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Hydrocortisone

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Active ingredient
Hydrocortisone 25 mg/1 g
Other brand names
Drug class
Corticosteroid
Dosage forms
  • Cream
  • Ointment
Route
Topical
Prescription status
Rx (prescription)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2006
Label revision date
January 6, 2026
FDA Insert
Prescribing information, PDF file
Active ingredient
Hydrocortisone 25 mg/1 g
Other brand names
Drug class
Corticosteroid
Dosage forms
  • Cream
  • Ointment
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 2006
Label revision date
January 6, 2026
Manufacturer
Padagis Israel Pharmaceuticals Ltd
Registration numbers
ANDA085027, ANDA085025
NDC roots
45802-004, 45802-014
FDA Insert
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Hydrocortisone Cream USP, 2.5% is a topical medication that contains hydrocortisone, a type of corticosteroid. It is primarily used to relieve inflammation and itching associated with certain skin conditions, known as corticosteroid-responsive dermatosis. This cream works by reducing inflammation and alleviating discomfort, making it helpful for various skin irritations.

When applied to the skin, hydrocortisone can be absorbed and acts similarly to corticosteroids that are taken systemically (through the body). This absorption can be influenced by factors such as the condition of your skin and whether an occlusive dressing (a covering that traps moisture) is used.

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 dermatosis, can cause discomfort and irritation, and using these medications can provide significant 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. Always consult with your healthcare provider for personalized advice and treatment options.

Dosage and Administration

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

However, if you notice any signs of infection, such as increased redness, swelling, or pus, you should stop using the occlusive dressings immediately. In that case, it's important to seek appropriate antimicrobial therapy (medications that fight infections) to address the infection properly. Always follow your healthcare provider's instructions for the best results.

What to Avoid

If you have a history of hypersensitivity (an extreme allergic reaction) to any ingredients in topical corticosteroids, you should not use these medications. It's important to be cautious and discontinue use if you experience any irritation, and seek appropriate treatment for that irritation. Additionally, if you have a dermatological infection, stop using the corticosteroid until the infection is properly managed.

Remember, using topical corticosteroids improperly can lead to issues such as dependence (a condition where your body relies on the medication) or misuse, so always follow your healthcare provider's guidance.

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.

Systemically, this medication can affect your body's hormone levels, potentially leading to conditions like Cushing's syndrome, which may cause symptoms such as weight gain and high blood sugar levels. If you are using this medication on children, be aware that they are more likely to experience these systemic effects, including growth delays and signs of increased pressure in the brain, such as headaches. Additionally, withdrawal symptoms may occur if the medication is stopped suddenly, so it's important to consult your healthcare provider if you have concerns.

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 high blood sugar. This risk increases if you use strong steroids over large areas of skin, for long periods, or with occlusive dressings (coverings that trap moisture). Children are particularly vulnerable to these effects, so it's important to monitor their use closely. If you notice any irritation, stop using the corticosteroid and seek appropriate treatment.

If you're using a potent topical steroid on a large area of skin, your doctor may recommend regular tests, such as the urinary free cortisol test and the ACTH stimulation test, to check for hormone suppression. If these tests indicate a problem, your doctor may suggest reducing the frequency of use or switching to a less potent steroid. Most people recover quickly once the medication is stopped, but some may experience withdrawal symptoms that require additional treatment.

If you develop a skin infection while using a corticosteroid, make sure to use the right antifungal or antibacterial treatment. If you don't see improvement quickly, stop using the corticosteroid until the infection is under control. Always consult your doctor if you have concerns or experience any unusual 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 signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when in doubt, it’s better to err on the side of caution and seek assistance.

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 often used to reduce inflammation. These medications are classified as Pregnancy Category C, meaning that while they may be harmful to a developing fetus in animal studies, there are no well-controlled studies in pregnant women to confirm these effects.

Topical corticosteroids (those applied to the skin) can also pose risks, especially if used in large amounts or for long periods. Therefore, you should only use these medications during pregnancy if your healthcare provider believes the benefits outweigh the potential risks to your baby. Always consult with your doctor before using any corticosteroids while pregnant.

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 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.

To minimize risks, you should use the smallest effective amount of topical corticosteroids for your child. Be vigilant for signs of potential side effects, such as slowed growth, delayed weight gain, low cortisol levels, or symptoms of increased pressure in the brain, like headaches or bulging fontanelles (the soft spots on a baby's head). Chronic use of these medications can affect your child's growth and development, so it's crucial to follow your healthcare provider's guidance closely.

