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Hydrocortisone

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Active ingredient
Hydrocortisone 25 mg/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
Route
Topical
Prescription status
Rx (prescription)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1986
Label revision date
October 10, 2025
FDA Insert
Prescribing information, PDF file
Active ingredient
Hydrocortisone 25 mg/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
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 1986
Label revision date
October 10, 2025
Manufacturer
Sportpharm, Inc. dba Sportpharm
Registration number
ANDA089414
NDC root
85766-081
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 cream and ointment are topical corticosteroids, which are a class of synthetic steroids used to reduce inflammation and relieve itching. These medications contain hydrocortisone, a compound that works by calming the skin's immune response, making it effective for treating various skin conditions that respond to corticosteroids.

You may use hydrocortisone cream or ointment to help alleviate symptoms associated with inflammatory skin conditions, such as redness, swelling, and itching. It is particularly useful for conditions that are responsive to corticosteroids, providing relief and promoting healing in affected areas.

Uses

Topical corticosteroids are used to help relieve inflammation and itching associated with certain skin conditions that respond to corticosteroid treatment. If you are experiencing skin issues that cause discomfort, these medications can provide relief from symptoms like redness and irritation.

It's important to note that there are no reported teratogenic effects (which means they do not cause birth defects) or nonteratogenic effects (which refer to other types of harmful effects) associated with these medications. Always consult with your healthcare provider for personalized advice and treatment options.

Dosage and Administration

To use this medication effectively, apply a thin layer to the affected area of your skin 2 to 4 times a day. The exact number of applications will depend on how severe your condition is. For certain skin issues like psoriasis or stubborn conditions, you can use occlusive dressings (coverings that keep the medication in place) to help manage your symptoms.

However, if you notice any signs of infection, such as increased redness, swelling, or pus, you should stop using the occlusive dressings immediately. In that case, it's important to seek appropriate treatment with antimicrobial therapy (medications that fight infections). Always follow these guidelines to ensure the best results from your treatment.

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 and you see improvement. Always prioritize your skin health and consult with a healthcare professional if you have any concerns.

Side Effects

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

Systemically, there are potential effects like reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis, which can lead to symptoms similar to Cushing's syndrome, such as increased blood sugar levels. If you are using this treatment in children, be aware that they may be at higher risk for these systemic effects, including growth delays and increased pressure in the brain. Signs of steroid withdrawal may also occur, which could require additional treatment.

Warnings and Precautions

Using topical corticosteroids can lead to some serious side effects, including potential suppression of your body's hormone production (known as HPA axis suppression), symptoms similar to Cushing's syndrome, and increased blood sugar levels. You should be particularly cautious if you are using strong steroids over large areas of your skin, for long periods, or with occlusive dressings (coverings that trap moisture). Children may be at higher risk for these effects, as they can absorb more of the medication.

If you are using a potent topical steroid, it's important to have regular check-ups to monitor for any signs of hormone suppression. If you notice any irritation, stop using the corticosteroid and seek appropriate treatment. Additionally, if you have a skin infection, make sure to use the right antifungal or antibacterial medication, and stop the corticosteroid until the infection is under control if you don't see improvement quickly.

For monitoring purposes, your doctor may recommend tests like the urinary free cortisol test or the ACTH stimulation test to check for hormone suppression. Always consult your doctor if you have concerns or experience any adverse effects.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the potential risks associated with taking any medication. If you suspect that you or someone else may have taken too much of a medication, look out for unusual symptoms such as extreme drowsiness, confusion, or difficulty breathing.

In the event of an overdose, it is crucial to seek immediate medical help. You can do this by calling your local emergency number or going to the nearest hospital. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, when in doubt, it's better to err on the side of caution and get help right away.

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

Currently, there is no specific information available regarding the use of this medication in children. This means that the safety and effectiveness of the drug for pediatric patients (children and adolescents) have not been established. If you are considering this medication for a child, it is essential to consult with a healthcare professional to discuss any potential risks and to explore alternative treatment options that may be more suitable for younger patients. Always prioritize your child's health and well-being by seeking expert advice.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about how it should be adjusted for dosage or any unique safety concerns. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney issues, it's important to know that the information regarding Hydrocortisone Cream USP, 2.5% does not specify any dosage adjustments or safety considerations for you. The cream is a type of corticosteroid, which is mainly processed in the liver and then removed from your body by the kidneys. However, the insert does not provide additional details on how this may affect you or any special monitoring that might be necessary.

