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Hydrocortisone

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Active ingredient
Hydrocortisone 10–25 mg
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 1973
Label revision date
January 12, 2026
FDA Insert
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10–25 mg
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 1973
Label revision date
January 12, 2026
Manufacturer
Crown Laboratories
Registration number
ANDA080706
NDC roots
0316-0186, 0316-0193
FDA Insert
Prescribing information, PDF file
Packaging Info (5 NDCs)
Packaging & NDC Codes (5)

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 corticosteroid, which is a type of synthetic steroid used to reduce inflammation and relieve itching. It works by being absorbed through the skin, where it can help treat various skin conditions that respond to corticosteroids. Hydrocortisone is commonly used in creams, available in different strengths, to address inflammatory and itchy skin issues.

When applied, hydrocortisone can penetrate the skin more effectively, especially when used with occlusive dressings, which can enhance its absorption. This makes it a valuable option for treating stubborn skin conditions that may not respond to other treatments.

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) associated with these medications, making them a safer option for many individuals. Always consult with your healthcare provider to determine the best treatment for your specific skin condition.

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. It's important to follow this schedule to help manage your symptoms effectively.

If you're dealing with psoriasis or other stubborn skin conditions, you might consider using occlusive dressings, which are coverings that help keep the medication in place and enhance its effectiveness. However, if you notice any signs of infection, such as increased redness or pus, you should stop using the occlusive dressings immediately and consult your healthcare provider for appropriate antimicrobial (infection-fighting) treatment.

What to Avoid

If you have a history of allergic reactions (hypersensitivity) 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. If you have a skin infection, it's important to use the right antifungal or antibacterial medication first. Do not continue using the corticosteroid until the infection is properly managed and you see improvement.

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 folliculitis (inflammation of hair follicles), hypertrichosis (excessive hair growth), acne-like eruptions, and changes in skin color. In some cases, you might also notice perioral dermatitis (a rash around the mouth), allergic contact dermatitis, skin maceration (softening), secondary infections, skin thinning, stretch marks, and miliaria (heat rash).

It's important to be aware that using topical corticosteroids can lead to systemic absorption, which may cause issues like HPA (hypothalamic-pituitary-adrenal) axis suppression, Cushing’s syndrome, high blood sugar, and glucosuria (sugar in urine). In children, there are additional risks, including growth delays and signs of increased pressure in the brain, such as headaches and bulging fontanelles (soft spots on a baby’s head). If you notice any concerning symptoms, please consult your healthcare provider.

Warnings and Precautions

Using topical corticosteroids can lead to some serious side effects, especially if used improperly. You should be aware that these medications can affect your body's hormone levels, potentially leading to conditions like Cushing’s syndrome (a hormonal disorder) or 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). Children may absorb more of these medications and could be at greater risk for side effects.

If you are using a potent topical steroid on a large area or under a dressing, your doctor may recommend tests to check your hormone levels, such as the urinary free cortisol test or ACTH stimulation test. If you notice any irritation, stop using the steroid and consult your doctor for alternative treatments. Additionally, if you have a skin infection, it’s important to treat that with the appropriate antifungal or antibacterial medication before continuing with the corticosteroid. If you don’t see improvement in your skin condition quickly, stop using the steroid until the infection is under control.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, if you suspect that you or someone else may have taken too much of a medication, it’s important to be aware of potential signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms, or if you have concerns about a possible overdose, seek immediate medical help. You can contact your local emergency services or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any risks.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with corticosteroids, which are a type of medication. These drugs are classified as Pregnancy Category C, meaning that while they may be necessary for certain conditions, they have shown potential risks in animal studies, including the possibility of causing birth defects (teratogenic effects). There is limited research on the effects of topical corticosteroids (applied to the skin) in pregnant women, so their safety is not fully established.

You should only use topical corticosteroids during pregnancy if your healthcare provider believes the benefits outweigh the risks to your baby. It's advisable to avoid using these medications extensively, in large amounts, or for long periods while pregnant. Always consult with your doctor before starting or continuing any medication during pregnancy to ensure the best care for 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) are less clear, as it is not known if they can be absorbed into the bloodstream in significant amounts to appear in breast milk.

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 is due to their larger skin surface area relative to their body weight. In some cases, using these medications 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 hormonal disorder caused by high levels of cortisol).

To minimize risks, you should use the smallest amount of topical corticosteroid necessary to effectively treat your child's condition. Be vigilant for signs of potential side effects, which can include slowed growth, delayed weight gain, and symptoms of increased pressure in the brain, such as headaches or 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

When it comes to using this medication in older adults, there is no specific information available about how it may affect you or if any dosage adjustments are necessary. This means that the safety and effectiveness of the medication for elderly patients have not been clearly established.

If you are an older adult or a caregiver, it's important to consult with a healthcare professional before starting this medication. They can provide guidance tailored to your individual health needs and help ensure that you are using the medication safely.

