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Deflazacort

Deflazacort is a corticosteroid (steroid medicine) used to treat Duchenne muscular dystrophy (DMD), a muscle-wasting genetic condition, in children and older patients.

Brand names EmflazaJaythariPyquviKymbeeJAYTHARI Oral Suspension
Drug class Corticosteroid
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 19 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Deflazacort at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Deflazacort (Emflaza) is a once-daily steroid that calms inflammation and the immune system, used for Duchenne muscular dystrophy (DMD) as one of the two standard steroid options alongside prednisone, and it is available generically. Expect real steroid effects, mostly a rounder, puffier face, belly weight gain, a bigger appetite, irritability and more colds, with infections, thinner bones, slower growth and mood changes as the longer-term concerns. The one rule never to break is stopping it suddenly, since the body comes to rely on it and the dose must come down gradually. Regular checks of blood pressure, blood sugar, bone density and eye pressure catch the slower problems early.

Clinical pearls

  • Deflazacort can be taken with or without food, but never with grapefruit juice.
  • Clarithromycin and fluconazole raise its levels, while rifampin, carbamazepine and phenytoin weaken it, so every new prescription needs checking.
  • Get vaccines done before starting, with live vaccines at least 4 to 6 weeks ahead, and no live vaccines during treatment.
  • Call the prescriber after any chickenpox or measles exposure if your child has not had them or been vaccinated.
How you get itPrescription only
Comes asTablet, Oral suspension
Earliest FDA record2008
Companies listing it with the FDA11
FDA label last updatedNov 13, 2025
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Deflazacort, written from its FDA label.

What Deflazacort is used for

▾

Deflazacort is used for one condition across the supported products.

  • Duchenne muscular dystrophy (DMD) in patients 2 years and older: Emflaza, Jaythari, JAYTHARI oral suspension, and deflazacort oral suspension.
  • DMD in patients 5 years and older: Pyquvi, Kymbee (tablet and suspension), and deflazacort tablets.

How Deflazacort works

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Deflazacort is a prodrug, so your body converts it to an active form called 21-desDFZ. This form works through the glucocorticoid receptor to lower inflammation and suppress the immune system.

How this helps muscles in DMD is not known.

Deflazacort dosage

▾

Deflazacort is taken by mouth once daily. The dose is based on body weight. It can be taken with or without food, but not with grapefruit juice.

  • Tablets (Jaythari and Kymbee) can be swallowed whole or crushed in applesauce and taken right away.
  • Suspensions (Jaythari, Pyquvi, Kymbee) should be shaken well and measured with the provided oral dispenser.
  • If taken for more than a few days, the dose must be lowered gradually when stopping.

Dosing details from the FDA-approved label

From the Deflazacort prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Recommended dosage (Emflaza, deflazacort oral suspension, Jaythari, Pyquvi, Kymbee)
    • Approximately 0.9 mg/kg/day orally once daily
    • If the oral suspension is used, round up to the nearest tenth of a milliliter (mL)
    • If tablets are used, round up to the nearest possible dose
    • Can be taken with or without food; do not administer with grapefruit juice; decrease dosage gradually if given for more than a few days
  • Patients taking moderate or strong CYP3A4 inhibitors
    • Give one third of the recommended dosage
    • For example, a 36 mg per day dose would be reduced to a 12 mg per day dose
    • Applies when administered with moderate or strong CYP3A4 inhibitors
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION The recommended once-daily dosage is approximately 0.9 mg/kg/day administered orally ( 2.2 ) Discontinue gradually when administered for more than a few days ( 2.3 ) 2.1 Assessments Prior to First Dose of EMFLAZA Administer all immunizations according to immunization guidelines prior to starting EMFLAZA. Administer live-attenuated or live vaccines at least 4 to 6 weeks prior to starting EMFLAZA [see Warnings and Precautions ( 5.8 )] . 2.2 Dosing Information The recommended oral dosage of EMFLAZA is approximately 0.9 mg/kg/day once daily. If tablets are used, round up to the nearest possible dose. Any combination of the four EMFLAZA tablet strengths can be used to achieve this dose. If the oral suspension is used, round up to the nearest tenth of a milliliter (mL). 2.3 Discontinuation Dosage of EMFLAZA must be decreased gradually if the drug has been administered for more than a few days [see Warnings and Precautions ( 5.1 )] . 2.4 Important Preparation and Administration Instructions EMFLAZA Tablets and Oral Suspension can be taken with or without food. Do not administer EMFLAZA with grapefruit juice [see Drug Interactions ( 7.1 )] EMFLAZA Tablets EMFLAZA Tablets can be administered whole or crushed and taken immediately after mixing with applesauce. EMFLAZA Oral Suspension Shake EMFLAZA Oral Suspension well before administration. Use only the oral dispenser provided with the product. After withdrawing the appropriate dose into the oral dispenser, slowly add the EMFLAZA Oral Suspension into 3 to 4 ounces of juice (except grapefruit juice) or milk and mix well. The dose should then be administered immediately. Discard any unused EMFLAZA Oral Suspension remaining after 1 month of first opening the bottle. 2.5 Dosage Modification for Use with CYP3A4 Inhibitors and Inducers CYP3A4 Inhibitors Give one third of the recommended dosage when EMFLAZA is administered with moderate or strong CYP3A4 inhibitors. For example, a 36 mg per day dose would be reduced to a 12 mg per day dose when used with moderate or strong CYP3A4 inhibitors [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 )] . CYP3A4 Inducers Avoid use with moderate or strong CYP3A4 inducers with EMFLAZA [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 )] .

