Prednisone: adverse event reports filed with FDA

183,867

reports as suspect product

0.9% of all reports · about 8,174 a year

15,614

reports, 12 months to June 2026

19,420 in the 12 months before

91.4%

marked serious by the reporter

77.7% across the class

15.4%

record death among outcomes, as reported

28,314 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 Prednisone reports recording the termmedian drug in corticosteroid

1. Drug ineffectivethe medicine did not work as expected16.5%30,289
2. Off label useused for a purpose or in a way not on the label10.7%19,645
3. Fatiguetiredness8.2%15,152
4. Painpain, site not specified8.2%15,011
5. Dyspnoeashortness of breath7.6%14,002
6. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease6.5%11,925
7. Condition aggravatedthe condition being treated got worse6.2%11,484
8. Asthmaasthma5.7%10,518
9. Pneumonialung infection5.4%9,928
10. Rashskin rash5.3%9,835
11. Arthralgiajoint pain5.3%9,707
12. Pyrexiafever5.2%9,569
13. Alopeciahair loss5.2%9,558
14. Abdominal discomfortstomach discomfort5.2%9,474
15. Systemic lupus erythematosuslupus, an autoimmune disease5%9,102
16. Nauseafeeling sick4.9%8,951
17. Wheezingwheezing4.7%8,707
18. Drug intolerancethe medicine was not tolerated4.6%8,479
19. Pemphigus4.6%8,477
20. Diarrhoealoose or frequent stools4.5%8,288
21. Swellingswelling4.5%8,274
22. Weight increasedweight gain4.5%8,241
23. Product use in unapproved indicationused for a purpose not on the label4.4%8,040
24. Joint swellinga swollen joint4.4%8,002
25. Vomitingbeing sick4.2%7,792
26. Glossodynia4.2%7,734
27. Headachehead pain4.2%7,717
28. Arthropathy4.1%7,515
29. Infectionan infection, type not specified3.9%7,204
30. Contraindicated product administered3.9%7,147

Top 30 of 6,997 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. 39.1% 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 183,867 reports.

Drugs most often listed in the same reports

Other products listed in reports where Prednisone is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

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 Prednisone as a suspect or interacting product; reports listing it only as a concomitant medication (340,568) 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.