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Hydrocortisone

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Active ingredient
Hydrocortisone 25 mg/1 mL
Other brand names
Drug class
Corticosteroid
Dosage form
Solution
Route
Topical
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 1, 2025
FDA Insert
Prescribing information, PDF file
Active ingredient
Hydrocortisone 25 mg/1 mL
Other brand names
Drug class
Corticosteroid
Dosage form
Solution
Route
Topical
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 1, 2025
Manufacturer
Trifluent Pharma LLC
Registration number
ANDA081271
NDC root
73352-455
FDA Insert
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

Hydrocortisone Topical Solution 2.5% is a medication that belongs to a class of drugs known as topical corticosteroids. It contains hydrocortisone, which is a synthetic steroid used to reduce inflammation and relieve itching (pruritus) associated with certain skin conditions. This solution is specifically indicated for the treatment of inflammatory and itchy skin issues that respond to corticosteroids.

When applied to the skin, hydrocortisone can be absorbed and works by modulating the body's inflammatory response. The effectiveness of this medication can be influenced by factors such as the condition of your skin and whether an occlusive dressing is used. Overall, hydrocortisone topical solution helps to soothe and manage skin irritations effectively.

Uses

Hydrocortisone Topical Solution 2.5% is used to help relieve inflammation and itching associated with certain skin conditions that respond to corticosteroids. If you are experiencing discomfort from these types of skin issues, this solution may provide the relief you need.

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. Always consult with your healthcare provider for personalized advice and treatment options.

Dosage and Administration

When using topical corticosteroids, you should apply a thin layer directly to the affected area of your skin. This should be done three to four times a day, depending on how severe your condition is. For certain skin issues like psoriasis or stubborn conditions, you might also use occlusive dressings, which are coverings that help keep the medication in contact with your skin.

However, if you notice any signs of infection, such as increased redness, swelling, or pus, you should stop using the occlusive dressings immediately. It's important to consult your healthcare provider for appropriate antimicrobial (infection-fighting) treatment in that case. Always follow your healthcare provider's instructions for the best results.

What to Avoid

If you have a history of hypersensitivity (allergic reactions) to any ingredients in topical corticosteroids, you should not use these medications. It's important to stop using them immediately if you experience any irritation and seek appropriate treatment for your skin.

Additionally, if you have a skin infection, you should use the right antifungal or antibacterial treatment first. Do not use topical corticosteroids until the infection is properly managed, as continuing their use could worsen the situation. Always prioritize your skin's health and consult with a healthcare professional if you're unsure.

Side Effects

You may experience some local side effects when using this medication, such as burning, itching, irritation, and dryness of the skin. Other possible reactions include folliculitis (inflammation of hair follicles), hypertrichosis (excessive hair growth), acne-like eruptions, and changes in skin color. In some cases, you might also notice allergic reactions, skin infections, or thinning of the skin.

Systemically, this medication can affect your body's hormone levels, potentially leading to conditions like Cushing's syndrome, which can cause symptoms such as weight gain and high blood sugar levels. In children, there is a risk of more severe effects, including growth delays and increased pressure in the brain, which can manifest as headaches or bulging fontanelles (soft spots on a baby's head). If you notice any signs of steroid withdrawal, you may need additional corticosteroids. It's important to be aware that children may absorb more of the medication, increasing their risk of side effects.

Warnings and Precautions

Using topical corticosteroids can lead to some serious side effects, including issues with your body's hormone regulation (known as HPA axis suppression), symptoms similar to Cushing's syndrome, and increased blood sugar levels. These risks are higher if you use strong steroids over large areas of skin, for long periods, or with occlusive dressings (coverings that trap moisture). If you notice any irritation, stop using the corticosteroid and seek appropriate treatment. If you have a skin infection, make sure to use the right antifungal or antibacterial medication, and stop the corticosteroid if you don't see improvement quickly.

If you're using a potent topical steroid on a large area or under a dressing, it's important to have regular check-ups. Your doctor may recommend tests like the urinary free cortisol test or ACTH stimulation test to monitor your hormone levels. Children are particularly at risk for side effects, as they can absorb more of the medication. If you experience any concerning symptoms, consult your doctor for guidance on whether to continue or adjust your treatment.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

Corticosteroids, a type of medication often used to reduce inflammation, may pose risks during pregnancy. Studies in laboratory animals have shown that these drugs can cause birth defects (teratogenic effects) even at low doses when given systemically. Additionally, more potent corticosteroids have been linked to similar risks when applied to the skin. However, there are no well-controlled studies in pregnant women to confirm these effects from topical (skin-applied) corticosteroids.

