What the label lists and what reports show
Deflazacort side effects
Deflazacort's FDA label: “The most common adverse reactions (≥ 10% for EMFLAZA and greater than placebo) are Cushingoid appearance, weight increased, increased appetite, upper respiratory tract infection, cough, pollakiuria, hirsutism, central obesity, and nasopharyngitis ( 6.1 ) To …” FAERS holds 6,358 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is weight increased (531 reports).
- Generic listed
Check it at the source: the deflazacort FDA label on DailyMed (effective November 13, 2025, PTC Therapeutics, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥ 10% for EMFLAZA and greater than placebo) are Cushingoid appearance, weight increased, increased appetite, upper respiratory tract infection, cough, pollakiuria, hirsutism, central obesity, and nasopharyngitis ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact PTC Therapeutics, Inc.
Table 1: Adverse Reactions that Occurred in ≥ 5% of Deflazacort-Treated Patients and Occurred More Frequently than in Placebo Patients with DMD (Study 1)
| Adverse Reaction | Deflazacort 0.9 mg/kg/d (N=51) % at 12 weeks | Placebo (N=50) % at 12 weeks 1 |
|---|---|---|
| Cushingoid appearance | 33 | 12 |
| Weight increased | 20 | 6 |
| Increased appetite | 14 | 2 |
| Upper respiratory tract infection | 12 | 10 |
| Cough | 12 | 6 |
| Pollakiuria | 12 | 2 |
| Nasopharyngitis | 10 | 6 |
| Hirsutism | 10 | 2 |
| Central obesity | 10 | 4 |
| Erythema | 8 | 6 |
| Irritability | 8 | 4 |
| Rhinorrhea | 8 | 0 |
| Abdominal discomfort | 6 | 2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are discussed in more detail in other sections: Alterations in Endocrine Function [see Warnings and Precautions ( 5.1 )] Immunosuppression and Increased Risk of Infection [see Warnings and Precautions ( 5.2 )] Alterations in Cardiovascular/Renal Function [see Warnings and Precautions ( 5.3 )] Gastrointestinal Perforation [see Warnings and Precautions ( 5.4 )] Behavioral and Mood Disturbances [see Warnings and Precautions ( 5.5 )] Effects on Bones [see Warnings and Precautions ( 5.6 )] Ophthalmic Effects [see Warnings and Precautions ( 5.7 )] Immunizations [see Warnings and Precautions ( 5.8 )] Serious Skin Rashes [see Warnings and Precautions ( 5.9 )] Effects on Growth and Development [see Warnings and Precautions ( 5.10 )] Myopathy [see Warnings and Precautions ( 5.11 )] Kaposi’s Sarcoma [see Warnings and Precautions ( 5.12 )] Risk of Serious Adverse Reactions in Infants because of Benzyl Alcohol Preservative [see Warnings and Precautions ( 5.13 )] Thromboembolic Events [see Warnings and Precautions ( 5.14 )] Anaphylaxis [see Warnings and Precautions ( 5.15 )] The most common adverse reactions (≥ 10% for EMFLAZA and greater than placebo) are Cushingoid appearance, weight increased, increased appetite, upper respiratory tract infection, cough, pollakiuria, hirsutism, central obesity, and nasopharyngitis ( 6.1 ) To report SUSPECTED …
Source: FDA drug label, 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?
6,358 reports list deflazacort among the medicines taken, 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. Of the 21 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Deflazacort: the full record
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- Report a side effect to the FDA
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