Hydrocortisone
Alkindi, Efmody, Plenadren · ATC code H02AB09
Also known as: Hydrocortison, Hidrokortizon, Idrocortisone, Hidrocortisona · Brand names: Alkindi, Efmody, Plenadren, Acecort, Ebenol Für Erwachsene Und Kinder Ab, Ebenol Zur Anwendung Bei Erwachsenen Und Kindern Ab Dem Vollendeten, Fenihydrocort, Hydrocort, Hydrocortipuren, Hydrocortison Acis, Hydrocortison Activase Pharmaceuticals, Hydrocortison Al, Hydrocortison Dexcel, Hydrocortison Galen, Hydrocortison Hoechst …
- Key facts
- Active substance
- Hydrocortisone
- Drug class
- Glucocorticoid
- ATC code
- H02AB09
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Alkindi 0.5 mg granules in capsules for opening / Alkindi 1 mg granules in capsules for opening / Alkindi 2 mg granules in capsules for opening · Efmody 5 mg modified-release hard capsules / Efmody 10 mg modified-release hard capsules · Plenadren 5 mg modified-release tablets / Plenadren 20 mg modified-release tablets
- Marketing authorisation holder
- Immedica Pharma AB, Takeda Pharmaceuticals International AG Ireland Branch
- Information as of
- 2026-11-03
Key facts
Hydrocortisone is the glucocorticoid used for cortisol replacement. This page covers the EU oral replacement products: Alkindi (granules in capsules for children from birth), Efmody (modified-release capsules for adrenal insufficiency and congenital adrenal hyperplasia from 12 years) and Plenadren (once-daily modified-release tablets for adults).
What it is used for
- Alkindi: replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old)
- Efmody: adrenal insufficiency (AI) and congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults
- Plenadren: adrenal insufficiency in adults
Dosing
- Dose individualised to clinical response; lowest possible dose
- Alkindi: 8-10 mg/m²/day in adrenal insufficiency alone and 10-15 mg/m²/day in CAH, typically in three or four divided doses; granules given orally, not chewed, never via nasogastric tube
- Efmody: adults and adolescents who have completed growth 15-25 mg/day, two thirds to three quarters at bedtime and the rest in the morning; starting dose above 40 mg per day not recommended
- Plenadren: common maintenance dose 20–30 mg once daily on awakening, at least 30 minutes before food, swallowed whole
- Switching from conventional hydrocortisone: identical total daily dose, with close monitoring (adrenal crisis reported after switching to Alkindi)
- Intercurrent illness: increase the oral dose temporarily (e.g. Alkindi doubled or tripled; Plenadren given twice or thrice daily); in severe illness, vomiting or surgery switch to parenteral hydrocortisone
Contraindications
- Hypersensitivity to hydrocortisone or any excipient
- Alkindi: dysphagia, or premature infants in whom oral feeding has not been established
Important warnings
- Sudden discontinuation or inadequate dosing can trigger adrenal crisis and death; parenteral hydrocortisone with sodium chloride infusion during crisis
- Infections: start stress dosing early; replacement doses do not cause immunosuppression and do not preclude live vaccines
- Over-replacement: Cushing-like features, hypertension, diabetes, reduced bone mineral density; growth retardation in children (monitor growth)
- Psychiatric reactions (euphoria, mania, psychosis); visual disturbance should prompt ophthalmological referral
