Summary
Octreotide is an eight amino acid somatostatin analog, a lab-made version of the hormone that switches off growth hormone and many gut hormones, that has been FDA approved since 1988 to control growth hormone excess in acromegaly and the flushing and diarrhea of carcinoid and VIPoma syndromes, which are caused by hormone-producing tumors. It normalizes growth hormone or IGF-1 in roughly half to two thirds of acromegaly patients, and in the PROMID trial it lengthened time to tumor progression (growth) in metastatic midgut neuroendocrine tumors, hormone-producing small bowel tumors that have spread, from 6.0 to 14.3 months (hazard ratio 0.34). It is available as short acting injection, monthly depot (slow release injection), and an oral capsule, all by prescription.
What is Octreotide?
Octreotide is a synthetic cyclic octapeptide analog of somatostatin (somatostatin receptor 2 and 5 agonist). It is also known as Sandostatin, Sandostatin LAR, Mycapssa, Bynfezia Pen, SMS 201-995, Octreotide acetate.
How does it work?
Octreotide binds somatostatin receptors, most strongly subtypes 2 and 5, on pituitary somatotrophs, neuroendocrine tumor cells, and gut endocrine cells. Receptor activation lowers cyclic AMP and calcium influx, suppressing secretion of growth hormone, glucagon, insulin, gastrin, VIP, serotonin, and other gut peptides, and slows tumor cell proliferation through phosphatase activation. Its half life of about 100 minutes is far longer than native somatostatin's 2 to 3 minutes.
| Cluster | Other peptides |
|---|---|
| Routes | Subcutaneous injection two to four times daily (Sandostatin, Bynfezia); Intramuscular depot every 4 weeks (Sandostatin LAR); Oral delayed release capsule (Mycapssa); Intravenous infusion (hospital use, for example variceal bleeding off label) |
| Conditions studied | Acromegaly |
| Record | v3, draft, verified Sep 23, 2026 |
FDA-approved uses of Octreotide
Yes, since 1988. The Sandostatin label covers acromegaly (excess growth hormone in adults) when surgery, pituitary irradiation, and bromocriptine have not worked or cannot be used, the severe diarrhea and flushing of metastatic carcinoid tumors (hormone-producing tumors that have spread), and the watery diarrhea of VIP secreting tumors (VIPomas). The monthly Sandostatin LAR Depot covers the same three uses in patients who responded to the injection, and the oral capsule Mycapssa covers acromegaly maintenance. The label notes that effects on tumor size were not shown in its trials. Generics exist; it is prescription only. [4] [6] [7]
What does the evidence say about Octreotide?
Decades of trials. A 2005 meta-analysis of long acting somatostatin analog trials in acromegaly found octreotide LAR normalized growth hormone in about 57% and IGF-1 in about 67% of patients, better in patients preselected as responders. PROMID (n = 85) was the first placebo controlled RCT showing antiproliferative effect in neuroendocrine tumors: median time to progression 14.3 versus 6.0 months, hazard ratio 0.34 (95% CI 0.20 to 0.59). Symptom control in carcinoid syndrome is supported by the original approval trials summarized in the 1996 NEJM review.
| Evidence type | Indexed studies | Participants (human) |
|---|---|---|
| Human randomized trials | 2 | 85 |
| Human observational studies | 1 | n/a |
| Animal studies | 0 | n/a |
| All indexed studies | 3 | 85 |
Human evidence
Freda 2005: meta-analysis of 44 studies of long acting somatostatin analogs in acromegaly; octreotide LAR achieved growth hormone control in about 57% and IGF-1 normalization in about 67% of patients overall. Rinke 2009 (PROMID): 85 treatment naive patients with metastatic well differentiated midgut neuroendocrine tumors randomized to octreotide LAR 30 mg monthly or placebo; median time to tumor progression 14.3 versus 6.0 months, hazard ratio 0.34; stable disease at 6 months in 66.7% versus 37.2%. Lamberts 1996 reviews the controlled trials that established symptom control of carcinoid syndrome flushing and diarrhea.
Animal evidence
Rodent and cell studies established receptor subtype selectivity, inhibition of hormone secretion, and antiproliferative signaling through somatostatin receptor 2. Animal toxicology showed no carcinogenicity signal relevant to the approved doses.