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, which can affect how well they work and the potential for side effects.

If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine if any special precautions or adjustments are needed based on individual health conditions and overall well-being. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney issues, it's important to be aware that corticosteroids, which are often used to treat various conditions, are processed mainly in the liver and then eliminated by the kidneys. Some of these medications can also be absorbed through the skin and may affect your body's hormone regulation, specifically the hypothalamic-pituitary-adrenal (HPA) axis. This can lead to a condition known as HPA axis suppression, which requires careful monitoring.

If you are using a strong topical corticosteroid over a large area of your skin or under a covering, your healthcare provider may recommend regular checks for HPA axis suppression. This can be done through tests that measure cortisol levels in your urine and assess your body's response to stimulation. If any suppression is detected, your doctor may suggest reducing the medication, changing to a less potent steroid, or stopping the treatment altogether. Fortunately, most people recover their normal hormone function quickly after discontinuing the corticosteroid.

Hepatic Impairment

If you have liver problems, it's important to be aware that corticosteroids are mainly processed in your liver and then removed by your kidneys. Some topical corticosteroids can also be found in bile, which is produced by the liver. If you use a strong topical steroid over a large area of your skin or under a covering, your doctor may need to monitor you for potential issues with your body's hormone regulation, specifically the hypothalamic-pituitary-adrenal (HPA) axis. This monitoring can involve 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 stopping the medication altogether. The good news is that if you stop using the corticosteroid, your hormone function typically returns to normal quickly and completely. Always consult your healthcare provider for personalized advice and monitoring.

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 share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20-25°C (68-77°F), which is considered a controlled room temperature. This helps maintain its quality. Additionally, it's important to keep the product out of the reach of children to prevent any accidental misuse or ingestion.

When handling the product, always do so with clean hands and in a safe environment to avoid contamination. Following these guidelines will help you use the product safely and effectively.

Additional Information

If you're concerned about the suppression of your hypothalamic-pituitary-adrenal (HPA) axis, certain tests can help evaluate its function. These include the urinary free cortisol test, which measures cortisol levels in your urine, and the ACTH (adrenocorticotropic hormone) stimulation test, which assesses how well your adrenal glands respond to ACTH. If you have questions about these tests or their implications, it's a good idea to discuss them with your healthcare provider.

FAQ

What is Hydrocortisone Cream USP, 2.5% used for?

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

How should I apply Hydrocortisone Cream USP, 2.5%?

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

What are the common side effects of Hydrocortisone Cream USP, 2.5%?

Common local side effects may include burning, itching, irritation, and dryness. More serious reactions can include skin atrophy and secondary infections.

Are there any contraindications for using Hydrocortisone Cream USP, 2.5%?

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

Can I use Hydrocortisone Cream USP, 2.5% if I have a skin infection?

No, you should discontinue use if a dermatological infection develops until the infection is adequately controlled.

Is Hydrocortisone Cream USP, 2.5% safe to use during pregnancy?

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

What should I do if I experience irritation while using Hydrocortisone Cream USP, 2.5%?

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

What precautions should I take when using Hydrocortisone Cream USP, 2.5%?

Monitor for signs of HPA axis suppression, especially if using a large dose or under an occlusive dressing, and consult your doctor if you notice any concerning symptoms.

What is the storage requirement for Hydrocortisone Cream USP, 2.5%?

Store the cream at 20-25°C (68-77°F) and keep it out of the reach of children.

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.

Hydrocortisone is available in multiple dosage forms and packaging configurations.
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

Each gram of Hydrocortisone Cream USP, 2.5% contains 25 mg of hydrocortisone in a cream base composed of cetyl alcohol, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, and stearyl alcohol. Each gram of Hydrocortisone Ointment USP, 2.5% contains 25 mg of hydrocortisone in an ointment base of light mineral oil and white petrolatum. Chemically, hydrocortisone is Pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)- with the molecular formula C21H30O5. Its molecular weight is 362.47, and its CAS Registry Number is 50-23-7.

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 reported in the available data.

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, depending on 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 develops, 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 addition, the use of topical corticosteroids should be discontinued if irritation develops, and appropriate therapy should be initiated. Furthermore, in cases of dermatological infections, the corticosteroid should not be used until the infection has been adequately controlled.

Warnings and Precautions

Systemic absorption of topical corticosteroids has been associated with reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, as well as manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in 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.

Children are particularly vulnerable to systemic toxicity due to their potential for greater absorption of topical corticosteroids. In cases where irritation occurs, it is imperative to discontinue the use of topical corticosteroids and initiate appropriate alternative therapy.

