Hydrocortisone

Overview

Hydrocortisone, or cortisol, is a glucocorticoid secreted by the adrenal cortex. Hydrocortisone is used to treat immune, inflammatory, and neoplastic conditions. It was discovered in the 1930s by Edward Kendall and named Compound F, or 17-hydroxycorticosterone. Hydrocortisone was granted FDA approval on 5 August 1952.

Indication

Otic solutions are indicated for infections of the external auditory canal caused by susceptible organisms and with inflammation. Hydrocortisone tablets are indicated for certain endocrine, rheumatic, collagen, allergic, ophthalmic, respiratory, hematologic, neoplastic, edematous, gastrointestinal, and other conditions. A hydrocortisone enema is indicated for ulcerative colitis, a topical ointment with antibiotics is indicated for corticosteroid responsive dermatoses with infections, and a topical cream with acyclovir is indicated to treat cold sores. Oral granules of hydrocortisone are used as a replacement therapy for Adrenocortical Insufficiency (AI) in children under 17 years of age.

Associated Conditions

Acute Gouty Arthritis
Acute Leukemia
Acute Otitis Externa
Adrenal Insufficiency
Allergic Conjunctivitis (AC)
Allergic Rhinitis (AR)
Allergic corneal marginal ulcers
Ankylosing Spondylitis (AS)
Aspiration Pneumonitis
Asthma
Atopic Dermatitis
Berylliosis
Bullous dermatitis herpetiformis
Chorioretinitis
Choroiditis
Congenital Adrenal Hyperplasia (CAH)
Congenital Hypoplastic Anemia
Contact Dermatitis
Crohn's Disease (CD)
Dermatitis
Dermatomyositis (DM)
Dermatosis
Drug hypersensitivity reaction
Epicondylitis
Erythroblastopenia
Fissure;Anal
Haemorrhoids
Herpes Labialis
Hypercalcemia of Malignancy
Immune Thrombocytopenia (ITP)
Infection of the Fenestration Cavity
Infection of the Mastoidectomy Cavity
Iridocyclitis
Iritis
Itching caused by Hemorrhoids
Itching of the Anus
Keratitis
Leukemias
Loeffler's syndrome
Lymphoma
Lymphomas NEC
Mycosis Fungoides (MF)
Ophthalmia, Sympathetic
Optic Neuritis
Pain caused by Hemorrhoids
Pemphigus
Posterior Uveitis
Posttraumatic Osteoarthritis
Primary adrenocortical insufficiency
Proctitis
Proteinuria
Pruritis of the skin
Psoriatic Arthritis
Rectal inflammations NEC
Rheumatic heart disease, unspecified
Rheumatoid Arthritis
Rheumatoid Arthritis, Juvenile
Secondary adrenocortical insufficiency
Secondary thrombocytopenia
Serum Sickness
Severe Seborrheic Dermatitis
Skin Diseases
Stevens-Johnson Syndrome
Synovitis
Systemic Lupus Erythematosus
Trichinosis
Tuberculous Meningitis
Ulcerative Colitis
Acquired immune hemolytic anemia
Acute Bursitis
Acute Tenosynovitis
Acute rheumatic carditis
Anterior eye segment inflammation
Cryptitis
Disseminated Pulmonary Tuberculosis (TB)
Exfoliative erythroderma
Fulminating Pulmonary Tuberculosis
Non-suppurative Thyroiditis
Severe Erythema multiforme
Severe Psoriasis
Subacute Bursitis
Superficial infection of the external auditory canal with inflammation
Symptomatic Sarcoidosis
Systemic Dermatomyositis
Varicella-zoster virus acute retinal necrosis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Sore Throat After Open Neck Elective Surgery	2025/08/15	NCT07124650	Not Applicable	Not yet recruiting	Saint Petersburg State University, Russia
Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL)	2025/07/18	NCT07072585	Not Applicable	Not yet recruiting	Children's Oncology Group
The Effects of Propranolol, Hydrocortisone, and Morphine on Military-Relevant Performance Outcomes	2025/05/21	NCT06982183	Phase 4	Recruiting	Walter Reed Army Institute of Research (WRAIR)
Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation	2025/04/24	NCT06942039	Early Phase 1	Not yet recruiting	C17 Council
Comparison Between Intravenous Hydrocortisone and Ondansetron in Prevention of Post Spinal Anesthesia Hypotension	2025/04/16	NCT06930456	Not Applicable	ENROLLING_BY_INVITATION	Nada kamel Elgamal
Intrathecal Cytarabine, Methotrexate, and Hydrocortisone for the Prevention of High-Grade Chimeric Antigen Receptor T-Cell-Associated Neurotoxicity Syndrome	2025/03/26	NCT06895473	Phase 2	Not yet recruiting	OHSU Knight Cancer Institute
Comparing Hydrocortisone and Prednisolone for Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)	2025/03/25	NCT06892210	Phase 4	Not yet recruiting	Copenhagen Respiratory Research
Comparing Hydrocortisone and Prednisolone for Community Acquired Pneumonia (CAP)	2025/03/25	NCT06892197	Phase 4	Not yet recruiting	Copenhagen Respiratory Research
Effects of Intravenous Metabolic Recovery Agent in Elderly Septic Patients on Prognosis and Microcirculation.	2024/12/09	NCT06723626	Not Applicable	Recruiting	Southeast University, China
Effect of Early Hydrocortisone on Risk of Gastrointestinal Perforations in Extremely Preterm Infants	2024/07/23	NCT06515405	N/A	Active, not recruiting	Imperial College London