Read the full Dosage and Administration section on DailyMed →

Deflazacort side effects

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The most common side effects in studies were:

Common side effects

  • Cushingoid appearance (rounded, puffy face)
  • Weight gain
  • Increased appetite
  • Excess hair growth (hirsutism)
  • Central (belly) obesity
  • Upper respiratory infection, cough, and stuffy or runny nose
  • Frequent urination
  • Irritability
  • Colds, cough, and stuffy nose

When to get medical help

  • Call your doctor right away if you have a skin rash. Serious skin reactions can occur, and the medicine should be stopped at the first sign of rash unless it is clearly unrelated.
  • Get help for signs of infection, such as fever. Steroids can hide or worsen infections.
  • Seek care for severe mood changes, depression, thoughts of suicide, hallucinations, or confusion.
  • Get help for severe stomach pain, which can signal a stomach or bowel perforation.
  • Seek emergency care for signs of a severe allergic reaction (anaphylaxis).
  • Report vision changes or eye pain, since cataracts and glaucoma can occur.
  • Call your doctor if you are exposed to chickenpox or measles and have not had them or been immunized.

Deflazacort warnings and precautions

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  • Do not stop suddenly. Abrupt stopping can cause dangerous adrenal insufficiency, so the dose must be tapered.
  • Infection risk is higher, and signs of infection may be hidden. Chickenpox and measles can be serious in non-immune people.
  • Blood pressure, potassium, blood sugar, and bone density may need monitoring.
  • Mood and behavior changes, cataracts, glaucoma, and slowed growth in children can occur.
  • Serious skin rashes (toxic epidermal necrolysis) have been reported, usually within 8 weeks.
  • Live vaccines should be avoided during treatment.

Deflazacort interactions

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Some medicines and foods change how much deflazacort your body has.

  • CYP3A4 inhibitors (clarithromycin, fluconazole, diltiazem, verapamil, grapefruit juice): raise levels of the active form, so a lower dose may be needed.
  • CYP3A4 inducers (rifampin, efavirenz, carbamazepine, phenytoin): can lower levels sharply and reduce effect.
  • Neuromuscular blockers (such as pancuronium): higher risk of acute muscle weakness.

Interactions listed in the FDA-approved label

From the Deflazacort prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Moderate or strong CYP3A4 inhibitors (e.g., clarithromycin, fluconazole, diltiazem, verapamil, grapefruit juice): Co-administration of deflazacort with clarithromycin, a strong CYP3A4 inhibitor, increased total exposure to the active metabolite 21-desDFZ by about 3-fold. Give one third the recommended dosage of PYQUVI.
  • Moderate or strong CYP3A4 inducers (strong e.g., efavirenz; moderate e.g., carbamazepine, phenytoin): Co-administration of deflazacort with rifampin, a strong CYP3A4 inducer, significantly decreased the exposure of 21-desDFZ and may reduce efficacy. Avoid concomitant use.
  • Neuromuscular blocking drugs (e.g., pancuronium): Patients receiving corticosteroids, including PYQUVI, with neuromuscular blocking drugs may be at increased risk of developing an acute myopathy.
Read the label’s full interactions text

