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Phenylephrine Hydrochloride

.1 mg/mL · Solution

  • Prescription only
  • alpha-1 Adrenergic Agonist
Made by
Somerset Therapeutics, LLC

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-03-05

What it is

alpha-1 Adrenergic Agonist

Used for
  • Phenylephrine hydrochloride injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
The label’s usual adult dose

Phenylephrine hydrochloride injection 500 mcg/5 mL (100 mcg/mL) MUST NOT BE DILUTED before administration as an intravenous bolus.

Full directions ↓
Do not take it if

None ( 4 ) None ( 4 )

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
116other products contain Phenylephrine Hydrochloride — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

  • Phenylephrine hydrochloride injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
  • Phenylephrine Hydrochloride Injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.( 1 )

From the official label · 2025-03-05 · DailyMed

How it works

From this product’s own US prescribing label.

Phenylephrine hydrochloride is an α-1 adrenergic receptor agonist.

Half-life5 min
Mostly cleared after≈ 25 minfive half-lives — our arithmetic
How the body breaks it down

Phenylephrine is metabolized primarily by monoamine oxidase and sulfotransferase.

How it leaves the body

After intravenous administration of radiolabeled phenylephrine, approximately 80% of the total dose was eliminated within first 12 h; and approximately 86% of the total dose was recovered in the urine within 48 h.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-03-05

Do not take it if

None ( 4 ) None ( 4 )

