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Phenylephrine hydrochloride

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Active ingredient
Phenylephrine Hydrochloride 25–100 mg
Other brand names
Drug class
alpha-1 Adrenergic Agonist
Dosage form
Solution/ Drops
Route
Ophthalmic
Prescription status
Rx (prescription)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
September 18, 2025
FDA Insert
Prescribing information, PDF file
Active ingredient
Phenylephrine Hydrochloride 25–100 mg
Other brand names
Drug class
alpha-1 Adrenergic Agonist
Dosage form
Solution/ Drops
Route
Ophthalmic
Prescription status
Rx (prescription)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
September 18, 2025
Manufacturer
Gland Pharma Limited
Registration number
ANDA218129
NDC roots
68083-593, 68083-594, 68083-680
FDA Insert
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Phenylephrine Hydrochloride Ophthalmic Solution is a clear, sterile liquid used in the eyes to help dilate the pupil. It works as a topical α-adrenergic agonist, meaning it stimulates certain receptors in the eye to cause the muscles that control pupil size to contract. This results in the pupil becoming larger, which can be useful during eye examinations or certain surgical procedures.

This solution is available in two strengths: 2.5% and 10%. When applied to the eye, maximal dilation typically occurs within 20 to 90 minutes and lasts for about 3 to 8 hours. By helping to widen the pupil, Phenylephrine Hydrochloride allows healthcare providers to better examine the interior of the eye.

Uses

Phenylephrine Hydrochloride Ophthalmic Solution is a medication that works by stimulating alpha-1 adrenergic receptors, which helps to dilate (widen) the pupil of your eye. This can be useful during certain eye examinations or procedures where a larger pupil is needed for better visibility.

It's important to note that there are no reported teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safe option for use in the appropriate medical settings.

Dosage and Administration

If you are 1 year of age or older, you can use Phenylephrine Hydrochloride Ophthalmic Solution, which comes in two strengths: 2.5% and 10%. To apply it, place one drop into the conjunctival fornix (the space between your eyelid and your eye) every 3 to 5 minutes, but do not exceed 3 drops in one eye. If you need a stronger effect, the 10% strength will provide greater dilation of your pupils (mydriasis).

For children under 1 year old, the process is similar, but you should only use the 2.5% strength. Instill one drop into the conjunctival fornix at the same intervals of 3 to 5 minutes, again not exceeding 3 drops per eye. Always follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

If you have high blood pressure (hypertension) or a condition called thyrotoxicosis, you should avoid using the 10% strength of this medication. Additionally, it is not safe for children under 1 year old because they are at a higher risk of experiencing serious side effects.

While there are no specific "do not take" instructions mentioned, it's always important to use medications responsibly and as directed by your healthcare provider to prevent any potential misuse or dependence (a condition where your body becomes reliant on a substance). If you have any concerns or questions about your health or medication, please consult your doctor.

Side Effects

You may experience some side effects when using this medication. Common ocular reactions include eye pain, stinging upon application, temporary blurred vision, and sensitivity to light (photophobia). Cardiovascular effects can include an increase in blood pressure, fainting (syncope), heart attack (myocardial infarction), rapid heartbeat (tachycardia), irregular heartbeats (arrhythmia), and bleeding in the brain (subarachnoid hemorrhage).

For those using the 10% strength, there is a risk of serious heart rhythm issues, some of which can be fatal. If you are a child under 5 years old or have a history of heart problems or hyperthyroidism, it's important to monitor your blood pressure closely after treatment. Additionally, if you take too much of the medication, you might experience a rapid rise in blood pressure, headache, anxiety, nausea, vomiting, and serious heart rhythm disturbances.

Warnings and Precautions

You should only use this medication as directed for topical (applied to the surface) eye use and never inject it. Be aware that using the 10% strength can lead to serious heart-related issues, including potentially fatal irregular heartbeats. If you have a history of heart problems, it's important to monitor your blood pressure closely, especially if you are a child under 5 years old or have conditions like hyperthyroidism.

If you are at high risk for blood pressure issues, make sure to have your blood pressure checked after treatment. Additionally, be cautious of rebound miosis, which is a condition where your pupils may constrict again after the medication wears off, and this can happen as soon as one day after use. Always consult your doctor if you have concerns or experience any unusual symptoms.

