Delflex: adverse event reports filed with FDA

8,765

reports as suspect product

0% of all reports · about 662 a year

676

reports, 12 months to June 2026

649 in the 12 months before

53.8%

marked serious by the reporter

54.5% across the class

7.7%

record death among outcomes, as reported

677 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 Delflex reports recording the termmedian drug in osmotic laxative

1. Peritonitis17.8%1,559
2. Peritonitis bacterial10.7%939
3. Abdominal distensiona bloated abdomen7%611
4. Abdominal painstomach or belly pain4.9%426
5. Deaththe patient died; cause not stated by this term3.9%339
6. Malaisegeneral feeling of being unwell3.6%315
7. Bloody peritoneal effluent3.2%284
8. Dyspnoeashortness of breath3.2%282
9. Painpain, site not specified3.1%274
10. Infectionan infection, type not specified3.1%268
11. Fluid overload3%265
12. Discomfortdiscomfort2.5%220
13. Abdominal discomfortstomach discomfort2.3%198
14. Vomitingbeing sick2.1%184
15. Diarrhoealoose or frequent stools2.1%182
16. Hypervolaemia2.1%180
17. Treatment noncompliancethe treatment was not taken as directed2%177
18. Cardiac arrestthe heart stopped1.9%169
19. Catheter site infectioninfection where a catheter enters1.9%168
20. Nauseafeeling sick1.8%157
21. Fluid retentionthe body holding extra fluid1.4%124
22. Pneumonialung infection1.3%113
23. Constipationconstipation1.2%109
24. Hypotensionlow blood pressure1.2%102
25. Peripheral swellingswelling of the arms or legs1.2%102
26. Swellingswelling1%90
27. Sepsisa severe body-wide response to infection1%87
28. Muscle spasmsmuscle cramps1%86
29. Fungal peritonitis1%85
30. Hernia1%84

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 17 drugs in the osmotic laxative 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 129,514 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. 99.7% 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 8,765 reports.

Drugs most often listed in the same reports

Other products listed in reports where Delflex 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 osmotic laxative 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 Delflex as a suspect or interacting product; reports listing it only as a concomitant medication (29) 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.