Plain-language summary, compiled from the cited regulatory records
Hydrocortisone is a corticosteroid used for local oral treatment [1]. It is approved to temporarily relieve itching associated with minor skin irritations, inflammation, and rashes. These conditions include eczema, psoriasis, reactions to poison ivy, oak, and sumac, insect bites, and rashes caused by detergents, jewelry, cosmetics, and soaps [1]. It is also indicated for seborrheic dermatitis and to temporarily relieve external anal and genital itching [1]. Other uses should only be under the advice and supervision of a doctor [1].
This active ingredient is available under various brand names, such as anti itch, Equate Cortisone, and Procto-Med HC [1]. In the past 12 months, there have been 7,283 adverse event reports associated with products containing hydrocortisone [2]. The most frequently reported issues in these reports include off-label use, the drug being ineffective, fatigue, aggravation of the condition, and rash [2].
This is not medical advice. Consult a qualified healthcare professional.
GBOfficial regulatory label· revised May 29, 2026[1]
Indications Eczema and dermatitis of all types including atopic, infantile and discoid eczema, photodermatitis, otitis externa, primary irritant and allergic dermatitis, intertrigo, prurigo nodularis, seborrhoeic dermatitis, and insect bite reactions.
Remarks on indications 1. There is no good evidence that topical corticosteroids are efficacious against immediate (type I) allergic skin reactions or short-lived wheal and flare reactions from other causes. 2. Topical corticosteroids are ineffective in granulomatous conditions and other inflammatory reactions involving the deeper regions of the dermis.
3. 4 Special Warnings and Special Precautions for Use.
How to take
USUnited States· FDA
76 products
Uses
USOfficial regulatory label· revised May 11, 2026[2]
INDICATIONS AND USAGE
Hydrocortisone Tablets are indicated in the following conditions. 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Non suppurative thyroiditis Hypercalcemia associated with cancer 2.
Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis 3.
CACanada· Health Canada
16 products
Uses
CAOfficial regulatory label· revised September 18, 2025[3]
Hydrocortisone sodium succinate for injection USP is indicated for: 1. Endocrine Disorders • In primary, secondary and acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance).
• Congenital adrenal hyperplasia • Nonsuppurative thyroiditis • Hypercalcemia associated with cancer 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: • Post-traumatic osteoarthritis • Synovitis of osteoarthritis • Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) • Acute and subacute bursitis • Epicondylitis • Acute nonspecific tenosynovitis • Acute gouty arthritis • Psoriatic arthritis • Ankylosing spondylitis 3.
Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: • Systemic lupus erythematosus • Acute rheumatic carditis • Systemic dermatomyositis (polymyositis) 4. Dermatologic Diseases • Pemphigus • Severe erythema multiforme (Stevens-Johnson syndrome) • Exfoliative dermatitis • Bullous dermatitis herpetiformis • Severe seborrheic dermatitis • Severe psoriasis • Mycosis fungoides Hydrocortisone sodium succinate for injection USP Page 5 of 41 5.
EUEuropean Union· EMA
3 products
Uses
EUOfficial regulatory label· revised March 10, 2026[4]
Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old).
How to take
EU
Drug interactions
Known interactions involving Hydrocortisone. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 600. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[2]FDA DailyMed · 0bbb8a63-ae1d-41… · revised May 11, 2026 [PDF]
[3]Health Canada (DPD) · 02497530 · revised September 18, 2025
[4]European Medicines Agency · EMEA/H/C/004416 · revised March 10, 2026
[5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
S02BA
Corticosteroids
GBOfficial regulatory label· revised May 29, 2026[1]
Posology Adults (including elderly) Gently apply a thin layer of ointment to the affected area two or three times daily. Children and infants Gently apply a thin layer of ointment to the affected area two or three times daily. Avoid prolonged use.
In infants, therapy should be limited to five to seven days. Hydrocortisone ointment should be considered for dry, scaly or lichenified conditions whereas the cream formulation is usually suitable for moist or weeping surfaces. Method of Administration For topical application warnings are given, see Section
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised May 29, 2026[1]
Hydrocortisone preparations are usually well tolerated but if signs of hypersensitivity appear, application should be stopped immediately. Epidermal thinning, telangectasia and striae may occur in areas of high absorption such as skin folds, the face and where occlusive dressings are used.
