclonidine does not significantly alter heart rate or blood pressure.

Irregular heart beats have been reported in less than 2% of patients undergoing laser surgery.

There have been occasional reports of bradycardia, chest heaviness or burning, palpitations, reduced blood pressure, and orthostatic hypotension when apraclonidine 1% is administered once or twice a day for 4 weeks to individuals not undergoing laser surgery.

In one study, blood pressure reduction averaged 6%, and was not considered clinically significant, although occasionally blood pressure decreased by 20%. Heart rate changes ranged from a 42% decrease to a 44% increase.

Cardiovascular side effects have included arrhythmias and peripheral edema in less than 3% of patients. Bradycardia, chest heaviness or burning, palpitations, reduced blood pressure, orthostatic hypotension, flushing, heat sensation, and clammy palms have also been reported.

Respiratory

Respiratory side effects have included nasal congestion (<2%). Rhinitis, dyspnea, pharyngitis, and asthma have been reported rarely. Increased pharyngeal secretions, nasal burning or dryness, and head cold sensations have also been reported.

Nonlaser patients on apraclonidine therapy for up to 4 weeks have reported increased pharyngeal secretions, nasal burning or dryness, and head cold sensations.

Psychiatric

Psychiatric side effects have rarely included depression (<1%).

Dermatologic

Dermatological side effects have included contact dermatitis and dermatitis (<3%), and pruritus.

Musculoskeletal

Musculoskeletal side effects have rarely included myalgia (0.2%).

Other

Other side effects have included chest pain, dry nose, facial edema, taste perversion, and parosmia in less than 3% of patients.

General

A 15% discontinuation rate has been reported. The most common side effects listed as causes for discontinuation of therapy, in decreasing order of frequency, are hyperemia, pruritus, tearing, discomfort, lid edema, dry mouth, and foreign body sensation.

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