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Hydrocortisone

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This product has been discontinued

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 2018
Label revision date
July 25, 2018
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 2018
Label revision date
July 25, 2018
Manufacturer
Teligent Pharma, Inc.
Registration number
ANDA203810
NDC root
52565-004
FDA Insert
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Hydrocortisone Cream 2.5% is a topical corticosteroid, which means it is a type of medication used to reduce inflammation and relieve itching in the skin. This cream contains hydrocortisone, a synthetic steroid that works by decreasing the immune response in the affected area, helping to alleviate symptoms associated with various skin conditions.

You can use this cream for the treatment of inflammatory and itchy skin conditions that respond to corticosteroids. It is important to apply it only to the skin and not to the eyes. The cream is designed to be absorbed through the skin, and its effectiveness can be enhanced by using occlusive dressings, which help the medication penetrate deeper into the skin.

Uses

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

It's important to note that the information provided does not mention any harmful effects on developing babies (teratogenic effects) or other non-harmful effects. This means that, based on the available data, these medications are considered safe in that regard. Always consult with your healthcare provider for personalized advice and treatment options.

Dosage and Administration

You should apply the medication to the affected area as a thin film, doing this 2 to 4 times each day. The exact number of applications depends on how severe your condition is.

If you are dealing with psoriasis or other stubborn skin issues, you can use occlusive dressings (coverings that keep the medication in place and enhance its effectiveness) to help manage your symptoms. However, if you notice any signs of infection, it’s important to stop using these dressings and seek appropriate treatment with antimicrobial (infection-fighting) therapy.

What to Avoid

You should avoid using topical corticosteroids if you have a history of hypersensitivity (allergic reactions) to any of the ingredients in the medication. It’s important to use this medication only for the specific condition your doctor prescribed it for. Do not cover the treated area with bandages or tight clothing unless your physician instructs you to do so. For children, avoid using tight-fitting diapers or plastic pants in the treated area, as these can trap the medication and increase absorption.

Be aware that using topical corticosteroids improperly can lead to serious side effects, including hormonal imbalances and increased blood sugar levels. If you notice any irritation or if your condition does not improve, stop using the medication and consult your doctor. Children may be at a higher risk for side effects due to their skin's ability to absorb more of the medication. Always follow your healthcare provider's instructions to minimize risks associated with misuse or dependence on these medications.

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), acne-like eruptions, and changes in skin color. In some cases, you might notice skin thinning, stretch marks, or secondary infections. If you develop irritation, it's important to stop using the medication and seek appropriate treatment.

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. Children may be more vulnerable to these effects, including growth delays and signs of increased pressure in the brain, like headaches. If you notice any concerning symptoms, especially signs of infection or steroid withdrawal, consult your healthcare provider for guidance.

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. This risk is 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 are using a strong topical steroid on a large area of your body 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. Be especially cautious if you are treating a child, as they may absorb more of the medication and be at greater risk for side effects.

Overdose

When using topical corticosteroids (medications applied to the skin to reduce inflammation), it's important to be aware that they can sometimes be absorbed into your bloodstream in amounts that may lead to systemic effects (effects throughout the body). This means that while these medications are intended for localized treatment, they can potentially impact other areas of your health if used excessively or improperly.

If you suspect an overdose, look for signs such as unusual changes in mood, weight gain, or increased blood sugar levels. If you experience any of these symptoms or have concerns about your use of topical corticosteroids, it’s crucial to seek medical advice promptly. Always consult your healthcare provider for guidance on the appropriate use of these medications and what to do if you think you may have used too much.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be aware of the potential risks associated with corticosteroids. These medications are classified as Pregnancy Category C, meaning that while they may be necessary for certain conditions, their effects on a developing fetus are not fully understood. Laboratory studies have shown that corticosteroids can cause birth defects (teratogenic effects) in animals, even at low doses, and more potent forms have shown similar risks when applied to the skin.

Due to the lack of adequate studies in pregnant women, topical corticosteroids should only be used if the benefits outweigh the risks to your baby. It's advisable to avoid using these medications extensively, in large amounts, or for long periods during pregnancy. Always consult your healthcare provider to discuss the best options for your health and the health of 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 less clear, as it is not known 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 the best options for your situation and 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 side effects, such as adrenal suppression (a condition where the body doesn't produce enough hormones) and Cushing's syndrome (a disorder caused by high cortisol levels). These risks are partly due to children's larger skin surface area relative to their body weight.