Local atrophic changes may occur in intertriginous areas or in nappy areas in young children where moist conditions favour hydrocortisone absorption. Sufficient systemic absorption from such sites may be sufficient to produce the features of hypercorticism and suppression of the pituitary adrenal axis after prolonged treatment.
This effect is more likely to occur in infants and children and if occlusive dressings are used or large areas of skin treated. 4).
Skin and Subcutaneous Tissue Disorders:
Frequency not known: Withdrawal reactions - redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules. 4). There are reports of pigmentation changes and hypertrichosis with topical steroids.
Contact dermatitis may also occur. Exacerbation of symptoms may occur. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store). By reporting side effects you can help provide more information on the safety of this medicine.
GBOfficial regulatory label· Warnings and precautions· revised May 29, 2026[1]
4 Special Warnings and Special Precautions for Use. 2 Posology and method of administration Posology Adults (including elderly) Gently apply a thin layer of ointment to the affected area two or three times daily. Children and infants Gently apply a thin layer of ointment to the affected area two or three times daily.
Avoid prolonged use. In infants, therapy should be limited to five to seven days. Hydrocortisone ointment should be considered for dry, scaly or lichenified conditions whereas the cream formulation is usually suitable for moist or weeping surfaces.
4 Special Warnings and Special Precautions for Use. 1. Untreated bacterial (eg impetigo) viral (eg herpes simplex) or fungal (eg candida or dermatophyte) infections. Scabetic infections. Rosacea. Perioral dermatitis. 1 Special warnings and precautions for use The use of an occlusive dressing can considerably increase the degree of systemic absorption.
If the treatment continues longer than two weeks, the risk of systemic side effects will increase especially in children. Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development of tolerance, risk of generalised pustular psoriasis and local and systemic toxicity due to impaired barrier function of the skin.
Careful patient supervision is important. Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy, and systemic administration of antimicrobial agents.
As with all corticosteroids, application to the face may damage the skin and should be avoided. Prolonged application to the face is undesirable. Caution should be taken to keep away from the eyes. Topical steroid withdrawal syndrome Long term use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome).
A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated.
Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advice is recommended in these cases or other treatment options should be considered.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised May 29, 2026[1]
1. Untreated bacterial (eg impetigo) viral (eg herpes simplex) or fungal (eg candida or dermatophyte) infections. Scabetic infections. Rosacea. Perioral dermatitis. 1 Special warnings and precautions for use The use of an occlusive dressing can considerably increase the degree of systemic absorption.
If the treatment continues longer than two weeks, the risk of systemic side effects will increase especially in children. Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development of tolerance, risk of generalised pustular psoriasis and local and systemic toxicity due to impaired barrier function of the skin.
Careful patient supervision is important. Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy, and systemic administration of antimicrobial agents.
As with all corticosteroids, application to the face may damage the skin and should be avoided. Prolonged application to the face is undesirable. Caution should be taken to keep away from the eyes. Topical steroid withdrawal syndrome Long term use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome).
A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated.
Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advice is recommended in these cases or other treatment options should be considered.
Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
Paediatric population In infants and children particularly, care should be taken that the lowest strength of hydrocortisone skin ointment that is clinically effective is used. Long-term continuous topical therapy should be avoided, where possible, as adrenal suppression can occur, even without occlusion.
Although generally regarded as safe, even for long-term administration in adults, there is a potential for adverse effects if over used in infancy. Extreme caution is required in dermatoses of infancy including napkin rash. In infants, the napkin may act as an occlusive dressing, and increase absorption.
Treatment should therefore be limited, where possible, to a maximum of 7 days. The label will state mild steroid.
This is not medical advice. Consult a qualified healthcare professional.
Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis 4. Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis 5.
Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Serum sickness Bronchial asthma Contact dermatitis Atopic dermatitis Drug hypersensitivity reactions 6.
Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic conjunctivitis Keratitis Allergic corneal marginal ulcers Herpes zoster ophthalmicus Iritis and iridocyclitis Chorioretinitis Anterior segment inflammation Diffuse posterior uveitis and choroiditis Optic neuritis Sympathetic ophthalmia 7.
Respiratory Diseases Symptomatic sarcoidosis Loeffler's syndrome not manageable by other means Berylliosis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Aspiration pneumonitis 8.
Leukemias and lymphomas in adults Acute leukemia of childhood 10. Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.
11. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis 12. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement 1.
Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Non suppurative thyroiditis Hypercalcemia associated with cancer 2.
Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis 3.
Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis 4. Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis 5.
Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Serum sickness Bronchial asthma Contact dermatitis Atopic dermatitis Drug hypersensitivity reactions 6.
Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic conjunctivitis Keratitis Allergic corneal marginal ulcers Herpes zoster ophthalmicus Iritis and iridocyclitis Chorioretinitis Anterior segment inflammation Diffuse posterior uveitis and choroiditis Optic neuritis Sympathetic ophthalmia 7.
Respiratory Diseases Symptomatic sarcoidosis Loeffler's syndrome not manageable by other means Berylliosis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Aspiration pneumonitis 8.
Leukemias and lymphomas in adults Acute leukemia of childhood 10. Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.
11. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis 12. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement
How to take
USOfficial regulatory label· revised May 11, 2026[2]
DOSAGE AND ADMINISTRATION
The initial dosage of hydrocortisone tablets may vary from 20 mg to 240 mg of hydrocortisone per day depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required.
The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, hydrocortisone tablets should be discontinued and the patient transferred to other appropriate therapy.
IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached.
It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of hydrocortisone tablets for a period of time consistent with the patient’s condition.
If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually, rather than abruptly.
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 7,283 reports total. [5]
Off Label Use 1,337
Drug Ineffective 1,023
Fatigue 833
Condition Aggravated 731
Rash 700
Nausea 690
Headache 663
Pain 649
Dyspnoea 614
Arthralgia 574
Diarrhoea 571
Hypertension 560
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised May 11, 2026[2]
ADVERSE REACTIONS
Fluid and Electrolyte Disturbances Sodium retention Fluid retention Congestive heart failure in susceptible patients Potassium loss Hypokalemic alkalosis Hypertension Musculoskeletal Muscle weakness Steroid myopathy Loss of muscle mass Osteoporosis Tendon rupture, particularly of the Achilles tendon Vertebral compression fractures Aseptic necrosis of femoral and humeral heads Pathologic fracture of long bones Gastrointestinal Peptic ulcer with possible perforation and hemorrhage Pancreatitis Abdominal distention Ulcerative esophagitis Increases in alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT) and alkaline phosphatase have been observed following corticosteroid treatment.
These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation. gov/medwatch. Fluid and Electrolyte Disturbances Sodium retention Fluid retention Congestive heart failure in susceptible patients Potassium loss Hypokalemic alkalosis Hypertension Musculoskeletal Muscle weakness Steroid myopathy Loss of muscle mass Osteoporosis Tendon rupture, particularly of the Achilles tendon Vertebral compression fractures Aseptic necrosis of femoral and humeral heads Pathologic fracture of long bones Gastrointestinal Peptic ulcer with possible perforation and hemorrhage Pancreatitis Abdominal distention Ulcerative esophagitis Increases in alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT) and alkaline phosphatase have been observed following corticosteroid treatment.
These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation. Dermatologic Impaired wound healing Thin fragile skin Petechiae and ecchymoses Facial erythema Increased sweating May suppress reactions to skin tests Neurological Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment Convulsions Vertigo Headache Epidural lipomatosis Endocrine Development of Cushingoid state Suppression of growth in children Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness Menstrual irregularities Decreased carbohydrate tolerance Manifestations of latent diabetes mellitus Increased requirements for insulin or oral hypoglycemic agents in diabetics Ophthalmic Central serous chorioretinopathy Posterior subcapsular cataracts Increased intraocular pressure Glaucoma Exophthalmos Metabolic Negative nitrogen balance due to protein catabolism
USOfficial regulatory label· Warnings and precautions· revised May 11, 2026[2]
WARNINGS
In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated. Immunosuppression and Increased Risk of Infection Corticosteroids, including hydrocortisone, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan or helminthic pathogens.
