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Fludrocortisone

Astonin H · ATC code H02AA02

Also known as: Fludrocortison, Fludrokortizon, fludrocortisone acetate · Brand names: Astonin H, Fludrocortison Accord, Fludrocortison Novumgen, Fludrocortisonacetat Burg Pharma, Fludrocortisonacetat Galen, Fludrocrotison Helm, Astonin-H

Key facts
Active substance
Fludrocortisone
Drug class
Mineralocorticoid
ATC code
H02AA02
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Key facts

Fludrocortisone (as fludrocortisone acetate) is a potent mineralocorticoid. Per the US prescribing information, it is used as partial replacement in adrenocortical insufficiency and for salt-losing adrenogenital syndrome.

What it is used for

  • Partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease
  • Salt-losing adrenogenital syndrome
  • Because of its marked effect on sodium retention, use in other conditions is not advised

Dosing

  • Dose depends on disease severity and response; reassess during stress (surgery, infection, trauma)
  • Addison's disease: usually 0.1 mg daily (0.1 mg three times a week to 0.2 mg daily has been used), preferably with cortisone (10 mg to 37.5 mg daily) or hydrocortisone (10 mg to 30 mg daily)
  • If transient hypertension develops, reduce to 0.05 mg daily
  • Salt-losing adrenogenital syndrome: 0.1 mg to 0.2 mg daily

Contraindications

  • Systemic fungal infections
  • History of possible or known hypersensitivity to corticosteroids

Important warnings

  • Marked sodium retention: monitor dose and salt intake to avoid hypertension, edema or weight gain; check electrolytes during prolonged therapy
  • May mask signs of infection and decrease resistance to infection
  • Chicken pox and measles can be serious or fatal in immunosuppressed patients
  • No smallpox vaccination; avoid other immunizations because of possible neurological complications and lack of antibody response
  • Latent tuberculosis may reactivate; prolonged use may cause cataracts and glaucoma

Side effects

  • Mineralocorticoid effects: hypertension, edema, cardiac enlargement, congestive heart failure, potassium loss, hypokalemic alkalosis
  • With prolonged use or with glucocorticoids: muscle weakness, osteoporosis, fractures, peptic ulcer, pancreatitis
  • Impaired wound healing, thin skin, bruising; convulsions, headache, severe mental disturbances

Interactions

  • Amphotericin B and potassium-depleting diuretics: enhanced hypokalemia
  • Digitalis glycosides: higher risk of arrhythmias with hypokalemia
  • Oral anticoagulants and antidiabetic drugs: diminished effect
  • Barbiturates, phenytoin, rifampin: increased clearance of fludrocortisone
  • Aspirin, anabolic steroids, estrogen: see the full prescribing information

Pregnancy and breastfeeding

  • Not known whether it can cause fetal harm; use in pregnancy only if clearly needed

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

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.

Austria

  • Astonin HMerck Gesellschaft Mbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • Astonin HMerck Healthcare Germany Gmbh · 1 register entry
  • Fludrocortison AccordAccord Healthcare B.V. · 1 register entry
  • Fludrocortison NovumgenNovumgen Limited · 1 register entry
  • Fludrocortisonacetat Burg PharmaBurg Pharma Gmbh · 1 register entry
  • Fludrocortisonacetat GalenGalenpharma Gmbh · 1 register entry
  • Fludrocrotison HelmHelm Pharmaceuticals Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • Astonin-HMERCK İLAÇ ECZA VE KİMYA TİC. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 22 more European countries
Bulgaria
Кортинеф
Croatia
Zonta
Denmark
Cortiflix, Florinef, Fludrocortisonacetat Galen
Finland
Cortiflix, Florinef
France
Flucortac, Fludrocortisone Acetate Accord, Fludrocortisone Acetlab
Greece
Felusil
Hungary
Astonin
Iceland
Florinef
Ireland
Fludrocortisone Acetate Mylan, Fludrocortisone Acetate Renata
Latvia
Cortineff, Fludrocortisone Acetate Renata
Lithuania
Cortineff
Luxembourg
Astonin H
Malta
Fludrocortisone Acetate Renata
Netherlands
Florinef Acetaat, Fludrace, Fludrocortisonacetaat
Norway
Cortiflix, Florinef
Poland
Cortineff, Fludrocortisone Acetate Ria, Fludrocortisone Adamed, Fludrokortyzonu Octan Novumgen
Portugal
Fludrocortisona Renata
Romania
Astonin H
Slovakia
Zonta
Slovenia
Zonta
Spain
Astonín, Fludrocortisona
Sweden
Cortiflix, Florinef

EMA – Article 57 product data (EU/EEA), 2026-10-29

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Sources

  1. U.S. Food and Drug Administration. fludrocortisone acetate (Eywa Pharma Inc) – Prescribing Information, 2026-05-13. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=eff2eae8-94ce-46ca-a027-6b1d08e7b96b
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC H02AA.

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.