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Hydrocortisone

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Active ingredient
Hydrocortisone 25 mg/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
Route
Topical
Prescription status
Rx (prescription)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
October 10, 2025
FDA Insert
Prescribing information, PDF file
Active ingredient
Hydrocortisone 25 mg/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
Route
Topical
Prescription status
Rx (prescription)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
October 10, 2025
Manufacturer
Sportpharm, Inc. dba Sportpharm
Registration number
ANDA080706
NDC root
85766-085
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 corticosteroid, which means it is a synthetic steroid used to reduce inflammation and relieve itching. It is commonly found in creams and is effective for treating various skin conditions that respond to corticosteroids. When applied to the skin, hydrocortisone works by being absorbed through the skin barrier, where it helps to alleviate symptoms associated with inflammatory skin disorders.

This medication is particularly useful for conditions that cause redness, swelling, and discomfort. By reducing inflammation, hydrocortisone can help improve the overall appearance and feel of affected skin areas.

Uses

Topical corticosteroids are used to help relieve inflammation and itching associated with certain skin conditions that respond to corticosteroid treatment. These conditions, known as corticosteroid-responsive dermatoses, can cause discomfort and irritation, and topical corticosteroids can provide effective relief.

It's important to note that the information provided does not mention any teratogenic effects (which are harmful effects on a developing fetus) or nonteratogenic effects, meaning that there are no known risks of these types associated with the use of topical corticosteroids.

Dosage and Administration

To use this medication effectively, apply a thin layer to the affected area of your skin. You should do this two to four times a day, depending on how severe your condition is. For certain skin issues like psoriasis or stubborn conditions, you can use occlusive dressings (coverings that keep the medication in place) to help manage your symptoms.

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

What to Avoid

If you have a history of 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 the situation. Always prioritize your health and consult with a healthcare professional if you have any concerns.

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 also notice skin thinning, stretch marks, or secondary infections.

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 more serious effects, including growth delays and increased pressure in the brain, which can manifest as headaches or bulging fontanelles (soft spots on a baby’s head). If you notice any signs of steroid withdrawal, you may need additional corticosteroids. Always consult your healthcare provider if you have concerns about these side effects.

Warnings and Precautions

Using topical corticosteroids can sometimes lead to serious side effects, including a condition called hypothalamic-pituitary-adrenal (HPA) axis suppression, which can affect your body’s hormone levels. This risk increases if you use strong steroids over large areas of skin, for long periods, 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 or 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. In children, be especially cautious, as they may absorb more of the medication and be at higher risk for side effects. If you experience symptoms of steroid withdrawal after stopping the medication, such as fatigue or weakness, contact your healthcare provider, as you may need additional treatment. Always seek emergency help if you have severe reactions or worsening symptoms.

Overdose

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

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

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with the use of corticosteroids. These medications are classified as Pregnancy Category C, meaning that while they may be necessary for certain conditions, their safety during pregnancy has not been fully established. Laboratory studies have shown that corticosteroids can cause developmental issues (teratogenic effects) in animals, even at low doses.

Because there are no well-controlled studies in pregnant women regarding the effects of topically applied corticosteroids, you should only use them if your healthcare provider believes the benefits outweigh the potential risks to your baby. It's also advised to avoid using these medications extensively, in large amounts, or for long periods during pregnancy. Always consult with your healthcare provider before starting or continuing any medication while pregnant.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware of how corticosteroids may affect you and your baby. While it is unclear whether applying corticosteroids to the skin can lead to enough absorption into your bloodstream to appear in breast milk, systemic (taken into the body) corticosteroids are known to be present in breast milk in amounts that are unlikely to harm your infant.

However, it's wise to be cautious when using topical corticosteroids (medications applied to the skin) 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 baby.

Pediatric Use

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

You should watch for signs of these issues, which can include slowed growth, delayed weight gain, low cortisol levels, headaches, and bulging fontanelles (the soft spots on a baby’s head). To minimize risks, use the smallest amount of topical corticosteroid necessary to effectively treat your child's condition, and be cautious with long-term use, as it may affect their growth and development. Always consult your child's healthcare provider for guidance on safe usage.