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • Phenylephrine hydrochloride injection 500 mcg/5 mL (100 mcg/mL) MUST NOT BE DILUTED before administration as an intravenous bolus.
  • It is supplied as a READY-TO-USE formulation.
  • Dosing for treatment of hypotension during anesthesia Bolus intravenous injection:
  • Initial dose is 40 mcg to 100 mcg.
  • Additional boluses up to 200 mcg may be administered every 1 to 2 minutes as needed.
  • Adjust the dose according to the pressor response (i.e., titrate to effect).
  • 2.1 General Dosage and Administration Instructions During Phenylephrine Hydrochloride Injection administration:
  • Correct intravascular volume depletion.
  • Correct acidosis.
  • Acidosis may reduce the effectiveness of phenylephrine.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
  • Do not use if the solution is colored or cloudy, or if it contains particulate matter.
  • Discard any unused portion.
  • Administration Instructions for Phenylephrine Hydrochloride Injection, 500 mcg/5 mL (100 mcg/mL):
  • Phenylephrine Hydrochloride Injection, 500 mcg/5 mL (100 mcg/mL) MUST NOT BE DILUTED before administration as an intravenous bolus.
  • It is supplied as READY-TO-USE formulation.
  • 2.2 Dosing for Treatment of Hypotension during Anesthesia The following are the recommended dosages for the treatment of hypotension during anesthesia.
  • Phenylephrine Hydrochloride Injection, 500 mcg/5 mL (100 mcg/mL):
  • The recommended initial dose is 40 to 100 mcg administered by intravenous bolus.
  • Additional boluses may be administered every 1-2 minutes as needed; not to exceed a total dosage of 200 mcg.
  • Adjust dosage according to the blood pressure goal.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension :
  • Phenylephrine Hydrochloride Injection can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure.
  • ( 5.1 ) Peripheral and Visceral Ischemia :
  • Phenylephrine Hydrochloride Injection can cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs.
  • ( 5.2 ) Skin and Subcutaneous Necrosis :
  • Extravasation during intravenous administration may cause necrosis or sloughing of tissue.
  • ( 5.3 ) Bradycardia:
  • Phenylephrine Hydrochloride Injection can cause severe bradycardia and decreased cardiac output.
  • ( 5.4 )
  • 5.1 Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension Because of its increasing blood pressure effects, phenylephrine hydrochloride injection can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure.
  • 5.2 Peripheral and Visceral Ischemia Phenylephrine hydrochloride injection can cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs, particularly in patients with extensive peripheral vascular disease.
  • 5.3 Skin and Subcutaneous Necrosis Extravasation of phenylephrine hydrochloride injection can cause necrosis or sloughing of tissue.
  • Avoid extravasation by checking infusion site for free flow.
  • 5.4 Bradycardia Phenylephrine hydrochloride injection can cause severe bradycardia and decreased cardiac output.
  • 5.5 Renal Toxicity Phenylephrine hydrochloride injection can increase the need for renal replacement therapy in patients with septic shock.
  • Monitor renal function.
  • 5.6 Risk of Augmented Pressor Affect in Patients with Autonomic Dysfunction The increasing blood pressure response to adrenergic drugs, including phenylephrine hydrochloride injection, can be increased in patients with autonomic dysfunction, as may occur with spinal cord injuries.
  • 5.7 Pressor Effect with Concomitant Oxytocic Drugs Oxytocic drugs potentiate the increasing blood pressure effect of sympathomimetic pressor amines including phenylephrine hydrochloride injection [see Drug Interactions ( 7.1 )] , with the potential for hemorrhagic stroke.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Risk Summary Data from randomized controlled trials and meta-analyses with phenylephrine hydrochloride injection use in pregnant women during caesarean section have not established a drug-associated risk of major birth defects and miscarriage.
  • These studies have not identified an adverse effect on maternal outcomes or infant Apgar scores [ see Data ] .
  • There are no data on the use of phenylephrine during the first or second trimester.
  • In animal reproduction and development studies in normotensive animals, evidence of fetal malformations was noted when phenylephrine was administered during organogenesis via a 1-hour infusion at 1.2 times the human daily dose (HDD) of 10 mg/60 kg/day.
  • Decreased pup weights were noted in offspring of pregnant rats treated with 2.9 times the HDD [See Data].
  • The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
  • All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
  • In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
  • Clinical Considerations Disease-Associated Maternal and/or Embryofetal Risk Untreated hypotension associated with spinal anesthesia for cesarean section is associated with an increase in maternal nausea and vomiting.
  • A sustained decrease in uterine blood flow due to maternal hypotension may result in fetal bradycardia and acidosis.
  • Data Human Data Published randomized controlled trials over several decades, which compared the use of phenylephrine injection to other similar agents in pregnant women during cesarean section, have not identified adverse maternal or infant outcomes.
  • At recommended doses, phenylephrine does not appear to affect fetal heart rate or fetal heart variability to a significant degree.
  • There are no studies on the safety of phenylephrine injection exposure during the period of organogenesis, and therefore, it is not possible to draw any conclusions on the risk of birth defects following exposure to phenylephrine injection during pregnancy.
  • In addition, there are no data on the risk of miscarriage following fetal exposure to phenylephrine injection.
  • Animal Data No clear malformations or fetal toxicity were reported when normotensive pregnant rabbits were treated with phenylephrine via continuous intravenous infusion over 1 hour (0.5 mg/kg/day; approximately equivalent to a HDD based on body surface area) from Gestation Day 7 to 19.
  • At this dose, which demonstrated no maternal toxicity, there was evidence of developmental delay (altered ossification of sternebra).
  • In a non-GLP dose range-finding study in normotensive pregnant rabbits, fetal lethality and cranial, paw, and limb malformations were noted following treatment with 1.2 mg/kg/day of phenylephrine via continuous intravenous infusion over 1 hour (2.3-times the HDD).
  • This dose was clearly maternally toxic (increased mortality and significant body weight loss).