Corticosteroids can: • Reduce resistance to new infections • Exacerbate existing infections • Increase the risk of disseminated infections • Increase the risk of reactivation or exacerbation of latent infections • Mask some signs of infection Corticosteroid-associated infections can be mild but can be severe and at times fatal.
The rate of infectious complications increases with increasing corticosteroid dosages. Monitor for the development of infection and consider hydrocortisone withdrawal or dosage reduction as needed. Tuberculosis If hydrocortisone is used to treat a condition in patients with latent tuberculosis or tuberculin reactivity, reactivation of tuberculosis may occur.
Closely monitor such patients for reactivation. During prolonged hydrocortisone therapy, patients with latent tuberculosis or tuberculin reactivity should receive chemoprophylaxis. Varicella Zoster and Measles Viral Infections Varicella and measles can have a serious or even fatal course in non-immune patients taking corticosteroids, including hydrocortisone.
In corticosteroid-treated patients who have not had these diseases or are non-immune, particular care should be taken to avoid exposure to varicella and measles: • If a hydrocortisone-treated patient is exposed to varicella, prophylaxis with varicella zoster immune globulin may be indicated.
If varicella develops, treatment with antiviral agents may be considered. • If a hydrocortisone-treated patient is exposed to measles, prophylaxis with immunoglobulin may be indicated. Hepatitis B Virus Reactivation Hepatitis B virus reactivation can occur in patients who are hepatitis B carriers treated with immunosuppressive dosages of corticosteroids, including hydrocortisone.
Reactivation can also occur infrequently in corticosteroid-treated patients who appear to have resolved hepatitis B infection. , prolonged) treatment with hydrocortisone. For patients who show evidence of hepatitis B infection, recommend consultation with physicians with expertise in managing hepatitis B regarding monitoring and consideration for hepatitis B antiviral therapy.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised May 11, 2026[2]
CONTRAINDICATIONS
Systemic fungal infections and known hypersensitivity to components.
This is not medical advice. Consult a qualified healthcare professional.
Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in: • Bronchial asthma • Contact dermatitis • Atopic dermatitis • Serum sickness • Drug hypersensitivity reactions • Urticarial transfusion reactions 6.
Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye, such as: • Herpes zoster ophthalmicus • Iritis, iridocyclitis • Chorioretinitis • Diffuse posterior uveitis and choroiditis • Optic neuritis • Sympathetic ophthalmia • Anterior segment inflammation • Allergic conjunctivitis • Allergic corneal marginal ulcers • Keratitis 7.
Gastrointestinal Diseases To tide the patient over a critical period of the disease in: • Ulcerative colitis (systemic therapy) • Regional enteritis (systemic therapy) 8. Respiratory Diseases • Symptomatic sarcoidosis • Berylliosis • Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy • Loeffler's syndrome not manageable by other means • Aspiration pneumonitis 9.
] administration is contraindicated) • Erythroblastopenia (RBC anemia) Hydrocortisone sodium succinate for injection USP Page 6 of 41 • Congenital (erythroid) hypoplastic anemia • Secondary thrombocytopenia in adults 10. Neoplastic Diseases For palliative management of: • Leukemias and lymphomas in adults • Acute leukemia of childhood 11.
Edematous States To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 12. ) following epinephrine (see 7 WARNINGS AND PRECAUTIONS). 13. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.
Trichinosis with neurologic or myocardial involvement. 1 Pediatrics Pediatrics (< 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of Hydrocortisone sodium succinate for injection USP in pediatric patients has been established.
