What Is Octreotide Used For? Approved Uses, Per the Label

Octreotide is a prescription medicine. It is a synthetic eight amino acid analog of the hormone somatostatin, given by injection as immediate-release and long-acting depot formulations and, in one product, as oral delayed-release capsules. In the United States it is dispensed only on a prescription, and the uses that count as approved uses are the indications printed in the FDA-approved prescribing information for each specific product. This page describes those label indications, the regulatory history behind them, and the published literature that discusses octreotide in each setting. A broader pharmacology overview sits on the octreotide learn page.

This page is for educational purposes only and is not medical advice; consult a licensed physician or the prescribing clinician who manages a given condition about whether any medicine is appropriate. No dosing information appears here, and nothing below should be read as a suggestion to use octreotide.

The Approved Indications at a Glance

Octreotide acetate is marketed in several forms. The indications differ slightly between the immediate-release injection, the long-acting depot suspension, and the oral capsule, so the product label governs. The table summarises the indications in substance as they appear in the current US prescribing information for each product family.

Those are the uses. Everything else described in the medical literature is either diagnostic imaging with a different, radiolabeled product or a use outside the approved labeling.

US label versions on DailyMed: Sandostatin (octreotide acetate) injection, DailyMed label version July 2026; Sandostatin LAR Depot, DailyMed label version December 2025. The current label for the specific product governs.

Indication 1: Acromegaly

Acromegaly is caused in most cases by a growth hormone secreting pituitary adenoma. The injection label frames the acromegaly indication around biochemical control, that is, reduction of circulating growth hormone and IGF-1, in patients whose disease has not been controlled by surgery, radiotherapy or dopamine agonist therapy, or for whom those options are unsuitable. The depot label frames the same population in terms of long-term maintenance therapy.

What the literature describes

A review of octreotide in acromegaly summarised the drug's pharmacology, its somatostatin receptor binding profile and its clinical role in lowering growth hormone and IGF-1 in acromegaly, and described the development of the long-acting formulation for maintenance therapy (PMID 30754185). The mechanistic basis has been examined in receptor pharmacology work: a review of somatostatin analog action at neuroendocrine tumor receptors described how octreotide and related ligands engage somatostatin receptor subtypes, chiefly SSTR2, and how receptor trafficking shapes the response to repeated exposure (PMID 24183675).

The oral capsule indication

The oral delayed-release capsule reached the US market with a narrower indication than the injections: long-term maintenance in people with acromegaly who had already responded to and tolerated injectable octreotide or lanreotide. A systematic review of oral administration of somatostatin receptor ligands in acromegaly focused on biochemical response and reported on the maintenance of IGF-1 control in patients switched from injectable therapy to oral octreotide (PMID 39598481). The formulation science behind that product has been reviewed separately: an overview of gastrointestinal permeation enhancers for oral peptide pharmaceuticals discussed the enhancer-based technologies that allow peptides such as octreotide to be absorbed after oral dosing (PMID 36559036).

Indication 2: Severe Diarrhea and Flushing With Metastatic Carcinoid Tumors

The second label indication is symptomatic. Metastatic carcinoid tumors, a subset of neuroendocrine tumors, can release vasoactive substances that produce flushing and secretory diarrhea, the picture commonly called carcinoid syndrome. The immediate-release label covers severe diarrhea and flushing episodes associated with metastatic carcinoid tumors; the depot label covers long-term treatment of the same symptoms. The labeled claim is symptom control, not tumor shrinkage.

Evidence on octreotide and neuroendocrine tumor biology has accumulated beyond the symptomatic claim. A post hoc analysis of the placebo arm of the RADIANT-2 trial examined octreotide long-acting repeatable in patients with advanced neuroendocrine tumors and reported progression-free survival outcomes in that arm, where patients received octreotide LAR plus placebo (PMID 26373569). Receptor-level work helps explain why the drug acts in these tumors at all: neuroendocrine tumor cells frequently overexpress somatostatin receptors, and researchers have mapped how analog binding to those receptors drives both inhibition of hormone secretion and internalisation of the receptor complex (PMID 24183675).

Indication 3: Profuse Watery Diarrhea With VIP-Secreting Tumors

The third indication covers profuse watery diarrhea associated with vasoactive intestinal peptide secreting tumors. VIPomas are rare pancreatic neuroendocrine tumors that cause large volume secretory diarrhea with electrolyte loss. As with carcinoid syndrome, the labeled benefit is control of the secretory syndrome. The immediate-release product carries the indication, and the depot product carries the long-term treatment version of it.

Regulatory History of the Indications

1. 1988: The US Food and Drug Administration approved octreotide acetate injection (Sandostatin), the first somatostatin analog marketed in the United States, carrying the acromegaly, carcinoid symptom and VIPoma diarrhea indications.
2. 1998: The long-acting release depot suspension was approved, extending the same three indication areas to monthly intramuscular maintenance therapy rather than multiple daily subcutaneous injections. A review of octreotide in acromegaly described this shift from short-acting to depot delivery and its role in long-term biochemical control (PMID 30754185).
3. 2000s onward: Generic octreotide acetate injection products and additional branded presentations, including prefilled pen devices, were approved with labeling that follows the originator indications.
4. 2020: Oral octreotide delayed-release capsules were approved for long-term maintenance treatment in acromegaly in patients who had responded to and tolerated injectable octreotide or lanreotide, the first oral somatostatin receptor ligand indication. A systematic review of oral somatostatin receptor ligands in acromegaly reported on biochemical response in this maintenance setting (PMID 39598481).

