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Hydrocortisone

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Active ingredient
Hydrocortisone 25 mg/1 g
Other brand names
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 2005
Label revision date
January 4, 2014
FDA Insert
Prescribing information, PDF file
Active ingredient
Hydrocortisone 25 mg/1 g
Other brand names
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 2005
Label revision date
January 4, 2014
Manufacturer
Aidarex Pharmaceuticals LLC
Registration number
ANDA088799
NDC root
33261-520
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 is a topical steroid that is primarily used to relieve inflammation and itching associated with certain skin conditions. It works by reducing the inflammatory response in the skin, making it effective for treating various corticosteroid-responsive dermatoses, which are skin disorders that respond to corticosteroids.

When applied to the skin, hydrocortisone can be absorbed and acts similarly to corticosteroids taken systemically (through the body). This medication is available in different strengths, such as 1% and 2.5% creams, and is intended for external use only.

Uses

Topical corticosteroids are medications that you can apply directly to your skin to help relieve inflammation and itching caused by certain skin conditions. These conditions are known as corticosteroid-responsive dermatoses, which means they respond well to this type of treatment. If you're dealing with skin issues that cause discomfort, topical corticosteroids can provide effective relief.

Dosage and Administration

When using topical corticosteroids, you should apply a thin layer directly to the affected area of your skin. Depending on how severe your condition is, you may need to do this two to four times a day. For certain skin issues like psoriasis or stubborn conditions, you can use occlusive dressings (coverings that keep the medication in contact with the skin) to enhance the treatment's effectiveness.

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 antimicrobial therapy (medications that fight infections) to address the infection properly. Always follow your healthcare provider's instructions for the best results.

What to Avoid

If you have a history of allergic reactions to any ingredients in topical corticosteroids, you should avoid using them. Additionally, if you experience any irritation while using these medications, stop using them immediately and seek appropriate treatment.

It's also important to note that 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 using them in such cases can worsen your condition.

Side Effects

You may experience some local side effects when using this medication, including burning, itching, irritation, and dryness of the skin. Other possible reactions are acne-like eruptions, skin thinning, and allergic contact dermatitis. In some cases, you might notice changes like increased hair growth or skin discoloration. If you develop any signs of infection or worsening skin conditions, it's important to stop using the medication and consult your healthcare provider.

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. In children, there is a risk of growth issues and increased pressure in the brain, which can manifest as headaches or bulging fontanelles (the soft spots on a baby's head). If you have concerns about these side effects, please discuss them with your healthcare provider.

Warnings and Precautions

Using topical corticosteroids can lead to some serious side effects, including a condition called hypothalamic-pituitary-adrenal (HPA) axis suppression, which can affect your body's hormone levels. This is more likely to happen if you use strong steroids over large areas of your skin, for a long time, or with occlusive dressings (coverings that trap moisture). If you are using a potent steroid in these ways, your doctor may recommend tests like the urinary free cortisol test and ACTH stimulation test to check your hormone levels.

If you notice any signs of irritation or if you develop a skin infection, stop using the corticosteroid and consult your doctor for appropriate treatment. It's important to be cautious, especially with children, as they may absorb more of the medication and be at higher risk for side effects. If you experience any concerning symptoms, such as those related to hormone imbalance, your doctor may suggest reducing the medication or switching to a less potent option. Generally, your hormone levels should return to normal quickly after stopping the medication, but in rare cases, you might need additional treatment.

Overdose

When using topically applied corticosteroids, it's important to know that they can be absorbed into your body in amounts that may lead to systemic effects, which means they can affect your entire system rather than just the area where they are applied.

If you suspect an overdose, look for signs such as unusual changes in mood, weight gain, or increased thirst. If you experience any of these symptoms or feel unwell, it’s crucial to seek medical help immediately. Always consult your healthcare provider if you have concerns about your medication or its effects.

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 developmental issues (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 use.

Because of these concerns, it is 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 your child, it's important to be aware that children may be more sensitive to these treatments than adults. This increased sensitivity can lead to serious conditions like adrenal suppression (a decrease in hormone production) and Cushing's syndrome (a hormonal disorder). Because children have a larger skin surface area relative to their body weight, they may absorb more of the medication, which can heighten these risks.