Because of these concerns, it’s important to use topical corticosteroids during pregnancy only if the potential benefits outweigh the risks to your baby. You should avoid using these medications extensively, in large amounts, or for long periods while pregnant. Always consult your healthcare provider before using any medication during pregnancy to ensure the safety of both you and your baby.

Lactation Use

If you are breastfeeding and considering the use of corticosteroids, it's important to know that while systemically administered corticosteroids (those taken by mouth or injection) do appear in breast milk, the amounts are generally not expected to harm your baby. However, the effects of topical corticosteroids (those applied directly to the skin) on breast milk are not well understood, as it is unclear if they can be absorbed into the bloodstream in significant amounts.

Given this uncertainty, it's wise to be cautious when using topical corticosteroids while nursing. Always consult with your healthcare provider to discuss any medications you are considering and to ensure the safety of both you and your infant.

Pediatric Use

When using topical corticosteroids (medications applied to the skin) for children, it's important to be aware that they may be more sensitive to side effects than adults. This is due to their larger skin surface area relative to their body weight. In some cases, children can experience serious conditions like adrenal suppression (a decrease in hormone production) and Cushing's syndrome (a hormonal disorder), as well as increased pressure in the brain.

To minimize risks, you should use the smallest amount of topical corticosteroids necessary to effectively treat your child's condition. Be vigilant for signs of potential side effects, such as slowed growth, delayed weight gain, low cortisol levels, headaches, or bulging fontanelles (the soft spots on a baby's head). Long-term use of these medications can affect your child's growth and development, so regular check-ins with your healthcare provider are essential.

Geriatric Use

As you age, your body may respond differently to medications, including topical corticosteroids. Older adults can be more sensitive to the side effects of these treatments, so it's important to use them with caution. While there are no specific dosage changes recommended for seniors, you should be aware that reduced kidney function can increase the risk of side effects.

If you or a loved one is using these medications, regular check-ups are essential to monitor for any potential issues, such as suppression of the hypothalamic-pituitary-adrenal (HPA) axis, especially if large doses are used or if occlusive dressings (which cover the skin) are applied. Careful monitoring is crucial to ensure safety and effectiveness.

Renal Impairment

If you have kidney issues, it's important to be aware that corticosteroids, which are often used for various conditions, are mainly processed in the liver and then removed from your body by the kidneys. Some of these medications can also enter the bile. When using topical corticosteroids, especially in large amounts or under a covering, there is a risk of affecting your body's hormone regulation (known as the hypothalamic-pituitary-adrenal or HPA axis).

To ensure your safety, your healthcare provider may monitor your hormone levels through tests like urinary free cortisol and ACTH stimulation tests. If any suppression of the HPA axis is detected, your doctor might suggest reducing the medication, changing to a less potent steroid, or stopping it altogether. Fortunately, most people recover their hormone function quickly after discontinuing the steroid, although some may experience withdrawal symptoms that could require additional treatment. Always discuss any concerns with your healthcare provider to ensure the best care for your kidney health.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using corticosteroids, as these medications are mainly processed in the liver. Some topical corticosteroids can be absorbed into your bloodstream, which may lead to a condition called hypothalamic-pituitary-adrenal (HPA) axis suppression. This can affect your body's hormone levels and may require monitoring.

If you're using a strong topical steroid over a large area of your skin or under a bandage, your doctor may recommend regular tests, such as urinary free cortisol and ACTH stimulation tests, to check for HPA axis suppression. If any issues arise, your doctor might suggest reducing the medication, changing to a less potent steroid, or stopping it altogether. Fortunately, most people recover quickly and completely once the medication is discontinued, although some may experience withdrawal symptoms that could need additional treatment. Always discuss your treatment plan with your healthcare provider to ensure your safety.

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 best performance and safety of your product, store it at a controlled room temperature between 15° to 30°C (59° to 86°F). This temperature range helps maintain the integrity of the device.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and effectiveness.

Additional Information

You may undergo specific tests to assess your adrenal function, such as the urinary free cortisol test and the ACTH (adrenocorticotropic hormone) stimulation test. The urinary free cortisol test measures the amount of cortisol, a hormone produced by your adrenal glands, in your urine over a 24-hour period. The ACTH stimulation test evaluates how well your adrenal glands respond to ACTH, which stimulates cortisol production. These tests can help your healthcare provider understand your hormone levels and diagnose any potential issues related to adrenal function.