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone	MWI	13985-608	OPHTHALMIC	10 mg in 1 g	3/23/2015
Hydrocortisone Iodoquinol	Westminster Pharmaceuticals, LLC	69367-286	TOPICAL	10 mg in 1 g	5/12/2023
Hydrocortisone	NuCare Pharmaceuticals,Inc.	68071-1598	TOPICAL	25 mg in 1 g	4/19/2023
Hydrocortisone	Actavis Pharma, Inc.	0472-0321	TOPICAL	10 mg in 1 g	6/30/2017
Avedana Hydrocortisone Cream with Aloe	Unipack LLC	43749-620	TOPICAL	10.2 mg in 1 g	7/13/2025
Cortizone 10	Chattem, Inc.	41167-0039	TOPICAL	10 mg in 1 g	8/1/2025
Alkindi Sprinkle	Eton Pharmaceuticals, Inc.	71863-112	ORAL	5 mg in 1 1	2/28/2024
hydrocortisone and acetic acid	Akorn Operating Company LLC	50383-901	AURICULAR (OTIC)	10.375 mg in 1 mL	10/13/2022
PROCTOZONE-HC	Bryant Ranch Prepack	63629-2396	TOPICAL	25 mg in 1 g	2/15/2022
Neomycin and Polymyxin B Sulfates and Hydrocortisone	NuCare Pharmaceuticals,Inc.	68071-4229	AURICULAR (OTIC)	10 mg in 1 mL	6/16/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Efmody	Neurocrine Netherlands B.V.,Van Heuven Goedhartlaan 935 A,1181 LD Amstelveen,NETHERLANDS	Authorised	5/27/2021
Alkindi	Neurocrine Netherlands B.V.,Van Heuven Goedhartlaan 935 A,1181 LD Amstelveen,NETHERLANDS	Authorised	2/9/2018
Plenadren	Takeda Pharmaceuticals International AG Ireland Branch,Block 2 Miesian Plaza,50-58 Baggot Street Lower,Dublin 2,Co Dublin,D02 HW68,Ireland	Authorised	11/3/2011

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
HYDROCORTISONE CREAM 1% w/w	XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD	SIN05104P	CREAM	1% w/w	10/3/1990
XEPACORT CREAM 1% W/W	XEPA-SOUL PATTINSON (M) SDN BHD	SIN16545P	CREAM	1.00% W/W	7/6/2022
AXCEL HYDROCORTISONE CREAM 1% w/w	KOTRA PHARMA (M) SDN BHD	SIN10970P	CREAM	1% w/w	6/5/1999
H-CORT CREAM 1% w/w	HOE PHARMACEUTICALS SDN BHD	SIN12211P	CREAM	1% w/w	2/28/2003
CANDACORT CREAM	HOE PHARMACEUTICALS SDN BHD	SIN11806P	CREAM	1% w/w	2/20/2002
CORTISONE CREAM 1%	HOVID BHD	SIN03897P	CREAM	1 g/100 g	2/23/1990
DERM-AID CREAM 0.5%	EGO PHARMACEUTICALS PTY LTD	SIN07122P	CREAM	0.5%	8/12/1992
EGOCORT CREAM 1%	EGO PHARMACEUTICALS PTY LTD	SIN04792P	CREAM	1% w/w	6/26/1990
H-CORT OINTMENT 1% w/w	HOE PHARMACEUTICALS SDN BHD	SIN12212P	OINTMENT	1% w/w	2/28/2003
HYDROCORTISON TABLET 10 mg	ORION CORPORATION (ESPOO PLANT), Orion Corporation (Turku Plant), Orion Corporation (Salo Plant) (Primary and Secondary Packager)	SIN07203P	TABLET	10.0 mg	10/12/1992

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
HYDROCORTISONE CREAM 1% (VIDA)	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	9/13/1979
UNI-CORT-N CREAM	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	8/1/1995
TINACORT CREAM	N/A	HOVID LIMITED	N/A	N/A	9/28/2009
UNI-CORT CREAM 1%	N/A	UNIVERSAL PHARMACEUTICAL LABORATORIES, LIMITED	N/A	N/A	8/1/1995
VIDACORTICIN CREAM	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	5/19/1979
DAFRIN-H CREAM	N/A	WILCOME PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	1/29/1983
HYDRO-FUNGA CREAM	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	12/5/1991
HYDROCORTISONE CREAM 1%	N/A	NEOCHEM PHARMACEUTICAL LABORATORIES LIMITED	N/A	N/A	4/26/1979
NEO-CONASONE CREAM	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	11/19/1999
UNI-CORT OINTMENT 1%	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	8/1/1995