Key studies
| Study | Design and population | Outcome | Grade |
|---|---|---|---|
| Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group2009 PMID 19704057 | Randomized, double blind, placebo controlled trialn = 85 Treatment naive adults with metastatic well differentiated midgut neuroendocrine tumors | Median time to tumor progression 14.3 versus 6.0 months (hazard ratio 0.34, 95% CI 0.20 to 0.59); stable disease at 6 months 66.7% versus 37.2% | Evidence: Human RCT evidence |
| Long-acting somatostatin analog therapy of acromegaly: a meta-analysis2005 PMID 15886238 | Meta-analysis of 44 studiesAdults with acromegaly treated with octreotide LAR or lanreotide | Octreotide LAR normalized growth hormone in about 57% and IGF-1 in about 67% of patients; higher in preselected responders | Evidence: Human observational evidence |
| Octreotide1996 PMID 8532003 | Narrative reviewClinical trials in acromegaly, carcinoid syndrome, VIPoma, and other endocrine tumors | Summarizes symptom control, hormone suppression, and side effects (gallstones, gastrointestinal effects) across the approval era trials | Evidence: Human RCT evidence |
Conditions studied
| Condition | Grade | Note |
|---|---|---|
| Acromegaly | Evidence: Human RCT evidence | FDA approved for acromegaly as a daily injection, a monthly LAR depot, and oral capsules; gallstones and gastrointestinal effects are common. |
Is Octreotide legal in the United States?
FDA and compounding status
FDA approved as Sandostatin injection in 1988 (acromegaly, carcinoid tumors, VIPomas), Sandostatin LAR depot in 1998, Bynfezia Pen in 2020, and Mycapssa oral capsules in 2020 for acromegaly. Generic octreotide injection and generic depot products are available. Compounding is limited to patient specific needs because approved products exist.
WADA status
Not WADA prohibited. Not named on the current prohibited list. Athletes should still confirm against the list in force for their season.
Regulatory timeline
No regulatory events recorded.
Octreotide dose on the FDA label
Doses below are quoted from the FDA label for its approved uses, plus the doses used in the pivotal trials where noted. The prescriber sets the dose; PeptideAgent does not recommend doses or protocols.
FDA labels (DailyMed). Sandostatin injection, subcutaneous or intravenous: acromegaly, 50 mcg three times daily for the first 2 weeks, most commonly 100 mcg three times daily for maintenance, up to 500 mcg three times daily; carcinoid tumors, 100 to 600 mcg a day in two to four divided doses for the first 2 weeks; VIPomas, 200 to 300 mcg a day in two to four divided doses for the first 2 weeks. Sandostatin LAR Depot, intragluteal every 4 weeks in patients who responded to and tolerated the injection: acromegaly, 20 mg every 4 weeks for 3 months, then adjusted between 10 and 40 mg; carcinoid tumors and VIPomas, 20 mg every 4 weeks for 2 months, then adjusted; 10 mg starting dose on dialysis or with cirrhosis. Mycapssa capsules, acromegaly maintenance after response to octreotide or lanreotide: 20 mg twice daily on an empty stomach, increased in 20 mg steps to a maximum of 80 mg a day.
Routes reported
| # | Route |
|---|---|
| 1 | Subcutaneous injection two to four times daily (Sandostatin, Bynfezia) |
| 2 | Intramuscular depot every 4 weeks (Sandostatin LAR) |
| 3 | Oral delayed release capsule (Mycapssa) |
| 4 | Intravenous infusion (hospital use, for example variceal bleeding off label) |
What are the side effects and interactions of Octreotide?
Side effects
| # | Reported side effect |
|---|---|
| 1 | Diarrhea, nausea, abdominal pain, and steatorrhea (up to 30 to 60% in acromegaly trials, usually easing over weeks) |
| 2 | Gallstones or biliary sludge (reported in up to about half of patients on long term treatment, mostly asymptomatic) |
| 3 | Hyperglycemia or hypoglycemia from suppressed insulin and glucagon |
| 4 | Bradycardia and conduction abnormalities |
| 5 | Hypothyroidism with long term use |
| 6 | Injection site pain (depot) |
| 7 | Vitamin B12 deficiency with prolonged use |
Interactions
| # | Interaction |
|---|---|
| 1 | Insulin and oral antidiabetic drugs: octreotide alters glucose regulation and doses may need adjustment |
| 2 | Cyclosporine: octreotide reduces cyclosporine absorption |
| 3 | Beta blockers and calcium channel blockers: additive bradycardia |
| 4 | Bromocriptine: octreotide increases bromocriptine bioavailability |
| 5 | Drugs metabolized by CYP3A4 with a narrow therapeutic index: octreotide may slow their clearance |
| 6 | Lutetium Lu 177 dotatate: the Sandostatin label says to stop short acting octreotide at least 24 hours before each dose |
Contraindications
| # | Contraindication |
|---|---|
| 1 | Hypersensitivity to octreotide |
| 2 | Use with caution in diabetes, gallbladder disease, cardiac conduction disease, and hypothyroidism |
| 3 | Pregnancy: limited data, use only if clearly needed |
How do people access Octreotide legally?