7 DRUG INTERACTIONS Moderate or strong CYP3A4 inhibitors: Give one third of the recommended dosage of PYQUVI ( 7.1 ) Avoid use of moderate or strong CYP3A4 inducers with PYQUVI, as they may reduce efficacy ( 7.1 ) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Additional pediatric use information is approved for PTC Therapeutics, Inc.'s Emflaza ® (deflazacort) oral suspension. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. 7.1 CYP3A4 Inhibitors and Inducers Moderate or Strong CYP3A4 Inhibitors The active metabolite of deflazacort, 21-desDFZ, is a substrate of CYP3A4 [see Clinical Pharmacology ( 12.3 )] . Co-administration of deflazacort with clarithromycin, a strong CYP3A4 inhibitor, increased total exposure to 21-desDFZ by about 3-fold. Therefore, give one third the recommended dosage of PYQUVI when moderate or strong CYP3A4 inhibitors (e.g., clarithromycin, fluconazole, diltiazem, verapamil, grapefruit juice) are used concomitantly with PYQUVI [see Dosage and Administration ( 2.5 ) and Clinical Pharmacology ( 12.3 )] . Moderate or Strong CYP3A4 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., efavirenz) or moderate (e.g., carbamazepine, phenytoin) CYP3A4 inducers with PYQUVI [see Dosage and Administration ( 2.5 ) and Clinical Pharmacology ( 12.3 )] . 7.2 Neuromuscular Blockers Patients receiving corticosteroids, including PYQUVI, and concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium) may be at increased risk of developing an acute myopathy [see Warnings and Precautions ( 5.11 )] .

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Deflazacort

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  • Do not use if you are allergic to deflazacort or its inactive ingredients.
  • Get vaccines up to date before starting.
  • Tell your doctor about infections, heart failure, high blood pressure, kidney, thyroid, stomach, or eye problems, or diabetes.
  • Pregnancy and breastfeeding: discuss risks and benefits with your doctor.
  • Children: the oral suspension contains benzyl alcohol and is not approved under age 2.
  • Older adults: DMD mainly affects children and young adults, so there is no experience in older adults.
  • Kidney problems: no dose adjustment needed. Mild or moderate liver problems: no adjustment needed.

Deflazacort overdose

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For a sudden overdose, treatment is immediate stomach emptying (lavage or vomiting) followed by supportive care. For long-term overdose in someone who needs ongoing steroids, the dose may be lowered temporarily or alternate-day dosing may be used. Contact a doctor or poison control right away.

What Deflazacort does in the body

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Deflazacort’s active form acts on glucocorticoid receptors to produce anti-inflammatory and immune-suppressing effects. How it benefits people with DMD is not fully known.

How your body processes Deflazacort

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After a dose by mouth, blood levels peak in about 1 hour. Food does not change how much is absorbed, and tablets and suspension are absorbed similarly. Esterase enzymes quickly convert it to its active form, which CYP3A4 then breaks down. About 68% leaves in the urine, and elimination is almost complete within 24 hours.

How to store Deflazacort

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Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15°C to 30°C (59°F to 86°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

180

Supplements & herbs that interact with Deflazacort

180 supplements and herbal products have documented interactions with Deflazacort in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 139
  • Minor · 38
Every supplement checked against Deflazacort — ranked by severity The full interaction hub: 3 major · 139 moderate · 38 minor · every one linked to its full report. Check Deflazacort against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Deflazacort: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Deflazacort — the kind of thing our pharmacy team would talk through with you at the counter.

What is deflazacort for?

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It treats Duchenne muscular dystrophy (DMD). The age it is approved for depends on the product: some are for ages 2 and older, and others for ages 5 and older. Your pharmacist can confirm which applies to yours.

How do I take it?

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You take it by mouth once a day, with or without food. Avoid grapefruit juice. If you use the suspension, shake it well and use the dispenser that comes with it. Some tablets can be crushed in applesauce and taken right away.

Can I stop it if my child feels fine?

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No, please don’t stop it on your own. After more than a few days, stopping suddenly can cause dangerous adrenal problems. Your doctor will lower the dose gradually if it needs to be stopped.

What side effects should I expect?

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Common ones include a rounder face, weight gain, bigger appetite, extra hair growth, and colds or cough. Call your doctor for rash, signs of infection, big mood changes, severe stomach pain, or vision changes.

Does it interact with other medicines?

