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Hydrocortisone

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This product has been discontinued

Active ingredient
Hydrocortisone 25 mg/1 mL
Other brand names
Dosage form
Lotion
Route
Topical
Prescription status
Rx (prescription)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
July 27, 2018
FDA Insert
Prescribing information, PDF file
Active ingredient
Hydrocortisone 25 mg/1 mL
Other brand names
Dosage form
Lotion
Route
Topical
Prescription status
Rx (prescription)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
July 27, 2018
Manufacturer
Teligent Pharma, Inc.
Registration number
ANDA203804
NDC root
52565-005
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 Lotion 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 that respond to corticosteroids. This lotion works by reducing inflammation and alleviating discomfort in affected areas of the skin.

As a topical corticosteroid, hydrocortisone is designed to be applied directly to the skin, where it can be absorbed to help manage symptoms of skin disorders. It is important to use this medication as directed by your healthcare provider to ensure its effectiveness and safety.

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. Always consult with your healthcare provider to ensure that this treatment is appropriate for your specific 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 each day. It's important to follow this schedule to help manage your symptoms effectively.

For certain skin conditions, like psoriasis or other stubborn issues, you might also consider using occlusive dressings. These are special coverings that can help enhance the effectiveness of the medication by keeping it in contact with your skin for a longer period. Always consult with your healthcare provider to determine the best approach for your specific situation.

What to Avoid

If you have a history of hypersensitivity (allergic reactions) to any ingredients in topical corticosteroids, you should not use these medications. It's important to pay attention to how your skin reacts; if you experience irritation, stop using the corticosteroid and seek appropriate treatment.

Additionally, if you have a skin infection, make sure to use the right antifungal or antibacterial medication first. Only after the infection is under control should you consider resuming the use of corticosteroids, as using them during an active infection can worsen your condition.

Side Effects

You may experience some local side effects when using this medication, including burning, itching, irritation, and dryness of the skin. Other possible reactions are 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 axis suppression (a disruption in hormone production), Cushing's syndrome (a condition caused by excess cortisol), high blood sugar, and glucosuria (sugar in urine). In children, there are additional risks, including growth retardation 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, including issues with your body's hormone regulation (known as HPA axis suppression), symptoms similar to Cushing's syndrome, and increased blood sugar levels. These risks are higher if you use strong corticosteroids over large areas of skin, for long periods, or with occlusive dressings (coverings that trap moisture). If you notice any irritation, stop using the corticosteroid and seek appropriate treatment. If you have a skin infection, make sure to use the right antifungal or antibacterial medication, and stop the corticosteroid if you don’t see improvement quickly.

If you are using a potent topical steroid on a large area or under a dressing, your doctor may want to check your hormone levels periodically with tests like the urinary free cortisol test and ACTH stimulation test. Children are particularly at risk for side effects because they can absorb more of the medication relative to their body size. If you stop using the corticosteroid, your hormone levels usually return to normal quickly, but in rare cases, you might experience withdrawal symptoms that require additional treatment.

Overdose

Using topical corticosteroids (medications applied to the skin to reduce inflammation) can sometimes lead to absorption into your body, which may cause effects beyond the skin. This means that while these medications are intended for local treatment, they can potentially impact your overall health if used excessively.

If you suspect an overdose, look for signs such as unusual changes in your body or health. It’s important to seek immediate medical help if you experience severe symptoms or if you have concerns about how much of the medication you have used. Always consult with a healthcare professional if you have questions about your medication or its effects.

Pregnancy Use

Currently, there is no specific information available about the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been clearly defined. If you are pregnant or planning to become pregnant, it is essential to discuss any medications you are taking with your healthcare provider to ensure the best care for you and your baby. Always prioritize open communication with your doctor regarding any concerns or questions you may have about medication use during pregnancy.

Lactation Use

If you are breastfeeding and considering the use of corticosteroids, it's important to know that while it is unclear if applying these medications to your skin can lead to enough absorption into your bloodstream to affect your breast milk, systemic (taken into the body) corticosteroids do appear in breast milk. However, the amounts are generally not expected to harm your baby.

That said, you should still be cautious when using topical corticosteroids (medications applied to the skin) while nursing. It's always a good idea to discuss any medications with your healthcare provider to 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 amount of the medication necessary to achieve the desired effect. Be vigilant for signs of potential side effects, such as slowed growth, delayed weight gain, low cortisol levels, headaches, or bulging fontanelles (the soft spots on a baby's head). If you notice any of these symptoms, consult your child's healthcare provider promptly. Chronic use of these medications can affect your child's growth and development, so regular monitoring is essential.

Geriatric Use

As you age, your body may process medications differently, particularly corticosteroids. Older adults often have reduced kidney function, which can impact how these medications are broken down and eliminated from the body. This means that if you or a loved one is using topical corticosteroids, it’s important to be aware that you might be more sensitive to their side effects.

When using these medications, caution is advised due to the risk of systemic absorption, which can lead to unwanted effects throughout the body. It may also be necessary to adjust the dosage based on your overall health and any other medications you are taking. Always consult with your healthcare provider to ensure safe and effective use tailored to your specific needs.

Renal Impairment

If you have kidney issues, it's important to be aware that corticosteroids, which are often used to treat various conditions, are mainly processed in the liver and then removed from your body by the kidneys. Some of these medications can also be absorbed through the skin and may affect your hormone levels, specifically the hypothalamic-pituitary-adrenal (HPA) axis, which regulates stress responses and other functions.

If you are using a strong topical corticosteroid over a large area of your skin or under a bandage, your doctor may want to monitor your hormone levels regularly. This can be done through tests that measure cortisol in your urine and assess how your body responds to stimulation. 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 it altogether. Fortunately, most people see a quick and full recovery of their hormone function once the corticosteroid is discontinued.

Hepatic Impairment

If you have liver problems, it's important to know that corticosteroids are mainly processed in your liver before being removed from your body by your kidneys. Some of these medications and their breakdown products can also be eliminated through 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 that traps the medication, your doctor may recommend regular check-ups. These evaluations typically involve tests to assess your adrenal function, such as measuring urinary free cortisol and conducting ACTH stimulation tests. This monitoring helps ensure that your body is responding appropriately to the medication and that your liver is handling it well.

Drug Interactions

It's important to talk to your healthcare provider about any medications you are using, especially if you are applying potent topical corticosteroids (a type of anti-inflammatory medication) over large areas of your skin or using them for a long time. These medications can sometimes be absorbed into your body, potentially leading to issues like hormonal imbalances, high blood sugar, or other health concerns.

If you are using these types of steroids, your doctor may recommend tests, such as the urinary free cortisol test or the ACTH stimulation test, to check how your body is responding. Regular evaluations can help ensure that you stay healthy while using these treatments. Always keep your healthcare provider informed about all medications and treatments you are using to avoid any unexpected interactions.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° and 25°C (68° and 77°F). It’s acceptable for the temperature to occasionally range from 15° to 30°C (59° to 86°F), but try to keep it within the recommended limits. Before using the product, make sure to shake it well to mix the contents thoroughly.

For safety, always keep the product out of the reach of children to prevent accidental ingestion or misuse. Following these guidelines will help you use the product safely and effectively.

Additional Information

You may need to undergo specific laboratory tests if you are being evaluated for certain medical conditions. These tests include the urinary free cortisol test, which measures the level of cortisol in your urine, and the ACTH stimulation test, which assesses how well your adrenal glands respond to adrenocorticotropic hormone (ACTH). These tests help your healthcare provider understand your hormone levels and adrenal function better.

FAQ

What is Hydrocortisone Lotion USP, 2.5%?

Hydrocortisone Lotion USP, 2.5% contains 25 mg of hydrocortisone per mL in a vehicle of various ingredients, used as a topical corticosteroid.

What are the indications for using Hydrocortisone Lotion?

It is indicated for the relief of inflammatory and pruritic (itchy) manifestations of corticosteroid-responsive dermatoses.

How should I apply Hydrocortisone Lotion?

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

Are there any contraindications for using this lotion?

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

What should I do if I experience irritation while using the lotion?

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

What are some local adverse reactions I might experience?

Local adverse reactions can include burning, itching, irritation, dryness, and acneiform eruptions, among others.

Can Hydrocortisone Lotion affect children differently?

Yes, children may absorb larger amounts and be more susceptible to systemic effects like HPA axis suppression and Cushing's syndrome.

