Cortef: adverse event reports filed with FDA

588

reports as suspect product

0% of all reports · about 27 a year

8

reports, 12 months to June 2026

15 in the 12 months before

68%

marked serious by the reporter

77.7% across the class

1.9%

record death among outcomes, as reported

11 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 Cortef reports recording the termmedian drug in corticosteroid

1. Fatiguetiredness14.8%87
2. Drug ineffectivethe medicine did not work as expected14.6%86
3. Dyspnoeashortness of breath12.6%74
4. Adrenal insufficiencythe adrenal glands produce too little hormone8.3%49
5. Painpain, site not specified8%47
6. Malaisegeneral feeling of being unwell7.7%45
7. Pneumonialung infection7.3%43
8. Arthralgiajoint pain7.1%42
9. Drug intolerancethe medicine was not tolerated7.1%42
10. Asthmaasthma6.8%40
11. Headachehead pain6.8%40
12. Astheniaweakness or lack of energy5.8%34
13. Nauseafeeling sick5.8%34
14. Weight increasedweight gain5.8%34
15. Vomitingbeing sick5.3%31
16. Therapeutic product effect incomplete4.9%29
17. Dizzinesslight-headedness or unsteadiness4.8%28
18. Pain in extremitypain in an arm or leg4.6%27
19. Loss of personal independence in daily activities4.3%25
20. Somnolencedrowsiness4.3%25
21. Wheezingwheezing4.3%25
22. Feeling abnormalfeeling odd or not right4.1%24
23. Adrenocortical insufficiency acute3.9%23
24. Diarrhoealoose or frequent stools3.9%23
25. Injection site painpain where the injection was given3.9%23
26. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease3.9%23
27. Blood pressure decreaseda low blood pressure reading3.6%21
28. Blood pressure increaseda raised blood pressure reading3.6%21
29. Hypersensitivityan allergic-type reaction3.6%21
30. Peripheral swellingswelling of the arms or legs3.6%21

Top 30 of 278 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. 63.9% 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 588 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 Cortef as a suspect or interacting product; reports listing it only as a concomitant medication (2,260) 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.