Evigrade

Hydrocortisone

AEMPS

Short-acting systemic glucocorticoid, identical to endogenous cortisol

ATC code: H02AB09

Brand names: Cortef, Solu-Cortef, Plenadren

Updated · Methodology

Indications

B

Severe allergic reactions

Adjunct

The only first-line treatment for anaphylaxis is intramuscular adrenaline; hydrocortisone never replaces it. Corticosteroids are used as an adjunct to adrenaline, mainly when bronchospasm accompanies the reaction. They do not reliably prevent biphasic reactions (US Practice Parameter 2020, Cochrane 2012). The Resuscitation Council UK (2021) and (2021) no longer recommend corticosteroids for routine emergency treatment of anaphylaxis; 2020 and the AEMPS label keep them as a second-line adjunct.

ICD-10: T78.2 · ICD-11: 4A84

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Identical to endogenous cortisol. Active immediately, no liver conversion required. Binds the glucocorticoid receptor and induces lipocortin synthesis (phospholipase A2 inhibitor) – blocking arachidonic acid, leukotriene and prostaglandin formation. Half-life 1–2 hours, biological action 8–12 hours.

Safety

Contraindications

  • Hypersensitivity to hydrocortisone
  • Systemic fungal infections
  • Live vaccines at immunosuppressive doses

Serious adverse effects

  • Adrenal crisis with missed dose or stress without dose increase
  • Severe infections at immunosuppressive doses
  • Avascular bone necrosis (prolonged high doses)

Common adverse effects

  • Weight gain (at above-replacement doses)
  • Sodium retention and oedema
  • Hyperglycaemia
  • Gastritis
  • Mood changes

Uncommon adverse effects

  • Adrenal crisis with missed dose or stress without dose increase
  • Avascular bone necrosis with prolonged high doses
  • Steroid-induced diabetes
  • Immunosuppression with latent infection reactivation
  • Hypertension and oedema

Pregnancy: can you take Hydrocortisone?

AEMPS summary of product characteristics (section 4.6): hydrocortisone can cross the placenta. There is no evidence that corticosteroids increase the incidence of congenital anomalies when given to pregnant women, although animal studies suggest a very small risk of cleft palate and intrauterine growth restriction in the fetus. When corticosteroids are essential, patients with normal pregnancies can be treated as if they were not pregnant, while those with pre-eclampsia or fluid retention need close monitoring. Some retrospective studies found a higher rate of low birth weight in babies of mothers taking corticosteroids (in humans the risk seems dose-related and may be reduced with lower doses), and cataracts have been seen in babies of mothers on long-term corticosteroid treatment. Newborns may in theory develop hypoadrenalism after prenatal exposure, so they are observed for its signs and treated if these appear.

Breastfeeding: can you take Hydrocortisone?

Compatible. Hale L2. Identical to endogenous cortisol – transfers into milk at physiological concentrations. Replacement doses require no infant monitoring; high doses follow the same approach as prednisone.

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Label mentions37 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • «Advertencias especiales: Se espera que el tratamiento conjunto con inhibidores de CYP3A, incluidos los productos que contienen cobicistat, aumente el riesgo de efectos secundarios sistémicos. Se debe…»

    AEMPS, section 4.4 · Open on CIMA

  • «Drug Interactions: The pharmacokinetic interactions listed below are potentially clinically important. Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampin may increase the…»

    FDA, section 7 · Open on DailyMed

  • «Drug Interactions: The pharmacokinetic interactions listed below are potentially clinically important. Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampin may increase the…»

    FDA, section 7 · Open on DailyMed

  • «Drug Interactions: The pharmacokinetic interactions listed below are potentially clinically important. Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampin may increase the…»

    FDA, section 7 · Open on DailyMed

  • ModerateAINEclass named in the label
    «Advertencias especiales: La aspirina y los agentes antiinflamatorios no esteroideos deben usarse con precaución junto con corticosteroides (ver sección 4.5).»

    AEMPS, section 4.4 · Open on CIMA

  • «Interacción/Efecto: Cuando se administran corticosteroides concomitantemente con agentes que reducen el potasio (es decir, diuréticos), se debe vigilar estrechamente a los pacientes para detectar el…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateanticoagulantesclass named in the label
    «Interacción/Efecto: El efecto de los corticosteroides sobre los anticoagulantes orales es variable. Hay informes con efectos de los anticoagulantes que mejoran y otros que disminuyen cuando se…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateanticoagulantsclass named in the label
    «Drug Interactions: The pharmacokinetic interactions listed below are potentially clinically important. Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampin may increase the…»

    FDA, section 7 · Open on DailyMed

  • Moderateantidiabéticosclass named in the label
    «Interacción/Efecto: Debido a que los corticosteroides pueden aumentar las concentrationes de glucosa en sangre, se debe realizar un ajuste de las dosis de los antidiabeticos.»

