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Deflazacort

AEMPS

Systemic glucocorticoid (oxazoline derivative)

ATC code: H02AB13

Brand names: Emflaza, Calcort

Updated · Methodology

Indications

A

Duchenne muscular dystrophy

First line

Drug of choice for Duchenne muscular dystrophy in boys from age 4–5. Per DMD Care Considerations 2018 and 2023, deflazacort slows loss of muscle function, delays loss of ambulation by 2–3 years, and reduces scoliosis risk. Versus prednisolone it produces fewer cushingoid features and less weight gain, so Spain and Italy often prefer it. Dose 0.9 mg/kg/day, lifelong, with scheduled monitoring of growth, bone density, and vision.

Sources

  1. AEMPS: Ficha técnica de Deflazacort (2024)
  2. DMD Care Considerations: Diagnosis and management of Duchenne muscular dystrophy (2018)

ICD-10: G71.0 · ICD-11: 8C70.1

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Chronic fatigue

Not recommended

Deflazacort is a systemic corticosteroid. It is prescribed for Duchenne muscular dystrophy, autoimmune diseases, and acute exacerbations of asthma (AEMPS Ficha Técnica). For chronic fatigue without a confirmed diagnosis, deflazacort is not indicated. The drug has serious risks on long-term use: adrenal suppression, steroid diabetes, osteoporosis, immunosuppression, psychiatric disturbances, cataract, and hypertension. If deflazacort was prescribed for fatigue without a confirmed diagnosis, seek a second opinion immediately.

Sources

  1. AEMPS: Ficha técnica de Deflazacort (2024)
  2. NICE: Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management (NG206) (2021)

ICD-10: R53 · ICD-11: MG22

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

A prednisolone derivative with an oxazoline ring. Metabolized to the active 21-desacetyl-deflazacort. Binds cytoplasmic glucocorticoid receptors and suppresses pro-inflammatory cytokines, NF-κB, and phospholipase A2. Anti-inflammatory potency: 6 mg deflazacort equals 5 mg prednisolone. Advantage: less impact on mineral metabolism and less weight gain than equidose prednisolone. In Spain it is among the popular systemic corticosteroids under brands Zamene and Dezacor.

Safety

Contraindications

  • Deflazacort hypersensitivity
  • Systemic fungal infection
  • Live vaccines during therapy
  • Active tuberculosis without concomitant treatment
  • Severe osteoporosis
  • Psychotic disorders without concomitant treatment

Serious adverse effects

  • Osteoporosis and pathologic fractures
  • Avascular necrosis of the femoral head
  • Steroid diabetes
  • Cataract and glaucoma
  • Gastrointestinal perforation
  • Steroid psychosis
  • Growth retardation in children
  • Increased risk of serious infections

Common adverse effects

  • Weight gain
  • Cushingoid features (moon face, fat redistribution)
  • Hypertension
  • Hyperglycemia
  • Mood changes
  • Insomnia
  • Adrenal suppression

Pregnancy: can you take Deflazacort?

In T1, glucocorticoids carry a small increase in cleft lip/palate risk (low absolute risk). With life-saving indications (Duchenne, severe asthma) therapy is continued. Prednisone or prednisolone with more pregnancy data are preferred.

Breastfeeding: can you take Deflazacort?

Milk concentrations are low. Compatible with breastfeeding. At high doses (over 40 mg/day) defer feeding for 4 hours after the dose.

Calculate RIDFull profile on NIH LactMed ↗

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

Practical notes

Timing and administration

Take in the morning with food to mimic the physiological cortisol rhythm. Abrupt stop after more than 2 weeks of use is hazardous – withdrawal syndrome and adrenal insufficiency. Taper based on duration and dose. Long-term therapy (Duchenne) requires calcium 1000 mg + vitamin D 800–1000 IU/day, monitoring of growth, bone density (DXA), blood pressure, glucose, and an annual ophthalmologic exam (cataract).
Label mentions22 mentions

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

From this drug’s label

  • MajorCarbamazepine
    «CYP3A4 Inhibitors and Inducers: Co-administration of deflazacort with rifampin, a strong CYP3A4 inducer, significantly decreased the exposure of 21-desDFZ. Avoid concomitant use of strong (e.g…»

    FDA, section 7 · Open on DailyMed

  • MajorClarithromycin
    «CYP3A4 Inhibitors and Inducers: The active metabolite of deflazacort, 21-desDFZ, is a substrate of CYP3A4 [see Clinical Pharmacology ( 12.3 )] . Co-administration of deflazacort with clarithromycin…»

    FDA, section 7 · Open on DailyMed

  • MajorCYP3A4 inducersclass named in the label
    «DRUG INTERACTIONS: Avoid use of moderate or strong CYP3A4 inducers with deflazacort, as they may reduce efficacy ( 7.1 )»

    FDA, section 7 · Open on DailyMed

  • MajorCYP3A4 inhibitorsclass named in the label
    «CYP3A4 Inhibitors and Inducers: Co-administration of deflazacort with rifampin, a strong CYP3A4 inducer, significantly decreased the exposure of 21-desDFZ. Avoid concomitant use of strong (e.g…»

    FDA, section 7 · Open on DailyMed

  • MajorEfavirenz
    «CYP3A4 Inhibitors and Inducers: Co-administration of deflazacort with rifampin, a strong CYP3A4 inducer, significantly decreased the exposure of 21-desDFZ. Avoid concomitant use of strong (e.g…»

    FDA, section 7 · Open on DailyMed

  • MajorPhenytoin
    «CYP3A4 Inhibitors and Inducers: Co-administration of deflazacort with rifampin, a strong CYP3A4 inducer, significantly decreased the exposure of 21-desDFZ. Avoid concomitant use of strong (e.g…»

