Dulcolax: adverse event reports filed with FDA

2,893

reports as suspect product

0% of all reports · about 129 a year

137

reports, 12 months to June 2026

86 in the 12 months before

63.8%

marked serious by the reporter

54.5% across the class

9.6%

record death among outcomes, as reported

278 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 Dulcolax reports recording the termmedian drug in osmotic laxative

1. Constipationconstipation26.9%779
2. Drug ineffectivethe medicine did not work as expected22.8%659
3. Painpain, site not specified16.6%480
4. Hypotensionlow blood pressure14.4%416
5. Falla fall14.3%414
6. Balance disorderproblems with balance13.5%390
7. Cognitive disorderproblems with thinking or memory13.4%389
8. Orthostatic hypotension13.1%379
9. Sedationdrowsiness from a medicine12.9%374
10. Depressed level of consciousness12.4%360
11. Mobility decreasedreduced ability to move about12.4%359
12. Blood calcium decreased12.3%357
13. Creatinine renal clearance decreased12.3%357
14. No adverse eventno adverse event was reported12.3%357
15. Off label useused for a purpose or in a way not on the label12.1%351
16. Sedation complication11.9%343
17. Nauseafeeling sick11.7%339
18. Abdominal painstomach or belly pain11.5%334
19. Vomitingbeing sick11.5%333
20. Toxicity to various agentspoisoning or toxic effect of one or more substances11.1%320
21. Diarrhoealoose or frequent stools8.8%256
22. Abdominal distensiona bloated abdomen8%231
23. General physical health deteriorationgeneral decline in health6.7%193
24. Hyponatraemialow blood sodium6.6%191
25. Appendicitis6.3%181
26. Appendicolith6.2%180
27. Ascitesfluid in the abdomen6.2%180
28. Dyspnoeashortness of breath6.2%179
29. Sepsisa severe body-wide response to infection6.2%178
30. Cardiogenic shockshock from the heart failing to pump6.1%177

Top 30 of 532 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. 60.4% 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 2,893 reports.

Drugs most often listed in the same reports

Other products listed in reports where Dulcolax 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 Dulcolax as a suspect or interacting product; reports listing it only as a concomitant medication (8,741) 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.