In summary, there are no specific recommendations or precautions for patients with renal impairment when using this cream. Always consult your healthcare provider for personalized advice and to ensure safe use of any medication.

Hepatic Impairment

If you have liver problems, it's important to be aware that corticosteroids are mainly processed in your liver and then removed from your body through your kidneys. Some topical corticosteroids can also be found in bile, which is produced by the liver. If you use topical corticosteroids, especially in large amounts or under a covering, you may need to have your hormone levels monitored, as these medications can affect your body's hormone balance (known as the hypothalamic-pituitary-adrenal or HPA axis).

If any issues with hormone levels are detected, your healthcare provider may suggest stopping the medication, reducing how often you use it, or switching to a less potent steroid. The good news is that your hormone levels usually return to normal quickly after you stop using the corticosteroid. Always consult your doctor for personalized advice and monitoring if you have liver conditions.

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, be sure to do so in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

If you're concerned about the effects of a medication on your body's hormone production, specific laboratory tests can help. The urinary free cortisol test and the ACTH stimulation test are useful for evaluating HPA (hypothalamic-pituitary-adrenal) axis suppression, which can occur with certain treatments. These tests measure how well your body is producing cortisol, a key hormone involved in stress response and metabolism. If you have questions about these tests or their implications, be sure to discuss them with your healthcare provider.

FAQ

What is Hydrocortisone Cream USP, 2.5% used for?

Hydrocortisone Cream USP, 2.5% is a topical corticosteroid indicated for the relief of inflammatory and pruritic (itchy) manifestations of corticosteroid-responsive dermatoses.

How should I apply Hydrocortisone Cream?

You should apply a thin film of the cream to the affected area 2 to 4 times daily, depending on the severity of your condition.

Are there any contraindications for using Hydrocortisone Cream?

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

What are some common local adverse reactions to Hydrocortisone Cream?

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

What should I do if I experience irritation while using Hydrocortisone Cream?

If irritation develops, you should discontinue use of the cream and consult your healthcare provider for appropriate therapy.

Can Hydrocortisone Cream be used during pregnancy?

Topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as there are no adequate studies on teratogenic effects in pregnant women.

Is it safe to use Hydrocortisone Cream while breastfeeding?

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

What are the storage conditions for Hydrocortisone Cream?

You should store Hydrocortisone Cream at a controlled room temperature of 15° to 30°C (59° to 86°F).

What should I do if I develop a dermatological infection while using Hydrocortisone Cream?

If a dermatological infection develops, you should discontinue the use of the cream and initiate appropriate antifungal or antibacterial 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 is a white to practically white crystalline powder. Chemically, it is identified as pregn-4-ene-3,20-dione, 11,17, 21-trihydroxy-, (11β)-. The molecular formula of hydrocortisone is C21H30O5, with a molecular weight of 362.47 g/mol. The 2.5% Cream formulation contains 25 mg of hydrocortisone, USP per gram, in a base that includes glyceryl monostearate, polyoxyl 40 stearate, glycerin, paraffin, stearyl alcohol, isopropyl palmitate, sorbitan monostearate, benzyl alcohol, potassium sorbate, lactic acid, and purified water.

Uses and Indications

Topical corticosteroids are 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

The medication should be applied to the affected area as a thin film, with a frequency of 2 to 4 times daily, contingent upon the severity of the condition being treated. For patients with psoriasis or other recalcitrant conditions, occlusive dressings may be utilized to enhance the therapeutic effect. However, should an infection occur, the use of occlusive dressings must be discontinued immediately, and appropriate antimicrobial therapy should be initiated 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 can lead to 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. It is important to note that children may absorb larger amounts of topical corticosteroids relative to their body size, making them more susceptible to systemic toxicity.

Patients receiving high doses of potent topical steroids, particularly when applied to large areas of the body or under occlusive dressings, should undergo periodic evaluations for signs of HPA axis suppression. Recommended laboratory tests for this purpose include the urinary free cortisol test and the ACTH stimulation test.