To minimize potential side effects, such as growth delays or increased pressure in the brain, you should use the smallest effective amount of topical corticosteroids for your child. Be vigilant for signs of complications, including slow growth, weight gain issues, headaches, or unusual swelling in the head. Always consult with your child's healthcare provider to ensure safe and appropriate use of these medications.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. 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 be aware that corticosteroids, including topical ones, are processed mainly by the liver and then eliminated by the kidneys. Some of these medications can also enter the bile. When using potent topical corticosteroids, especially over large areas of skin or under a bandage, you may need regular check-ups to monitor for potential suppression of the hypothalamic-pituitary-adrenal (HPA) axis, which is a system that helps regulate hormones in your body.

If tests show signs of HPA axis suppression, your healthcare provider may suggest reducing the amount you use, changing to a less potent steroid, or stopping the medication altogether. Fortunately, if you stop using the corticosteroid, your HPA axis function usually returns to normal quickly. Always discuss any concerns with your doctor to ensure safe use of these medications.

Hepatic Impairment

If you have liver problems, it's important to be aware that corticosteroids, which are often used to treat various conditions, are mainly processed in the liver. This means that if your liver isn't functioning well, it can affect how these medications work in your body. Some topical corticosteroids can also enter your bile, which is another way your body eliminates substances.

If you're using a strong topical steroid over a large area of skin or under a bandage, your doctor may want to monitor you for potential side effects, specifically looking for signs of hypothalamic-pituitary-adrenal (HPA) axis suppression. This is a condition where your body’s hormone production can be affected. Tests like urinary free cortisol and ACTH stimulation tests may be used to check for this. If any issues are found, your doctor might suggest reducing the amount you use, changing to a less potent steroid, or stopping the medication altogether. Additionally, if you are nursing, be cautious, as it’s unclear if these medications can pass into breast milk.

Drug Interactions

It's important to be aware that using topical corticosteroids (medications applied to the skin) can sometimes lead to serious side effects, such as affecting your body's hormone levels. This can happen if the steroid is very strong, used over large areas of skin, or covered with a bandage for a long time. These effects may include symptoms like Cushing's syndrome, high blood sugar, and changes in hormone production.

If you are using a potent topical steroid, especially in large amounts or with dressings, your healthcare provider may recommend tests to check your hormone levels, such as the urinary free cortisol test and the ACTH stimulation test. Always discuss any medications you are taking and any tests you may need with your healthcare provider to ensure your safety and well-being.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20°-25°C (68°-77°F), which is considered a controlled room temperature according to the United States Pharmacopeia (USP). It's important to keep the product away from freezing temperatures, as this can damage it.

When handling the product, make sure to dispense it in tight containers as specified in the USP. This helps maintain its integrity and safety. Always follow these guidelines to ensure the product remains effective and safe for use.

Additional Information

You may need to undergo specific laboratory tests, such as a urinary free cortisol test and an ACTH (adrenocorticotropic hormone) stimulation test, to monitor your health condition. These tests help assess how your body is responding to certain treatments or conditions.

Currently, there is no additional information available regarding the potential for abuse, administration methods, or patient counseling related to this medication.

FAQ

What is Hydrocortisone?

Hydrocortisone is a topical steroid used as an anti-inflammatory and antipruritic agent, primarily for treating corticosteroid-responsive dermatoses.

How should I use Hydrocortisone?

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

What are the common side effects of Hydrocortisone?

Common local side effects include burning, itching, irritation, and dryness. Systemic effects may include hyperglycemia and signs of adrenal suppression.

Can I use Hydrocortisone if I have a skin infection?

If you have a dermatological infection, you should use an appropriate antifungal or antibacterial agent and discontinue Hydrocortisone until the infection is controlled.

Is Hydrocortisone safe to use during pregnancy?

Hydrocortisone should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus, as there are no adequate studies on its teratogenic effects.

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

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

Are there any contraindications for using Hydrocortisone?

Hydrocortisone is contraindicated in patients with a history of hypersensitivity to any of its components.