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. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach for your individual health needs, especially since older adults may have different responses to medications compared to younger individuals. Always keep an open line of communication with your doctor about any changes in health or medication 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 processed mainly in the liver and then eliminated by the kidneys. Some topical corticosteroids can also be absorbed into the bloodstream, potentially affecting your body's hormone regulation system, known as the hypothalamic-pituitary-adrenal (HPA) axis. This may require monitoring, especially if you are using a strong topical steroid over a large area of skin or under a bandage.

To ensure your safety, your healthcare provider may periodically check for signs of HPA axis suppression through tests like urinary free cortisol and ACTH stimulation tests. If any suppression is detected, your doctor might suggest reducing the steroid dose, changing to a less potent option, or stopping the medication altogether. Fortunately, most people see a quick and complete recovery of their hormone function once the corticosteroid is discontinued.

Hepatic Impairment

If you have liver problems, it's important to be aware that corticosteroids, which are medications often used to reduce inflammation, are mainly processed in your liver. Some of these medications can also be found in your bile, which is produced by the liver. If you are using a strong topical corticosteroid over a large area of your skin or under a covering, you may need to have your hormone levels checked regularly. This is because these medications can affect your body's hormone balance, particularly the hypothalamic-pituitary-adrenal (HPA) axis, which helps regulate stress responses and other functions.

For those with liver impairment, the effects of corticosteroids can be more significant, so close monitoring is essential. Always discuss your treatment plan with your healthcare provider to ensure that your liver function is taken into account and that any necessary adjustments to your medication or monitoring schedule are made.

Drug Interactions

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

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

Storage and Handling

To ensure the best performance and safety of your product, store it at a 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 temperature range helps maintain the integrity of the device.

When handling the product, always do so in a clean environment to avoid contamination. Make sure to follow any specific disposal instructions provided to ensure safe and responsible disposal of any components. By adhering to these guidelines, you can help ensure the product remains effective and safe for use.

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 level 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 insights into your adrenal health.

FAQ

What is Hydrocortisone?

Hydrocortisone is a topical corticosteroid used as an anti-inflammatory and antipruritic agent. It is a synthetic steroid with the chemical formula C21H30O5.

How should I apply 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 side effects may include reversible hypothalamic-pituitary-adrenal (HPA) axis suppression and hyperglycemia.

Can I use Hydrocortisone if I am pregnant?

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

Is Hydrocortisone safe for children?

Children may be more susceptible to systemic toxicity from topical corticosteroids, including HPA axis suppression and Cushing’s syndrome, so use should be limited to the least amount necessary.

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

If irritation develops, discontinue 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° to 25°C (68° to 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 pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-, (11β)-. Its molecular formula is C21H30O5, and it has a molecular weight of 362.47 g/mol. Hydrocortisone Cream USP, 2.5% contains 25 mg of hydrocortisone USP per gram, formulated in a cream base that includes 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. 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 frequency 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 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.

In cases of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be initiated. If irritation develops, topical corticosteroids must be discontinued, and if a favorable response to infection treatment does not occur promptly, the corticosteroid should be stopped until the infection is adequately controlled.

Warnings and Precautions

Systemic absorption of topical corticosteroids has been associated with reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, which may manifest as Cushing’s syndrome, hyperglycemia, and glucosuria in certain patients. The risk of systemic absorption is heightened under specific conditions, including the use of more potent steroids, application over extensive surface areas, prolonged treatment duration, and the use of occlusive dressings.

Patients who are administered a large dose of a potent topical steroid, particularly when applied to a significant body surface area or under an occlusive dressing, 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 evidence of HPA axis suppression be identified, it is advisable to consider withdrawing the corticosteroid, reducing the frequency of application, or transitioning 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.

It is important to note that children may absorb topical corticosteroids in proportionally larger amounts, rendering them more susceptible to systemic toxicity. In cases where irritation occurs, the use of topical corticosteroids should be discontinued, and appropriate therapeutic measures should be initiated. Furthermore, in the presence of dermatological infections, it is essential to employ an appropriate antifungal or antibacterial agent. If there is no prompt favorable response, the corticosteroid should be discontinued until the infection is adequately managed.

