Prescription medicine
Deflazacort Brand names: Emflaza, Jaythari, Kymbee, Pyquvi
Deflazacort (Emflaza) is a prescription medicine with an FDA approval on record since 2017. FDA's NDC Directory lists it from 10 generic labelers.
- Generic listed
Check it at the source: the deflazacort FDA label on DailyMed (effective November 13, 2025, PTC Therapeutics, Inc.); the NDA 208684 record on Drugs@FDA; every deflazacort label on DailyMed.
Highlights of the record
FDA label of November 13, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageEMFLAZA is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.
Forms and strengths
- 6 mg
- 18 mg
- 30 mg
- 36 mg
- 22.75 mg/ml
Tablet; suspension.
On the market
- Earliest approval on file
- February 9, 2017 Emflaza, Ptc Therap; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first February 9, 2024; 12 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 11 of which 10 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 6,358 through July 30, 2026
What is deflazacort used for?
From the label: indications and usageEMFLAZA is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. EMFLAZA is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older
FDA pharmacologic class: Corticosteroid.
Source: FDA drug label (EMFLAZA), PTC Therapeutics, Inc., effective November 13, 2025 (SPL set 31b347d2-f156-4055-9d8f-7cf0df420296), via openFDA; the full label on DailyMed
Is there a generic for deflazacort (Emflaza)?
The FDA approved the first generic deflazacort on February 9, 2024. 12 generic applications are approved; 12 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists deflazacort from 10 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2017 earliest approval on file
- 2024 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the deflazacort label say about other medicines?
The deflazacort label names 9 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carbamazepine | drug interactions | Avoid concomitant use of strong (e.g., efavirenz) or moderate (e.g., carbamazepine, phenytoin) CYP3A4 inducers with EMFLAZA [see Dosage and Administration ( 2.5 ) and Clinical Pharmacology ( 12.3 )]. |
| Clarithromycin | drug interactions | Co-administration of deflazacort with clarithromycin, a strong CYP3A4 inhibitor, increased total exposure to 21-desDFZ by about 3-fold. |
| Diltiazem | drug interactions | Therefore, give one third the recommended dosage of EMFLAZA when moderate or strong CYP3A4 inhibitors (e.g., clarithromycin, fluconazole, diltiazem, verapamil, grapefruit juice) are used concomitantly with EMFLAZA [see Dosage and Administration ( 2.5 ) and Clinical Pharmacology ( 12.3 )]. |
| Efavirenz | drug interactions | Avoid concomitant use of strong (e.g., efavirenz) or moderate (e.g., carbamazepine, phenytoin) CYP3A4 inducers with EMFLAZA [see Dosage and Administration ( 2.5 ) and Clinical Pharmacology ( 12.3 )]. |
| Fluconazole | drug interactions | Therefore, give one third the recommended dosage of EMFLAZA when moderate or strong CYP3A4 inhibitors (e.g., clarithromycin, fluconazole, diltiazem, verapamil, grapefruit juice) are used concomitantly with EMFLAZA [see Dosage and Administration ( 2.5 ) and Clinical Pharmacology ( 12.3 )]. |
| Levothyroxine | warnings and precautions | When concomitant administration of corticosteroids and levothyroxine is required, administration of corticosteroid should precede the initiation of levothyroxine therapy to reduce the risk of adrenal crisis. |
| Phenytoin | drug interactions | Avoid concomitant use of strong (e.g., efavirenz) or moderate (e.g., carbamazepine, phenytoin) CYP3A4 inducers with EMFLAZA [see Dosage and Administration ( 2.5 ) and Clinical Pharmacology ( 12.3 )]. |
| Rifampin | drug interactions | Moderate or Strong CYP3A4 Inducers Co-administration of deflazacort with rifampin, a strong CYP3A4 inducer, significantly decreased the exposure of 21-desDFZ. |
| Verapamil | drug interactions | Therefore, give one third the recommended dosage of EMFLAZA when moderate or strong CYP3A4 inhibitors (e.g., clarithromycin, fluconazole, diltiazem, verapamil, grapefruit juice) are used concomitantly with EMFLAZA [see Dosage and Administration ( 2.5 ) and Clinical Pharmacology ( 12.3 )]. |
Source: FDA drug label (EMFLAZA), PTC Therapeutics, Inc., effective November 13, 2025 (SPL set 31b347d2-f156-4055-9d8f-7cf0df420296), via openFDA; the full label on DailyMed
What do FAERS reports show for deflazacort?
The FDA Adverse Event Reporting System holds 6,358 reports that list deflazacort among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 306 are coded as a death and 1,578 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2019 (1,635, against a median of 331 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other corticosteroids
- the pharmacologic class, with prices and generics
- Deflazacort side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other