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
DERMAID 0.5% Cream	10605	Ego Pharmaceuticals Pty Ltd	Medicine	A	8/2/1991
DERMAID SOFT 0.5% CREAM hydrocortisone 5mg/g cream tube	71683	Ego Pharmaceuticals Pty Ltd	Medicine	A	10/29/1999
CIPROXIN HC EAR DROPS 0.2% ciprofloxacin (as hydrochloride) and 1% hydrocortisone ear drops	136662	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	3/12/2008
DermAid 1% solution hydrocortisone 10mg/g solution bottle	260373	Ego Pharmaceuticals Pty Ltd	Medicine	A	9/29/2015
DermAid 1% spray	225475	Ego Pharmaceuticals Pty Ltd	Medicine	A	7/8/2014
Hydrocortisone Cream 1% (Noumed)	397892	NOUMED PHARMACEUTICALS PTY LTD	Medicine	A	10/17/2022
HYDROCORTISONE VIATRIS 4 hydrocortisone 4 mg tablet bottle	290097	Alphapharm Pty Ltd	Medicine	A	9/21/2017
HYDROZOLE hydrocortisone / clotrimazole cream tube	10319	Haleon Australia Pty Ltd	Medicine	A	8/13/1991
Hysone '20' Tablets	27926	Alphapharm Pty Ltd	Medicine	A	10/21/1991
ALKINDI hydrocortisone 2 mg granules (in capsule) bottle	319410	Chiesi Australia Pty Ltd	Medicine	A	8/18/2020

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
PROCTOSEDYL OINTMENT	hoechst roussel canada inc.	01988549	Ointment - Rectal	5 MG / G	12/31/1971
CORTATE CRM 1%	schering-plough canada inc	00502200	Cream - Topical	10 MG / G	12/31/1980
AQUACORT LOTION 2.5%	merit industries inc.	01940120	Lotion - Topical	2.5 %	12/31/1992
TEXACORT SOLUTION 1%	genderm corporation	00740330	Lotion - Topical	1 %	12/31/1988
SARNA HC	GlaxoSmithKline Inc	00856711	Lotion - Topical	2.5 %	12/31/1990
HYDROCORTISONE CREAM 0.5%	d.c. labs limited	00551953	Cream - Topical	500 MG / 100 G	12/31/1982
BARRIERE HC 1%	allen & hanburys a glaxo canada ltd. co.	00465070	Jelly , Cream - Topical	1 %	12/31/1979
CORTISPORIN	GlaxoSmithKline Inc	01912828	Solution - Otic	10 MG / ML	12/31/1991
PROCTOSEDYL	Aptalis Pharma Canada ULC	02223252	Ointment - Rectal	0.5 %	4/1/2003
HYDROCORTISONE CREAM USP 0.5%	ksl pharmaceuticals	00756679	Cream - Topical	0.5 %	12/31/1994

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
EFMODY 5 MG CAPSULAS DURAS DE LIBERACION MODIFICADA	Diurnal Europe B.V.	1211549001	CÁPSULA DURA DE LIBERACIÓN MODIFICADA	Diagnóstico Hospitalario	Not Commercialized
ALKINDI 0,5 MG GRANULADO EN CAPSULAS PARA ABRIR	Diurnal Europe B.V.	1171260001	GRANULADO EN CAPSULAS PARA ABRIR	Medicamento Sujeto A Prescripción Médica	Not Commercialized
ALKINDI 5 MG GRANULADO EN CAPSULAS PARA ABRIR	Diurnal Europe B.V.	1171260004	GRANULADO EN CAPSULAS PARA ABRIR	Medicamento Sujeto A Prescripción Médica	Not Commercialized
EFMODY 10 MG CAPSULAS DURAS DE LIBERACION MODIFICADA	Diurnal Europe B.V.	1211549002	CÁPSULA DURA DE LIBERACIÓN MODIFICADA	Diagnóstico Hospitalario	Not Commercialized
BRENTÁN 20 MG/G + 10 MG/G CREMA	Esteve Pharmaceuticals S.A.	52664	CREMA	Medicamento Sujeto A Prescripción Médica	Commercialized
HIDROALTESONA 20 MG COMPRIMIDOS	Laboratorios Alter S.A.	25699	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
CALMIOX 5 mg/g CREMA	Esteve Pharmaceuticals S.A.	60889	CREMA	Sin Receta	Commercialized
HIDROCISDIN 5 mg/g ESPUMA CUTANEA	Isdin S.A.	60890	ESPUMA CUTÁNEA	Sin Receta	Not Commercialized
PLENADREN 5 MG COMPRIMIDOS DE LIBERACION MODIFICADA	Takeda Pharmaceuticals International Ag Ireland Branch	111715001	COMPRIMIDO DE LIBERACIÓN MODIFICADA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
CALMIOX 5 mg/g ESPUMA CUTANEA	Esteve Pharmaceuticals S.A.	60888	ESPUMA CUTÁNEA	Sin Receta	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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