Drug · FAERS side-effect profile with label screen
Deflazacort side effects: what 6,356 FDA adverse event reports show
Brand names
Emflaza
openFDA label
Who reports
6,356 reports · 51% serious · 306 with death outcome · 34% female
openFDA FAERS counts, all years, deduplication not applied
Used for
EMFLAZA 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 ( 1 )
FDA label, Indications and Usage
What it is
The active ingredient in EMFLAZA is deflazacort (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 13Labeled (related wording) 7Reporting / coding artifact 3Not in label — unassessed 17
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 247 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Increased appetite | 98 | 17.3 14.2–21.0ROR 17.5 · χ² 1,480 / p <1e-300 | 17.1 EB05 14.5 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · ♀ 4% (drug 34%) | no trial data cached |
| Gastroenteritis viral | 74 | 13.5 10.8–17.0ROR 13.7 · χ² 843 / p 1e-185 | 13.4 EB05 10.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · ♀ 0% (drug 34%) | no trial data cached |
| Intentional dose omission | 103 | 12.5 10.3–15.1ROR 12.7 · χ² 1,072 / p 2e-235 | 12.3 EB05 10.4 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 0.8 · ♀ 0% (drug 34%) · 97% clinician | no trial data cached |
| Poor venous access | 37 | 11.9 8.6–16.4ROR 11.9 · χ² 356 / p 1e-79 | 11.4 EB05 8.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=4 · ♀ 0% (drug 34%) · 100% clinician | no trial data cached |
| Abnormal behaviour | 138 | 11.4 9.7–13.5ROR 11.7 · χ² 1,303 / p 1e-285 | 11.3 EB05 9.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 · ♀ 13% (drug 34%) | no trial data cached |
| Anger | 98 | 9.5 7.8–11.6ROR 9.7 · χ² 740 / p 3e-163 | 9.3 EB05 7.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 1.8 · ♀ 0% (drug 34%) | no trial data cached |
| Ligament sprain | 27 | 9.0 6.2–13.2ROR 9.1 · χ² 185 / p 2e-42 | 8.2 EB05 5.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 39 | 8.5 6.2–11.7ROR 8.6 · χ² 252 / p 5e-57 | 8.0 EB05 6.0 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.7 · ♀ 76% (drug 34%) · 94% clinician | no trial data cached |
| Lower limb fracture | 46 | 8.0 6.0–10.6ROR 8.0 · χ² 273 / p 2e-61 | 7.5 EB05 5.8 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.1 · ♀ 11% (drug 34%) | no trial data cached |
| Mood altered | 65 | 7.9 6.2–10.1ROR 8.0 · χ² 385 / p 6e-86 | 7.6 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Weight increased (weight gain) | 531 | 7.9 7.3–8.5ROR 8.5 · χ² 3,208 / p <1e-300 | 7.8 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | no trial data cached |
| Immunodeficiency | 35 | 7.9 5.6–10.9ROR 7.9 · χ² 202 / p 4e-46 | 7.3 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 · ♀ 80% (drug 34%) · 74% consumer | no trial data cached |
| Femur fracture | 71 | 7.6 6.0–9.5ROR 7.6 · χ² 397 / p 1e-88 | 7.3 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.5 | no trial data cached |
| Pharyngitis | 27 | 7.2 4.9–10.4ROR 7.2 · χ² 137 / p 7e-32 | 6.5 EB05 4.6 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.4 · ♀ 80% (drug 34%) | no trial data cached |
| Osteoporosis | 88 | 7.1 5.7–8.7ROR 7.1 · χ² 452 / p 2e-100 | 6.8 EB05 5.7 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.3 · ♀ 64% (drug 34%) | no trial data cached |
| Emotional disorder | 62 | 6.6 5.2–8.5ROR 6.7 · χ² 289 / p 4e-65 | 6.3 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 | no trial data cached |
| Tachypnoea | 26 | 6.3 4.3–9.3ROR 6.4 · χ² 112 / p 2e-26 | 5.7 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 · ♀ 0% (drug 34%) · 100% clinician | no trial data cached |