    AEMPS, section 4.5 · Open on CIMA

  • Moderatebloqueantes neuromuscularesclass named in the label
    «Interacción/Efecto: Los corticosteroides pueden influir en el efecto de los anticolinérgicos. 1) Se ha notificado una miopatía aguda con el uso concomitante de altas dosis de corticosteroides y…»

    AEMPS, section 4.5 · Open on CIMA

  • «Inhibidores de CYP3A4 - pueden disminuir el aclaramiento hepático y aumentar la concentración plasmática de hidrocortisona. En presencia de un inhibidor de CYP3A4 (p. ej., Ketoconazol, itraconazol…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderatedigitálicosclass named in the label
    «Interacción/Efecto: El uso simultáneo de corticosteroides con glucósidos cardíacos puede aumentar la posibilidad de arritmias o toxicidad digitálica asociada con hipopotasemia. En todos los pacientes…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderatediuréticosclass named in the label
    «Interacción/Efecto: Cuando se administran corticosteroides concomitantemente con agentes que reducen el potasio (es decir, diuréticos), se debe vigilar estrechamente a los pacientes para detectar el…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateinhibidores del CYP3A4class named in the label
    «Inhibidores de CYP3A4 - pueden disminuir el aclaramiento hepático y aumentar la concentración plasmática de hidrocortisona. En presencia de un inhibidor de CYP3A4 (p. ej., Ketoconazol, itraconazol…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateItraconazole
    «Inhibidores de CYP3A4 - pueden disminuir el aclaramiento hepático y aumentar la concentración plasmática de hidrocortisona. En presencia de un inhibidor de CYP3A4 (p. ej., Ketoconazol, itraconazol…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateKetoconazole
    «Inhibidores de CYP3A4 - pueden disminuir el aclaramiento hepático y aumentar la concentración plasmática de hidrocortisona. En presencia de un inhibidor de CYP3A4 (p. ej., Ketoconazol, itraconazol…»

    AEMPS, section 4.5 · Open on CIMA

  • «Interacción/Efecto: Anti-inflamatorios no-esteroideos (AINEs) - Acido acetilsalicílico a dosis altas»

    AEMPS, section 4.5 · Open on CIMA

  • antagonistas del calcioclass named in the label
    «Interacción/Efecto: Bloqueantes de canales de Calcio - Diltiazem»

    AEMPS, section 4.5 · Open on CIMA

  • anticonceptivos hormonalesclass named in the label
    «Interacción/Efecto: Estrogenos (incluyendo anticonceptivos orales que contienen estrogenos)»

    AEMPS, section 4.5 · Open on CIMA

  • antiepilépticosclass named in the label
    «Interacción/Efecto: Anticonvulsivantes - Carbamazepina»

    AEMPS, section 4.5 · Open on CIMA

  • «Inductores de CYP3A4 - pueden aumentar el aclaramiento hepático y disminuir las concentraciones plasmáticas de hidrocortisona. En presencia de un inductor de CYP3A4 (p. ej., Rifampicina…»

    AEMPS, section 4.5 · Open on CIMA

  • «Interacción/Efecto: Immunosupresores - Ciclosporina»

    AEMPS, section 4.5 · Open on CIMA

  • «Interacción/Efecto: Glucósidos Cardiácos - Digoxina»

    AEMPS, section 4.5 · Open on CIMA

  • «Interacción/Efecto: Bloqueantes de canales de Calcio - Diltiazem»

    AEMPS, section 4.5 · Open on CIMA

  • «Interacción/Efecto: Antibacterianos Macrólidos - Claritromicina - Eritromicina»

    AEMPS, section 4.5 · Open on CIMA

  • inductores del CYP3A4class named in the label
    «Inductores de CYP3A4 - pueden aumentar el aclaramiento hepático y disminuir las concentraciones plasmáticas de hidrocortisona. En presencia de un inductor de CYP3A4 (p. ej., Rifampicina…»

