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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
December 8, 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
December 8, 2025
Manufacturer
SOLA Pharmaceuticals, LLC
Registration number
ANDA215183
NDC roots
70512-865, 70512-866
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, colorless liquid used in eye care. It is a topical medication that acts as an α-1 adrenergic agonist, meaning it stimulates specific receptors in the eye to help dilate the pupil. This dilation, known as mydriasis, is useful during eye examinations and certain surgical procedures.

The solution is available in two concentrations: 2.5% and 10%, with the 10% solution providing a stronger effect. When applied, it works by contracting the muscle that dilates the pupil and constricting blood vessels in the eye, allowing for better visibility of the interior structures of the eye. The effects typically begin within 20 to 90 minutes and can last for several hours.

Uses

Phenylephrine Hydrochloride Ophthalmic Solution is used to help dilate your pupil. This can be important for various eye examinations or procedures where a larger pupil is needed for better visibility.

It's worth noting that there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safe option for its intended use.

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, opt for the 10% strength.

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

You should avoid using the 10% strength of this medication if you have hypertension (high blood pressure) or thyrotoxicosis (an overactive thyroid). Additionally, it is not safe for children under 1 year of age due to a higher risk of serious side effects. Always consult with your healthcare provider if you have any concerns or questions about your health and medication use.

Side Effects

You may experience some side effects while using this medication. Common ocular reactions include eye pain, stinging upon application, temporary blurred vision, and sensitivity to light (photophobia). Cardiovascular effects can also occur, such as increased blood pressure, fainting (syncope), rapid heart rate (tachycardia), irregular heartbeats (arrhythmia), and in rare cases, serious conditions like heart attack (myocardial infarction) or bleeding in the brain (subarachnoid hemorrhage).

If you are using the 10% strength of this medication, be aware that it may lead to serious heart rhythm issues, some of which can be fatal. It's important to monitor your blood pressure, especially if you have a history of heart problems or are under 5 years old. Overdosage can cause a rapid increase in blood pressure, along with symptoms like headache, anxiety, nausea, and vomiting. If you notice any concerning symptoms, please consult your healthcare provider.

Warnings and Precautions

This medication is intended for use in the eyes only and should never be injected. If you have a history of heart problems, be aware that using the 10% strength can lead to serious heart issues, including potentially fatal irregular heartbeats. It's important to monitor your blood pressure if you have cardiovascular disease.

If you are a parent, take extra care when using this medication in children under 5 years old, as well as in individuals with heart conditions or hyperthyroidism (an overactive thyroid). After treatment, you should also keep an eye on blood pressure in those at high risk. Additionally, be aware that you might experience rebound miosis (a condition where the pupils constrict) as soon as one day after using the medication.

If you notice any severe side effects or have concerns, seek emergency help immediately. If you experience any unusual symptoms or reactions, stop using the medication and contact your doctor right away.

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 provider if you experience any concerning symptoms after taking phenylephrine.

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 or fetal development. Because of this uncertainty, it's important to be cautious. If you are pregnant, phenylephrine hydrochloride should only be used if your healthcare provider determines that it is clearly necessary for your situation. Always consult with your doctor before using any medication during pregnancy to ensure the safety of both you and your baby.

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 health and your infant's well-being when considering any medication.

Pediatric Use

If you are considering using phenylephrine hydrochloride ophthalmic solution 10% for your child, it's important to know that this medication 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 eye solution. 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. Staying informed and discussing your treatment options can help ensure the best care for you or your loved one.

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 safety considerations and monitoring practices for patients with renal impairment (kidney issues) are not detailed.

It's always best to 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 provide guidance tailored to your specific situation.

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 safety while using any medication. Your well-being is a 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 lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

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 in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). Make sure the container is tightly closed to protect it from light and excessive heat, which 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 it until the expiration date printed on the label. Always follow these guidelines to ensure safe and effective use of the product.

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 solution?

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 side effects of Phenylephrine Hydrochloride Ophthalmic Solution?

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

What should I do if I experience an overdose?

Symptoms of overdose may include a rapid rise in blood pressure, headache, anxiety, nausea, vomiting, and ventricular arrhythmias. Seek medical attention immediately.

Is Phenylephrine Hydrochloride safe to use during pregnancy?

It 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 administering it to a nursing woman.

What storage conditions are recommended for this solution?