How should I store Hydrocortisone?

Store Hydrocortisone at 20°-25°C (68°-77°F) and protect it from freezing.

What should I monitor while using Hydrocortisone?

Patients using large doses or applying it under occlusive dressings should be evaluated for evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression.

Can children use Hydrocortisone?

Yes, but children may absorb larger amounts and be more susceptible to systemic toxicity, so use the least amount necessary for effective treatment.

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 synthetic steroid belonging to the class of topical steroids, utilized for its anti-inflammatory and antipruritic properties. The chemical name of hydrocortisone is Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11β)-, with a molecular formula of C21H30O5 and a molecular weight of 362.47.

Hydrocortisone is available in cream form, specifically Hydrocortisone Cream USP, with concentrations of 1% and 2.5%. Each gram of the 1% formulation contains 10 mg of hydrocortisone, while the 2.5% formulation contains 25 mg of hydrocortisone. The cream is formulated in a base that includes purified water, propylene glycol, propylene glycol monostearate, mineral oil, lanolin alcohol, isopropyl palmitate, polysorbate 60, cetyl alcohol, sorbitan monostearate, polyoxyl 40 stearate, sorbic acid, methylparaben, and propylparaben.

Uses and Indications

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations associated with corticosteroid-responsive dermatoses. These conditions may include, but are not limited to, eczema, psoriasis, and dermatitis.

Limitations of Use: Topical corticosteroids should be used with caution in patients with a history of hypersensitivity to corticosteroids or any of the components of the formulation. Prolonged use may lead to skin atrophy and other local adverse effects. It is recommended to follow established guidelines for the duration and frequency of application to minimize potential risks.

Dosage and Administration

Topical corticosteroids should be applied to the affected area as a thin film, with a frequency of two 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 can lead to significant adverse effects, including reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in certain patients. The risk of systemic absorption is heightened under specific conditions, such as the application of more potent steroids, use over extensive surface areas, prolonged treatment duration, and the application of occlusive dressings.

For patients receiving high doses of potent topical steroids applied to large areas of the body or under occlusive dressings, it is essential to conduct periodic evaluations for signs of HPA axis suppression. This can be assessed through laboratory tests, specifically the urinary free cortisol test and the ACTH stimulation test. Should evidence of HPA axis suppression be identified, it is recommended to withdraw the corticosteroid, reduce the frequency of application, or consider switching to 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.

Particular caution should be exercised when prescribing topical corticosteroids to children, as they may absorb larger amounts relative to their body size, increasing their susceptibility to systemic toxicity. In cases where irritation occurs, the use of topical corticosteroids should be discontinued, and appropriate therapeutic measures should be initiated.

In the presence of dermatological infections, it is crucial to implement treatment with an appropriate antifungal or antibacterial agent. If there is no prompt favorable response, the corticosteroid should be discontinued until the infection is adequately managed.

Side Effects

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

Local adverse reactions are common and may include burning, itching, irritation, dryness, hypertrichosis, acneiform eruptions, secondary infections, perioral dermatitis, hypopigmentation, skin atrophy, maceration of the skin, striae, folliculitis, allergic contact dermatitis, and miliaria. In cases where irritation develops, it is recommended that topical corticosteroids be discontinued and appropriate therapy instituted. Additionally, in the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be initiated. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection is adequately controlled.

Systemic adverse reactions, although less common, may include reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, glucosuria, and signs and symptoms of steroid withdrawal, which may necessitate the use of supplemental systemic corticosteroids.

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

Patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression. It is important to note that children may absorb proportionally larger amounts of topical corticosteroids, making them more susceptible to systemic toxicity.

Drug Interactions

Systemic absorption of topical corticosteroids can lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, which may manifest as 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.

For patients receiving high doses of potent topical corticosteroids, particularly when applied to large areas of the body or under occlusive dressings, it is recommended that they undergo periodic evaluations for signs of HPA axis suppression. This can be assessed through urinary free cortisol and ACTH stimulation tests. The urinary free cortisol test and ACTH stimulation test are both useful in monitoring potential HPA axis suppression in these patients.