3 Pediatrics, 4 DOSAGE AND ADMINISTRATION). 4 Geriatrics, 4 DOSAGE AND ADMINISTRATION).
How to take
CAOfficial regulatory label· revised September 18, 2025[3]
). 4 Geriatrics, 4 DOSAGE AND ADMINISTRATION). 2 CONTRAINDICATIONS Hydrocortisone sodium succinate for injection USP (hydrocortisone sodium succinate) is contraindicated: • in patients with known hypersensitivity to any components of the product (see
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised September 18, 2025[3]
). Symptoms typically emerge within a few days or weeks of starting treatment. Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary. Psychological effects have been reported upon withdrawal of corticosteroids; the frequency is unknown.
Patients/caregivers should be encouraged to seek medical attention if psychological symptoms develop in the patient, especially if depressed mood or suicidal ideation is suspected. Patients/caregivers should be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/withdrawal of systemic steroids.
Renal Corticosteroids should be used with caution in patients with renal insufficiency. Other In post marketing experience tumor lysis syndrome (TLS) has been reported in patients with malignancies, including hematological malignancies and solid tumors, following the use of systemic corticosteroids alone or in combination with other chemotherapeutic agents.
Patients at high risk of TLS, such as patients with tumors that have a high proliferative rate, high tumor burden and high sensitivity to cytotoxic agents, should be monitored closely and appropriate precautions should be taken.
Reproductive Health:
Female and Male Potential Hydrocortisone sodium succinate for injection USP Page 17 of 41 Fertility Steroids may increase or decrease motility and number of spermatozoa in some patients (see 16 NON- CLINICAL TOXICOLOGY). , angioedema) may occur.
Because rare instances of skin reactions and anaphylactic/anaphylactoid reactions have occurred in patients receiving corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug (see 8 ADVERSE REACTIONS).
Skin Injection of Hydrocortisone sodium succinate for injection USP may result in dermal and/or subdermal changes forming depressions in the skin at the injection site. In order to minimize the incidence of dermal and subdermal atrophy, care must be exercised not to exceed recommended doses in injections.
Injection into the deltoid muscle should be avoided because of a high incidence of subcutaneous atrophy. 1 Pregnant Women Corticosteroids readily cross the placenta. Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to human dose.
Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits, have yielded an increase incidence of cleft palate in the off-spring. However, corticosteroids do not appear to cause congenital anomalies when given to pregnant women.
There are no adequate and well-controlled studies in pregnant women. Some retrospective studies have found an increased incidence of low birth weights in infants born of mothers receiving corticosteroids. The risk of low birth weight appears to be dose related and may be minimized by administering lower corticosteroid doses.
Cataracts have been observed in infants born to mothers treated with long-term corticosteroids during pregnancy. Since there is inadequate evidence of safety in human pregnancy, Hydrocortisone sodium succinate for injection USP should be used during pregnancy at the lowest possible dose, only if clearly needed and the potential benefit justifies the potential risk to the embryo or fetus.
Infants born of mothers who have received substantial doses of corticosteroids during pregnancy must be carefully observed and evaluated for signs of adrenal insufficiency. There are no known effects of corticosteroids on labor and delivery.
Cataracts have been observed in infants born to mothers undergoing long-term treatment with corticosteroids during pregnancy. 2 Breast-feeding Hydrocortisone sodium succinate for injection USP Page 18 of 41 Systemically administered corticosteroids are excreted in breast milk and may suppress infant growth, interfere with endogenous corticosteroid production, or cause other untoward effects.
Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a careful benefit-risk assessment should be conducted and a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
3 Pediatrics Pediatrics (<18 years of age) Pediatric patients may experience a decrease in their growth velocity at low systemic doses and in the absence of laboratory evidence of HPA axis suppression. Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function.
In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose over the shortest period of time. The growth and development of pediatric patients on prolonged corticosteroid therapy should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.
Infants and children on prolonged corticosteroid therapy are at special risk from raised intracranial pressure. High doses of corticosteroids may produce pancreatitis in children. Hypertrophic cardiomyopathy was reported as one of the adverse effects of prophylactic or therapeutic administration of hydrocortisone to prematurely born infants and few months old babies (< 12 months), therefore appropriate diagnostic evaluation and monitoring of cardiac function and structure must be performed (preferably two-dimensional echocardiography).