FAQ

What is Hydrocortisone Topical Solution 2.5% used for?

Hydrocortisone Topical Solution 2.5% is indicated for the relief of inflammatory and pruritic (itchy) manifestations of corticosteroid-responsive dermatoses.

How should I apply Hydrocortisone Topical Solution?

Apply a thin film of the solution to the affected area three to four times daily, depending on the severity of your condition.

Are there any contraindications for using this medication?

Yes, it is contraindicated in patients with a history of hypersensitivity to any of its components.

What are some common local adverse reactions?

Common local adverse reactions include burning, itching, irritation, dryness, and acneiform eruptions.

What should I do if I experience irritation?

If irritation develops, discontinue use of the topical corticosteroid and consult your healthcare provider for appropriate therapy.

Can Hydrocortisone Topical Solution be used during pregnancy?

Topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Is it safe to use Hydrocortisone Topical Solution while breastfeeding?

Caution should be exercised when administering topical corticosteroids to nursing women, as it is not known if they can be absorbed into breast milk.

What are the potential systemic effects of using this medication?

Potential systemic effects include reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria.

How should I store Hydrocortisone Topical Solution?

Store the solution at a controlled room temperature between 15° to 30°C (59° to 86°F).

What should I do if I develop a skin infection while using this medication?

If an infection develops, discontinue the use of occlusive dressings and initiate appropriate antimicrobial therapy.

Packaging Info

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

Packaging configurations for Hydrocortisone.
Details

FDA Insert (PDF)

This is the full prescribing document for Hydrocortisone, 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

Hydrocortisone Topical Solution 2.5% contains hydrocortisone as the active corticosteroid, with the chemical formula Pregn-4-ene-3, 20-dione, 11,17,21-trihydroxy-, (11 ß)-. The molecular weight of hydrocortisone is 362.47, and its empirical formula is C21H30O5. Each milliliter of the solution contains 25 mg of hydrocortisone (2.5% W/V) in a specially formulated vehicle that includes alcohol (48.8% W/W), purified water, polysorbate 20, and isoceteth-20.

Uses and Indications

Hydrocortisone Topical Solution 2.5% is indicated for the relief of the inflammatory and pruritic manifestations associated with corticosteroid-responsive dermatoses.

There are no teratogenic or nonteratogenic effects reported for this medication.

Dosage and Administration

Topical corticosteroids should be applied to the affected area as a thin film, with a frequency of three to four times daily, depending on the severity of the condition being treated. For patients with psoriasis or other recalcitrant conditions, occlusive dressings may be utilized to enhance the efficacy of the treatment.

In cases where an infection develops, it is imperative to discontinue the use of occlusive dressings immediately and to initiate appropriate antimicrobial therapy to address the infection.

Contraindications

Topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of the components of the preparation.

In cases of irritation, the use of topical corticosteroids should be discontinued, and appropriate therapy should be initiated. Additionally, in the presence of dermatological infections, it is essential to use an appropriate antifungal or antibacterial agent. If a favorable response is not observed promptly, the corticosteroid should be discontinued until the infection is adequately controlled.

Warnings and Precautions

Systemic absorption of topical corticosteroids has been associated with reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, as well as manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in certain patients. Factors that may enhance systemic absorption include the use of more potent steroids, application over extensive surface areas, prolonged treatment duration, and the use of occlusive dressings. Should irritation occur, the application of topical corticosteroids must be discontinued, and appropriate alternative therapy should be initiated.

In cases where dermatological infections are present, it is imperative to employ an appropriate antifungal or antibacterial agent. If there is no prompt favorable response, the corticosteroid treatment should be halted until the infection is adequately managed.

Patients receiving high doses of potent topical steroids, particularly when applied to large areas or under occlusive dressings, should undergo periodic evaluations for signs of HPA axis suppression. This can be assessed through urinary free cortisol and ACTH stimulation tests. If evidence of HPA axis suppression is detected, it is recommended to withdraw the corticosteroid, reduce the frequency of application, or consider switching to a less potent steroid. Generally, recovery of HPA axis function occurs swiftly and completely upon discontinuation of the corticosteroid; however, in rare instances, withdrawal symptoms may arise, necessitating the use of supplemental systemic corticosteroids.