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

What is the expected time for maximal mydriasis after using this solution?

Maximal mydriasis occurs within 20 to 90 minutes, with recovery after 3 to 8 hours.

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, topical α-adrenergic agonist intended for ophthalmic use. The chemical name is (R)-3-hydroxy-(methylamino)methylbenzenemethanol hydrochloride, with a molecular formula of C9H13NO2.HCl and a molecular weight of 203.67 g/mol.

The formulation is available in two strengths: the 2.5% solution contains 25 mg of Phenylephrine Hydrochloride per mL, while the 10% solution contains 100 mg of Phenylephrine Hydrochloride per mL. Inactive ingredients for both formulations include Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, and Water for Injection. Additionally, phosphoric acid and/or sodium hydroxide may be used to adjust the pH within the range of 4.0 to 7.5. The tonicity is 340 mOsm/kg for the 2.5% solution and 985 mOsm/kg for the 10% solution. The preservative used in the formulation is Benzalkonium Chloride at a concentration of 0.1 mg (0.01%).

Uses and Indications

Phenylephrine Hydrochloride Ophthalmic Solution is indicated for the dilation of the pupil.

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

Dosage and Administration

For patients aged 1 year and older, one drop of Phenylephrine Hydrochloride Ophthalmic Solution (available in 2.5% or 10% strength) should be applied to the conjunctival fornix at intervals of 3 to 5 minutes, with a maximum of 3 drops per eye. To achieve a greater degree of mydriasis, the 10% strength is recommended.

For 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, it is contraindicated in pediatric patients under 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.

Healthcare professionals should be aware of the potential for serious cardiovascular reactions associated with the 10% strength formulation. These reactions may include ventricular arrhythmias, some of which have resulted in fatal outcomes. It is imperative to monitor blood pressure in patients with pre-existing cardiovascular disease to mitigate risks.

Significant elevations in blood pressure have been observed, 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 patient safety.

Additionally, rebound miosis has been reported as a potential effect occurring one day after instillation. Healthcare providers should be vigilant in observing for this reaction and counsel patients accordingly.

Side Effects

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

Cardiovascular adverse reactions can occur, with notable events including increases in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia, and subarachnoid hemorrhage. Serious cardiovascular reactions have been observed with the 10% strength formulation, particularly ventricular arrhythmias, some of which have been fatal. It is recommended that blood pressure be monitored in patients with pre-existing cardiovascular disease.

Significant elevations in blood pressure have been reported, particularly in pediatric patients under 5 years of age, as well as in patients with cardiovascular disease or hyperthyroidism. For patients at high risk, it is advised to monitor blood pressure following treatment.

Rebound miosis has been noted, typically occurring one day after instillation. In cases of overdosage, patients may experience a rapid rise in blood pressure, accompanied by headache, anxiety, nausea, vomiting, and ventricular arrhythmias.

Drug Interactions

There are currently no documented drug interactions associated with 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 children, and healthcare professionals should carefully evaluate the risks and benefits in this population.

Geriatric Use

Elderly patients, defined as those aged 65 years and older, have not demonstrated any overall differences in safety and effectiveness compared to younger adult patients. Therefore, no specific dosage adjustments are necessary for this population.

However, it is essential for healthcare providers to remain vigilant when prescribing to geriatric patients, as individual responses may vary. Continuous monitoring for any potential adverse effects or changes in therapeutic response is recommended to ensure optimal treatment outcomes in this demographic.

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 are advised to 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 regarding the possible effects on breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 overdose, 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 and stabilize the patient’s condition. Monitoring of vital signs and supportive care should be provided as necessary to ensure patient safety and effective management of symptoms.

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.

No specific non-teratogenic effects or additional nonclinical toxicology details have been provided. Furthermore, there are no specific findings related to animal pharmacology and toxicology available in the current data.

Postmarketing Experience

Reports from postmarketing surveillance have identified serious cardiovascular reactions associated with the use of phenylephrine 10%. These reactions include ventricular arrhythmias and myocardial infarctions, with some cases resulting in fatalities. Such events have predominantly occurred in patients with pre-existing cardiovascular conditions.

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

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 take appropriate measures to protect their eyes in bright lighting conditions to avoid discomfort.

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 SOLA Pharmaceuticals, LLC. 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 (ANDA215183) 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.