Octreotide
Also sold as: Sandostatin, Sandostatin LAR Depot, Mycapssa, Bynfezia Pen, octreotide acetate
Octreotide is an FDA-approved synthetic somatostatin analogue, approved under four new drug applications — Sandostatin Injection (NDA 019667), Sandostatin LAR Depot (NDA 021008), Mycapssa delayed-release oral capsules (NDA 208232) and Bynfezia Pen (NDA 213224) — plus thirteen generic octreotide acetate ANDAs listed in Drugs@FDA. The approved indications are narrow and product-specific: acromegaly after inadequate response to surgery, pituitary irradiation and bromocriptine; severe diarrhea and flushing episodes associated with metastatic carcinoid tumors; and profuse watery diarrhea associated with VIPomas — with Sandostatin LAR Depot and Mycapssa approved only as maintenance in patients who already responded to another somatostatin analogue. The Sandostatin Injection label states its own limitation verbatim: 'Improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials performed with Sandostatin Injection; these trials were not optimally designed to detect such effects.' The same label reports a 63% incidence of biliary tract abnormalities in clinical trials. Octreotide appears in none of Categories 1, 2 or 3 of FDA's 503A bulk drug substances list updated 2026-05-14.
Which molecule this is. A synthetic somatostatin analogue. The Sandostatin Injection label describes octreotide as 'a cyclic octapeptide' and 'a long-acting octapeptide with pharmacologic actions mimicking those of the natural hormone somatostatin', giving its molecular weight as 1019.3 g/mol for the free peptide, C49H66N10O10S2. Every FDA-approved octreotide product contains the ACETATE SALT. The disambiguation that matters here is not sequence — all four applications are the same molecule — it is PRODUCT. Sandostatin Injection is a subcutaneous or intravenous solution; Sandostatin LAR Depot is a long-acting injectable suspension; Mycapssa is a delayed-release oral capsule; Bynfezia Pen is a subcutaneous solution in a pen. Their labels are not interchangeable, and two of them are approved only as maintenance in patients who have already responded to something else. 'Octreotide' does not identify a product.
FDA status
FDA has approved this as a drug. Approval is always for a specific indication and a specific population — check which one, because it is frequently not the use it is marketed for.
FDA-approved, and unusually well-populated: Drugs@FDA returns four NDAs and thirteen ANDAs for octreotide. Verified 2026-08-02 by querying openFDA `drug/drugsfda` on `openfda.generic_name:"octreotide"` (17 applications) and cross-checking `products.active_ingredients.name`. The four NDAs, with the original approval action Drugs@FDA records for each: NDA 019667 SANDOSTATIN, Novartis, 1988-10-21, priority review, Type 1 New Molecular Entity; NDA 021008 SANDOSTATIN LAR DEPOT, Novartis, 1998-11-25; NDA 208232 MYCAPSSA, Chiesi, 2020-06-26; NDA 213224 BYNFEZIA PEN, Sun Pharmaceutical, 2024-09-27 (read the fdaFindings entry on this one — the date is not the whole story). Marketing status is per-product, not per-molecule: two Sandostatin Injection strengths are listed Discontinued, each carrying the Drugs@FDA annotation 'Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons', while three remain Prescription. The franchise is marketed. Approval is always for a specific indication and population — read the approval record below, and read the Limitations of Use under fdaFindings, which are in the label itself.
“Sandostatin Injection is a somatostatin analogue indicated: Acromegaly: To reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses.”Checked against the source on .
Evidence
Efficacy established by adequate, well-controlled trials in humans.