- Modified-release forms not recommended with increased gastrointestinal motility such as chronic diarrhoea
- Efmody: hypokalaemia (monitor potassium), restored fertility in CAH with risk of unexpected pregnancy
Side effects
- Fatigue (very common with Efmody and Plenadren), headache, dizziness or vertigo
- Nausea, diarrhoea, upper abdominal pain
- Efmody: weight increase, appetite changes, asthenia, insomnia, carpal tunnel syndrome
- Reported with other hydrocortisone replacement products: psychosis, mania, euphoria, gastritis, hypokalaemic alkalosis
Interactions
- CYP3A4 inducers (phenytoin, carbamazepine, rifampicin, rifabutin, barbiturates, efavirenz, nevirapine, St. John's wort): lower cortisol, dose increase may be needed
- CYP3A4 inhibitors (itraconazole, posaconazole, voriconazole, clarithromycin, erythromycin, ritonavir, grapefruit juice, liquorice): higher cortisol, dose decrease may be needed
- Corticosteroids antagonise insulin and other hypoglycaemic drugs; effect may be reduced for 3-4 days after mifepristone
- Hypokalaemic diuretics, stimulant laxatives, fludrocortisone and amphotericin B increase the risk of hypokalaemia
Pregnancy and breastfeeding
- Replacement therapy can be used and should be continued during pregnancy; placental 11βHSD2 inactivates much of the hydrocortisone; monitor the dose
- Excreted in breast milk, but replacement doses can be used during breast-feeding
Summary of the official product information, written with AI on 2026-11-03. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- AlkindiImmedica Pharma AB · EMEA/H/C/004416
- EfmodyImmedica Pharma AB · EMEA/H/C/005105
- PlenadrenTakeda Pharmaceuticals International AG Ireland Branch · EMEA/H/C/002185
Source: European Medicines Agency (EMA), product information
Germany
- AcecortAce Pharmaceuticals Bv · 1 register entry
- Ebenol Für Erwachsene Und Kinder AbStrathmann Gmbh & Co. Kg · 1 register entry
- Ebenol Zur Anwendung Bei Erwachsenen Und Kindern Ab Dem VollendetenStrathmann Gmbh & Co. Kg · 1 register entry
- FenihydrocortHaleon Germany Gmbh · 1 register entry
- Hydrocort1 A Pharma Gmbh · 1 register entry
- HydrocortipurenPuren Pharma Gmbh & Co. Kg · 1 register entry
- Hydrocortison AcisMibe Gmbh Arzneimittel · 1 register entry
- Hydrocortison Activase PharmaceuticalsActivase Pharmaceuticals Limited · 1 register entry
- Hydrocortison AlAliud Pharma Gmbh · 1 register entry
- Hydrocortison DexcelDexcel Pharma Gmbh · 1 register entry
- Hydrocortison GalenGalenpharma Gmbh · 1 register entry
- Hydrocortison HoechstTeofarma S.R.L. · 1 register entry
Show all 33 brand names
- Hydrocortison Hoechst® .Teofarma S.R.L. · 1 register entry
- Hydrocortison HualanHualan · 1 register entry
- Hydrocortison JenapharmMibe Gmbh Arzneimittel · 1 register entry
- Hydrocortison PanpharmaPanpharma Gmbh · 2 register entries
- Hydrocortison PfizerPfizer Pharma Gmbh · 1 register entry
- Hydrocortison-Pos NUrsapharm Arzneimittel Gmbh · 1 register entry
- Hydrocortison RatiopharmRatiopharm Gmbh · 1 register entry
- Hydrocortison RobugenRobugen Gmbh Pharmazeutische Fabrik · 1 register entry
- Hydrocortison StadaStada Consumer Health Deutschland Gmbh · 1 register entry
- Hydrocortison TiofarmaTiofarma B.V. · 1 register entry