  • An increase in the incidence of limb malformation (hyperextension of the forepaw) coincident with high fetal mortality was noted in a single litter at 0.6 mg/kg/day (1.2-times the HDD) in the absence of maternal toxicity.
  • No malformations or embryo-fetal toxicity were reported when normotensive pregnant rats were treated with up to 3 mg/kg/day phenylephrine via continuous intravenous infusion over 1 hour (2.9-times the HDD) from Gestation Day 6 to 17.
  • This dose was associated with some maternal toxicity (decreased food consumption and body weights).
  • Decreased pup weights were reported in a pre-and postnatal development toxicity study in which normotensive pregnant rats were administered phenylephrine via continuous intravenous infusion over 1 hour (0.3, 1.0, or 3.0 mg/kg/day; 0.29, 1, or 2.9 times the HDD) from Gestation Day 6 through Lactation Day 21).
  • No adverse effects on growth and development (learning and memory, sexual development, and fertility) were noted in the offspring of pregnant rats at any dose tested.
  • Maternal toxicities (mortality late in gestation and during lactation period, decreased food consumption and body weight) occurred at 1 and 3 mg/kg/day of phenylephrine (equivalent to and 2.9 times the HDD, respectively).
  • IN SPECIFIC POPULATIONS
  • 8.1 Pregnancy Risk Summary Data from randomized controlled trials and meta-analyses with phenylephrine hydrochloride injection use in pregnant women during caesarean section have not established a drug-associated risk of major birth defects and miscarriage.
  • These studies have not identified an adverse effect on maternal outcomes or infant Apgar scores [ see Data ] .
  • There are no data on the use of phenylephrine during the first or second trimester.
  • In animal reproduction and development studies in normotensive animals, evidence of fetal malformations was noted when phenylephrine was administered during organogenesis via a 1-hour infusion at 1.2 times the human daily dose (HDD) of 10 mg/60 kg/day.
  • Decreased pup weights were noted in offspring of pregnant rats treated with 2.9 times the HDD [See Data].
  • The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
  • All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
  • In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
  • Clinical Considerations Disease-Associated Maternal and/or Embryofetal Risk Untreated hypotension associated with spinal anesthesia for cesarean section is associated with an increase in maternal nausea and vomiting.
  • A sustained decrease in uterine blood flow due to maternal hypotension may result in fetal bradycardia and acidosis.
  • Data Human Data Published randomized controlled trials over several decades, which compared the use of phenylephrine injection to other similar agents in pregnant women during cesarean section, have not identified adverse maternal or infant outcomes.
  • At recommended doses, phenylephrine does not appear to affect fetal heart rate or fetal heart variability to a significant degree.
  • There are no studies on the safety of phenylephrine injection exposure during the period of organogenesis, and therefore, it is not possible to draw any conclusions on the risk of birth defects following exposure to phenylephrine injection during pregnancy.
  • In addition, there are no data on the risk of miscarriage following fetal exposure to phenylephrine injection.
  • Animal Data No clear malformations or fetal toxicity were reported when normotensive pregnant rabbits were treated with phenylephrine via continuous intravenous infusion over 1 hour (0.5 mg/kg/day; approximately equivalent to a HDD based on body surface area) from Gestation Day 7 to 19.
  • At this dose, which demonstrated no maternal toxicity, there was evidence of developmental delay (altered ossification of sternebra).
  • In a non-GLP dose range-finding study in normotensive pregnant rabbits, fetal lethality and cranial, paw, and limb malformations were noted following treatment with 1.2 mg/kg/day of phenylephrine via continuous intravenous infusion over 1 hour (2.3-times the HDD).
  • This dose was clearly maternally toxic (increased mortality and significant body weight loss).
  • An increase in the incidence of limb malformation (hyperextension of the forepaw) coincident with high fetal mortality was noted in a single litter at 0.6 mg/kg/day (1.2-times the HDD) in the absence of maternal toxicity.
  • No malformations or embryo-fetal toxicity were reported when normotensive pregnant rats were treated with up to 3 mg/kg/day phenylephrine via continuous intravenous infusion over 1 hour (2.9-times the HDD) from Gestation Day 6 to 17.
  • This dose was associated with some maternal toxicity (decreased food consumption and body weights).
  • Decreased pup weights were reported in a pre-and postnatal development toxicity study in which normotensive pregnant rats were administered phenylephrine via continuous intravenous infusion over 1 hour (0.3, 1.0, or 3.0 mg/kg/day; 0.29, 1, or 2.9 times the HDD) from Gestation Day 6 through Lactation Day 21).
  • No adverse effects on growth and development (learning and memory, sexual development, and fertility) were noted in the offspring of pregnant rats at any dose tested.
  • Maternal toxicities (mortality late in gestation and during lactation period, decreased food consumption and body weight) occurred at 1 and 3 mg/kg/day of phenylephrine (equivalent to and 2.9 times the HDD, respectively).
  • 8.2 Lactation Risk Summary There are no data on the presence of phenylephrine hydrochloride injection or its metabolite in human or animal milk, the effects on the breastfed infant, or the effects on milk production.
  • The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for phenylephrine hydrochloride injection and any potential adverse effects on the breastfed infant from phenylephrine hydrochloride injection or from the underlying maternal condition.
  • 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.
  • 8.5 Geriatric Use Clinical studies of phenylephrine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
  • Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
  • In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
  • 8.6 Hepatic Impairment In patients with liver cirrhosis [Child Pugh Class B and Class C], dose-response data indicate decreased responsiveness to phenylephrine.
  • Start dosing in the recommended dose range but more phenylephrine may be needed in this population.
  • 8.7 Renal Impairment In patients with end stage renal disease (ESRD), dose-response data indicate increased responsiveness to phenylephrine.
  • Consider starting at the lower end of the recommended dose range, and adjusting dose based on the target blood pressure goal.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

