Applies to apraclonidine ophthalmic: ophthalmic solution.

Serious side effects

Along with its needed effects, apraclonidine 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 apraclonidine ophthalmic:

For 0.5% apraclonidine

More common

• Allergic reaction (redness, itching, tearing of the eye)

Less common

• Blurred vision or change in vision
• chest pain
• clumsiness or unsteadiness
• depression
• dizziness
• eye discharge, irritation, or pain
• irregular heartbeat
• numbness or tingling in the fingers or toes
• raising of the upper eyelid
• rash around the eyes
• redness of the eyelid or inner lining of the eyelid
• swelling of the eye, eyelid, or inner lining of the eyelid
• swelling of the face, hands, or feet

For 1% apraclonidine

Less common

• Blurred vision
• diarrhea
• dry mouth
• eye redness
• fainting
• feeling cold or sleepy
• irregular heartbeat
• lightheadedness
• redness, swelling, or whitening of the eyelids
• slow heartbeat
• stomach pain
• stuff or runny nose
• swelling of the eyelid
• trouble sleeping
• unusual dreams
• unusual taste in the mouth
• vomiting
• watering of eye

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

For 1% apraclonidine

Symptoms of overdose

• Confusion
• clumsiness
• drowsiness
• low body temperature
• muscle aches
• muscle weakness
• shivering
• sleepiness
• slow heartbeat
• tiredness
• weak or feeble pulse
• weight gain

Other side effects

Some side effects of apraclonidine 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:

For 0.5% apraclonidine

More common

• Dryness of the mouth
• eye discomfort

Less common

• Change in taste or smell
• constipation
• crusting or scales on the eyelid or corner of the eye
• discoloration of white part of the eye
• drowsiness or sleepiness
• dry nose or eyes
• general feeling of discomfort or illness
• headache
• increased sensitivity of the eyes to light
• muscle aches
• nausea
• nervousness
• paleness of the eye or inner lining of the eyelid
• runny nose
• sore throat
• tiredness or weakness
• trouble in sleeping

For 1% apraclonidine

More common

• Increase in size of the pupil of the eye
• paleness of the eye or inner lining of the eyelid

Less common

• Runny nose

For Healthcare Professionals

Applies to apraclonidine ophthalmic: ophthalmic solution.

General

The most commonly reported side effects were hyperemia, pruritus, discomfort, and tearing.^[Ref]

Ocular

Very common (10% or more): Conjunctivitis (up to 23%), eye pruritus (up to 23%), ocular hyperemia/hyperemia (up to 23%), increased lacrimation/tearing (up to 15%), lid edema/eyelid edema (up to 15%), ocular discomfort/discomfort (up to 15%), ocular pruritus/pruritus (up to 15%)

Common (1% to 10%): Blurred vision, conjunctival blanching, conjunctival follicles, dimmed vision, dry eye, eye disorder, eyelid margin crusting, eyelid/lid retraction, mydriasis, ocular blanching, ocular discharge, ocular inflammation

Uncommon (0.1% to 1%): Abnormal vision, blepharitis, blepharoconjunctivitis, conjunctival edema, conjunctival hemorrhage, corneal erosion, corneal infiltrates, corneal staining, eye discharge, eye edema, eye inflammation, eye irritation, eye pain, eyelid/lid disorder/upper lid elevation, eyelid/lid erythema, eyelid/lid scales, hypotony of eye, keratitis, keratopathy, photophobia, punctate keratitis, visual acuity reduced, visual impairment

Frequency not reported: Conjunctival microhemorrhage^[Ref]

Gastrointestinal

Very common (10% or more): Dry mouth (up to 15%)

Common (1% to 10%): Constipation, nausea

Uncommon (0.1% to 1%): Abdominal pain, diarrhea, stomach discomfort, throat irritation, vomiting

Frequency not reported: Emesis^[Ref]

Local

Very common (10% or more): Abnormal sensation in eye/foreign body sensation (up to 15%)

Common (1% to 10%): Ocular injection

Uncommon (0.1% to 1%): Edema, irritation, pain

Frequency not reported: Burning, hypotony, itching^[Ref]

Respiratory

Common (1% to 10%): Asthma, dyspnea, nasal decongestion, nasal dryness/dry nose, parosmia, pharyngitis, rhinitis

Uncommon (0.1% to 1%): Rhinorrhea

Rare (0.01% to 0.1%): Increased upper airway secretion, nasal discomfort

Frequency not reported: Increased pharyngeal secretion, nasal burning, shortness of breath^[Ref]

Nervous system

Common (1% to 10%): Abnormal coordination, dizziness, dysgeusia, headache, paresthesia, somnolence, taste perversion

Uncommon (0.1% to 1%): Abnormal dreams, blepharospasm, eyelid ptosis, postural dizziness, vasovagal syncope

Rare (0.01% to 0.1%): Hypoesthesia

Frequency not reported: Dream disturbances, extremity numbness, taste abnormality, vasovagal attack

Postmarketing reports: Syncope^[Ref]

Cardiovascular

Bradycardia was reported in neonates and infants given after a single dose of the 1% ophthalmic solution.^[Ref]

Common (1% to 10%): Arrythmia, chest pain, irregular heart rate, peripheral edema

Uncommon (0.1% to 1%): Bradycardia, conjunctival vascular disorders, orthostatic hypotension, palpitations, vasodilation

Frequency not reported: Chest burning, chest heaviness, hypertension, hypotension, orthostatic episode^[Ref]

Dermatologic

Common (1% to 10%): Contact dermatitis, dermatitis, facial/face edema

Rare (0.01% to 0.1%): Hyperhidrosis, pruritus

Frequency not reported: Clammy palms, pruritus not associated with rash, sweaty palms^[Ref]

Other

Lethargy was reported in neonates and infants given after a single dose of the 1% ophthalmic solution.^[Ref]

Common (1% to 10%): Asthenia, fatigue, malaise

Rare (0.01% to 0.1%): Feeling cold and hot, feeling hot

Frequency not reported: Body heat sensation, head cold sensation, lethargy^[Ref]

Psychiatric

Common (1% to 10%): Depression, insomnia, nervousness

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

Musculoskeletal

Common (1% to 10%): Myalgia

Rare (0.01% to 0.1%): Extremity pain^[Ref]

Immunologic

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

Genitourinary

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

Hypersensitivity

Frequency not reported: Allergic response, hypersensitivity^[Ref]

Metabolic

Frequency not reported: Decreased oxygen saturation^[Ref]

Decreased oxygen saturation was reported in neonates and infants given after a single dose of the 1% ophthalmic solution.^[Ref]