Overdose

If you take too much phenylephrine, you may experience a sudden increase in blood pressure, along with symptoms like headache, anxiety, nausea, vomiting, and irregular heartbeats (ventricular arrhythmias). It's important to be aware of these signs, as they can indicate an overdose.

If you suspect an overdose, seek immediate medical help. Healthcare professionals may administer a fast-acting medication called phentolamine to help manage the situation effectively. Always prioritize your health and safety by contacting a medical professional if you have any concerns about your medication use.

Pregnancy Use

There have been no studies on the effects of topical phenylephrine in animals, so we don't have information on how it might affect pregnancy. It's also unclear whether phenylephrine could harm a developing fetus or impact your ability to have children in the future. Because of this uncertainty, phenylephrine hydrochloride should only be used during pregnancy if it is clearly necessary. Always consult with your healthcare provider to discuss any medications you may need while pregnant.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be cautious when using phenylephrine hydrochloride ophthalmic solution (a medication often used for eye conditions). Currently, it is not known whether this drug passes into human breast milk. Since many medications can be found in breast milk, you should consult your healthcare provider before using this treatment to ensure it is safe for you and your baby. Always prioritize your infant's health and well-being when considering any medication while nursing.

Pediatric Use

When considering the use of phenylephrine hydrochloride ophthalmic solution 10% for your child, it's important to note that it should not be used in children under 1 year of age. This means that if your child is younger than this age, you should avoid using this medication. Always consult with your child's healthcare provider for guidance on safe and appropriate treatments for their specific age and health needs.

Geriatric Use

As an older adult or caregiver, it's reassuring to know that there are no significant differences in safety and effectiveness when using this medication compared to younger adults. This means that you can expect similar results and side effects, regardless of age.

However, it's always important to consult with your healthcare provider about any specific health concerns or conditions you may have, as individual needs can vary. Your doctor can help ensure that the medication is appropriate for you and adjust dosages if necessary.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment and what steps to take for your safety.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your liver is functioning well while you are on medication. Your safety and well-being are the top priority, so don’t hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any tests you might be undergoing. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the safety and effectiveness of your Phenylephrine Hydrochloride Ophthalmic Solution, it's important to store it properly. Keep the solution at a temperature between 20° to 25°C (68° to 77°F) and make sure the container is tightly closed to prevent contamination. Protect the solution from light and excessive heat, as these factors can affect its quality.

When handling the solution, check for any discoloration or particles; do not use it if the solution appears brown or contains any precipitate (solid particles). Once you open the bottle, you can continue to use the solution until the expiration date printed on the label. Always follow these guidelines to ensure safe and effective use.

Additional Information

No further information is available.

FAQ

What is Phenylephrine Hydrochloride Ophthalmic Solution used for?

Phenylephrine Hydrochloride Ophthalmic Solution is indicated to dilate the pupil.

What are the active ingredients in Phenylephrine Hydrochloride Ophthalmic Solution?

Each mL of the 2.5% solution contains 25 mg of Phenylephrine Hydrochloride, while the 10% solution contains 100 mg.

How should I use Phenylephrine Hydrochloride Ophthalmic Solution?

For patients 1 year of age and older, apply one drop to the conjunctival fornix at 3 to 5 minute intervals, up to a maximum of 3 drops per eye.

Are there any contraindications for using the 10% strength of this medication?

Yes, the 10% strength is contraindicated in patients with hypertension, thyrotoxicosis, and in pediatric patients less than 1 year of age.

What are some common ocular side effects of Phenylephrine Hydrochloride?

Common ocular side effects include eye pain, stinging on instillation, temporary blurred vision, and photophobia.

What cardiovascular reactions can occur with Phenylephrine Hydrochloride?

Cardiovascular reactions may include increased blood pressure, tachycardia, arrhythmia, and in severe cases, myocardial infarction.

What should I do if I experience symptoms of overdosage?

Symptoms of overdosage may include a rapid rise in blood pressure, headache, anxiety, nausea, and vomiting. Seek medical attention if these occur.