In cases where irritation occurs, it is essential to discontinue the use of topical corticosteroids and initiate appropriate alternative therapy. Additionally, if dermatological infections are present, the use of suitable antifungal or antibacterial agents should be implemented. Should there be no prompt improvement in the infection, the corticosteroid treatment must be halted until the infection is adequately managed.

Healthcare professionals are advised to remain vigilant for these potential complications and to monitor patients accordingly to ensure safe and effective use of topical corticosteroids.

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 adverse reactions, while less frequent, can be serious. These 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. Children may also experience intracranial hypertension, which can manifest as bulging fontanelles, headaches, and bilateral papilledema. Additional manifestations of adrenal suppression in this demographic 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 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 Hydrocortisone, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone.
Details

Pediatric Use

No specific pediatric use information is provided in the insert. Therefore, the safety and efficacy of this medication in pediatric patients have not been established. Healthcare professionals should exercise caution when considering this medication for children, infants, or adolescents, as the absence of data limits the ability to make informed treatment decisions in these populations.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments or safety concerns. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted clinical data in this population.

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 to assess the teratogenic effects of topically applied corticosteroids.

Given the potential risks, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is advised that drugs of 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. Healthcare professionals should carefully consider the risks and benefits before prescribing these medications to women of childbearing potential.

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

Patients with renal impairment do not require specific dosage adjustments or safety considerations when using Hydrocortisone Cream USP, 2.5%. Although corticosteroids are primarily metabolized in the liver and subsequently excreted by the kidneys, the prescribing information does not provide additional details regarding the impact of reduced kidney function on the drug's pharmacokinetics. Furthermore, there are no special monitoring requirements or recommendations for patients with kidney problems outlined in the provided drug insert.

Hepatic Impairment

Corticosteroids are primarily metabolized in the liver, with subsequent excretion occurring via the kidneys. In patients with hepatic impairment, the metabolism and clearance of corticosteroids may be affected, necessitating careful consideration of dosing and monitoring.

Topical corticosteroids, along with their metabolites, are also excreted into the bile. Systemic absorption of these agents can lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, which is particularly relevant in patients with compromised liver function. Therefore, it is essential to monitor these patients for signs of HPA axis suppression, especially when a large dose of a potent topical steroid is applied over a significant surface area or under an occlusive dressing.

In cases where HPA axis suppression is observed, it is recommended to withdraw the corticosteroid, reduce the frequency of application, or consider substituting with a less potent steroid. Fortunately, recovery of HPA axis function is typically prompt and complete following the discontinuation of the corticosteroid. Regular evaluation and monitoring are crucial to ensure the safety and efficacy of treatment in patients with hepatic impairment.

Overdosage

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on clinical judgment.

For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.

Nonclinical Toxicology

Long-term animal studies have not been conducted to assess the carcinogenic potential or the effects on fertility of topical corticosteroids. Additionally, investigations into 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. Infrequent occurrences of signs and symptoms related to steroid withdrawal have been noted, which may necessitate the administration of supplemental systemic corticosteroids.

In pediatric patients, reports indicate that HPA axis suppression, Cushing's syndrome, and intracranial hypertension can arise from the use of topical corticosteroids. 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 reported include bulging fontanelles, headaches, and bilateral papilledema.

Local adverse reactions associated with topical corticosteroids have been reported infrequently, though their incidence may increase 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 instruct patients to report any signs of local adverse reactions, particularly if they occur under occlusive dressings. 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, as these garments may act as occlusive dressings and exacerbate potential side effects.

Finally, healthcare providers may consider discussing the utility of certain tests, such as the urinary free cortisol test and the ACTH stimulation test, which can be helpful in evaluating potential HPA axis suppression in patients undergoing treatment.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. 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 product is kept within this temperature range to maintain its integrity and efficacy.

Additional Clinical Information

Laboratory tests that may assist in evaluating hypothalamic-pituitary-adrenal (HPA) axis suppression include the urinary free cortisol test and the ACTH stimulation test. These assessments can provide valuable insights for clinicians managing patients potentially affected by HPA axis dysfunction.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Hydrocortisone as submitted by Sportpharm, Inc. dba Sportpharm. 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 (ANDA089414) 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.