Pentasa: adverse event reports filed with FDA

3,082

reports as suspect product

0% of all reports · about 137 a year

141

reports, 12 months to June 2026

158 in the 12 months before

80.1%

marked serious by the reporter

86.5% across the class

5.5%

record death among outcomes, as reported

168 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 Pentasa reports recording the termmedian drug in aminosalicylate

1. Drug ineffectivethe medicine did not work as expected25.1%774
2. Macular degenerationa disease of the central retina11.4%350
3. Off label useused for a purpose or in a way not on the label9.8%303
4. Colitis ulcerative8.6%265
5. Product use issuea problem in how the product was used7%215
6. Crohn's disease6.8%211
7. Diarrhoealoose or frequent stools6.4%197
8. Pyrexiafever6%186
9. Painpain, site not specified5.3%163
10. Nauseafeeling sick5.2%160
11. No adverse eventno adverse event was reported5.1%157
12. Abdominal painstomach or belly pain5%153
13. Malaisegeneral feeling of being unwell4.6%143
14. Haematocheziablood in the stool4.5%139
15. Weight decreasedweight loss4%124
16. Headachehead pain4%122
17. Frequent bowel movements3.7%113
18. Condition aggravatedthe condition being treated got worse3.5%108
19. Anaemialow red blood cells3.4%106
20. Deaththe patient died; cause not stated by this term3.2%99
21. Colitisinflamed bowel2.9%90
22. Dyspepsiaindigestion2.8%87
23. Therapeutic product effect incomplete2.8%86
24. Procedural painpain from a procedure2.8%85
25. Rectal haemorrhage2.5%76
26. Vomitingbeing sick2.4%74
27. Arthralgiajoint pain2.3%71
28. Paraesthesia oral2.3%71
29. Chronic sinusitis2.3%70
30. Infusion related reactiona reaction during or soon after an infusion2.2%69

Top 30 of 667 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 7 drugs in the aminosalicylate 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 59,220 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. 40.9% 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 3,082 reports.

Drugs most often listed in the same reports

Other products listed in reports where Pentasa 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 aminosalicylate 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 Pentasa as a suspect or interacting product; reports listing it only as a concomitant medication (14,065) 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.