Deflazacort: adverse event reports filed with FDA

531

reports as suspect product

0% of all reports · about 26 a year

62

reports, 12 months to June 2026

47 in the 12 months before

96.8%

marked serious by the reporter

77.7% across the class

9.6%

record death among outcomes, as reported

51 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Deflazacort reports recording the termmedian drug in corticosteroid

1. Off label useused for a purpose or in a way not on the label10.9%58
2. Drug ineffectivethe medicine did not work as expected10.5%56
3. Angioedemadeep swelling of skin or mucous membranes7.9%42
4. Urticariahives6.8%36
5. Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement5.6%30
6. Product use in unapproved indicationused for a purpose not on the label4.7%25
7. Drug interactionan interaction between medicines4.5%24
8. Drug hypersensitivityan allergic-type reaction to a medicine4.3%23
9. Toxic epidermal necrolysisa severe skin reaction with peeling4.3%23
10. Syncopefainting3.8%20
11. Dyspnoeashortness of breath2.8%15
12. Osteoporosisthinning of the bones2.8%15
13. Pyrexiafever2.8%15
14. Influenzaflu2.6%14
15. Weight increasedweight gain2.6%14
16. Depressed level of consciousness2.4%13
17. Multiple organ dysfunction syndromeseveral organs failing2.4%13
18. Allergy test positive2.3%12
19. Vomitingbeing sick2.3%12
20. Back painback pain2.1%11
21. Confusional stateconfusion2.1%11
22. Cushing's syndrome2.1%11
23. Diarrhoealoose or frequent stools2.1%11
24. Face oedemaswelling of the face2.1%11
25. Haemodynamic instability2.1%11
26. Pneumonia aspirationlung infection from breathing in material2.1%11
27. Stevens-Johnson syndromea severe skin and mucous-membrane reaction2.1%11
28. Condition aggravatedthe condition being treated got worse1.9%10
29. Muscle atrophy1.9%10
30. Fatiguetiredness1.7%9

Top 30 of 264 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 74 drugs in the corticosteroid class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 808,789 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 9.8% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 531 reports.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the corticosteroid class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Deflazacort as a suspect or interacting product; reports listing it only as a concomitant medication (2,019) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.