4 Geriatrics In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of […]
CAOfficial regulatory label· Warnings and precautions· revised September 18, 2025[3]
1 PREGNANT WOMEN 08/2025 7 WARNINGS AND PRECAUTIONS, MUSCULOSKELETAL 08/2025 TABLE OF CONTENTS Certain sections or subsections that are not applicable at the time of the preparation of the most recent authorized product monograph are not listed.
RECENT MAJOR LABEL CHANGES ........................................................................................................ 2 TABLE OF CONTENTS ..........................................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ................................................................................... 4 1 INDICATIONS..........................................................................................................................
10 7 WARNINGS AND PRECAUTIONS ............................................................................................ 1 Special Populations..............................................................................................................
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised September 18, 2025[3]
Hydrocortisone sodium succinate for injection USP (hydrocortisone sodium succinate) is contraindicated: • in patients with known hypersensitivity to any components of the product (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING); Hydrocortisone sodium succinate for injection USP Page 7 of 41 • in patients with systemic fungal infections; • in idiopathic thrombocytopenic purpura when administered intramuscularly; • in patients administered with live or live, attenuated vaccines while receiving immunosuppressive doses of corticosteroids; • in herpes simplex of the eye, except when used for short-term or emergency therapy as in acute sensitivity reactions; • in patients with vaccinia and varicella, except when used for short-term or emergency therapy as in acute sensitivity reactions.
Hydrocortisone sodium succinate for injection USP is not indicated for epidural route of administration. Hydrocortisone sodium succinate for injection USP is not indicated for intrathecal route of administration, except as part of certain chemotherapeutic regimens (diluents containing benzyl alcohol must not be used).
Reports of serious medical events, including death, have been associated with epidural and intrathecal routes of corticosteroid administration.
This is not medical advice. Consult a qualified healthcare professional.
Posology Dose must be individualised according to the response of the individual patient. The lowest possible dose should be used. g. surgery, infection, trauma). During stress it may be necessary to increase the dose temporarily. Replacement therapy in primary and secondary adrenal insufficiency Alkindi is given as replacement therapy by oral administration of granules according to clinical practice, in a dose to be titrated against individual clinical response.
Recommended replacement doses of hydrocortisone are 8-10 mg/m2/day for patients with adrenal insufficiency alone and 10-15 mg/m2/day in patients with congenital adrenal hyperplasia (CAH), typically in three or four divided doses. In patients with some remaining endogenous cortisol production a lower dose may be sufficient.
In situations when the body is exposed to excessive physical and/or mental stress, patients may need an increased dose, especially in the afternoon or evening. Pre-operatively, during serious trauma or illness in patients with known adrenal insufficiency or doubtful adrenal reserve Pre-operatively, anaesthetists must be informed if the patient is taking corticosteroids or has previously taken corticosteroids.
In less severe situations when parenteral administration of hydrocortisone is not required, for instance low grade infections, moderate fever of any aetiology and stressful situations such as minor surgical procedures, there should be high awareness of the risk of developing acute adrenal insufficiency, and the normal oral daily replacement dose should be increased temporarily; the Alkindi total daily dose should be increased by doubling or tripling the usual dose.
Once the intercurrent illness episode is over, patients can return to the normal replacement dose of Alkindi. In severe situations, an increase in dose is immediately required and oral administration of hydrocortisone must be replaced with parenteral treatment.
Parenteral administration of hydrocortisone is warranted during transient illness episodes such as severe infections, in particular gastroenteritis associated with vomiting and/or diarrhoea, high fever of any aetiology or extensive physical stress, such as for instance serious accidents and surgery under general anaesthesia.
Where parenteral hydrocortisone is required, the patient should be treated in a facility with resuscitation facilities in case of evolving adrenal crisis. 4 Changing from conventional oral glucocorticoid treatment to Alkindi When changing patients from conventional oral hydrocortisone replacement therapy, crushed or compounded, to Alkindi, an identical total daily dose may be given.