Typical cost: Generic subcutaneous octreotide runs roughly 200 to 800 USD per month at cash prices depending on dose. Sandostatin LAR lists at roughly 4,000 to 8,000 USD per monthly injection, with generic depot products somewhat lower. Insurance and Medicare Part B or D typically cover it for approved indications.
Verified access options
Step 1
Prescription from an endocrinologist, oncologist, or gastroenterologist filled at a specialty pharmacy, or administered in clinic for the depot.
Step 2
Not available through compounding or telehealth peptide clinics.
Access paths are verified against public regulatory records and prescriber licensing. We never list unlicensed vendors.
Compare Octreotide
Frequently asked questions
Does octreotide work for acromegaly?
For most patients, partly or fully. A 2005 meta-analysis of long acting somatostatin analog trials found octreotide LAR normalized growth hormone in about 57% of patients and IGF-1 in about 67%, with higher rates in patients known to respond to short acting octreotide. Tumor shrinkage occurs in a subset. [2] [3]
Does octreotide slow neuroendocrine tumors?
Yes for midgut tumors. In the PROMID trial, 85 patients with metastatic well differentiated midgut neuroendocrine tumors were randomized to octreotide LAR 30 mg monthly or placebo; median time to progression was 14.3 versus 6.0 months (hazard ratio 0.34), and 66.7% versus 37.2% had stable disease at 6 months. Overall survival did not differ, partly because placebo patients crossed over. [1]
What are the side effects of octreotide?
Gastrointestinal effects dominate early: loose stools, nausea, cramping, and fatty stools. Gallstones or sludge develop in a large share of long term users, usually without symptoms. Blood sugar can go up or down, heart rate can slow, and thyroid function can fall over time. The depot causes injection site pain. [3] [4]
What is the octreotide (Sandostatin) dose on the FDA label?
Acromegaly starts at 50 mcg under the skin three times daily, usually maintained at 100 mcg three times daily and up to 500 mcg three times daily. Carcinoid tumors start at 100 to 600 mcg a day and VIPomas at 200 to 300 mcg a day, in two to four divided doses. Responders can switch to Sandostatin LAR Depot, 20 mg into the buttock every 4 weeks and then adjusted (10 to 40 mg in acromegaly). Mycapssa capsules start at 20 mg twice daily, up to 80 mg a day. [4] [6] [7]
How much does octreotide cost?
Generic subcutaneous vials cost roughly 200 to 800 USD per month at cash prices. The monthly depot lists at roughly 4,000 to 8,000 USD per injection, with generic depots lower. Insurance, including Medicare, generally covers it for approved diagnoses. Prices were checked on the last verified date. [4]
Is octreotide banned by WADA?
No. Somatostatin analogs are not on the WADA Prohibited List. Because octreotide suppresses growth hormone it has no doping rationale; athletes should still confirm with their anti-doping organization. [5]
Octreotide vs lanreotide: what is the difference?
Both are somatostatin analogs with similar receptor profiles, efficacy in acromegaly, and side effects. Octreotide comes in short acting, depot, and oral forms; lanreotide is a deep subcutaneous depot given every 4 weeks (or every 6 to 8 weeks in stable acromegaly) that patients can self inject. Lanreotide has the larger antiproliferative trial (CLARINET, pancreatic and intestinal tumors); octreotide's PROMID trial covered midgut tumors only. [1] [2]
Decisions about starting, stopping, or combining any treatment belong with a licensed clinician who knows your history.
Sources
Numbered citations above point to these primary sources. PubMed entries link to the indexed abstract.
- [1]Rinke A et al. Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors (PROMID). J Clin Oncol 2009PubMed 19704057, 2009
- [2]Freda PU et al. Long-acting somatostatin analog therapy of acromegaly: a meta-analysis. J Clin Endocrinol Metab 2005PubMed 15886238, 2005
- [3]Lamberts SW et al. Octreotide. N Engl J Med 1996PubMed 8532003, 1996
- [4]FDA prescribing information for Sandostatin (octreotide acetate) injection, via DailyMedFDA, 2026
- [5]WADA Prohibited ListWADA, 2026
- [6]FDA prescribing information for Sandostatin LAR Depot (octreotide acetate), via DailyMedFDA, 2025
- [7]FDA prescribing information for Mycapssa (octreotide) delayed-release capsules, via DailyMedFDA, 2025
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<a href="https://peptideagent.ai/peptides/octreotide">Octreotide: evidence, legality, and access</a>, PeptideAgent, updated September 23, 2026.