| Bursitis | 23 | 6.3 4.2–9.5ROR 6.3 · χ² 97 / p 3e-23 | 5.6 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · ♀ 95% (drug 34%) | no trial data cached |
| Foot deformity | 21 | 6.3 4.1–9.6ROR 6.3 · χ² 87 / p 5e-21 | 5.6 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · ♀ 80% (drug 34%) | no trial data cached |
| Face oedema | 32 | 6.2 4.4–8.8ROR 6.3 · χ² 135 / p 1e-31 | 5.8 EB05 4.3 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.9 · 94% clinician | no trial data cached |
| Influenza | 209 | 6.2 5.4–7.1ROR 6.3 · χ² 904 / p 6e-199 | 6.1 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 | no trial data cached |
| Bone disorder | 32 | 5.8 4.1–8.1ROR 5.8 · χ² 121 / p 2e-28 | 5.3 EB05 4.0 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.0 · ♀ 90% (drug 34%) | no trial data cached |
| Inflammation | 88 | 5.7 4.6–7.0ROR 5.7 · χ² 333 / p 9e-75 | 5.5 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · ♀ 62% (drug 34%) | no trial data cached |
| Localised infection | 41 | 5.6 4.1–7.6ROR 5.6 · χ² 150 / p 8e-35 | 5.3 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.6 · ♀ 87% (drug 34%) | no trial data cached |
| Psychomotor hyperactivity | 28 | 5.5 3.8–8.0ROR 5.6 · χ² 100 / p 9e-24 | 5.1 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Gait inability | 55 | 5.5 4.2–7.1ROR 5.5 · χ² 197 / p 4e-45 | 5.3 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Joint range of motion decreased | 22 | 5.4 3.6–8.3ROR 5.5 · χ² 75 / p 2e-18 | 4.9 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · ♀ 90% (drug 34%) | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 41 | 5.3 3.9–7.2ROR 5.3 · χ² 139 / p 3e-32 | 5.0 EB05 3.9 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.0 · ♀ 79% (drug 34%) · 100% clinician | no trial data cached |
| Personality change | 15 | 5.3 3.2–8.8ROR 5.3 · χ² 48 / p 2e-12 | 4.6 EB05 3.0 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | – | no trial data cached |
| Product dose omission | 105 | 5.2 4.3–6.3ROR 5.3 · χ² 356 / p 1e-79 | 5.1 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 5.3 · ♀ 5% (drug 34%) | no trial data cached |
| Foot fracture | 29 | 5.0 3.5–7.2ROR 5.1 · χ² 90 / p 1e-21 | 4.7 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Skin ulcer | 39 | 5.0 3.6–6.8ROR 5.0 · χ² 120 / p 3e-28 | 4.7 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.3 · ♀ 100% (drug 34%) | no trial data cached |
| Crying | 55 | 5.0 3.8–6.5ROR 5.0 · χ² 171 / p 2e-39 | 4.8 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · ♀ 62% (drug 34%) | no trial data cached |
| Aggression | 75 | 4.9 3.9–6.2ROR 5.0 · χ² 232 / p 1e-52 | 4.8 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 0.9 · ♀ 4% (drug 34%) | no trial data cached |
| Tuberculosis | 19 | 4.9 3.1–7.6ROR 4.9 · χ² 55 / p 7e-14 | 4.4 EB05 3.0 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| Pollakiuria (frequent urination) | 61 | 4.8 3.8–6.2ROR 4.9 · χ² 182 / p 9e-42 | 4.7 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 0.9 · ♀ 0% (drug 34%) | no trial data cached |
| Synovitis | 26 | 4.8 3.2–7.0ROR 4.8 · χ² 73 / p 5e-18 | 4.4 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · ♀ 83% (drug 34%) | no trial data cached |