- Hydrocortison ZentivaZentiva Pharma Gmbh · 1 register entry
- HydrocutanDermapharm Ag · 1 register entry
- HydrogalenGalenpharma Gmbh, Dr. August Wolff Gmbh & Co. Kg Arzneimittel · 3 register entries
- Linola AkutDr. August Wolff Gmbh & Co. Kg Arzneimittel · 1 register entry
- Linolacort HydroDr. August Wolff Gmbh & Co. Kg Arzneimittel · 1 register entry
- MuniRobugen Gmbh Pharmazeutische Fabrik · 1 register entry
- Sanatison MonoRobugen Gmbh Pharmazeutische Fabrik · 1 register entry
- SoftacortLaboratoires Thea · 1 register entry
- Soventol HydrocortMedice Pharma Gmbh & Co. Kg · 3 register entries
- Soventol HydrocortisonacetatMedice Pharma Gmbh & Co. Kg · 2 register entries
- SystralRobugen Gmbh Pharmazeutische Fabrik, Meda Pharma Gmbh & Co. Kg, Viatris Healthcare Gmbh · 3 register entries
Source: EMA – Article 57 product data (EU/EEA), as of 2026-11-03
Austria
- Ekzemsalbe „f“Agepha Pharma S.R.O · 1 register entry
- HydrocortisonInresa Arzneimittel Gmbh, Fairmed Healthcare Gmbh, Hualan · 3 register entries
- Hydrocortisone Hualan PharmaceuticalsHualan · 1 register entry
- HydrocortoneTeva B.V · 1 register entry
- SoftacortLaboratoires Thea · 1 register entry
- Soventol HydrocortisonacetatMedice Pharma Gmbh & Co. Kg · 1 register entry
- TopalindStada Arzneimittel Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-11-03
Turkey
- GenkortGEN İLAÇ VE SAĞLIK ÜRÜNLERİ SAN. VE TİC. A.Ş. · 1 register entry
- HidrozonVEM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- Hydrocort-LiyoKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-11-03
Brand names in 28 more European countries
- Belgium
- Acecort, Cremicort, Hydrocortison Hualan, Hydrocortison Tiofarma, Hydrocortisone Bepb, Hydrocortisone Conforma, Hydrocortisone Hualan, Hydrocortisone Pos Ursapharm Benelux, Pannocort, Softacor, Solu-Cortef
- Bulgaria
- Софтакорт, Хидрокортизон Ромфарм
- Croatia
- Cortef, Cortovex, Hidrokortizon Medochemie, Softacort, Solu-Cortef
- Cyprus
- Cortizi® Preservative Free, Cortopin, Dermaid, Eping, Hydrocortison Vuab, Hydrocortisone Activase, Hydrocortisone Medo, Hydrocortisone Renata, Hydrocortisonum-Sf, Softacort
- Czechia
- Hydrocortison Léčiva, Hydrocortison Vuab, Hydrocortisone Medochemie, Hydrocortisone Panpharma, Hydrocortisone Quintesence, Ophthalmo, Softacort
- Denmark
- Hydrocortison Strides, Hydrocortisone Activase, Hydrocortisone G.L. Pharma, Hydrokortison Dak, Hydrokortison Evolan, Hydrokortison Orion, Lilinorm, Mildison Lipid, Nordison, Petacort, Softacort, Solu-Cortef
- Estonia
- Abix, Hydrocortisone Dak, Hydrocortisone Medochemie, Solu-Cortef
- Finland
- Ampikyy, Hydrocortison Orion, Hydrocortison Ratiopharm, Hydrocortisone Activase, Hydrocortisone Morningside, Hydrocortisone Orion, Hydrocortisone Panpharma, Kyypakkaus, Petacort, Softacort, Solu-Cortef
- France
- Colofoam, Corazed, Cortapaisyl, Cortisedermyl, Dermofenac Demangeaisons, Hydracort, Hydrocortisone Arrow, Hydrocortisone Panpharma, Hydrocortisone Roussel, Hydrocortisone Substipharm, Hydrocortisone Upjohn, Lenaster, Softacort
- Greece
- Cortizi, Drosone, Edicot, Fasmicor, Hydracort, Hydrocortisone Ι.Φ.Ε.Τ., Lyo-Cortin, Softacort, Solu-Cortef
- Hungary
- Cortef, Hikomicron, Hydrocortison Rompharm, Hydrocortison Wagner, Solu-Cortef
- Iceland
- Alkindi, Efmody, Hydrokortison Evolan, Hydrokortison Orion, Mildison Lipid, Plenadren, Softacort, Solu-Cortef