    AEMPS, section 4.5 · Open on CIMA

  • macrólidosclass named in the label
    «Interacción/Efecto: Antibacterianos Macrólidos - Claritromicina - Eritromicina»

    AEMPS, section 4.5 · Open on CIMA

  • «Inductores de CYP3A4 - pueden aumentar el aclaramiento hepático y disminuir las concentraciones plasmáticas de hidrocortisona. En presencia de un inductor de CYP3A4 (p. ej., Rifampicina…»

    AEMPS, section 4.5 · Open on CIMA

  • «Inductores de CYP3A4 - pueden aumentar el aclaramiento hepático y disminuir las concentraciones plasmáticas de hidrocortisona. En presencia de un inductor de CYP3A4 (p. ej., Rifampicina…»

    AEMPS, section 4.5 · Open on CIMA

  • «Inductores de CYP3A4 - pueden aumentar el aclaramiento hepático y disminuir las concentraciones plasmáticas de hidrocortisona. En presencia de un inductor de CYP3A4 (p. ej., Rifampicina…»

    AEMPS, section 4.5 · Open on CIMA

  • «Interacción/Efecto: Inhibidores (y substratos) CYP3A4 1) Los inhibidores de la proteasa, como indinavir y ritonavir, pueden aumentar las concentraciones plasmáticas de corticosteroides. 2) Los…»

    AEMPS, section 4.5 · Open on CIMA

  • «Interacción/Efecto: Immunosupresores - Ciclofosfamida - Tacrolimus»

    AEMPS, section 4.5 · Open on CIMA

From other drugs’ labels

  • «Corticoides (glucocorticoides sistémicos y mineralocorticoides) : disminución de la eficacia. Las consecuencias de esta situación son particularmente significativas en pacientes con la enfermedad de…»

    AEMPS, section 4.5 · Open on CIMA

  • «Drug Interactions: Amphotericin B injection and potassium-depleting agents: When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics)…»

    FDA, section 7 · Open on DailyMed

  • «- Algunos informes describen que prednisona e hidrocortisona antagonizan el bloqueo neuromuscular en pacientes con insuficiencia corticosuprarrenal tratados con pancuronio.»

    AEMPS, section 4.5 · Open on CIMA

  • «Bloqueantes neuromusculares no despolarizantes: algunos informes describen que prednisona e hidrocortisona antagonizan el bloqueo neuromuscular en pacientes con insuficiencia corticosuprarrenal…»

    AEMPS, section 4.5 · Open on CIMA

  • «Drug Interactions:: hydrocortisone theophylline absorption)»

    FDA, section 7 · Open on DailyMed

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Frequently asked

What is Hydrocortisone used for?

Hydrocortisone is evaluated for the following indications with varying evidence strength: Adrenal insufficiency (evidence tier A), Severe allergic reactions (evidence tier B). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Hydrocortisone?

Common side effects of Hydrocortisone (≥ 1 in 100): Weight gain (at above-replacement doses), Sodium retention and oedema, Hyperglycaemia, Gastritis, Mood changes. See the Safety section for uncommon and serious reactions.

Is Hydrocortisone safe during pregnancy?

AEMPS summary of product characteristics (section 4.6): hydrocortisone can cross the placenta. There is no evidence that corticosteroids increase the incidence of congenital anomalies when given to pregnant women, although animal studies suggest a very small risk of cleft palate and intrauterine growth restriction in the fetus. When corticosteroids are essential, patients with normal pregnancies can be treated as if they were not pregnant, while those with pre-eclampsia or fluid retention need close monitoring. Some retrospective studies found a higher rate of low birth weight in babies of mothers taking corticosteroids (in humans the risk seems dose-related and may be reduced with lower doses), and cataracts have been seen in babies of mothers on long-term corticosteroid treatment. Newborns may in theory develop hypoadrenalism after prenatal exposure, so they are observed for its signs and treated if these appear.

Is Hydrocortisone compatible with breastfeeding?

Compatible. Hale L2. Identical to endogenous cortisol – transfers into milk at physiological concentrations. Replacement doses require no infant monitoring; high doses follow the same approach as prednisone.

Who should not take Hydrocortisone?

Hydrocortisone is contraindicated in: Hypersensitivity to hydrocortisone; Systemic fungal infections; Live vaccines at immunosuppressive doses. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

Other drugs in this group

Betamethasone, Deflazacort, Dexamethasone, Fludrocortisone, Methylprednisolone, Prednisolone, Prednisone