Pharmacologic class (EPC) · 6 drug pages

Somatostatin analog: adverse event reports filed with FDA

18,073 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

18,073
reports across the class: 0.1% of all reports; 1,416
reports, 12 months to June 2026: 1,383 in the 12 months before; 77.3%
marked serious by the reporter: 57.4% across all reports; 6
drugs with a page: brand and generic names counted separately

Somatostatin analog is a pharmacologic class (an FDA Established Pharmacologic Class) with 6 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 18,073 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026.

1,416 reports arrived in the 12 months to June 2026, close to the 1,383 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 77.3% of the class's reports are marked serious, 19% record death among the outcomes and 31.8% record hospitalisation, as reported.

Across the class the reactions recorded most often are diarrhoea (19.2%), fatigue (15.3%) and death (14.1%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
SandostatinOctreotide acetate	brand	5,413	71	90.3%	Diarrhoea
Somatuline DepotLanreotide acetate	brand	4,295	127	35.3%	Diarrhoea
Octreotide	generic	3,372	366	92.1%	Drug ineffective
Lanreotide acetate	generic	3,005	690	93.9%	Death
Octreotide acetate	generic	1,227	120	88.9%	Diarrhoea
SigniforPasireotide	brand	761	42	73.5%	Nausea

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Diarrhoealoose or frequent stools19.2%3,470
Fatiguetiredness15.3%2,769
Deaththe patient died; cause not stated by this term14.1%2,552
Nauseafeeling sick12.2%2,205
Off label useused for a purpose or in a way not on the label11.9%2,151
Blood pressure increaseda raised blood pressure reading10.3%1,854
Injection site painpain where the injection was given10.1%1,831
Abdominal painstomach or belly pain9.7%1,746
Malaisegeneral feeling of being unwell9.2%1,654
Painpain, site not specified8.9%1,608
Blood pressure systolic increased8.3%1,492
Headachehead pain8.2%1,480
Malignant neoplasm progression8.2%1,478
Dizzinesslight-headedness or unsteadiness8.1%1,464
Astheniaweakness or lack of energy8%1,444
Weight decreasedweight loss7.7%1,400
Vomitingbeing sick7.4%1,338
Drug ineffectivethe medicine did not work as expected7.3%1,313
Inappropriate schedule of product administrationthe product was taken at the wrong times6.7%1,203
Dyspnoeashortness of breath5.9%1,068
Arthralgiajoint pain5.8%1,052
Falla fall5.5%1,003
Back painback pain5.4%972
Needle issuea problem with the needle5%911
Body temperature decreased5%910

Solid bar: share of all class reports. Hollow bar: the median share across the 6 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death19%3,434

Life-threatening3%542

Hospitalisation (initial or prolonged)31.8%5,748

Disability1.1%200

Congenital anomaly0.1%13

Other serious55.2%9,973

Not serious22.7%4,094

Patient age

Under 21.2%216

2 to 110.6%102

12 to 170.4%72

18 to 449.1%1,642

45 to 6428.5%5,154

65 to 7415.1%2,726

75 and over11.6%2,105

Age not given33.5%6,056

Who reported

Physician17.5%3,169

Pharmacist4.4%803

Other health professional33.8%6,112

Lawyer0%0

Consumer or non-health professional41.8%7,562

Not given2.4%427

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Somatostatin analog reports

Which drugs are in the Somatostatin analog class on this site?

Sandostatin, Somatuline Depot, Octreotide, Lanreotide acetate, Octreotide acetate and Signifor. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

18,073 reports through June 2026, 1,416 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

diarrhoea (19.2%), fatigue (15.3%), death (14.1%), nausea (12.2%) and off label use (11.9%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.