Labels are revised periodically, and indication wording, warnings and populations can change between revisions. The authoritative text for any product is the current FDA-approved prescribing information for that exact product and manufacturer.

Radiolabeled Somatostatin Analogs Are Separate Approved Products

Searches for octreotide often surface nuclear medicine agents. These are distinct products with their own labels, not the octreotide acetate therapeutic formulations. A practical review of lutetium-177 DOTATATE described peptide receptor radionuclide therapy for somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors, including patient selection and radiation safety considerations (PMID 35717045). On the diagnostic side, researchers evaluated 99mTc-HYNIC octreotide scintigraphy in children with neuroblastoma and reported on its performance for detecting somatostatin receptor expressing lesions (PMID 19039561). Imaging and radioligand therapy indications belong to those specific radiopharmaceuticals.

Uses Studied in the Literature That Are Not Approved Indications

One short note for completeness, and none of the following is an approved use of octreotide: researchers have studied octreotide in gastrointestinal angiodysplasia-related bleeding, where the multicenter randomized OCEAN trial compared octreotide with standard of care in patients with transfusion-dependent angiodysplasia bleeding and reported on transfusion and iron requirements (PMID 38158089), with narrative reviews covering the same question in small bowel bleeding (PMID 36159407) and in pharmacological therapy for gastrointestinal angiodysplasia (PMID 41538904); a review examined octreotide in the management of post-esophagectomy chylothorax (PMID 38391198); and preclinical chemistry work described an octreotide-periplocymarin conjugate prodrug evaluated in vitro and in vivo for tumor targeting (PMID 27861145). These remain research or off-label contexts, and decisions about them rest with a treating physician.

Tolerability: What Studies Report

Adverse reactions for each octreotide product are listed in that product's prescribing information, which is the appropriate reference for a complete safety profile. In the published literature, a review of octreotide in acromegaly summarised the efficacy and tolerability data behind the acromegaly indication, including the safety considerations associated with long-term somatostatin analog therapy (PMID 30754185). The randomized OCEAN trial in angiodysplasia-related bleeding reported safety alongside efficacy outcomes for octreotide compared with standard of care (PMID 38158089), and the systematic review of oral somatostatin receptor ligands in acromegaly reported tolerability alongside biochemical response in patients maintained on oral therapy (PMID 39598481). Individual risk depends on the condition, the formulation and other medicines, which is a conversation for a prescribing clinician.

How to Read an Indication

• The indication names a population, not just a disease. The acromegaly indications specify prior surgery, radiotherapy or drug therapy status, and the oral capsule indication specifies prior response to and tolerance of injectable therapy.
• Symptom indications are not tumor indications. The carcinoid and VIPoma indications address diarrhea and flushing, while antitumor questions have been studied separately, for example in the RADIANT-2 placebo arm analysis of octreotide LAR in advanced neuroendocrine tumors (PMID 26373569).
• Formulation matters. Immediate-release injection, depot suspension and oral capsule products carry different indication wording even though the active ingredient is the same.
• The current label wins. Any summary, including this page, lags behind label revisions.

Questions Better Directed to a Prescribing Clinician

Whether an approved indication fits a particular person, which formulation a specialist would consider, how monitoring is handled, and how octreotide interacts with other treatments are all clinical judgments made by a licensed physician with access to the full medical record. This page does not substitute for that assessment.

References

• Octreotide for acromegaly (Expert Review of Endocrinology & Metabolism, 2007)
• Illuminating somatostatin analog action at neuroendocrine tumor receptors (Trends in Pharmacological Sciences, 2013)
• Efficacy of octreotide long-acting repeatable in neuroendocrine tumors: RADIANT-2 placebo arm post hoc analysis (Endocrine-Related Cancer, 2015)
• Advances in the Oral Administration of Somatostatin Receptor Ligands in Acromegaly: A Systematic Review Focusing on Biochemical Response (Pharmaceutics, 2024)
• Gastrointestinal Permeation Enhancers for the Development of Oral Peptide Pharmaceuticals (Pharmaceuticals, 2022)
• Lutetium-177 DOTATATE: A Practical Review (Practical Radiation Oncology, 2022)
• 99mTc-HYNIC octreotide in neuroblastoma (Annals of Nuclear Medicine, 2008)
• Standard of Care Versus Octreotide in Angiodysplasia-Related Bleeding (the OCEAN Study): A Multicenter Randomized Controlled Trial (Gastroenterology, 2024)
• Role of octreotide in small bowel bleeding (World Journal of Clinical Cases, 2022)
• Pharmacological therapy for gastrointestinal angiodysplasia (Medicina Clinica, 2026)
• Octreotide's role in the management of post-esophagectomy chylothorax (Diseases of the Esophagus, 2024)
• Octreotide-periplocymarin conjugate prodrug for improving targetability and anti-tumor efficiency (Oncotarget, 2016)