Applies to cyclopentolate ophthalmic: ophthalmic solution.

Serious side effects

Along with its needed effects, cyclopentolate 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 as soon as possible if any of the following side effects occur while taking cyclopentolate ophthalmic:

Symptoms of too much medicine being absorbed into the body

• Clumsiness or unsteadiness
• confusion
• constipation, full feeling, passing gas, or stomach cramps or pain
• fast or irregular heartbeat
• convulsions (seizures)
• fever
• flushing or redness of face
• hallucinations (seeing, hearing, or feeling things that are not there)
• passing urine less often
• skin rash
• slurred speech
• swollen stomach (in infants)
• thirst or dryness of mouth
• unusual behavior, such as disorientation to time or place, failure to recognize people, hyperactivity, or restlessness, especially in children
• unusual drowsiness, tiredness, or weakness

Other side effects

Some side effects of cyclopentolate 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:

• Blurred vision
• burning of eye
• eye irritation not present before therapy
• increased sensitivity of eyes to light

For Healthcare Professionals

Applies to cyclopentolate ophthalmic: compounding powder, ophthalmic solution.

General

Local irritation may occur following instillation and the frequency is dependent upon the concentration used.^[Ref]

Ocular

Frequency not reported: Intraocular pressure increased, burning, photophobia, vision blurred, irritation, hyperemia, conjunctivitis, blepharoconjunctivitis, punctate keratitis, synechiae, redness of eyes, lacrimation, mucus discharge, allergic conjunctivitis, eye pruritus

Postmarketing reports: Mydriasis prolonged, eye irritation, eye pain^[Ref]

Nervous system

Frequency not reported: Ataxia, incoherent speech, hyperactivity, seizure, drowsiness, coma, medullary paralysis, convulsion, somnolence, incoordination, poor balance, tremor

Postmarketing reports: Retrograde amnesia, dizziness, headache^[Ref]

Respiratory

Frequency not reported: Secretion decreased in pharynx/bronchi/nasal passages^[Ref]

Cardiovascular

Frequency not reported: Tachycardia, vasodilation^[Ref]

Dermatologic

Frequency not reported: Skin rash, flushing, dry skin

Postmarketing reports: Erythema^[Ref]

Gastrointestinal

Frequency not reported: Abdominal distention infants, gastrointestinal motility diminished, salivary secretion decreased, sweat gland secretion decreased, necrotizing colitis, gastroenteritis, dry mouth

Postmarketing reports: Nausea, vomiting^[Ref]

Genitourinary

Frequency not reported: Urinary retention^[Ref]

Psychiatric

Frequency not reported: Restlessness, hallucination, disorientation, failure to recognize people

Postmarketing reports: Confusion, agitation^[Ref]

Immunologic

Postmarketing reports: Hypersensitivity^[Ref]

Metabolic

Frequency not reported: Feeding intolerance^[Ref]

Other

Frequency not reported: Hyperpyrexia, death, vertigo

Postmarketing reports: Pyrexia, fatigue, gait disturbed^[Ref]