Phenylephrineside effects
phenylephrine hydrochloride 100 MG/ML Ophthalmic Solution
Adverse reactions
The following serious adverse reactions are described below and elsewhere in the labeling: Cardiovascular Effects Elevation in Blood Pressure The following adverse reactions have been identified following use of phenylephrine hydrochloride ophthalmic solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Ocular adverse reactions include eye pain and stinging on instillation, temporary blurred vision, and photophobia Cardiovascular adverse reactions include increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia and subarachnoid hemorrhage To report SUSPECTED ADVERSE REACTIONS, contact Lifestar Pharma LLC at 1-888-995-4337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Ocular Adverse
Reactions Eye pain and stinging on instillation, temporary blurred vision and photophobia, and conjunctival sensitization may occur.
6.2 Systemic
Adverse Reactions A marked increase in blood pressure has been reported particularly, but not limited to low weight premature neonates, infants and hypertensive patients. Cardiovascular effects which have been seen primarily in hypertensive patients following topical ocular use of phenylephrine hydrochloride ophthalmic solution 10% include marked increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia and subarachnoid hemorrhage.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective July 30, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Contraindications
The 10% strength is contraindicated in: Patients with hypertension, or thyrotoxicosis Pediatric patients less than 1 year of age due to increased risk of systemic toxicity
4.1 Cardiac and
Endocrine Disease Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in patients with hypertension or thyrotoxicosis. Phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients.
4.2 Pediatric
Patients Less Than 1 Year of Age Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age due to the increased risk of systemic toxicity. Phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective July 30, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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