Brand name · Octreotide acetate
Sandostatin: adverse event reports filed with FDA
5,413 reports list it as a suspect or interacting product, 2004–2026. Class: Somatostatin analog.
- 5,413
- reports as suspect product
- 0% of all reports · about 241 a year
- 71
- reports, 12 months to June 2026
- 116 in the 12 months before
- 90.3%
- marked serious by the reporter
- 77.3% across the class
- 23.3%
- record death among outcomes, as reported
- 1,261 reports · not verified by FDA
Between January 2004 and June 2026, 5,413 adverse event reports received by FDA list the brand name Sandostatin (octreotide acetate) as a suspect or interacting product. Reports that mention it only as a concomitant medication (2,318) are left out of every figure here.
In the 12 months to June 2026, 71 reports listed it, down 39% from 116 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 241 reports a year and 0% of the 20,646,523 reports in the database, and 30% of the reports for the somatostatin analog class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are diarrhoea (29.5%), blood pressure increased (28.2%) and fatigue (27.1%). A report can list several reactions, so shares add to more than 100%; 1,576 different terms appear across these reports. Diarrhoea is recorded in 29.5% of these reports, a larger share than in the median somatostatin analog drug (15%).
90.3% of the reports are marked serious by the reporter (77.3% across the class); 23.3% record death among the outcomes and 42.5% record hospitalisation, as reported. 41.7% of the reports came from consumers, and the largest patient age group is 45 to 64 (29.2%). 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 reports recording the termmedian drug in somatostatin analog
- Diarrhoealoose or frequent stools29.5%1,595
- Blood pressure increaseda raised blood pressure reading28.2%1,529
- Fatiguetiredness27.1%1,468
- Blood pressure systolic increased25.2%1,364
- Nauseafeeling sick20.8%1,126
- Injection site painpain where the injection was given19.7%1,068
- Malaisegeneral feeling of being unwell19.4%1,048
- Painpain, site not specified19.4%1,048
- Abdominal painstomach or belly pain17.8%962
- Deaththe patient died; cause not stated by this term17.6%954
- Astheniaweakness or lack of energy16.3%880
- Malignant neoplasm progression16.2%877
- Dizzinesslight-headedness or unsteadiness16.1%874
- Body temperature decreased15.6%846
- Weight decreasedweight loss15.3%827
- Headachehead pain14.8%803
- Inappropriate schedule of product administrationthe product was taken at the wrong times14.6%789
- Vomitingbeing sick14.5%785
- Needle issuea problem with the needle14.1%764
- Coughcough12.7%690
- Falla fall12.7%688
- Arthralgiajoint pain12.6%682
- Back painback pain12.6%680
- Dyspnoeashortness of breath12.5%675
- Heart rate decreased11.7%636
- Pain in extremitypain in an arm or leg11.2%607
- Nasopharyngitisa cold9.6%520
- Abdominal distensiona bloated abdomen9.5%512
- Decreased appetitereduced appetite9.5%512
Top 30 of 1,576 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
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. 21.1% 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 | 676 | 12.5% |
| Carcinoid tumour | 638 | 11.8% |
| Acromegaly | 581 | 10.7% |
| Carcinoid syndrome | 211 | 3.9% |
| Pancreatic neuroendocrine tumour | 111 | 2.1% |
| Neuroendocrine carcinoma | 71 | 1.3% |
The indication field is filled in by the reporter and is often blank; shares are of all 5,413 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Sandostatin reports |
|---|---|---|
| Sandostatin LAR Depot | 1,583 | 29.2% |
| Metformin | 409 | 7.6% |
| Afinitor | 407 | 7.5% |
| Synthroid | 301 | 5.6% |
| Amlodipine | 296 | 5.5% |
| Ramipril | 240 | 4.4% |
| Pantoprazole | 236 | 4.4% |
| Aspirin | 214 | 4% |
| Metoprolol | 207 | 3.8% |
| Bisoprolol | 201 | 3.7% |
Other products listed in reports where Sandostatin 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 | Somatostatin analog | All reports |
|---|---|---|---|
| Reports as suspect product | 5,413 | 18,073 | 20,646,523 |
| Share of that pool | — | 30% | 0% |
| Reports, latest 12 months | 71 | — | 1,332,454 |
| Marked serious | 90.3% | 77.3% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 233 | 190 | 91 |
| Hospitalisation recorded, per 1,000 reports | 425 | 318 | 213 |
| Consumer-filed share | 41.7% | 41.8% | 45.8% |
| Top term, share of reports | Diarrhoea 29.5% | median 15% | 3.1% |
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."
Other drugs in the somatostatin analog class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Somatuline Depot | brand | 4,295 | 127 | 35.3% |
| Octreotide | generic | 3,372 | 366 | 92.1% |
| Lanreotide acetate | generic | 3,005 | 690 | 93.9% |
| Octreotide acetate | generic | 1,227 | 120 | 88.9% |
| Signifor | brand | 761 | 42 | 73.5% |
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.
Questions about Sandostatin reports
How many adverse event reports has FDA received for Sandostatin?
5,413 reports list Sandostatin as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 71 of them arrived in the latest 12 months. Another 2,318 list it only as a concomitant medication.
What reactions are recorded in Sandostatin reports?
diarrhoea (29.5%), blood pressure increased (28.2%), fatigue (27.1%), blood pressure systolic increased (25.2%) and nausea (20.8%). 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 was responsible.
How serious are the reports?
90.3% are marked serious by the reporter. Among the outcomes recorded, 23.3% of reports include death and 42.5% 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 (41.7%), other health professional (36%) and physician (15.9%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Sandostatin rising?
71 reports in the 12 months to June 2026, down 39% from 116 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 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?
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 as a suspect or interacting product; reports listing it only as a concomitant medication (2,318) 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.