▾
Yes. Some antibiotics, antifungals, and heart medicines raise its levels, and some seizure and HIV medicines can lower its effect a lot. Grapefruit juice is also a problem. Always share your full medicine list with me or your doctor.

What about vaccines?

▾
Get routine vaccines up to date before starting. Live vaccines should be given at least 4 to 6 weeks before treatment and avoided during it. Also stay away from people with chickenpox or measles if you aren’t immune.

Is Deflazacort available over the counter?

▾
No. Deflazacort is a prescription medicine: every Deflazacort product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Deflazacort first available?

▾
The earliest FDA record we hold for Deflazacort is from 2008: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Deflazacort was first used.

Who makes Deflazacort?

▾
11 companies currently list Deflazacort products in the FDA's NDC Directory, including Doppel Farmaceutici S.r.l., Zydus Pharmaceuticals (USA) Inc., Upsher-Smith Laboratories, LLC. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Deflazacort on HelloPharmacist

Detailed data & references for Deflazacort Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Deflazacort forms and strengths (how it comes)

Deflazacort is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Deflazacort inactive ingredients by manufacturer.

Tablet

By mouth
Brands Emflaza Jaythari Kymbee
How this form is used
What it may be used for
  • Emflaza and Jaythari tablets are labeled for DMD in patients 2 years and older.
  • Kymbee and deflazacort tablets are labeled for DMD in patients 5 years and older.
Important instructions
  • Jaythari and Kymbee tablets can be swallowed whole or crushed and taken right away mixed with applesauce.
  • Kymbee, Jaythari, and Emflaza tablets can be taken with or without food.
  • Any combination of the available tablet strengths can be used to reach the prescribed dose.
Available strengths 4 strengths
64 FDA-listed product records ⓘ

Oral suspension

By mouth
Brands Emflaza JAYTHARI Oral Suspension Kymbee Pyquvi
How this form is used
What it may be used for
  • Emflaza and JAYTHARI oral suspension are labeled for DMD in patients 2 years and older.
  • Pyquvi and Kymbee oral suspension are labeled for DMD in patients 5 years and older.
Important instructions
  • Pyquvi, Kymbee, and JAYTHARI oral suspension should be shaken well before use.
  • Pyquvi, Kymbee, and JAYTHARI oral suspension should be measured only with the oral dispenser provided.
  • Emflaza oral suspension doses are rounded up to the nearest tenth of a milliliter.
  • Emflaza and Pyquvi oral suspension can be taken with or without food.
Available strengths 1 strength
18 FDA-listed product records ⓘ

Deflazacort on the U.S. market: products, makers and brands

How Deflazacort appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

11 companies list 54 Deflazacort product records with the FDA, mostly as tablet, oral suspension; the earliest marketing or approval year on record is 2008. Brand names on the directory include Emflaza, Jaythari, Pyquvi and 2 more; the rest are generics.

2
Dose forms ⓘ
11
Labelers (makers, repackagers, distributors)
7
Brand names
54
FDA-listed product records ⓘ
2008
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (8) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Doppel Farmaceutici S.r.l.19%
Zydus Pharmaceuticals (USA) Inc.19%
Upsher-Smith Laboratories, LLC17%
PTC Therapeutics, Inc.9%
Sun Pharmaceutical Industries, Inc.9%
Amneal Pharmaceuticals NY LLC7%
Other makers20%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Deflazacort is used (Medicaid data)

A general measure of how commonly Deflazacort is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Deflazacort is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

13,468
Medicaid prescriptions filled (Q1–Q4 2025)
$158.6M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Deflazacort prescribed? Of the 1,601 medications we measure, Deflazacort ranks #882 by Medicaid prescriptions — more than 45% of them.

Where Deflazacort ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Deflazacort product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 22.75 mg/mL oral suspension is the most-dispensed Deflazacort product — about 27% of these Medicaid prescriptions.

deflazacort 22.75 MG/ML Oral Suspension Most dispensed

3,616 Medicaid prescriptions (Q1–Q4 2025) 27% of Deflazacort prescriptions shown $51.1M gross reimbursement (before rebates) ≈ $14,122 per prescription (gross)

Summed across the 2 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1870964

deflazacort 30 MG Oral Tablet

3,272 Medicaid prescriptions (Q1–Q4 2025) 24% of Deflazacort prescriptions shown $45.8M gross reimbursement (before rebates) ≈ $13,991 per prescription (gross)

