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Hydrocortisone

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Active ingredient
Hydrocortisone 25 mg/1 mL
Other brand names
Drug class
Corticosteroid
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 2008
Label revision date
December 31, 2023
FDA Insert
Prescribing information, PDF file
Active ingredient
Hydrocortisone 25 mg/1 mL
Other brand names
Drug class
Corticosteroid
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 2008
Label revision date
December 31, 2023
Manufacturer
Padagis Israel Pharmaceuticals Ltd
Registration number
ANDA089074
NDC root
45802-937
FDA Insert
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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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 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 a healthcare professional 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. These conditions, known as corticosteroid-responsive dermatoses, can cause discomfort and irritation, and using these medications can provide significant relief.

It's important to note that there are no reported teratogenic effects (which means they do not cause birth defects) or nonteratogenic effects (which refer to other potential harmful effects unrelated to birth defects) associated with these medications. This makes them a safer option for managing skin issues.

Dosage and Administration

Before you use your topical corticosteroid, make sure to shake the bottle well. This helps ensure that the medication is mixed properly for effective use. You will apply a thin layer of the medication directly to the affected area of your skin. Depending on how severe your condition is, you should do this two to four times a day.

If you are dealing with psoriasis or other stubborn skin conditions, you might consider using occlusive dressings. These are special coverings that can help enhance the effectiveness of the treatment by keeping the medication in contact with your skin for a longer period. Always follow your healthcare provider's instructions for the best results.

What to Avoid

If you have a history of hypersensitivity (allergic reactions) to any ingredients in topical corticosteroids, you should avoid using them. If you experience irritation while using these medications, stop using them immediately and seek appropriate treatment. Additionally, if you have a skin infection, it's important to use the right antifungal or antibacterial medication first. Do not continue using the corticosteroid until the infection is properly treated and under control.

Side Effects

You may experience some local side effects when using this medication, such as burning, itching, irritation, and dryness of the skin. Other possible reactions include folliculitis (inflammation of hair follicles), acne-like eruptions, and changes in skin color. In some cases, you might notice skin thinning, stretch marks, or secondary infections. If you have a history of allergies, be aware that allergic contact dermatitis could also occur.

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. Children are particularly sensitive to these effects, with risks including growth delays and increased pressure in the brain. If you notice any signs of irritation or infection, it's important to stop using the medication and consult your healthcare provider for appropriate treatment.

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 steroids over large areas of skin, for long periods, or with occlusive dressings (coverings that trap moisture). If you notice any irritation, stop using the corticosteroid and seek appropriate treatment. If you have a skin infection, make sure to use the right antifungal or antibacterial medication, and stop the corticosteroid if you don't see improvement quickly.

If you're using a potent topical steroid on a large area or under a dressing, it's important to have regular check-ups. Your doctor may recommend tests like the urinary free cortisol test or ACTH stimulation test to monitor your hormone levels. Children are particularly at risk for side effects, as they can absorb more of the medication. If you experience any concerning symptoms, it's best to consult your doctor for guidance.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, you should call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

Corticosteroids, a type of medication often used to reduce inflammation, may pose risks during pregnancy. Studies in laboratory animals have shown that these drugs can cause birth defects (teratogenic effects) even at low doses when given systemically. Additionally, more potent corticosteroids have been linked to similar risks when applied to the skin. However, there are no well-controlled studies in pregnant women to confirm these effects from topical (skin-applied) corticosteroids.

Because of these concerns, it’s important to use topical corticosteroids during pregnancy only if the potential benefits outweigh the risks to your baby. You should avoid using these medications extensively, in large amounts, or for long periods while pregnant. Always consult your healthcare provider before using any medication during pregnancy to ensure the safety of both you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware of how medications may affect you and your baby. While it is unclear whether applying corticosteroids (a type of medication used to reduce inflammation) to your 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 while nursing. Always consult with your healthcare provider to ensure that any treatment you consider is safe for both you and your baby.

Pediatric Use

When using topical corticosteroids (medications applied to the skin) for your child, it's important to be aware that children may be more sensitive to these treatments than adults. This is due to their larger skin surface area relative to their body weight. As a result, there is a risk of serious side effects, such as adrenal suppression (a condition where the body doesn't produce enough hormones) and Cushing's syndrome (a hormonal disorder caused by high levels of cortisol).

To minimize these risks, you should use the smallest amount of the medication necessary to achieve the desired effect. Be vigilant for signs of potential complications, which can include slowed growth, delayed weight gain, and symptoms of increased pressure in the brain, such as headaches or bulging fontanelles (the soft spots on a baby's head). If you notice any concerning symptoms, consult your child's healthcare provider promptly.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about how it should be adjusted for dosage or any unique safety concerns. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your healthcare team are essential to ensure safety and effectiveness.

Renal Impairment

If you have kidney issues, it's important to be aware that corticosteroids are mainly processed in the liver and then removed from your body by the kidneys. Some topical corticosteroids can also be eliminated through bile. When using these medications, especially in large amounts or under a covering, you may need to be monitored for potential suppression of your body's hormone system (known as the hypothalamic-pituitary-adrenal or HPA axis).

To check for this, your doctor might perform tests like measuring urinary free cortisol and conducting ACTH stimulation tests. If any suppression is detected, your healthcare provider may suggest reducing the dosage, changing to a less potent steroid, or stopping the medication altogether. Fortunately, most people see a quick and full recovery of their hormone function after discontinuing the drug, although some may experience withdrawal symptoms that could require additional corticosteroids.

Hepatic Impairment

If you have liver problems, it's important to be aware that corticosteroids are mainly processed in your liver and then removed from your body through your kidneys. Some topical corticosteroids can also be found in your bile. If you use a strong topical steroid over a large area of your skin or under a covering, your doctor may need to monitor your hormone levels, specifically looking for signs of hypothalamic-pituitary-adrenal (HPA) axis suppression. This condition can affect your body's hormone balance.

To check for HPA axis suppression, your healthcare provider might recommend tests like urinary free cortisol and ACTH stimulation tests. If any suppression is detected, your doctor may suggest reducing the steroid's use, switching to a less potent option, or stopping it altogether. The good news is that if you stop using the corticosteroid, your hormone levels usually return to normal quickly. 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 health conditions you have to receive the best care possible.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F), which is considered a controlled room temperature. Make sure the container is tightly closed to protect its contents. Additionally, it's important to keep the product out of the reach of children to prevent any accidental exposure or misuse. Following these guidelines will help maintain the quality and safety of the product.

Additional Information

If you're concerned about the suppression of your hypothalamic-pituitary-adrenal (HPA) axis, certain tests can help evaluate its function. The urinary free cortisol test measures the level of cortisol in your urine, while the ACTH (adrenocorticotropic hormone) stimulation test assesses how well your adrenal glands respond to ACTH. These tests can provide valuable insights into your adrenal health. If you have questions about these tests or their implications, consider discussing them with your healthcare provider.

FAQ

What is Hydrocortisone Lotion USP, 2.5% used for?

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

How should I use Hydrocortisone Lotion?

You should apply a thin film of the lotion to the affected area two to four times daily, depending on the severity of your condition. Shake well before using.

Are there any contraindications for using this lotion?

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

What are some common local side effects?

Common local side effects may include burning, itching, irritation, dryness, and acneiform eruptions.

What should I do if I experience irritation?

If irritation develops, you should discontinue use of the lotion and seek appropriate therapy.

Can I use this lotion 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 on teratogenic effects.

Is it safe to use Hydrocortisone Lotion while breastfeeding?

It is not known if topical corticosteroids appear in breast milk, so caution should be exercised when administering it to nursing women.

What should I know about pediatric use?

Pediatric patients may be more susceptible to systemic effects like HPA axis suppression and Cushing's syndrome due to a larger skin surface area relative to body weight.

How should I store Hydrocortisone Lotion?

Store the lotion at 20-25°C (68-77°F) and keep it tightly closed and 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, USP, in a vehicle that includes carbomer homopolymer type C, ceteareth-20, cetyl alcohol, dehydroacetic acid, DMDM hydantoin, fragrance, glyceryl stearate, isopropyl palmitate, lactic acid, light mineral oil, myristyl alcohol, myristyl lactate, PEG-100 stearate, purified water, sodium hydroxide, sodium PCA, and stearyl alcohol. Hydrocortisone is chemically defined as Pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-, (11ß)-, with a molecular formula of C21H30O5. The molecular weight of hydrocortisone is 362.46, 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 medications are effective in managing conditions characterized by inflammation and itching, providing symptomatic relief to affected patients.

There are no teratogenic or nonteratogenic effects associated with the use of topical corticosteroids as per the available data.