To minimize these risks, you should use the smallest amount of the medication necessary to effectively treat your child's condition. Be vigilant for signs of potential side effects, which can include slowed growth, delayed weight gain, low cortisol levels, headaches, and bulging fontanelles (the soft spots on a baby's head). If you notice any concerning symptoms, consult your child's healthcare provider promptly.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. As you age, your body may process medications differently, and factors like kidney function (renal impairment) and changes in cognition can affect how well a drug works or how it may impact you.

If you are an older adult or a caregiver, it’s wise to discuss any concerns with your healthcare provider. They can help determine the best approach for your individual health needs, ensuring that any medication you take is safe and effective for you. Always keep your doctor informed about all medications you are taking, as this can help prevent potential interactions or side effects.

Renal Impairment

If you have kidney issues, it's important to be aware that corticosteroids, which are often used to treat various conditions, are primarily processed in the liver and then excreted by the kidneys. When using topical corticosteroids, especially in large amounts or under occlusive dressings (which trap the medication against the skin), there is a risk of affecting your body's hormone balance, specifically the hypothalamic-pituitary-adrenal (HPA) axis. This may require monitoring through tests like urinary free cortisol and ACTH stimulation tests.

If any signs of HPA axis suppression are detected, your healthcare provider may suggest reducing the steroid's use, switching to a less potent option, or even stopping the medication altogether. Occasionally, you might experience withdrawal symptoms, which could necessitate additional systemic corticosteroids (medications that work throughout the body). If you are nursing, be cautious, as it’s unclear whether topical corticosteroids can enter breast milk in significant amounts. Always consult your healthcare provider for personalized advice and monitoring.

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 also be absorbed into your bloodstream, potentially affecting your body's hormone levels. This can lead to a condition called hypothalamic-pituitary-adrenal (HPA) axis suppression, which may require monitoring through specific tests, such as urinary free cortisol and ACTH stimulation tests.

If you are using a strong topical steroid over a large area of your skin or under a bandage, your healthcare provider may want to check for signs of HPA axis suppression regularly. If any issues are found, they might suggest reducing the amount you use, changing how often you apply it, or switching to a less potent steroid. Always discuss your treatment plan with your doctor to ensure it’s safe for your liver health.

Drug Interactions

It's important to be aware that using strong topical corticosteroids (medications applied to the skin) can sometimes lead to serious side effects, such as affecting your body's hormone levels. This can result in conditions like Cushing's syndrome, high blood sugar, and other health issues, especially if the medication is used over large areas of skin, for a long time, or covered with a bandage.

If you are using a potent topical steroid, your healthcare provider may recommend regular check-ups to monitor your hormone levels. Tests like the urinary free cortisol test and ACTH stimulation test can help assess whether your body’s hormone production is being affected. Always discuss any medications or tests 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° to 25°C (68° to 77°F). It’s acceptable for the temperature to occasionally range from 15° to 30°C (59° to 86°F), but try to keep it within the recommended limits as much as possible.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any specific instructions provided for use to ensure safety and effectiveness. If you have any questions about storage or handling, don’t hesitate to reach out for guidance.

Additional Information

You may need to undergo certain laboratory tests, such as a urinary free cortisol test or an ACTH stimulation test, as part of your treatment plan. It's important to use this medication exactly as your doctor prescribes. Remember, it is for external use only, so avoid getting it in your eyes. Do not use it for any condition other than what your doctor has recommended.

When applying the medication, do not cover the treated area with bandages or wraps unless your doctor instructs you to do so. If you notice any unusual reactions, especially when using occlusive dressings, inform your doctor right away. If you are a parent treating a child in the diaper area, avoid using tight-fitting diapers or plastic pants, as these can trap moisture and worsen the condition.

FAQ

What is Hydrocortisone Cream 2.5% used for?

Hydrocortisone Cream 2.5% is 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.

Can I use occlusive dressings with Hydrocortisone Cream?

Occlusive dressings may be used for managing psoriasis or recalcitrant conditions, but should be discontinued if an infection develops.

What are the possible local side effects of using Hydrocortisone Cream?

Local side effects may include burning, itching, irritation, dryness, and other skin reactions.

Are there any systemic side effects associated with Hydrocortisone Cream?

Yes, systemic absorption can lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, hyperglycemia, and glucosuria.

Is Hydrocortisone Cream safe to use during pregnancy?

Hydrocortisone Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

What precautions should I take when using Hydrocortisone Cream on children?

Children may absorb larger amounts of the cream and be more susceptible to systemic toxicity, so use the least amount necessary for effective treatment.

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

If irritation develops, you should discontinue use and consult your physician for appropriate therapy.

Can I use Hydrocortisone Cream for any skin condition?

