Somatuline Depot: adverse event reports filed with FDA

4,295

reports as suspect product

0% of all reports · about 230 a year

127

reports, 12 months to June 2026

150 in the 12 months before

35.3%

marked serious by the reporter

77.3% across the class

6.7%

record death among outcomes, as reported

287 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 Somatuline Depot reports recording the termmedian drug in somatostatin analog

1. Diarrhoealoose or frequent stools18.7%805
2. Off label useused for a purpose or in a way not on the label12.4%531
3. Fatiguetiredness11.9%513
4. Injection site painpain where the injection was given9.9%426
5. Nauseafeeling sick8.6%368
6. Headachehead pain6.3%269
7. Injection site mass6.2%268
8. Deaththe patient died; cause not stated by this term5.3%226
9. Painpain, site not specified4.7%200
10. Abdominal painstomach or belly pain4.6%196
11. Product dose omission issuea dose was missed4.1%177
12. Dizzinesslight-headedness or unsteadiness4.1%174
13. Flatulencewind3.9%169
14. Arthralgiajoint pain3.7%161
15. Malaisegeneral feeling of being unwell3.7%161
16. Drug ineffectivethe medicine did not work as expected3.6%155
17. Alopeciahair loss3.6%154
18. Blood glucose increasedraised blood sugar reading3.5%152
19. Abdominal discomfortstomach discomfort3.5%149
20. Abdominal pain upperupper stomach pain3.4%145
21. Astheniaweakness or lack of energy3.2%137
22. Inappropriate schedule of drug administrationthe medicine was taken at the wrong times3.1%131
23. Abdominal distensiona bloated abdomen2.8%122
24. Vomitingbeing sick2.8%122
25. Weight decreasedweight loss2.8%121
26. Constipationconstipation2.5%108
27. Feeling abnormalfeeling odd or not right2.3%99
28. Flushingsudden reddening or warmth of the skin2.1%92
29. Anxietyanxiety2%86
30. Cholelithiasisgallstones1.9%82

Top 30 of 511 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 6 drugs in the somatostatin analog 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 18,073 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. 97.3% 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 4,295 reports.

Drugs most often listed in the same reports

Other products listed in reports where Somatuline Depot 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 somatostatin analog 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 Somatuline Depot as a suspect or interacting product; reports listing it only as a concomitant medication (312) 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.