Is it safe to use Hydrocortisone Lotion during pregnancy?

The provided information does not specify safety concerns or dosage modifications for use during pregnancy.

What precautions should I take if I am elderly?

Elderly patients may have reduced kidney function and increased sensitivity to side effects, so caution is advised.

How should I store Hydrocortisone Lotion?

Store it at 20° - 25°C (68° and 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.

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

Each mL of Hydrocortisone Lotion USP, 2.5% contains 25 mg of hydrocortisone, a synthetic corticosteroid. The formulation includes a vehicle composed of carbomer 980, propylene glycol, polysorbate 40, propylene glycol monostearate, cholesterol, isopropyl myristate, sorbitan monopalmitate, cetyl alcohol, trolamine, sorbic acid, simethicone, and purified water.

Hydrocortisone is chemically defined as pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11β)-, with a molecular formula of C21H30O5 and a molecular weight of 362.47. This compound belongs to a class of topical corticosteroids utilized for their anti-inflammatory and antipruritic properties. The structural representation of hydrocortisone is provided in the accompanying structural formula.

Uses and Indications

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

Limitations of Use: Topical corticosteroids should be used with caution in patients with a history of hypersensitivity to corticosteroids or any of the components of the formulation. Prolonged use may lead to skin atrophy and other local adverse effects; therefore, they should be used according to the prescribing guidelines to minimize risks.

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 employed to enhance the efficacy of the treatment. It is essential that healthcare professionals assess the individual patient's needs and adjust the frequency and method of application accordingly to optimize therapeutic outcomes.

Contraindications

Topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of the components of the preparation.

In cases of irritation, the use of topical corticosteroids should be discontinued, and appropriate therapy should be initiated. Additionally, in the presence of dermatological infections, it is essential to initiate treatment with an appropriate antifungal or antibacterial agent. If a favorable response is not observed promptly, the corticosteroid should be discontinued until the infection is adequately controlled.

Warnings and Precautions

Systemic absorption of topical corticosteroids has been associated with reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, which may manifest as Cushing's syndrome, hyperglycemia, and glucosuria in certain patients. Factors that can enhance systemic absorption include the use of more potent corticosteroids, application over extensive surface areas, prolonged treatment duration, and the use of occlusive dressings. Should irritation occur, the application of topical corticosteroids must be discontinued, and appropriate alternative therapy should be initiated.

In cases where dermatological infections are present, it is imperative to employ an appropriate antifungal or antibacterial agent. If there is no prompt favorable response, the corticosteroid treatment should be halted until the infection is adequately managed.

Patients receiving high doses of potent topical steroids, particularly when applied to large areas or under occlusive dressings, should undergo periodic evaluations for signs of HPA axis suppression. This can be assessed through urinary free cortisol and ACTH stimulation tests. Generally, recovery of HPA axis function is swift and complete following the cessation of the corticosteroid. However, in rare instances, withdrawal symptoms may arise, necessitating the administration of supplemental systemic corticosteroids.

It is important to note that children may absorb larger amounts of topical corticosteroids relative to their body size, rendering them more vulnerable to systemic toxicity. Therefore, careful monitoring is essential in this population.

For monitoring purposes, the following laboratory tests are recommended: urinary free cortisol test and ACTH stimulation test.

Side Effects

Patients using topical corticosteroids may experience a range of local adverse reactions. Commonly reported reactions include burning, itching, irritation, and dryness of the skin. 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 associated with serious adverse effects, including reversible hypothalamic-pituitary-adrenal (HPA) axis suppression. This may manifest as Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Signs and symptoms of steroid withdrawal may also occur, necessitating the use of supplemental systemic corticosteroids.

Particular caution is warranted in pediatric patients, as reports indicate that they may be at increased risk for HPA axis suppression, Cushing's syndrome, and intracranial hypertension when using topical corticosteroids. Manifestations of adrenal suppression in this population 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

Systemic absorption of topical corticosteroids can lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, which may manifest as Cushing's syndrome, hyperglycemia, and glucosuria in certain patients. Factors that may enhance systemic absorption include the use of more potent corticosteroids, application over extensive body areas, prolonged treatment duration, and the use of occlusive dressings.