No, you should only use this medication for the specific disorder for which it was prescribed.

How should I store Hydrocortisone Cream?

Store the cream at 20° to 25°C (68° to 77°F), with excursions permitted between 15° - 30°C (59° - 86°F).

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 Cream 2.5% is a topical formulation that contains hydrocortisone, a synthetic corticosteroid recognized for its anti-inflammatory and antipruritic properties. The active ingredient, hydrocortisone, is characterized as a white to practically white crystalline powder with the chemical structure of pregn-4-ene-3,20-dione, 11, 17,21-trihydroxy-, (11β)-. Each gram of the cream delivers 25 mg of hydrocortisone, incorporated in a base that includes glyceryl monostearate, polyoxyl 40 stearate, glycerin, paraffin, stearyl alcohol, isopropyl palmitate, sorbitan monostearate, potassium sorbate, lactic acid, methylparaben, propylparaben, and purified water.

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 a variety of skin disorders that respond positively to corticosteroid treatment.

There are no teratogenic or nonteratogenic effects noted in the available data.

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, if an infection occurs, 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.

This medication should only be used for the specific disorder for which it was prescribed. The treated skin area must not be bandaged or covered in an occlusive manner unless directed by a physician. In pediatric patients, tight-fitting diapers or plastic pants should not be used in the diaper area during treatment, as these may act as occlusive dressings.

Topical corticosteroids should be discontinued if irritation develops, and appropriate therapy should be initiated. If there is no favorable response in the presence of dermatological infections, the corticosteroid should be discontinued until the infection is adequately controlled.

Systemic absorption of topical corticosteroids can lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, hyperglycemia, and glucosuria. Conditions that may increase systemic absorption include the use of more potent steroids, application over large surface areas, prolonged use, and the use of occlusive dressings.

Signs and symptoms of steroid withdrawal may infrequently occur, necessitating supplemental systemic corticosteroids. Children may absorb larger amounts of topical corticosteroids relative to their body size, increasing their risk of systemic toxicity.

Warnings and Precautions

Systemic absorption of topical corticosteroids has been associated with reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, which may manifest as Cushing's syndrome, hyperglycemia, and glucosuria in certain patients. Factors that can enhance systemic absorption include the use of more potent steroids, application over extensive surface areas, prolonged treatment duration, and the use of occlusive dressings. In cases where irritation occurs, it is imperative to discontinue the use of topical corticosteroids and initiate appropriate therapeutic measures.

In instances of dermatological infections, it is essential to employ an appropriate antifungal or antibacterial agent. Should there be a lack of prompt favorable response, the corticosteroid treatment must 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. Recommended monitoring parameters include urinary free cortisol and ACTH stimulation tests. If evidence of 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.

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. Therefore, careful consideration and monitoring are warranted in pediatric patients.

To assess HPA axis suppression, the following laboratory tests may be beneficial:

  • Urinary free cortisol test

  • ACTH stimulation test

Healthcare professionals should remain vigilant in monitoring patients for potential adverse effects associated with topical corticosteroid use, particularly in those at higher risk.

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 may 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. If irritation develops, it is recommended that topical corticosteroids be discontinued and appropriate therapy instituted. In cases where dermatological infections are present, the use of an appropriate antifungal or antibacterial agent should be initiated. Should a favorable response 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, and glucosuria.

Pediatric patients are noted to have a greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome. Manifestations of adrenal suppression in this population may include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Additionally, signs of intracranial hypertension, such as bulging fontanelles, headaches, and bilateral papilledema, may also be observed in pediatric patients.

It is important to note that signs and symptoms of steroid withdrawal may occur, necessitating the use of supplemental systemic corticosteroids.

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 advisable to conduct periodic evaluations for signs of HPA axis suppression. Recommended assessments include the urinary free cortisol test and the ACTH stimulation test, which can provide valuable information regarding the patient's HPA axis function. Regular monitoring is essential to mitigate potential adverse effects associated with systemic absorption of these medications.

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 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 consider 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

Pregnancy Category C. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Additionally, more potent corticosteroids have demonstrated teratogenic effects following dermal application in animal studies. However, there are no adequate and well-controlled studies in pregnant women to assess the teratogenic effects of topically applied corticosteroids.

Topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is recommended that drugs of this class not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time to minimize potential risks to 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.

For patients receiving large doses of potent topical steroids applied to extensive areas or under occlusive dressings, periodic evaluation for HPA axis suppression is recommended. This can be assessed through urinary free cortisol and ACTH stimulation tests. Should HPA axis suppression be detected, it is advisable to consider withdrawing the corticosteroid, reducing the frequency of application, or substituting with a less potent steroid.