Healthcare professionals are encouraged to remain vigilant regarding these warnings and to utilize the recommended laboratory tests to ensure patient safety during the use of topical corticosteroids.

Side Effects

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

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

Systemic adverse reactions, while less frequent, can be serious. These include reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria.

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

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

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Hydrocortisone.
Details

Pediatric Use

Pediatric patients may exhibit increased susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing’s syndrome compared to mature patients, primarily due to a larger skin surface area relative to body weight. Reports indicate that 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 classified as Pregnancy Category C, indicating that risk cannot be ruled out. Animal studies have demonstrated that corticosteroids can be teratogenic when administered systemically at relatively low dosage levels. Additionally, more potent corticosteroids have shown teratogenic effects following dermal application in laboratory animals. 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 prescribed during pregnancy only if the potential benefits to the mother outweigh the potential risks to the fetus. It is advised that drugs within this class not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time to minimize any potential adverse fetal outcomes.

Lactation

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

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

Renal Impairment

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

Patients receiving large doses of potent topical steroids, especially when applied to extensive areas of the skin or under occlusive dressings, should be periodically evaluated for signs of HPA axis suppression. This evaluation can be conducted using urinary free cortisol and ACTH stimulation tests.

If HPA axis suppression is detected, it is advisable to consider withdrawing the corticosteroid, reducing the frequency of application, or substituting with a less potent steroid. Notably, recovery of HPA axis function is typically prompt and complete following discontinuation of the corticosteroid.

Hepatic Impairment

Corticosteroids are primarily metabolized in the liver and subsequently excreted by the kidneys. In patients with hepatic impairment, the metabolism and excretion 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. This effect may be more pronounced in patients with compromised liver function. Therefore, it is recommended that 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, be evaluated periodically for signs of HPA axis suppression.

Monitoring for HPA axis suppression is essential in this patient population to ensure safety and efficacy of treatment. Adjustments to dosing or treatment regimens may be required based on the clinical assessment and laboratory findings related to liver function.

Overdosage

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

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, altered mental status, cardiovascular instability, or gastrointestinal disturbances.

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

In summary, while specific overdosage data is not available, healthcare professionals should exercise caution, remain alert to the signs of overdose, and implement appropriate management strategies as needed.

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.

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 withdraw the drug, reduce the frequency of application, or switch to a less potent steroid. Recovery of HPA axis function is typically prompt and complete following discontinuation of the drug; however, in rare instances, signs and symptoms of steroid withdrawal may necessitate the use of supplemental systemic corticosteroids.

Pediatric patients may exhibit increased susceptibility to HPA axis suppression and Cushing’s syndrome due to a higher skin surface area to body weight ratio. Reports indicate that HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have occurred in pediatric patients using topical corticosteroids. 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.

Infrequent local adverse reactions associated with topical corticosteroids may occur more frequently with 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.

For reporting suspected adverse reactions, individuals are encouraged to contact ANI Pharmaceuticals, Inc. at 1-800-308-6755 or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Patient Counseling

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

It is essential to advise patients not to use this medication for any condition other than the specific disorder for which it was prescribed. This ensures the medication's efficacy and safety.

Patients should also 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. This is important to minimize the risk of local adverse reactions.

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 medical evaluation or adjustment of treatment.

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. Such garments can act as occlusive dressings, potentially leading to increased risk of adverse effects.

Storage and Handling

The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a temperature range of 20° to 25°C (68° to 77°F), adhering to the guidelines set forth by the United States Pharmacopeia (USP) for Controlled Room Temperature. 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 Sportpharm, Inc. dba Sportpharm. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Hydrocortisone, retrieved by a validated AI data-extraction workflow.

All FDA-approved dosage forms and strengths are listed in the Packaging & NDC Codes section above. Regulatory status, pharmacologic class (EPC), and mechanism of action (MoA) were cross-checked against the FDA Orange Book (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

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.