| Muscle atrophy | 18 | 4.7 3.0–7.5ROR 4.7 · χ² 49 / p 1e-12 | 4.2 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Myoclonus | 17 | 4.7 2.9–7.6ROR 4.7 · χ² 46 / p 6e-12 | 4.2 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| No adverse event | 247 | 4.6 4.1–5.2ROR 4.7 · χ² 697 / p 8e-154 | 4.6 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | ♀ 1% (drug 34%) · 99% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Weight increased (weight gain) | 531 | 7.9 7.3–8.5ROR 8.5 · χ² 3,208 / p <1e-300 | 7.8 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | no trial data cached |
| Off label use (used outside approved label) | 413 | 1.6 1.4–1.7ROR 1.6 · χ² 88 / p 3e-21 | 1.6 EB05 1.4 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.6 | no trial data cached |
| Fall | 300 | 3.0 2.7–3.3ROR 3.1 · χ² 398 / p 7e-89 | 3.0 EB05 2.7 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Vomiting | 256 | 1.8 1.6–2.0ROR 1.8 · χ² 92 / p 3e-22 | 1.8 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Product dose omission issue | 255 | 3.0 2.6–3.3ROR 3.0 · χ² 332 / p 2e-74 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 1.6 · ♀ 3% (drug 34%) | no trial data cached |
| No adverse event | 247 | 4.6 4.1–5.2ROR 4.7 · χ² 697 / p 8e-154 | 4.6 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | ♀ 1% (drug 34%) · 99% clinician | no trial data cached |
| Pyrexia (fever) | 227 | 2.2 1.9–2.5ROR 2.2 · χ² 143 / p 3e-33 | 2.2 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Malaise (feeling unwell) | 216 | 1.6 1.4–1.8ROR 1.6 · χ² 52 / p 3e-13 | 1.6 EB05 1.4 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.8 | no trial data cached |
| Influenza | 209 | 6.2 5.4–7.1ROR 6.3 · χ² 904 / p 6e-199 | 6.1 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 | no trial data cached |
| Arthralgia (joint pain) | 188 | 1.5 1.3–1.7ROR 1.5 · χ² 31 / p 1e-8 | 1.5 EB05 1.3 · IC025 +0.3 | Labeled (related wording) related wording | serious PRR 2.8 · ♀ 75% (drug 34%) · 72% consumer | no trial data cached |
| Weight decreased (weight loss) | 188 | 2.2 1.9–2.6ROR 2.3 · χ² 127 / p 1e-29 | 2.2 EB05 2.0 · IC025 +0.9 | Labeled (related wording) related wording | serious PRR 2.0 | no trial data cached |
| Nasopharyngitis (common cold) | 181 | 3.2 2.8–3.7ROR 3.3 · χ² 279 / p 6e-63 | 3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | no trial data cached |
| Pain in extremity | 162 | 1.8 1.6–2.1ROR 1.8 · χ² 59 / p 9e-15 | 1.8 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 3.1 · ♀ 77% (drug 34%) · 71% consumer | no trial data cached |
| Cough | 140 | 1.7 1.4–1.9ROR 1.7 · χ² 36 / p 1e-9 | 1.6 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Erythema (skin redness) | 139 | 2.2 1.9–2.6ROR 2.3 · χ² 94 / p 1e-22 | 2.2 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Gastroenteritis viral — n=74, PRR 13.5
- Poor venous access — n=37, PRR 11.9
- Abnormal behaviour — n=138, PRR 11.4
- Anger — n=98, PRR 9.5
- Ligament sprain — n=27, PRR 9.0
- Immunodeficiency — n=35, PRR 7.9
- Tachypnoea — n=26, PRR 6.3
- Bursitis — n=23, PRR 6.3
- Foot deformity — n=21, PRR 6.3
- Inflammation — n=88, PRR 5.7
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Deflazacort?
In FDA FAERS, the most frequently co-reported reaction terms for Deflazacort are weight increased, fall, vomiting, pyrexia, malaise, influenza. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Deflazacort have an FDA boxed warning?
No. The FDA label retrieved for Deflazacort has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Deflazacort causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 31b347d2-f156-4055-9d8f-7cf0df420296, effective 20251113; matched on
openfda.generic_name.exact:"DEFLAZACORT") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 287 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.