warnings
WARNING: PHYSICIANS SHOULD COMPLETELY FAMILIARIZE THEMSELVES WITH THE COMPLETE CONTENTS OF THIS LEAFLET BEFORE PRESCRIBING PHENYLEPHRINE HYDROCHLORIDE.
FDA label bd890630-756c-4a13-b9af-c022cebec79d
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
- 602e866f-18de-f904-a1f4-f6a1a94a9a41
- SPL ID
- bd890630-756c-4a13-b9af-c022cebec79d
- Version
- 2
- Effective date
- 2017-07-25
- Source export date
- 2026-10-12
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 03:03:06
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 | bd890630-756c-4a13-b9af-c022cebec79d | id | |
| spl set id | 602e866f-18de-f904-a1f4-f6a1a94a9a41 | set_id |
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, 2.5% 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 propanolol. Concomitant use of phenylephrine and atropine may enhance the pressor effects and induce tachycardia in some patients, especially infants. 1 Contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.