Is Phenylephrine Hydrochloride safe to use during pregnancy?

Phenylephrine should be given to a pregnant woman only if clearly needed, as it is not known whether it can cause fetal harm.

Can Phenylephrine Hydrochloride be used while breastfeeding?

It is not known whether this drug is excreted in human breast milk, so caution should be exercised when administered to a nursing woman.

How should I store Phenylephrine Hydrochloride Ophthalmic Solution?

Store at 20° to 25°C (68° to 77°F), keep the container tightly closed, and protect it from light and excessive heat.

Packaging Info

The table below lists all NDC Code configurations of Phenylephrine Hydrochloride, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Phenylephrine Hydrochloride.
Details

FDA Insert (PDF)

This is the full prescribing document for Phenylephrine Hydrochloride, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.

View FDA-approved insert (PDF)

Description

Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow solution that is free of foreign matter. The chemical name is (R)-3-hydroxy-α(methylamino)methylbenzenemethanol hydrochloride, with a molecular formula of C9H13NO2.HCl and a molecular weight of 203.67 g/mol.

The formulation includes two strengths: each mL of the 2.5% solution contains 25 mg of Phenylephrine Hydrochloride as the active ingredient, along with inactive ingredients of Sodium Phosphate Monobasic Anhydrous, Sodium Phosphate Dibasic Anhydrous, and Water for Injection. Each mL of the 10% solution contains 100 mg of Phenylephrine Hydrochloride, with the same inactive ingredients.

Phosphoric Acid and/or Sodium Hydroxide may be added to adjust the pH to a range of 4.0 to 7.0. The tonicity of the 2.5% solution is 340 mOsm/kg, while the 10% solution has a tonicity of 985 mOsm/kg. Additionally, the solution contains Benzalkonium Chloride as a preservative at a concentration of 0.1 mg (0.01%).

Uses and Indications

Phenylephrine Hydrochloride Ophthalmic Solution is indicated for the dilation of the pupil as an alpha-1 adrenergic receptor agonist.

There are no teratogenic or nonteratogenic effects associated with this medication.

Dosage and Administration

For patients aged 1 year and older, it is recommended to apply one drop of Phenylephrine Hydrochloride Ophthalmic Solution at a concentration of either 2.5% or 10% to the conjunctival fornix. This should be done at intervals of 3 to 5 minutes, with a maximum of 3 drops administered per eye. For those requiring a greater degree of mydriasis, the 10% strength is advised.

In pediatric patients under 1 year of age, one drop of the 2.5% strength should be instilled into the conjunctival fornix at 3 to 5 minute intervals, also with a maximum of 3 drops per eye.

Contraindications

The 10% strength is contraindicated in patients with hypertension or thyrotoxicosis due to the potential for exacerbating these conditions. Additionally, its use is contraindicated in pediatric patients less than 1 year of age because of an increased risk of systemic toxicity.

Warnings and Precautions

Topical ophthalmic use is the only approved route for administration; this product is not intended for injection.

Serious cardiovascular reactions have been reported with the 10% strength formulation, including ventricular arrhythmias, some of which have resulted in fatal outcomes. It is imperative to monitor blood pressure in patients with pre-existing cardiovascular disease.

Significant elevations in blood pressure may occur, particularly in pediatric patients under 5 years of age, as well as in individuals with cardiovascular disease or hyperthyroidism. For patients identified as high risk, it is recommended to monitor blood pressure following treatment to ensure safety.

Rebound miosis has been documented, occurring as soon as one day after instillation.

Healthcare professionals should remain vigilant and consider these warnings and precautions when prescribing and administering this medication, ensuring appropriate monitoring of blood pressure in at-risk populations.

Side Effects

Patients may experience a range of adverse reactions associated with treatment. Ocular adverse reactions include eye pain and stinging upon instillation, temporary blurred vision, and photophobia.

Cardiovascular adverse reactions have been noted, including increases in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia, and subarachnoid hemorrhage. Notably, serious cardiovascular reactions have been observed with the 10% strength formulation, including ventricular arrhythmias, some of which have been fatal. Significant elevations in blood pressure warrant caution, particularly in pediatric patients under 5 years of age and in individuals with pre-existing cardiovascular disease or hyperthyroidism. For patients at high risk, monitoring of blood pressure post-treatment is recommended.