For patients receiving high doses of potent topical corticosteroids, particularly when applied to large surface areas or under occlusive dressings, it is advisable to conduct periodic evaluations for signs of HPA axis suppression. Monitoring can be performed using urinary free cortisol and ACTH stimulation tests. These tests are beneficial in assessing the extent of HPA axis suppression and guiding further management.

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 present with reduced kidney function, which can significantly impact the metabolism and excretion of corticosteroids. This alteration in pharmacokinetics necessitates careful consideration when prescribing these medications to geriatric patients.

Additionally, elderly patients may demonstrate increased sensitivity to the side effects associated with topical corticosteroids. Therefore, caution should be exercised when administering these agents, as there is a potential for systemic absorption leading to adverse effects.

It is important to evaluate the overall health status of elderly patients and consider their concurrent medications, as dosage adjustments may be necessary to ensure safety and efficacy in this population. Regular monitoring for side effects and therapeutic response is recommended to mitigate risks associated with corticosteroid use in geriatric patients.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while on this medication.

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.

Typically, recovery of HPA axis function occurs promptly and completely following the discontinuation of the corticosteroid.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism and excretion of corticosteroids, as these agents are primarily metabolized in the liver and subsequently excreted by the kidneys. Given that some topical corticosteroids and their metabolites are also excreted into the bile, caution is advised when administering these medications to individuals with compromised liver function.

For patients receiving a large dose of a potent topical steroid applied to a significant surface area or under an occlusive dressing, periodic evaluation for evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression is recommended. This evaluation should include monitoring urinary free cortisol levels and conducting ACTH stimulation tests to assess adrenal function.

Healthcare providers should consider these factors when prescribing corticosteroids to patients with hepatic impairment and adjust treatment plans accordingly to ensure patient safety and efficacy.

Overdosage

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

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

Management of corticosteroid overdosage primarily involves discontinuation of the topical agent and supportive care. In severe cases, particularly where adrenal suppression is suspected, further evaluation and appropriate interventions may be necessary. Healthcare providers should consider consulting a specialist in endocrinology for guidance on managing potential complications arising from systemic absorption.

Regular assessment and patient education regarding the proper use of topical corticosteroids can help mitigate the risk of overdosage and its associated complications.

Nonclinical Toxicology

Pregnancy Category C indicates that corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. More potent corticosteroids have demonstrated teratogenic effects following dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women regarding the teratogenic effects of topically applied corticosteroids. Consequently, the use of topical corticosteroids during pregnancy should be limited to situations where the potential benefit outweighs the potential risk to the fetus. It is advised that drugs within this class not be used extensively on pregnant patients, in large amounts, or for prolonged durations.

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

Postmarketing Experience

Postmarketing experience has identified several adverse events associated with the use of topical corticosteroids, particularly in pediatric patients. Reports indicate occurrences of hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension. Manifestations of adrenal suppression in this population may include linear growth retardation, delayed weight gain, low plasma cortisol levels, and an absence of response to ACTH stimulation. Symptoms of intracranial hypertension reported include bulging fontanelles, headaches, and bilateral papilledema.

Additionally, local adverse reactions have been infrequently reported with topical corticosteroids, with a potential increase in frequency 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, striae, and miliaria.

Healthcare professionals are encouraged to report any suspected adverse reactions to Teligent Pharma, Inc. at 1-856-697-1441, or to the FDA at 1-800-FDA-1088 or via www.fda.gov/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 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. For pediatric patients, it is essential to advise parents against 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 various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20° to 25°C (68° to 77°F), with permissible excursions between 15° to 30°C (59° to 86°F) as per USP Controlled Temperature guidelines.

Prior to use, it is essential to shake the product well. Additionally, it must be kept out of the reach of children to ensure safety.

Additional Clinical Information

Patients may undergo specific laboratory tests to assess their condition, including the urinary free cortisol test and the ACTH stimulation test. These tests are essential for clinicians to evaluate adrenal function and diagnose related disorders effectively.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Hydrocortisone as submitted by Teligent Pharma, Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)

Data Generation & Sources

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

All FDA-approved dosage forms and strengths are listed in the Packaging & NDC Codes section above. Regulatory status, pharmacologic class (EPC), and mechanism of action (MoA) were cross-checked against the FDA Orange Book (ANDA203804) 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.