  • Agonistic Effects (increase in Phenylephrine Hydrochloride Injection blood pressure effect) can occur with monoamine oxidase inhibitors (MAOI), oxytocin and oxytocic drugs, tricyclic antidepressants, angiotensin and aldosterone, atropine, steroids, norepinephrine transporter inhibitors, ergot alkaloids.
  • ( 7.1 ) Antagonistic Effects (decrease in Phenylephrine Hydrochloride Injection blood pressure effect) can occur with α-adrenergic antagonists, phosphodiesterase Type 5 inhibitors, mixed α-and β-receptor antagonists, calcium channel blockers, benzodiazepines and ACE inhibitors, centrally acting sympatholytic agents.
  • ( 7.2 )
  • 7.1 Interactions that Augment the Pressor Effect The increasing blood pressure effect of phenylephrine hydrochloride injection is increased in patients receiving:
  • Monoamine oxidase inhibitors (MAOI) Oxytocin and oxytocic drugs Tricyclic antidepressants Angiotensin, aldosterone Atropine Steroids, such as hydrocortisone Norepinephrine transporter inhibitors, such as atomoxetine Ergot alkaloids, such as methylergonovine maleate
  • 7.2 Interactions that Antagonize the Pressor Effect The increasing blood pressure effect of phenylephrine hydrochloride injection is decreased in patients receiving:
  • α-adrenergic antagonists Phosphodiesterase Type 5 inhibitors Mixed α-and β-receptor antagonists Calcium channel blockers, such as nifedipine Benzodiazepines ACE inhibitors Centrally acting sympatholytic agents, such as reserpine, guanfacine

