Brand name · Octreotide acetate
Sandostatin LAR Depot: adverse event reports filed with FDA
16,955 reports list it as a suspect or interacting product, 2008–2026. Also reported as Sandostatin Lar Depot Suspension.
- 16,955
- reports as suspect product
- 0.1% of all reports · about 951 a year
- 152
- reports, 12 months to June 2026
- 357 in the 12 months before
- 73%
- marked serious by the reporter
- 57.4% across all reports
- 22.9%
- record death among outcomes, as reported
- 3,889 reports · not verified by FDA
16,955 adverse event reports received by FDA list the brand name Sandostatin LAR Depot (octreotide acetate) as a suspect or interacting product, from September 2008 to June 2026. A further 748 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 152 reports listed it, down 57% from 357 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 951 reports a year and 0.1% of the 20,646,523 reports in the database. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are death (18.1%), diarrhoea (15%) and needle issue (13.7%). A report can list several reactions, so shares add to more than 100%; 2,101 different terms appear across these reports. Death is recorded in 18.1% of these reports, against 4.1% of all reports in the database.
73% of the reports are marked serious by the reporter; 22.9% record death among the outcomes and 31.3% record hospitalisation, as reported. 59.8% of the reports came from consumers, and the largest patient age group is 45 to 64 (19.5%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
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 Sandostatin LAR Depot reports recording the termall reports in the database
- Deaththe patient died; cause not stated by this term18.1%3,072
- Diarrhoealoose or frequent stools15%2,551
- Needle issuea problem with the needle13.7%2,330
- Malaisegeneral feeling of being unwell12.6%2,130
- Fatiguetiredness12.1%2,058
- Blood pressure increaseda raised blood pressure reading11.6%1,973
- Painpain, site not specified10.2%1,737
- Malignant neoplasm progression9.7%1,637
- Blood pressure systolic increased9.6%1,636
- Nauseafeeling sick9.1%1,549
- Astheniaweakness or lack of energy9%1,526
- Injection site painpain where the injection was given8.7%1,477
- Abdominal painstomach or belly pain8.6%1,465
- Weight decreasedweight loss8.4%1,417
- Inappropriate schedule of product administrationthe product was taken at the wrong times8.2%1,383
- Headachehead pain7.5%1,272
- Dizzinesslight-headedness or unsteadiness7.5%1,264
- Falla fall7.3%1,245
- Vomitingbeing sick7%1,186
- Arthralgiajoint pain6.4%1,089
- Dyspnoeashortness of breath6%1,018
- Body temperature decreased5.9%992
- Back painback pain5.7%970
- Pain in extremitypain in an arm or leg5.6%956
- Drug ineffectivethe medicine did not work as expected5%852
- Coughcough5%841
- Pyrexiafever4.8%820
- Abdominal pain upperupper stomach pain4.8%813
- Decreased appetitereduced appetite4.6%778
- Gait disturbancedifficulty walking4.4%739
Top 30 of 2,101 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 share of all reports in the database; 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 20,646,523 reports. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 38.1% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Neuroendocrine tumour | 2,703 | 15.9% |
| Acromegaly | 1,742 | 10.3% |
| Carcinoid tumour | 1,179 | 7% |
| Carcinoid syndrome | 964 | 5.7% |
| Pancreatic neuroendocrine tumour | 332 | 2% |
| Gastroenteropancreatic neuroendocrine tumour disease | 217 | 1.3% |
The indication field is filled in by the reporter and is often blank; shares are of all 16,955 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Sandostatin LAR Depot reports |
|---|---|---|
| Sandostatin | 1,613 | 9.5% |
| Afinitor | 844 | 5% |
| Metformin | 563 | 3.3% |
| Amlodipine | 409 | 2.4% |
| Aspirin | 331 | 2% |
| Synthroid | 328 | 1.9% |
| Metoprolol | 303 | 1.8% |
| Hydrochlorothiazide | 268 | 1.6% |
| Cabergoline | 259 | 1.5% |
| Atorvastatin | 240 | 1.4% |
Other products listed in reports where Sandostatin LAR 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
| Measure | Sandostatin LAR Depot | All reports |
|---|---|---|
| Reports as suspect product | 16,955 | 20,646,523 |
| Share of that pool | — | 0.1% |
| Reports, latest 12 months | 152 | 1,332,454 |
| Marked serious | 73% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 229 | 91 |
| Hospitalisation recorded, per 1,000 reports | 313 | 213 |
| Consumer-filed share | 59.8% | 45.8% |
| Top term, share of reports | Death 18.1% | 4.1% |
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."
Questions about Sandostatin LAR Depot reports
How many adverse event reports has FDA received for Sandostatin LAR Depot?
16,955 reports list Sandostatin LAR Depot as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 152 of them arrived in the latest 12 months. Another 748 list it only as a concomitant medication.
What reactions are recorded in Sandostatin LAR Depot reports?
death (18.1%), diarrhoea (15%), needle issue (13.7%), malaise (12.6%) and fatigue (12.1%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Sandostatin LAR Depot was responsible.
How serious are the reports?
73% are marked serious by the reporter. Among the outcomes recorded, 22.9% of reports include death and 31.3% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (59.8%), other health professional (20.5%) and physician (16.3%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Sandostatin LAR Depot rising?
152 reports in the 12 months to June 2026, down 57% from 357 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Sandostatin LAR Depot was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Sandostatin LAR Depot?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
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 Sandostatin LAR Depot as a suspect or interacting product; reports listing it only as a concomitant medication (748) 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.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.