Alkindi is therapeutically equivalent to conventional oral hydrocortisone formulations. 4). Missed or Incomplete Dose If a full dose of Alkindi is missed, that dose should be administered as soon as possible, as well as their next dose at the usual time, even if this means that the child receives two doses at the same time.
Patients and/or caregivers should be instructed to contact their healthcare provider if most of the granules in a dose are regurgitated, vomited or spat out, as a repeat dose may be required to avoid adrenal insufficiency. Method of administration The granules must be given orally and should not be chewed.
The capsule shell must not be swallowed but carefully be opened as follows: - The capsule is held so that the printed strength is at the top, and tapped to ensure all the granules are in the lower half of the capsule. - The bottom of the capsule is gently squeezed.
- The top of the capsule is twisted off. - The granules are either poured directly onto the child’s tongue, or the granules are poured onto a spoon and placed in the child’s mouth. For children who are able to take soft food, the granules may be sprinkled onto a spoonful of cold or room temperature soft food (such as yoghurt or fruit puree) and given immediately.
- Whichever method is used, the capsule is tapped to ensure all the granules are removed. Immediately after administration a drink such as water, milk, breast-milk, or formula-milk should be given to help ensure all granules are swallowed.
If the granules are sprinkled onto a spoonful of soft food this should be given immediately (within 5 minutes) and not stored for future use. The granules must not be added to liquid as this can result in less than the full dose being given, and may affect the taste masking which will allow the bitter taste of hydrocortisone to become apparent.
4). Detailed pictograms on how to administer the granules are provided in the package leaflet.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised March 10, 2026[4]
Summary of safety profile A total of 30 healthy (but dexamethasone-suppressed) adult male subjects in two phase 1 studies and 24 paediatric patients with adrenal insufficiency in two phase 3 studies have been treated with Alkindi. There were no adverse reactions and no episodes of adrenal crisis seen in any of the studies.
4). Tabulated list of adverse reactions The following adverse reactions have been reported in the scientific literature in adult patients for other hydrocortisone medicinal products when given as adrenal insufficiency replacement therapy with frequency not known (cannot be estimated from the available data).
4). 4). It is unclear if these relate to hydrocortisone therapy using current replacement regimens. 8 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
EUOfficial regulatory label· Warnings and precautions· revised March 10, 2026[4]
Adrenal crisis Where a child is vomiting or acutely unwell parenteral hydrocortisone should be started without delay, carers should be trained in adminstering this in an emergency. Sudden discontinuation of therapy with hydrocortisone risks triggering an adrenal crisis and death.
Medicinal product-induced secondary adrenocortical insufficiency may result from too rapid a withdrawal of corticosteroids and may be minimised by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, corticosteroid therapy should be reinstated.
Adrenal crisis can occur when switching from conventional oral hydrocortisone formulations, crushed or compounded, to Alkindi. Close monitoring of patients is recommended in the first week after switch. Healthcare professionals should inform carers and patients that extra doses of Alkindi should be given if symptoms of adrenal insufficiency are seen.
If this is required, then an increase in the total daily dose of Alkindi should be considered and immediate medical advice should be sought. Immunisation Replacement schedules of corticosteroids for people with adrenal insufficiency do not cause immunosuppression and are not, therefore, contraindications for administration of live vaccines.
2). Patients with adrenal insufficiency are at risk of life-threatening adrenal crisis during infection so clinical suspicion of infection should be high and specialist advice should be sought early. Undesirable effects of corticosteroid replacement therapy Most undesirable effects of corticosteroids are dose and duration of exposure related.
Undesirable effects are therefore less likely when using corticosteroids as replacement therapy. Corticosteroids may cause growth retardation in infancy, childhood and adolescence; this may be irreversible. Treatment should be limited to the minimum dose required to achieve desired clinical response and when reduction in dose is possible, the reduction should be gradual.
Excessive weight gain with decreased height velocity or other symptoms or signs of Cushing syndrome indicate excessive glucocorticoid replacement. Infants require frequent assessment and should be evaluated at a minimum every 3 to 4 months to assess growth, blood pressure, and general well-being.
