Uceris: adverse event reports filed with FDA

769

reports as suspect product

0% of all reports · about 59 a year

1

reports, 12 months to June 2026

10 in the 12 months before

40.2%

marked serious by the reporter

77.7% across the class

2.6%

record death among outcomes, as reported

20 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 Uceris reports recording the termmedian drug in corticosteroid

1. Off label useused for a purpose or in a way not on the label16.4%126
2. Drug ineffectivethe medicine did not work as expected12.7%98
3. Diarrhoealoose or frequent stools7.4%57
4. Colitis ulcerative7.2%55
5. Product use in unapproved indicationused for a purpose not on the label5.1%39
6. Treatment noncompliancethe treatment was not taken as directed4.7%36
7. Therapy cessation4%31
8. Malaisegeneral feeling of being unwell3.9%30
9. Inability to afford medication3.6%28
10. Headachehead pain3.4%26
11. Fatiguetiredness3.3%25
12. Nauseafeeling sick3.3%25
13. Drug dose omissiona dose was missed3.1%24
14. No adverse eventno adverse event was reported3.1%24
15. Condition aggravatedthe condition being treated got worse3%23
16. Abdominal painstomach or belly pain2.9%22
17. Weight decreasedweight loss2.6%20
18. Crohn's disease2.5%19
19. Insurance issue2.5%19
20. Weight increasedweight gain2.5%19
21. Ill-defined disordera condition that was not clearly described2.3%18
22. Insomniadifficulty sleeping2.2%17
23. Abdominal pain upperupper stomach pain2.1%16
24. Contusiona bruise2.1%16
25. Product use issuea problem in how the product was used2.1%16
26. Drug effect incomplete2%15
27. Haemorrhagebleeding2%15
28. Constipationconstipation1.8%14
29. Hospitalisationadmission to hospital1.8%14
30. Astheniaweakness or lack of energy1.7%13

Top 30 of 205 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. 97.8% 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 769 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 Uceris as a suspect or interacting product; reports listing it only as a concomitant medication (842) 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.