Summed across the 3 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 153880

deflazacort 18 MG Oral Tablet

2,547 Medicaid prescriptions (Q1–Q4 2025) 19% of Deflazacort prescriptions shown $22.5M gross reimbursement (before rebates) ≈ $8,852 per prescription (gross)

Summed across the 2 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1870954

deflazacort 6 MG Oral Tablet

2,033 Medicaid prescriptions (Q1–Q4 2025) 15% of Deflazacort prescriptions shown $7.7M gross reimbursement (before rebates) ≈ $3,792 per prescription (gross)

Summed across the 2 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 153098

deflazacort 36 MG Oral Tablet

2,000 Medicaid prescriptions (Q1–Q4 2025) 15% of Deflazacort prescriptions shown $31.5M gross reimbursement (before rebates) ≈ $15,764 per prescription (gross)

Summed across the 2 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1870958

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Deflazacort, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 11 of 49 listed Deflazacort NDCs with Medicaid activity.

Compare Deflazacort products

A representative set of FDA-listed product records for Deflazacort — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 54 of 54 products — FDA National Drug Code Directory. See every product, package size and price: browse all 54 Deflazacort NDCs →

Deflazacort side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Deflazacort — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Deflazacort are weight increased, fall, vomiting; about 51% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

6,359
Reports mentioning it
51%
Reported as serious
12
Distinct effects shown
Most reported effects
Weight Increased
531
Fall
300
Vomiting
256
Pain
228
Pyrexia
227
Headache
219
Malaise
216
Influenza
209
Arthralgia
188
Weight Decreased
188
Age groups
Adult · 209Elderly · 112Child · 29Infant · 4Adolescent · 3Neonate · 2

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Deflazacort in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Deflazacort FDA approval history

How Deflazacort went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Deflazacort was first approved by the FDA in 2008; the first generic version was approved in 2024. It remains available in U.S. pharmacies today.

2008
First FDA approval
2024
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Deflazacort recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Deflazacort recalls since July 2021.

✅No Deflazacort recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Deflazacort RxCUI 22396 2 dose forms · 6 strengths
  1. Dose form (SCDF) Oral Suspension RxCUI 1870963 In current FDA listings
    Clinical drug / strength (SCD) 22.75 MG/ML RxCUI 1870964
  2. Dose form (SCDF) Oral Tablet RxCUI 371693 In current FDA listings
    Clinical drug / strength (SCD) 1 MG RxCUI 226432 6 MG RxCUI 153098 18 MG RxCUI 1870954 30 MG RxCUI 153880 36 MG RxCUI 1870958

Look up RxCUI 22396 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Deflazacort brand names

Deflazacort is sold under 5 brand names in the FDA directory — Emflaza, Jaythari, Pyquvi, Kymbee and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Emflaza Jaythari Pyquvi Kymbee JAYTHARI Oral Suspension

Who makes Deflazacort: manufacturers and labelers

11 companies list Deflazacort products with the FDA. By number of product records, the largest are Doppel Farmaceutici S.r.l., Zydus Pharmaceuticals (USA) Inc., Upsher-Smith Laboratories, LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Doppel Farmaceutici S.r.l. 10 Zydus Pharmaceuticals (USA) Inc. 10 Upsher-Smith Laboratories, LLC 9 PTC Therapeutics, Inc. 5 Sun Pharmaceutical Industries, Inc. 5 Amneal Pharmaceuticals NY LLC 4 Aurobindo Pharma Limited 4 AvKARE 4 Aucta Pharmaceuticals, Inc. 1 Biocon Pharma Inc. 1 Cranbury Pharmaceuticals, LLC 1

Deflazacort drug class (RxNorm)

Deflazacort belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Glucocorticoids
How it works Corticosteroid Hormone Receptor Agonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Deflazacort page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

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FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Nov 13, 2025
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Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Deflazacort.
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Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Deflazacort after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
19
Finished products in the current FDA directory
54
Companies listing them (makers, repackagers, distributors)
11
FDA labeler codes behind them ⓘ
13
Linked representative label ⓘ
PTC Therapeutics, Inc.
Linked label effective
Nov 13, 2025
Composite sections available
22
Linked SPL Set ID
31b347d2-f156-4055-9d8f-7cf0df420296
Linked SPL Document ID
604ae0b3-a373-40c0-b585-419abeac74eb
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. PTC Therapeutics, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →