Solu-medrol: adverse event reports filed with FDA

10,288

reports as suspect product

0.1% of all reports · about 457 a year

432

reports, 12 months to June 2026

668 in the 12 months before

88.8%

marked serious by the reporter

77.7% across the class

15.9%

record death among outcomes, as reported

1,636 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 Solu-medrol reports recording the termmedian drug in corticosteroid

1. Drug ineffectivethe medicine did not work as expected8.7%899
2. Off label useused for a purpose or in a way not on the label8.7%898
3. Dyspnoeashortness of breath6.9%712
4. Pyrexiafever6.7%687
5. Headachehead pain6.6%681
6. Fatiguetiredness6.5%670
7. Nauseafeeling sick6.1%626
8. Condition aggravatedthe condition being treated got worse6%622
9. Rashskin rash5.9%606
10. Painpain, site not specified5.8%600
11. Malaisegeneral feeling of being unwell5.5%570
12. Hypertensionhigh blood pressure5.3%543
13. Vomitingbeing sick5.2%539
14. Hypersensitivityan allergic-type reaction5.2%537
15. Diarrhoealoose or frequent stools5.1%526
16. Pruritusitching5.1%524
17. Infusion related reactiona reaction during or soon after an infusion4.9%506
18. Drug hypersensitivityan allergic-type reaction to a medicine4.6%469
19. Arthralgiajoint pain4.5%467
20. Hypoaesthesianumbness4.4%450
21. Urticariahives4.2%435
22. Dizzinesslight-headedness or unsteadiness4.2%432
23. Weight increasedweight gain3.9%405
24. Decreased appetitereduced appetite3.9%402
25. General physical health deteriorationgeneral decline in health3.9%401
26. Abdominal discomfortstomach discomfort3.6%372
27. Swellingswelling3.6%370
28. Alopeciahair loss3.6%366
29. Astheniaweakness or lack of energy3.5%365
30. Hepatic enzyme increasedraised liver enzymes3.5%365

Top 30 of 1,725 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. 31.1% 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 10,288 reports.

Drugs most often listed in the same reports

Other products listed in reports where Solu-medrol 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 Solu-medrol as a suspect or interacting product; reports listing it only as a concomitant medication (18,336) 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.