It is important to note that children may absorb larger amounts of topical corticosteroids relative to their body size, rendering them more susceptible to systemic toxicity.

Healthcare professionals should remain vigilant and consider the aforementioned factors when prescribing and monitoring the use of topical corticosteroids, ensuring that appropriate laboratory tests, such as the urinary free cortisol test and ACTH stimulation test, are utilized as necessary.

Side Effects

Patients may experience a range of local and systemic adverse reactions associated with the use of this medication.

Local adverse reactions are commonly reported and include burning, itching, irritation, and dryness of the skin. Other local effects may consist of folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infections, skin atrophy, striae, and miliaria.

Systemic effects, although less frequent, can occur and include reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria.

In pediatric populations, there is an increased risk of HPA axis suppression and Cushing's syndrome. Additionally, children may experience intracranial hypertension, which can manifest as bulging fontanelles, headaches, and bilateral papilledema. Signs of adrenal suppression in children may include linear growth retardation, delayed weight gain, low plasma cortisol levels, and an absence of response to ACTH stimulation.

It is important to note that signs and symptoms of steroid withdrawal may occur, necessitating the use of supplemental systemic corticosteroids. Furthermore, children may absorb proportionally larger amounts of topical corticosteroids, making them more susceptible to systemic toxicity.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Hydrocortisone.
Details

Pediatric Use

Pediatric patients may exhibit increased susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome compared to mature patients, primarily due to a larger skin surface area relative to body weight. Reports indicate that children receiving topical corticosteroids have experienced HPA axis suppression, Cushing's syndrome, and intracranial hypertension.

Manifestations of adrenal suppression in pediatric patients can include linear growth retardation, delayed weight gain, low plasma cortisol levels, and a lack of response to ACTH stimulation. Additionally, signs of intracranial hypertension may present as bulging fontanelles, headaches, and bilateral papilledema.

To mitigate these risks, the administration of topical corticosteroids in children should be restricted to the minimum amount necessary to achieve an effective therapeutic outcome. It is important to note that chronic corticosteroid therapy may adversely affect the growth and development of pediatric patients.

Geriatric Use

Elderly patients may exhibit increased sensitivity to the side effects of topical corticosteroids. While there are no specific dosage adjustments recommended for this population, caution is advised due to the potential for heightened sensitivity and the likelihood of reduced kidney function in geriatric patients.

It is recommended that healthcare providers conduct periodic evaluations for evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression, particularly in patients receiving large doses or utilizing occlusive dressings. Additionally, geriatric patients may be at an elevated risk for systemic absorption and associated adverse effects, which underscores the necessity for careful monitoring during treatment.

Pregnancy

Corticosteroids are generally considered teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Additionally, more potent corticosteroids have demonstrated teratogenic effects following dermal application in these animal studies. However, there are no adequate and well-controlled studies in pregnant women that specifically assess the teratogenic effects of topically applied corticosteroids.

Given the potential risks, topical corticosteroids should be utilized during pregnancy only if the anticipated benefits outweigh the potential risks to the fetus. It is advised that drugs within this class not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time to minimize any potential adverse fetal outcomes.

Lactation

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. However, systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the breastfed infant.

Caution should be exercised when topical corticosteroids are administered to lactating mothers.

Renal Impairment

Corticosteroids are primarily metabolized in the liver and subsequently excreted by the kidneys. In patients with renal impairment, systemic absorption of topical corticosteroids may lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, necessitating careful monitoring.

Patients receiving large doses of potent topical steroids, especially when applied to extensive areas of the skin or under occlusive dressings, should be periodically evaluated for signs of HPA axis suppression. This evaluation can be conducted using urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is detected, it is advisable to consider withdrawing the corticosteroid, reducing the frequency of application, or substituting with a less potent steroid.

Typically, recovery of HPA axis function occurs promptly and completely following discontinuation of the corticosteroid. However, in rare instances, patients may experience signs and symptoms of steroid withdrawal, which may necessitate the administration of supplemental systemic corticosteroids.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism and excretion of corticosteroids, which are primarily metabolized in the liver and excreted by the kidneys. Given that some topical corticosteroids and their metabolites are also excreted into the bile, caution is warranted when administering these medications to this patient population.

Systemic absorption of topical corticosteroids has been associated with reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, a condition that may pose additional risks for patients with compromised liver function. For patients receiving a large dose of a potent topical steroid applied to extensive areas of the skin or under occlusive dressings, periodic evaluation for evidence of HPA axis suppression is recommended. This can be assessed through urinary free cortisol and ACTH stimulation tests.