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, especially when applied to large areas or under occlusive dressings, should undergo periodic evaluations for signs of HPA axis suppression. This can be assessed through urinary free cortisol and ACTH stimulation tests. If evidence of HPA axis suppression is detected, it is recommended to withdraw the corticosteroid, reduce the frequency of application, or switch to a less potent steroid. Typically, recovery of HPA axis function occurs rapidly and completely upon discontinuation of the corticosteroid; however, in rare cases, withdrawal symptoms may arise, necessitating the use of supplemental systemic corticosteroids.

Monitoring parameters include the urinary free cortisol test and the ACTH stimulation test to ensure patient safety and effective management during treatment.

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, although 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 a noted greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome. Manifestations 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. Additionally, signs of intracranial hypertension, such as bulging fontanelles, headaches, and bilateral papilledema, have been observed.

It is important to note that signs and symptoms of steroid withdrawal may occur, necessitating the use of supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids, increasing their risk for systemic toxicity.

Drug Interactions

There are currently no documented drug interactions associated with the use of 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.

Hydrocortisone is available in multiple dosage forms and packaging configurations.
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

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended 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 dosage levels. 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 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

Patients with renal impairment may require careful consideration when using corticosteroids, as these agents are primarily metabolized in the liver and excreted by the kidneys. Systemic absorption of topical corticosteroids can lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, necessitating monitoring in this patient population.

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 withdraw the corticosteroid, reduce the frequency of application, or consider substituting with a less potent steroid.

Typically, recovery of HPA axis function occurs promptly and completely 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 treatment regimens. Some topical corticosteroids and their metabolites are also 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. Therefore, patients with hepatic impairment who are receiving large doses of potent topical steroids, particularly when applied to extensive surface areas or under occlusive dressings, should be monitored periodically for signs of HPA axis suppression. This monitoring can be conducted using urinary free cortisol and 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. It is important to note that recovery of HPA axis function is typically prompt and complete following the discontinuation of the corticosteroid.

Overdosage

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Monitoring of vital signs and laboratory parameters may be warranted to assess the patient's condition and guide further management.

Healthcare professionals should remain vigilant for potential symptoms that could indicate an overdosage scenario, although specific symptoms have not been detailed. If any adverse reactions or unexpected clinical presentations occur, appropriate medical intervention should be sought immediately.

For further guidance, healthcare providers are encouraged to consult local poison control centers or relevant medical authorities to obtain the most current recommendations for managing suspected overdosage cases.

Nonclinical Toxicology

Long-term animal studies have not been conducted to assess the carcinogenic potential or the effects on fertility of topical corticosteroids. Additionally, investigations into the mutagenicity of prednisolone and hydrocortisone have yielded negative results.

Postmarketing Experience

Systemic absorption of topical corticosteroids has been associated with reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, as well as manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Reports indicate that pediatric patients receiving topical corticosteroids may experience HPA axis suppression, Cushing's syndrome, and intracranial hypertension. In this population, manifestations of adrenal suppression have included linear growth retardation, delayed weight gain, low plasma cortisol levels, and an absence of response to ACTH stimulation. Symptoms of intracranial hypertension reported include bulging fontanelles, headaches, and bilateral papilledema.

Infrequent local adverse reactions associated with topical corticosteroids have been noted, particularly with the use of occlusive dressings. These reactions 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.

Patient Counseling

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

It is important for healthcare providers to emphasize that patients should not use this medication for any condition other than the one for which it was prescribed. Additionally, patients should be informed that the treated skin area should not be bandaged or covered in a manner that creates an occlusive environment unless specifically directed by their physician.

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

For pediatric patients, healthcare providers should counsel parents to avoid using tight-fitting diapers or plastic pants on children being treated in the diaper area, as these garments may act as occlusive dressings and could exacerbate any potential 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 20-25°C (68-77°F), adhering to the guidelines set forth by the United States Pharmacopeia (USP) for Controlled Room Temperature.

It is essential to keep the product out of the reach of children to ensure safety. Proper handling and storage conditions must be maintained to preserve the integrity of the product.

Additional Clinical Information

The evaluation of hypothalamic-pituitary-adrenal (HPA) axis suppression in patients may benefit from specific diagnostic tests. Clinicians may consider utilizing the urinary free cortisol test and the ACTH stimulation test to assess HPA axis function effectively.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Hydrocortisone as submitted by Padagis Israel Pharmaceuticals Ltd. 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 (ANDA085025) 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.