Renal Impairment

If you have kidney issues, it's important to be aware that corticosteroids, which are often used to treat various conditions, are processed mainly in the liver and then eliminated by the kidneys. Some topical corticosteroids can also be found in bile. When using these medications, especially in large amounts or under a covering, you may need to be monitored for potential suppression of the hypothalamic-pituitary-adrenal (HPA) axis, a system that helps regulate hormones in your body.

To check for HPA axis suppression, your doctor may recommend tests like urinary free cortisol and ACTH stimulation tests. If any suppression is detected, your healthcare provider might suggest reducing the dosage, changing to a less potent steroid, or stopping the medication altogether. Fortunately, most people recover quickly and completely from HPA axis suppression once the corticosteroid is discontinued, although some may experience withdrawal symptoms that could require additional treatment with systemic corticosteroids.

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. Some of these medications can also affect your body's hormone regulation, specifically the hypothalamic-pituitary-adrenal (HPA) axis, which is responsible for managing stress responses and other functions. This can be a concern for you if you have hepatic impairment (liver issues).

If you are using a strong topical corticosteroid over a large area of your skin or under a covering, your doctor may recommend regular checks to monitor your hormone levels. This can involve tests like measuring urinary free cortisol and conducting ACTH stimulation tests. If any suppression of the HPA axis is detected, your healthcare provider may suggest reducing the medication, changing to a less potent steroid, or stopping the treatment altogether. The good news is that your hormone function usually returns to normal quickly after stopping the medication.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20 to 25 °C (68 to 77 °F), which is considered a controlled room temperature according to the United States Pharmacopeia (USP). This helps maintain the quality of the device.

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

Additional Information

If you're concerned about the function of your adrenal glands, which are part of the hypothalamic-pituitary-adrenal (HPA) axis, certain tests can help evaluate their activity. The urinary free cortisol test measures the amount of cortisol (a hormone produced by the adrenal glands) in your urine, while the ACTH stimulation test assesses how well your adrenal glands respond to adrenocorticotropic hormone (ACTH). These tests can provide valuable information about your adrenal health.

FAQ

What is hydrocortisone?

Hydrocortisone is a topical corticosteroid used as an anti-inflammatory and antipruritic agent.

What are the indications for using hydrocortisone?

Hydrocortisone is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

How should hydrocortisone be applied?

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

What are the potential side effects of hydrocortisone?

Local adverse reactions may include burning, itching, irritation, dryness, and skin atrophy, among others.

Are there any contraindications for using hydrocortisone?

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

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

If irritation develops, discontinue use of hydrocortisone and consult your doctor for appropriate therapy.

Can hydrocortisone be used during pregnancy?

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

Is hydrocortisone safe for pediatric patients?

Pediatric patients may be more susceptible to systemic effects, so hydrocortisone should be used at the lowest effective dose.

What are the storage conditions for hydrocortisone?

Store hydrocortisone at 20 - 25 °C (68 - 77 °F) to maintain its effectiveness.

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 chemically identified as pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-, (11β)-. Its molecular formula is C21H30O5, with a molecular weight of 362.47 g/mol. Hydrocortisone Cream USP is available in two strengths: 1% and 2.5%. Each gram of Hydrocortisone Cream USP, 1%, contains 10 mg of hydrocortisone USP, formulated in a cream base that includes purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate, and sorbic acid. Each gram of Hydrocortisone Cream USP, 2.5%, contains 25 mg of hydrocortisone USP, also in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate, and sorbic acid.

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

Topical corticosteroids should be applied to the affected area as a thin film, with the frequency of application ranging from two to four times daily, contingent upon the severity of the condition being treated.

For the management of psoriasis or other recalcitrant conditions, occlusive dressings may be utilized to enhance the efficacy of the treatment. 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.

In cases where irritation develops, the use of topical corticosteroids should be discontinued, and appropriate therapy should be initiated. The presence of dermatological infections necessitates the use of an appropriate antifungal or antibacterial agent. If a favorable response to treatment does not occur 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.

Pediatric patients are particularly at risk, as they may absorb larger amounts of topical corticosteroids relative to their body size, increasing their susceptibility to systemic toxicity.

Patients receiving high doses of potent topical steroids, especially when applied to large areas or under occlusive dressings, should undergo periodic evaluations for signs of HPA axis suppression. Recommended laboratory tests for this assessment include the urinary free cortisol test and the ACTH stimulation test. Should HPA axis suppression be detected, it is advisable to consider withdrawing the medication, reducing the frequency of application, or switching to a less potent steroid. Typically, recovery of HPA axis function occurs promptly and completely upon discontinuation of the corticosteroid; however, in rare cases, withdrawal symptoms may arise, necessitating the use of supplemental systemic corticosteroids.

In instances of irritation, the use of topical corticosteroids should be halted, and appropriate alternative therapies should be initiated. Furthermore, if dermatological infections are present, it is essential to implement suitable antifungal or antibacterial treatments. Should there be no prompt improvement, the corticosteroid should be discontinued until the infection is adequately managed.

