Glycerin: adverse event reports filed with FDA

891

reports as suspect product

0% of all reports · about 42 a year

58

reports, 12 months to June 2026

93 in the 12 months before

93.2%

marked serious by the reporter

7.3% across the class

2.7%

record death among outcomes, as reported

24 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 Glycerin reports recording the termmedian drug in non-standardized chemical allergen

1. Drug ineffectivethe medicine did not work as expected65.2%581
2. Macular degenerationa disease of the central retina64.4%574
3. Painpain, site not specified34.2%305
4. Off label useused for a purpose or in a way not on the label31.2%278
5. Constipationconstipation28.2%251
6. Chronic sinusitis24.1%215
7. Therapeutic product effect incomplete24%214
8. Pyrexiafever23.5%209
9. Malaisegeneral feeling of being unwell22.6%201
10. Paraesthesia oral22.6%201
11. Nauseafeeling sick22.4%200
12. Weight decreasedweight loss22.4%200
13. Infusion related reactiona reaction during or soon after an infusion21%187
14. Dyspepsiaindigestion20.3%181
15. Procedural painpain from a procedure20.3%181
16. Headachehead pain17.1%152
17. Abdominal painstomach or belly pain16.9%151
18. Erythemaskin redness16.8%150
19. Haematocheziablood in the stool16.8%150
20. Colitisinflamed bowel16.7%149
21. Rectal haemorrhage16.7%149
22. Anaemialow red blood cells16.6%148
23. Colitis ulcerative16.6%148
24. Female genital tract fistula16.5%147
25. Frequent bowel movements16.5%147
26. Oral candidiasisoral thrush16.4%146
27. Proctitis16.3%145
28. Radiculopathy16.3%145
29. Vaginal discharge16.3%145
30. Vaginal flatulence16.3%145

Top 30 of 117 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 3 drugs in the non-standardized chemical allergen 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 15,731 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. 9.3% 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 891 reports.

Drugs most often listed in the same reports

Other products listed in reports where Glycerin 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 non-standardized chemical allergen 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 Glycerin as a suspect or interacting product; reports listing it only as a concomitant medication (1,948) 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.