Additionally, there is a potential for signs and symptoms of steroid withdrawal to manifest, which may require the administration of supplemental systemic corticosteroids. Caution is also warranted when administering topical corticosteroids to nursing women, as the potential for systemic absorption and subsequent presence in breast milk is not fully understood.

Hepatic Impairment

Corticosteroids are primarily metabolized in the liver and subsequently excreted by the kidneys. In patients with hepatic impairment, caution is advised when administering topical corticosteroids, as their metabolism and clearance may be affected. Some topical corticosteroids and their metabolites are also excreted into the bile, which further underscores the need for careful consideration in this patient population.

Systemic absorption of topical corticosteroids has been associated with reversible hypothalamic-pituitary-adrenal (HPA) axis suppression. Therefore, patients with hepatic impairment who are receiving a large dose of a potent topical steroid, particularly when applied to a large surface area or under an occlusive dressing, should be periodically evaluated for signs of HPA axis suppression. This evaluation may include monitoring urinary free cortisol levels and conducting ACTH stimulation tests.

In cases where HPA axis suppression is detected, it is recommended to consider withdrawing the corticosteroid, reducing the frequency of application, or substituting a less potent steroid. Regular monitoring and appropriate adjustments are essential to ensure the safety and efficacy of treatment in patients with compromised liver function.

Overdosage

Topically applied corticosteroids have the potential to be absorbed in quantities sufficient to elicit systemic effects. Healthcare professionals should be aware that overdosage may occur, particularly with prolonged use or application over large surface areas.

In the event of suspected overdosage, it is crucial to monitor 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. Healthcare providers should assess the severity of symptoms and may consider additional interventions based on the clinical presentation. Regular monitoring of the patient's condition is recommended to ensure appropriate recovery and to mitigate any long-term effects associated with 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 potential risks to the fetus. It is advised that drugs within this class not be used extensively on pregnant patients, in large quantities, 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, 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 applied to extensive areas or under occlusive dressings should be periodically evaluated for signs of HPA axis suppression, utilizing urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is detected, it is recommended to consider withdrawing the drug, reducing the frequency of application, or substituting a less potent steroid. Infrequently, signs and symptoms of steroid withdrawal may occur, necessitating the use of supplemental systemic corticosteroids.

Pediatric patients may exhibit increased susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome compared to adults, attributed to a larger skin surface area relative to body weight. Reports indicate that pediatric patients 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 lack of response to ACTH stimulation. Symptoms of intracranial hypertension may present as bulging fontanelles, headaches, and bilateral papilledema.

Local adverse reactions associated with topical corticosteroids, although reported infrequently, may occur more frequently 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

Patients should be instructed to use this medication strictly as directed by their physician, emphasizing that it is intended for external use only. They must be cautioned to avoid contact with the eyes to prevent irritation or injury.

Healthcare providers should advise patients not to use this medication for any condition other than the specific disorder for which it was prescribed. It is important to ensure that patients understand the necessity of adhering to this guidance to avoid potential complications.

Patients should be informed that the treated skin area should not be bandaged or covered in a manner that creates an occlusive dressing unless specifically directed by their physician. This is crucial to prevent adverse effects and ensure the medication works effectively.

Additionally, patients should be encouraged to report any signs of local adverse reactions, particularly if they occur under an occlusive dressing. Prompt reporting can facilitate timely management of any issues that may arise.

For parents of pediatric patients, it is essential to advise against the use of tight-fitting diapers or plastic pants on children being treated in the diaper area. These garments can act as occlusive dressings, potentially leading to increased risk of adverse reactions.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). Temporary excursions are permitted between 15° and 30°C (59° to 86°F), in accordance with USP Controlled Room Temperature guidelines. Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

Laboratory tests relevant for monitoring include the urinary free cortisol test and the ACTH stimulation test.

Clinicians should counsel patients on the proper use of the medication, emphasizing that it is for external use only and should be applied as directed by the physician. Patients must avoid contact with the eyes and should not use the medication for any condition other than the one prescribed. The treated area should not be covered with occlusive dressings unless specifically instructed by the physician. Patients are advised to report any local adverse reactions, particularly when using occlusive dressings. Additionally, parents of pediatric patients should refrain from using tight-fitting diapers or plastic pants in the diaper area during treatment, as these may act as occlusive dressings.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Hydrocortisone as submitted by Teligent Pharma, Inc.. 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 (ANDA203810) 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

Last AI update:

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.