Side Effects

Patients may experience a range of local adverse reactions associated with the use of topical corticosteroids. Common local reactions include burning, itching, irritation, and dryness. Other local effects may include folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infections, skin atrophy, striae, and miliaria.

In addition to local reactions, systemic absorption of topical corticosteroids has been observed, leading to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression in some patients. This may manifest as Cushing’s syndrome, hyperglycemia, and glucosuria. Patients may also experience signs and symptoms of steroid withdrawal, which could necessitate the use of supplemental systemic corticosteroids.

Particular caution is warranted in pediatric patients, as reports indicate that they may be at risk for HPA axis suppression, Cushing’s syndrome, and intracranial hypertension when receiving topical corticosteroids. Manifestations of adrenal suppression in children can include linear growth retardation, delayed weight gain, low plasma cortisol levels, and an absence of response to ACTH stimulation. Symptoms of intracranial hypertension may present as bulging fontanelles, headaches, and bilateral papilledema.

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

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.

In children, manifestations of adrenal suppression 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 consider that chronic corticosteroid therapy may adversely affect the growth and development of pediatric patients.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

Corticosteroids are classified as Pregnancy Category C, indicating that they may pose risks to fetal development. Animal studies have demonstrated teratogenic effects associated with systemic administration of corticosteroids at relatively low dosages. Additionally, more potent corticosteroids have shown teratogenicity following dermal application in laboratory animals.

Currently, there are no adequate and well-controlled studies in pregnant women to assess the teratogenic effects of topically applied corticosteroids. Therefore, the use of topical corticosteroids during pregnancy should be considered only when the potential benefits outweigh the potential risks to the fetus.

Healthcare professionals are advised to avoid extensive use of corticosteroids in pregnant patients, particularly in large amounts or for prolonged periods, 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 following discontinuation of the corticosteroid. However, in rare cases, signs and symptoms of steroid withdrawal may manifest, which may require the administration of supplemental systemic corticosteroids.

Hepatic Impairment

Corticosteroids are primarily metabolized in the liver, with subsequent excretion occurring via the kidneys. In patients with hepatic impairment, the metabolism of corticosteroids may be affected, leading to potential alterations in drug efficacy and safety. Additionally, some topical corticosteroids and their metabolites are excreted into the bile, which may further complicate their use in this population.

Systemic absorption of topical corticosteroids has been associated with reversible hypothalamic-pituitary-adrenal (HPA) axis suppression. This is particularly concerning for patients with compromised liver function, as their ability to metabolize these agents may be diminished. Therefore, patients receiving a large dose of a potent topical steroid, especially when applied to a large surface area or under an occlusive dressing, should be monitored periodically for signs of HPA axis suppression. Monitoring can be conducted through urinary free cortisol and ACTH stimulation tests.

In cases where HPA axis suppression is detected, it is recommended to withdraw the corticosteroid, reduce the frequency of application, or consider substituting a less potent steroid. Fortunately, recovery of HPA axis function is generally prompt and complete upon discontinuation of the corticosteroid. Careful consideration and monitoring are essential when treating patients with hepatic impairment to ensure their safety and optimize therapeutic outcomes.

Overdosage

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

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or any other unusual clinical manifestations.

Management of an overdose should be tailored to the individual patient and may involve supportive care, symptomatic treatment, and, if applicable, the use of specific antidotes. It is crucial to consult local poison control guidelines and the product's prescribing information for detailed management protocols.

In all instances of suspected overdose, prompt reporting and documentation are recommended to ensure patient safety and to facilitate further investigation into the incident.

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, 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 use of occlusive dressings.

Pediatric patients may experience a higher degree of systemic absorption of topical corticosteroids, making them more susceptible to systemic toxicity. Reports indicate that HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have occurred in pediatric patients treated with 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 may present as bulging fontanelles, headaches, and bilateral papilledema.

Local adverse reactions associated with topical corticosteroids have been reported infrequently, but may occur more frequently when occlusive dressings are used. 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.

For reporting suspected adverse reactions, individuals are encouraged to contact Crown Laboratories, Inc. at 1-423-926-4413 or the FDA at 1-800-FDA-1088 or visit https://www.fda.gov/Safety/MedWatch/.

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 patients to understand that this medication should not be used for any condition other than the specific disorder for which it was prescribed. Providers should emphasize the necessity of adhering to the prescribed treatment plan.

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. This is crucial to prevent potential adverse effects.

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

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. Such garments may act as occlusive dressings, which could lead to increased risk of adverse reactions.

Storage and Handling

The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a controlled room temperature of 20 to 25 °C (68 to 77 °F), as defined by the United States Pharmacopeia (USP). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

Clinicians may consider utilizing specific tests to evaluate hypothalamic-pituitary-adrenal (HPA) axis suppression in patients. The urinary free cortisol test and the ACTH stimulation test are recommended as potentially helpful diagnostic tools in this assessment.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Hydrocortisone as submitted by Crown Laboratories. 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 (ANDA080706) 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.