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

  • Overdose of phenylephrine hydrochloride injection (phenylephrine hydrochloride) can cause a rapid rise in blood pressure.
  • Symptoms of overdose include headache, vomiting, hypertension, reflex bradycardia, a sensation of fullness in the head, tingling of the extremities, and cardiac arrhythmias including ventricular extrasystoles and ventricular tachycardia.

Quoted from the official label, section “Overdosage”.

Use in children

Safety and effectiveness in pediatric patients have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

  • Clinical studies of phenylephrine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
  • Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
  • In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Quoted from the official label, section “Geriatric Use”.

Side effects

  • Adverse reactions to phenylephrine hydrochloride injection are primarily attributable to excessive pharmacologic activity.
  • Adverse reactions reported in published clinical studies, observational trials, and case reports of phenylephrine hydrochloride injection are listed below by body system.
  • Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.
  • Cardiac disorders :
  • Reflex bradycardia, lowered cardiac output, ischemia, hypertension, arrhythmias Gastrointestinal disorders :
  • Epigastric pain, vomiting, nausea Nervous system disorders :
  • Headache, blurred vision, neck pain, tremors Vascular disorders :
  • Hypertensive crisis Respiratory, Thoracic and Mediastinal Disorders :
  • Dyspnea Skin and subcutaneous tissue disorders :
  • Pruritis Most common adverse reactions during treatment:
  • nausea, vomiting, and headache.
  • ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at 1-800-417-9175 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

If applicable, inform patient, family member, or caregiver that certain medical conditions and medications might influence how phenylephrine hydrochloride injection works.

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

  • FORMS AND STRENGTHS Ampule Phenylephrine hydrochloride injection USP, 500 mcg/5 mL (100 mcg/mL), for intravenous use, is a clear and colorless solution available in a type I clear ampule white snap off and blue band, 5 mL single-dose ampule containing 5 mL of solution for injection, corresponding to 0.5 mg of phenylephrine hydrochloride per ampule, (equivalent to 0.41 mg of phenylephrine base).
  • Phenylephrine hydrochloride injection 500 mcg/5 mL (100 mcg/mL):
  • 5 mL single-dose ampule containing 5 mL of solution for injection corresponding to 0.5 mg of phenylephrine hydrochloride per ampule.

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

  • Phenylephrine hydrochloride injection USP, 500 mcg/5 mL (100 mcg/mL) for intravenous use, is a clear colorless solution, essentially free from visible extraneous matter available in a clear glass ampule with white snap off and blue band and is supplied as follows:
  • NDC No.
  • Strength How Supplied NDC 70069-591-10 Pack of 10 '5 mL Single-Dose ampules' 500 mcg/5 mL (100 mcg/mL) 10 ampules per carton Store phenylephrine hydrochloride injection USP, 500 mcg/5 mL (100 mcg/mL), at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
  • Protect from light.
  • Discard any unused portion.

Quoted from the official label, section “How Supplied”.

What is in it

  • Phenylephrine is an alpha-1 adrenergic receptor agonist.
  • The chemical name of phenylephrine hydrochloride is (-)- m -hydroxy-α-[(methylamino) methyl] benzyl alcohol hydrochloride, its molecular formula is C 9 H 13 NO 2 · HCl (Molecular Weight:
  • 203.67 g/mol) and its structural formula is depicted below:
  • Phenylephrine hydrochloride is soluble in water and ethanol, and insoluble in chloroform and ethyl ether.
  • Phenylephrine hydrochloride injection, 500 mcg/5 mL (100 mcg/mL):
  • Phenylephrine hydrochloride injection, 500 mcg/5 mL (100 mcg/mL), is a sterile, nonpyrogenic, clear and colorless solution for intravenous use.
  • It MUST NOT BE DILUTED before administration as an intravenous bolus.
  • Each mL contains:
  • phenylephrine hydrochloride 100 mcg (equivalent to 80 mcg of phenylephrine base), sodium chloride 9.0 mg, in water for injection.
  • The pH is adjusted with hydrochloric acid if necessary.
  • The pH range is 3.0 to 5.0.
  • Image

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

CanadaNo exact match for this strength and form

Every strength and form (19)

Details

Made bySomerset Therapeutics, LLC
Active substancePhenylephrine Hydrochloride
Strength.1 mg/mL
FormSolution
RouteIntravenous
Packs10 AMPULE in 1 CARTON / 5 mL in 1 AMPULE
NDC70069-591

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

62 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Show all forms · 5 forms

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

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