Rebound miosis has been reported as an adverse reaction occurring one day after instillation. In cases of overdosage, patients may experience a rapid rise in blood pressure, headache, anxiety, nausea, vomiting, and ventricular arrhythmias.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

The table below lists all NDC Code configurations of Phenylephrine Hydrochloride, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Phenylephrine Hydrochloride.
Details

Pediatric Use

Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age. Caution should be exercised when considering the use of this medication in infants and young children due to the potential for adverse effects. Healthcare professionals should evaluate the risks and benefits before prescribing this treatment to pediatric patients.

Geriatric Use

Elderly patients have been evaluated in clinical studies, and no overall differences in safety and effectiveness have been observed when compared to younger adult patients. Therefore, dosage adjustments based solely on age are not necessary.

However, healthcare providers should remain vigilant when prescribing to geriatric patients, as individual responses may vary. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the possibility of altered pharmacokinetics and pharmacodynamics in this population.

Pregnancy

Animal reproduction studies have not been conducted with topical phenylephrine. Therefore, it is not known whether phenylephrine can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Given the lack of data, phenylephrine hydrochloride should be administered to a pregnant woman only if clearly needed. Healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of this medication in pregnant patients.

Lactation

It is not known whether phenylephrine hydrochloride ophthalmic solution 2.5% and 10% is excreted in human breast milk. Due to the potential for many drugs to be excreted in human milk, caution should be exercised when administering this medication to lactating mothers. Healthcare professionals should consider the risks and benefits of treatment in nursing women, particularly in relation to the possible effects on breastfed infants.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

Overdosage of phenylephrine can lead to significant adverse effects, primarily characterized by a rapid increase in blood pressure. Healthcare professionals should be vigilant for symptoms that may include headache, anxiety, nausea, vomiting, and the potential for ventricular arrhythmias.

In the event of an overdosage, it is crucial to initiate prompt management. The administration of a rapidly acting alpha-adrenergic blocking agent, such as phentolamine, is recommended to counteract the hypertensive effects. Monitoring of the patient's cardiovascular status is essential, and supportive care should be provided as necessary to address any additional symptoms that may arise.

Nonclinical Toxicology

Animal reproduction studies have not been conducted with topical phenylephrine. The potential for phenylephrine to cause fetal harm when administered to a pregnant woman or to affect reproductive capacity is not known. Therefore, phenylephrine hydrochloride should be administered to a pregnant woman only if clearly needed.

A marked increase in blood pressure has been reported, particularly in low weight premature neonates, infants, and hypertensive patients. Cardiovascular effects observed primarily in hypertensive patients following the topical ocular use of phenylephrine hydrochloride ophthalmic solution 10% include marked increases in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia, and subarachnoid hemorrhage.

Postmarketing Experience

No specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients not to touch the dropper tip to any surface, as this may lead to contamination of the solution. It is important for patients to understand that maintaining the integrity of the dropper is crucial for their safety and the effectiveness of the treatment.

Additionally, healthcare providers should inform patients that they may experience sensitivity to light, particularly when their pupils are dilated. Patients should be counseled to protect their eyes in bright lighting conditions to prevent discomfort. This guidance will help ensure that patients are adequately prepared for their treatment and can manage any potential side effects effectively.

Storage and Handling

Phenylephrine Hydrochloride Ophthalmic Solution, USP is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at a temperature range of 20° to 25°C (68° to 77°F) and protected from light and excessive heat.

Healthcare professionals are advised to inspect the solution prior to use; it should not be used if it appears brown or contains any precipitate. Once opened, the solution can be utilized until the expiration date indicated on the bottle.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Phenylephrine Hydrochloride as submitted by Gland Pharma Limited. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Phenylephrine Hydrochloride, retrieved by a validated AI data-extraction workflow.

All FDA-approved dosage forms and strengths are listed in the Packaging & NDC Codes section above. Regulatory status, pharmacologic class (EPC), and mechanism of action (MoA) were cross-checked against the FDA Orange Book (ANDA218129) and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.