boxed warning
WARNING: PHYSICIANS SHOULD COMPLETELY FAMILIARIZE THEMSELVES WITH THE COMPLETE CONTENTS OF THIS LEAFLET BEFORE PRESCRIBING PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION.
FDA label 156da33c-e407-4b9b-a97b-ef39d95b563e
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- SPL set ID
- c2f8f116-f2ff-40fa-9931-f4278a28ffdb
- SPL ID
- 156da33c-e407-4b9b-a97b-ef39d95b563e
- Version
- 2
- Effective date
- 2011-10-14
- Source export date
- 2026-08-01
- Source partition
- 1
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-08-01/0689a4374f1490600b5244071db3b04bd3bbc29ceda7a856edb8225323adf20a/drug-label-0001-of-0014.json.zip
- Source manifest SHA-256
- bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
- Import run
- 20260801T225920Z
- Imported at
- 2026-08-01 22:59:56
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 156da33c-e407-4b9b-a97b-ef39d95b563e | id | |
| spl set id | c2f8f116-f2ff-40fa-9931-f4278a28ffdb | set_id |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
WARNINGS: Not for intraocular use. As with other adrenergic drugs, when Phenylephrine Hydrochloride Ophthalmic Solution is administered simultaneously with, or up to 21 days after, administration of monoamine oxidase (MAO) inhibitors, careful supervision and adjustment of dosages are required since exaggerated adrenergic effects may result. The pressor response of adrenergic agents may also be potentiated by tricyclic antidepressants. Systemic side effects are more common in patients taking beta adrenergic blocking agents such as propranolol. Concomitant use of phenylephrine and atropine may enhance the pressor effects and induce tachycardia in some patients, especially infants. 1 There have been rare reports associating the use of phenylephrine hydrochloride 10% ophthalmic solutions with the development of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions. These episodes, some ending fatally, have usually occurred in elderly patients with preexisting cardiovascular diseases.
Adverse reactions cross-check#
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adverse reactions
ADVERSE REACTIONS: A marked increase in blood pressure has been reported in low-weight premature neonates, infants and adult patients with idiopathic orthostatic hypotension. Cardiovascular reactions which have occurred primarily in elderly patients include marked increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia, and fatal subarachnoid hemorrhage. 2 Other reactions include bradycardia, headache, and excitability.