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 HPA axis suppression, Cushing's syndrome, and intracranial hypertension have occurred in this population following the use of topical corticosteroids.

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 adrenocorticotropic hormone (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 pediatric patients 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 not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for 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.

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 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 upon discontinuation of the corticosteroid. Additionally, the potential for systemic effects from topically applied corticosteroids should be taken into account in patients with renal impairment, as sufficient absorption may occur.

Hepatic Impairment

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

Systemic absorption of topical corticosteroids can lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression. Therefore, patients with compromised liver function who are receiving large doses of potent topical steroids, particularly when applied to extensive surface 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 withdraw the corticosteroid, reduce the frequency of application, or consider substituting with a less potent steroid to mitigate potential risks.

Additionally, caution is advised when administering topical corticosteroids to nursing women, as the potential for systemic absorption and subsequent transfer to breast milk is not well established. Monitoring and clinical judgment should guide the use of these medications in this population.

Overdosage

Topically applied corticosteroids have the potential to be absorbed in quantities sufficient to elicit systemic effects. Healthcare professionals should be vigilant in monitoring for signs of overdosage, particularly in patients who may have used these medications excessively or inappropriately.

In cases of suspected overdosage, it is essential to assess the patient for potential symptoms associated with systemic corticosteroid effects. These may include, but are not limited to, adrenal suppression, Cushing's syndrome, and other hormonal imbalances.

Management of corticosteroid overdosage primarily involves discontinuation of the topical agent and supportive care. In severe cases, particularly where systemic effects are evident, further medical intervention may be required. Healthcare providers should consider consulting a poison control center or a specialist in toxicology for guidance on the appropriate management strategies tailored to the individual patient's needs.

Close monitoring and follow-up are recommended to ensure the resolution of symptoms and to prevent any long-term complications associated with corticosteroid overdosage.

Nonclinical Toxicology

Corticosteroids have been shown to exhibit teratogenic effects in laboratory animals when administered systemically at relatively low dosage levels. Additionally, more potent corticosteroids have demonstrated teratogenicity following dermal application in these animal models. 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 risks to the fetus. It is advised that drugs within this class not be used extensively, in large amounts, or for prolonged periods in pregnant patients.

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

Postmarketing experience has identified several adverse events associated with the use of topical corticosteroids, reported voluntarily or through surveillance programs. Notably, cases of hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, hyperglycemia, and glucosuria have been documented, attributed to systemic absorption of these medications.

Pediatric patients appear to exhibit a heightened susceptibility to HPA axis suppression and Cushing's syndrome compared to adults. In this population, manifestations of adrenal suppression may include linear growth retardation, delayed weight gain, low plasma cortisol levels, and an absence of response to ACTH stimulation. Additionally, pediatric patients have reported cases of intracranial hypertension, with symptoms such as bulging fontanelles, headaches, and bilateral papilledema.

Local adverse reactions, although infrequent, may occur more commonly when topical corticosteroids are used with occlusive dressings. These reactions include burning, hypertrichosis, maceration of the skin, itching, acneiform eruptions, secondary infections, irritation, hypopigmentation, skin atrophy, dryness, perioral dermatitis, striae, folliculitis, and allergic contact dermatitis, as well as miliaria.

Patient Counseling

Healthcare providers should advise patients to use this medication strictly as directed by their physician, emphasizing that it 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 inform patients that this medication should not be used for any condition other than the one for which it was prescribed. Additionally, patients should be instructed 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. 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 potentially exacerbate adverse effects.

Storage and Handling

The product is supplied in tight containers, as specified in the USP. It should be stored at a temperature range of 20°-25°C (68°-77°F), in accordance with USP Controlled Room Temperature guidelines. It is essential to protect the product from freezing to maintain its integrity and efficacy.

Additional Clinical Information

Patients may undergo specific laboratory tests, including the urinary free cortisol test and the ACTH stimulation test, as part of their evaluation and management. No additional information is available regarding abuse potential, administration routes, patient counseling, or postmarketing experiences.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Hydrocortisone as submitted by Aidarex 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 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 (ANDA088799) 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.

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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.