    FDA, section 7 · Open on DailyMed

  • Moderatebarbitúricosclass named in the label
    «La rifampicina, los barbitúricos y la fenitoína pueden acelerar el metabolismo de los glucocorticoides, por lo que, en pacientes estabilizados en tratamiento glucocorticoideo, la adición –o la…»

    AEMPS, section 4.5 · Open on CIMA

  • ModeratePhenytoin
    «La rifampicina, los barbitúricos y la fenitoína pueden acelerar el metabolismo de los glucocorticoides, por lo que, en pacientes estabilizados en tratamiento glucocorticoideo, la adición –o la…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateRifampicin
    «La rifampicina, los barbitúricos y la fenitoína pueden acelerar el metabolismo de los glucocorticoides, por lo que, en pacientes estabilizados en tratamiento glucocorticoideo, la adición –o la…»

    AEMPS, section 4.5 · Open on CIMA

  • Acetylsalicylic acid
    «En pacientes con hipoprotrombinemia se aconseja prudencia al asociar ácido acetilsalicílico y corticosteroides.»

    AEMPS, section 4.5 · Open on CIMA

  • AINEclass named in the label
    «La administración concomitante con antiinflamatorios no esteroideos puede aumentar el riesgo de úlceras gastrointestinales.»

    AEMPS, section 4.5 · Open on CIMA

  • anticoagulantesclass named in the label
    «Los corticoesteroides pueden aumentar o disminuir los efectos de los anticoagulantes.»

    AEMPS, section 4.5 · Open on CIMA

  • anticonceptivos hormonalesclass named in the label
    «El efecto de los corticoesteroides puede verse aumentado en mujeres por la administración concomitante de estrógenos o anticonceptivos orales, por lo que la dosis de corticoesteroides en alguno de…»

    AEMPS, section 4.5 · Open on CIMA

  • antidiabéticosclass named in the label
    «Los diuréticos deplectores de potasio pueden potenciar la hipokalemia de los glucocorticoides, mientras que los digitálicos pueden potenciar la posibilidad de arritmias asociadas a hipokalemia. Puede…»

    AEMPS, section 4.5 · Open on CIMA

  • bloqueantes neuromuscularesclass named in the label
    «En pacientes tratados con corticosteroides sistémicos, la utilización de fármacos relajantes musculares no despolarizantes puede dar por resultado una prolongación del efecto relajante.»

    AEMPS, section 4.5 · Open on CIMA

  • digitálicosclass named in the label
    «Los diuréticos deplectores de potasio pueden potenciar la hipokalemia de los glucocorticoides, mientras que los digitálicos pueden potenciar la posibilidad de arritmias asociadas a hipokalemia. Puede…»

    AEMPS, section 4.5 · Open on CIMA

  • Diltiazem
    «CYP3A4 Inhibitors and Inducers: deflazacort when moderate or strong CYP3A4 inhibitors (e.g., clarithromycin, fluconazole, diltiazem, verapamil, grapefruit juice) are used concomitantly with…»

    FDA, section 7 · Open on DailyMed

  • diuréticosclass named in the label
    «Los diuréticos deplectores de potasio pueden potenciar la hipokalemia de los glucocorticoides, mientras que los digitálicos pueden potenciar la posibilidad de arritmias asociadas a hipokalemia. Puede…»

    AEMPS, section 4.5 · Open on CIMA

  • Fluconazole
    «CYP3A4 Inhibitors and Inducers: deflazacort when moderate or strong CYP3A4 inhibitors (e.g., clarithromycin, fluconazole, diltiazem, verapamil, grapefruit juice) are used concomitantly with…»

    FDA, section 7 · Open on DailyMed

  • neuromuscular blockersclass named in the label
    «Neuromuscular Blockers: Patients receiving corticosteroids, including deflazacort, and concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium) may be at increased risk of developing…»

    FDA, section 7 · Open on DailyMed

  • relajantes muscularesclass named in the label
    «En pacientes tratados con corticosteroides sistémicos, la utilización de fármacos relajantes musculares no despolarizantes puede dar por resultado una prolongación del efecto relajante.»

    AEMPS, section 4.5 · Open on CIMA

  • Verapamil
    «CYP3A4 Inhibitors and Inducers: deflazacort when moderate or strong CYP3A4 inhibitors (e.g., clarithromycin, fluconazole, diltiazem, verapamil, grapefruit juice) are used concomitantly with…»

    FDA, section 7 · Open on DailyMed

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Frequently asked

What is Deflazacort used for?

Deflazacort is evaluated for the following indications with varying evidence strength: Duchenne muscular dystrophy (evidence tier A), Asthma exacerbation (evidence tier B), Chronic fatigue (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Deflazacort?

Common side effects of Deflazacort (≥ 1 in 100): Weight gain, Cushingoid features (moon face, fat redistribution), Hypertension, Hyperglycemia, Mood changes, Insomnia. See the Safety section for uncommon and serious reactions.

Is Deflazacort safe during pregnancy?

In T1, glucocorticoids carry a small increase in cleft lip/palate risk (low absolute risk). With life-saving indications (Duchenne, severe asthma) therapy is continued. Prednisone or prednisolone with more pregnancy data are preferred.

Is Deflazacort compatible with breastfeeding?

Milk concentrations are low. Compatible with breastfeeding. At high doses (over 40 mg/day) defer feeding for 4 hours after the dose.

Who should not take Deflazacort?

Deflazacort is contraindicated in: Deflazacort hypersensitivity; Systemic fungal infection; Live vaccines during therapy; Active tuberculosis without concomitant treatment; Severe osteoporosis. Full list in the Safety section.

Official sources

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

Other drugs in this group

Betamethasone, Dexamethasone, Fludrocortisone, Hydrocortisone, Methylprednisolone, Prednisolone, Prednisone