In cases where HPA axis suppression is detected, it is advisable to consider withdrawing the corticosteroid, reducing the frequency of application, or substituting a less potent steroid. Recovery of HPA axis function is typically prompt and complete following discontinuation of the corticosteroid. However, it is important to note that, in rare instances, signs and symptoms of steroid withdrawal may occur, necessitating the use of supplemental systemic corticosteroids.

Overall, careful monitoring and consideration of dosage adjustments are essential when treating patients with hepatic impairment to mitigate potential systemic absorption and adverse effects associated with topical corticosteroids.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, altered mental status, or any unusual physiological responses.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on managing overdose cases.

In summary, while no specific overdosage information is available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate management in the event of an overdose.

Nonclinical Toxicology

Corticosteroids are generally recognized as teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Additionally, more potent corticosteroids have demonstrated teratogenic effects following dermal application in these animals. However, there are no adequate and well-controlled studies in pregnant women regarding the teratogenic effects of topically applied corticosteroids. Consequently, the use of topical corticosteroids during pregnancy should be considered only when the potential benefits outweigh the potential risks to the fetus. It is advised that drugs within this class not be used extensively on pregnant patients, in large amounts, or for prolonged durations.

Long-term animal studies have not been conducted to assess the carcinogenic potential or the effects on fertility associated with topical corticosteroids. Furthermore, studies evaluating the mutagenicity of prednisolone and hydrocortisone have yielded negative results.

Postmarketing Experience

Systemic absorption of topical corticosteroids has been associated with reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, as well as manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Factors that may enhance systemic absorption include the use of more potent steroids, application over large surface areas, prolonged use, and the application of occlusive dressings.

Patients receiving high doses of potent topical steroids, particularly when applied to extensive areas or under occlusive dressings, should be periodically evaluated for signs of HPA axis suppression. This evaluation can be conducted using urinary free cortisol and ACTH stimulation tests. In cases where HPA axis suppression is identified, it is recommended to consider withdrawing the medication, reducing the frequency of application, or substituting a less potent steroid. Recovery of HPA axis function is typically prompt and complete following discontinuation of the drug; however, in rare instances, signs and symptoms of steroid withdrawal may necessitate the use of supplemental systemic corticosteroids.

Pediatric patients may exhibit a heightened susceptibility to HPA axis suppression and Cushing's syndrome induced by topical corticosteroids, attributed to a larger skin surface area relative to body weight. Reports indicate that children receiving topical corticosteroids have experienced HPA axis suppression, Cushing's syndrome, and intracranial hypertension. Manifestations of adrenal suppression in this population may include linear growth retardation, delayed weight gain, low plasma cortisol levels, and a lack of response to ACTH stimulation. Symptoms of intracranial hypertension may present as bulging fontanelles, headaches, and bilateral papilledema.

Infrequent local adverse reactions associated with topical corticosteroids may occur, particularly with the use of occlusive dressings. These reactions include burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

Patient Counseling

Healthcare providers should advise patients that this medication is to be used strictly as directed by their physician and is intended for external use only. Patients must be cautioned to avoid contact with the eyes to prevent irritation or injury.

It is important for healthcare providers to emphasize that patients should not use this medication for any condition other than the one for which it was prescribed. Additionally, patients should be informed that the treated skin area should not be bandaged or covered in a manner that creates an occlusive environment unless specifically directed by their physician.

Healthcare providers should encourage patients to report any signs of local adverse reactions, particularly if they occur under occlusive dressings, as this may indicate a need for reevaluation of the treatment plan.

For parents of pediatric patients, it is crucial to advise against the use of tight-fitting diapers or plastic pants on children being treated in the diaper area. These garments can create an occlusive dressing, which may exacerbate potential side effects or hinder the effectiveness of the treatment.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature ranging from 15° to 30°C (59° to 86°F). Care should be taken to ensure that the storage environment maintains these temperature conditions to preserve product integrity.

Additional Clinical Information

Patients may undergo a urinary free cortisol test and an ACTH stimulation test as part of the diagnostic process. These tests are utilized to assess adrenal function and cortisol levels, providing valuable information for clinicians in the evaluation of related conditions.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Hydrocortisone as submitted by Trifluent Pharma 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 Hydrocortisone, 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 (ANDA081271) 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.