Bone mineral density may be impacted in children when higher doses of replacement steroids are used. The lowest appropriate dose of steroid according to the response of the individual patient should be used. 8). Symptoms typically emerge within a few days or weeks of starting the treatment.
5), although dose levels do not allow prediction of the onset, type, severity or duration of reactions. Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary. Patients/carers should be encouraged to seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected.
Patients/carers should also be alert to possible psychiatric disturbances that may occur either during or immediately 6 after dose tapering/withdrawal of systemic steroids, although such reactions have been reported infrequently. Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroids, especially when a patient has a history of allergies to medicinal products.
Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy which have been reported after use of systemic and topical corticosteroids.
Excretion of granules The granules may sometimes be seen in stools since the centre of the granule is not absorbed in the gut after it has released the active substance. This does not mean the medicinal product has been ineffective and the patient should not take another dose for this reason.
Nasogastric tube feeding Alkindi granules are not suitable for nasogastric administration as they may cause tube blockage.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised March 10, 2026[4]
1. Patients with dysphagia or premature infants where oral feeding has not been established. 5
This is not medical advice. Consult a qualified healthcare professional.
Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
Paediatric population In infants and children particularly, care should be taken that the lowest strength of hydrocortisone skin ointment that is clinically effective is used. Long-term continuous topical therapy should be avoided, where possible, as adrenal suppression can occur, even without occlusion.
Although generally regarded as safe, even for long-term administration in adults, there is a potential for adverse effects if over used in infancy. Extreme caution is required in dermatoses of infancy including napkin rash. In infants, the napkin may act as an occlusive dressing, and increase absorption.
Treatment should therefore be limited, where possible, to a maximum of 7 days. The label will state mild steroid.
Fungal Infections Corticosteroids, including hydrocortisone, may exacerbate systemic fungal infections; therefore, avoid hydrocortisone use in the presence of such infections unless hydrocortisone is needed to control drug reactions.
For patients on chronic hydrocortisone therapy who develop systemic fungal infections, hydrocortisone withdrawal or dosage reduction is recommended. Amebiasis Corticosteroids, including hydrocortisone, may activate latent amebiasis.
Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating hydrocortisone in patients who have spent time in the tropics or patients with unexplained diarrhea. Strongyloides Infestation Corticosteroids, including hydrocortisone, should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation.
In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.
Cerebral Malaria Avoid corticosteroids, including hydrocortisone, in patients with cerebral malaria. Ophthalmic Effects Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.
Kaposi’s Sarcoma Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement of Kaposi’s sarcoma.
Hypertension, Volume Overload, and Hypokalemia Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses.
Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Vaccinations Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids.
Killed or inactivated vaccines may be administered to patients receiving immunosuppressive doses of corticosteroids; however, the response to such vaccines may be diminished. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids.
Usage in Pregnancy Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers or women of child bearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus.
Infants born of mothers who have received substantial doses of corticosteroids during pregnancy, should be carefully observed for signs of hypoadrenalism. Corticosteroids have been shown to impair fertility in male rats. Usage in Pregnancy Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers or women of child bearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus.
Infants born of mothers who have received substantial doses of corticosteroids during pregnancy, should be carefully observed for signs of hypoadrenalism. Corticosteroids have been shown to impair fertility in male rats.
1 Pregnant Women .......................................................................................................... 2 Breast-feeding...............................................................................................................
19 9 DRUG INTERACTIONS ........................................................................................................... 2 Drug Interactions Overview.................................................................................................
27 11 STORAGE, STABILITY AND DISPOSAL ..................................................................................... 28 12 SPECIAL HANDLING INSTRUCTIONS .......................................................................................
29 PART II: SCIENTIFIC INFORMATION.................................................................................................... 30 13 PHARMACEUTICAL INFORMATION ........................................................................................
32 Hydrocortisone sodium succinate for injection USP Page 4 of 41 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Hydrocortisone sodium succinate for injection USP is indicated for: 1. Endocrine Disorders • In primary, secondary and acute […]