Dosage and Administration

Healthcare professionals should instruct patients to shake the product well before use. Topical corticosteroids are to be applied as a thin film to the affected area, with the frequency of application ranging from two to four times daily, contingent upon the severity of the condition being treated.

For specific cases such as psoriasis or other recalcitrant conditions, occlusive dressings may be employed to enhance the efficacy of the treatment. It is essential to monitor the patient's response to therapy and adjust the frequency of application as necessary based on clinical evaluation.

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 use 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 steroids, application over extensive body areas, prolonged treatment duration, and the use of occlusive dressings. Should irritation occur, the application of topical corticosteroids must be discontinued, and appropriate therapeutic measures should be initiated.

In cases where dermatological infections are present, it is imperative to employ suitable antifungal or antibacterial agents. 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 surface 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 advisable to withdraw the corticosteroid, reduce the frequency of application, or consider switching to a less potent steroid. Recovery of HPA axis function typically occurs rapidly and completely upon discontinuation of the corticosteroid; however, in rare instances, withdrawal symptoms may arise, necessitating the use 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.

Monitoring parameters such as the urinary free cortisol test and ACTH stimulation test are recommended to ensure safe use of topical corticosteroids, particularly in patients at higher risk for systemic absorption and associated complications.

Side Effects

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

Local adverse reactions are common and may include burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. In cases where irritation develops, it is recommended that the topical corticosteroids be discontinued and appropriate therapy instituted.

Systemic adverse reactions, although less common, can occur and include reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria.

Pediatric patients are particularly susceptible to adverse reactions, including greater risks of topical corticosteroid-induced HPA axis suppression and Cushing's syndrome. Specific manifestations of adrenal suppression in this population may include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Additionally, signs of intracranial hypertension, such as bulging fontanelles, headaches, and bilateral papilledema, may also be observed.

It is important to note that signs and symptoms of steroid withdrawal may occur, necessitating the use of supplemental systemic corticosteroids. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be initiated. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

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.

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 or safety concerns. As such, 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 generally considered teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Additionally, more potent corticosteroids have demonstrated teratogenic effects following dermal application in these animal studies. However, there are no adequate and well-controlled studies in pregnant women that specifically assess the teratogenic effects of topically applied corticosteroids.

Given the potential risks, topical corticosteroids should be utilized during pregnancy only if the anticipated benefits outweigh the potential risks to the fetus. It is advised that drugs within this class not be used extensively on pregnant patients, in large 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.

Typically, recovery of HPA axis function occurs promptly and completely following discontinuation of the corticosteroid. However, in rare cases, signs and symptoms of steroid withdrawal may manifest, which may necessitate the administration of supplemental systemic corticosteroids.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism and excretion of corticosteroids, which are primarily metabolized in the liver and excreted by the kidneys. Given that some topical corticosteroids and their metabolites are also excreted into the bile, caution is warranted in this population.

Systemic absorption of topical corticosteroids can lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression. Therefore, patients with compromised liver function 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

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, increased severity of known side effects, altered mental status, or any unusual physiological responses.

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 no specific overdosage information is provided, healthcare professionals should exercise caution, remain alert to potential overdose symptoms, 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

Postmarketing experience has identified several local adverse reactions associated with the use of topical corticosteroids, particularly when occlusive dressings are employed. These reactions, although reported infrequently, may occur with greater frequency under such conditions. The adverse events include burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

Patient Counseling

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

Healthcare providers should advise patients not to use this medication for any condition other than the specific disorder for which it was prescribed. It is important to communicate that the treated skin area should not be bandaged or covered in a manner that creates an occlusive environment unless specifically directed by the physician.

Patients should be encouraged to report any signs of local adverse reactions, particularly if they occur under occlusive dressings, as this may indicate a need for medical evaluation or adjustment of treatment.

For parents of pediatric patients, it is essential to advise against the use of tight-fitting diapers or plastic pants on children being treated in the diaper area. These garments can create an occlusive dressing, which may exacerbate potential side effects or hinder the effectiveness of the treatment.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It should be stored at a temperature range of 20-25°C (68-77°F), in accordance with USP Controlled Room Temperature guidelines.

To maintain the quality of the product, it is essential to keep the container tightly closed when not in use. Additionally, the product must be kept out of the reach of children to ensure safety.

Additional Clinical Information

The evaluation of hypothalamic-pituitary-adrenal (HPA) axis suppression in patients may be supported by 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 (ANDA089074) 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.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.