- Ireland
- Cortopin, Hc45, Hydrocortison Hualan, Hydrocortisone, Hydrocortone, Solu-Cortef, Zoftacot
- Italy
- Cortidro, Cortivis, Dermirit, Dermocortal, Euclorina Eritemi E Dermatiti, Flebocortid, Foille Insetti, Lenirit, Sofacor, Sterovis
- Latvia
- Hydrocortisone Medochemie, Hydrocortisone Renata, Hydrocortisonum Pharmaswiss, Solu-Cortef
- Liechtenstein
- Alkindi, Efmody, Plenadren
- Lithuania
- Hydrocortisone Orifarm
- Luxembourg
- Cortisedermyl, Cremicort, Hydrocortisone Bepb, Pannocort, Softacor, Solu-Cortef S.A.B. Act-O-Vial, Soventol Hydrocort, Soventol Hydrocortisonacetat
- Malta
- Carplexil, Hydrocortisone Panpharma, Hydrokortyzon Allefin Max
- Netherlands
- Acecort, Hydrocortison, Hydrocortisone Hualan Pharmaceuticals, Softacor, Solu-Cortef, Zure Oordruppels Met Hydrocortison Fna
- Norway
- Alkindi, Efmody, Hydrokortison Evolan, Lilinorm, Mildison Lipid, Plenadren, Softacort, Solu-Cortef
- Poland
- Akortor, Corhydron, Dermocort, Hydrocort, Hydrocortison Vuab, Hydrocortisone Panpharma, Hydrocortisone Pharmis, Hydrocortisone Pharmline, Hydrocortisonum Aflofarm, Hydrocortisonum Afp, Hydrocortisonum Amara, Hydrocortisonum Jelfa, Hydrocortisonum Max Ziaja, Hydrocortisonum-Sf, Hydrocortisonum Ziaja, Hydrokortyzon Allefin, Maxicortan, Softacort
- Portugal
- Carplexil, Hidrocortisona, Pandermil, Proctorrane, Softacort, Solu-Cortef
- Romania
- Hidrocortizon Atb, Hidrocortizon Fiterman, Hidrocortizon Hf, Hidrocortizon Panpharma, Hidrocortizon Rompharm, Hidrocortizon Zentiva, Hydrocortisone Succinat Sodic Eipico, Softacort
- Slovakia
- Cortovex, Hydrocortison Léčiva, Hydrocortison Vuab, Hydrocortisone Medochemie, Ophthalmo-Hydrocortison Léčiva, Softacort
- Slovenia
- Hidrokortizon Altamedics, Hidrokortizon Medochemie, Hidrokortizon Orion, Hidrokortizon Renata Pharmaceuticals (Ireland), Softacort, Solu-Cortef
- Spain
- Actocortina, Calmiox, Dermosa Hidrocortisona, Hemodren, Hemorrane, Hidroaltesona, Hidrocortisona, Oftalmolosa Cusí Hidrocortisona, Softacort
- Sweden
- Ficortril, Hydrocortisone Activase, Hydrocortisone G.L. Pharma, Hydrocortisone Morningside, Hydrocortisone Panpharma, Hydrokortison Evolan, Hydrokortison Orion, Hydrokortison Pharmswed, Hydrokortison Strides, Kortifarm, Lilinorm, Mildison Lipid, Nordison, Nordisone, Petacort, Softacort, Solu-Cortef
EMA – Article 57 product data (EU/EEA), 2026-11-03
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Sources
- European Medicines Agency. Alkindi – EPAR, Product Information. 2026-11-03. https://www.ema.europa.eu/en/documents/product-information/alkindi-epar-product-information_en.pdf
- European Medicines Agency. Efmody – EPAR, Product Information. 2026-11-03. https://www.ema.europa.eu/en/documents/product-information/efmody-epar-product-information_en.pdf
- European Medicines Agency. Plenadren – EPAR, Product Information. 2026-11-03. https://www.ema.europa.eu/en/documents/product-information/plenadren-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-11-03. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-11-03. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-11-03. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC H02AB.
Editorial: Medelix editorial team · last updated 2026-11-03 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.