Administration check RUN, not assumed. OPTIMAL (NCT03252353) was opened and read on 2026-08-02: intervention type DRUG, octreotide capsules administered orally versus matching placebo capsules, Phase 3, randomised, parallel-assignment, triple-masked (participant, care provider, investigator), enrolment 56 ACTUAL, lead sponsor Chiasma, Inc., primary completion 2019-06-13 ACTUAL, hasResults true. Octreotide was ADMINISTERED to humans — it was not measured as an endogenous biomarker, which is the trap that reduces MOTS-c and TB-500 from an apparent five human RCTs to an actual zero. The trial is described independently in section 14 of the FDA-approved MYCAPSSA label, which reports that in this 9-month randomised, double-blind, placebo-controlled study of 56 patients with acromegaly, 58% of patients treated with MYCAPSSA versus 19% of patients treated with placebo maintained the biochemical response defined as IGF-1 at or below the upper limit of normal at the end of treatment, and that 25% of patients treated with MYCAPSSA required discontinuation and treatment with other somatostatin analogs at some point during the study. The SANDOSTATIN LAR DEPOT label additionally describes three acromegaly trials — two enrolling 101 patients in total and a third 12-month study enrolling 151 — and a 6-month trial in 93 patients with malignant carcinoid syndrome. Those trials also administered the drug. SCOPE, and it is narrow. This tier attaches to the approved products and the approved endpoints, which are biochemical and symptomatic. It does NOT extend to tumour outcomes: the Sandostatin Injection label states that improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in its clinical trials, and the LAR label states the effect on tumor size, rate of growth and development of metastases has not been determined in carcinoid syndrome and VIPomas. Both statements are recorded verbatim under fdaFindings. A tier label is coarse; this is where it is true.
What FDA actually approved
- Application
- NDA 019667 (Sandostatin Injection); NDA 021008 (Sandostatin LAR Depot); NDA 208232 (Mycapssa delayed-release capsules); NDA 213224 (Bynfezia Pen) — Sandostatin, Sandostatin LAR Depot, Mycapssa, Bynfezia Pen
- Approved indication
- SANDOSTATIN INJECTION (NDA 019667) — 1.1 Acromegaly: Sandostatin Injection is indicated to reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. 1.2 Carcinoid Tumors: Sandostatin Injection is indicated for treatment of severe diarrhea and flushing episodes associated with metastatic carcinoid tumors. 1.3 Vasoactive Intestinal Peptide Tumors: Sandostatin Injection is indicated for the treatment of the profuse watery diarrhea associated with vasoactive intestinal peptide tumors (VIPomas)-secreting tumors. 1.4 Important Limitations of Use: Improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials performed with Sandostatin Injection; these trials were not optimally designed to detect such effects. — SANDOSTATIN LAR DEPOT (NDA 021008): SANDOSTATIN LAR DEPOT 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with Sandostatin Injection has been shown to be effective and tolerated. 1.1 Acromegaly: Long-term maintenance therapy in acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy, is not an option. 1.2 Carcinoid Tumors: Long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors. 1.3 Vasoactive Intestinal Peptide Tumors (VIPomas): Long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors. — MYCAPSSA (NDA 208232): MYCAPSSA is indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. — BYNFEZIA PEN (NDA 213224): BYNFEZIA PEN is a somatostatin analogue indicated: Acromegaly: To reduce blood levels of growth hormone (GH) and insulin growth factor 1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. Carcinoid Tumors: For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. Vasoactive Intestinal Peptide Tumors (VIPomas): For the treatment of profuse watery diarrhea associated with VIP-secreting tumors.
Verbatim from four labels, read separately on 2026-08-02; the `source` field can only carry one, so each of the other three is cited against its own document under fdaFindings. Four things are worth reading precisely. (1) The Sandostatin Injection acromegaly indication is SECOND-LINE on its face — it is confined to patients 'who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses'. (2) Sandostatin LAR Depot and Mycapssa are MAINTENANCE products: LAR is indicated in patients in whom initial treatment with Sandostatin Injection has been shown effective and tolerated, and Mycapssa in patients who have responded to and tolerated octreotide or lanreotide. Neither label describes a starting point. (3) The approved endpoints are hormonal and symptomatic — reducing GH and IGF-1, suppressing diarrhea and flushing — not tumour outcomes, which the labels expressly exclude. (4) `discontinued` is false for the franchise, but two Sandostatin Injection strengths are individually listed Discontinued in Drugs@FDA, each with the Federal Register annotation that the product was not discontinued or withdrawn for safety or effectiveness reasons. GAP: strengths appear here only where the label's own indication sentence names them as product identification. Nothing in this record states how much to take, how often, or for how long, and the labels' Dosage and Administration sections are deliberately not reproduced. See /editorial-policy.
What FDA found
FDA’s own words. These are the most citable thing on this site, and the least likely to appear anywhere funded by someone selling the compound.
The FDA-approved labeling for Sandostatin Injection carries an Important Limitations of Use section stating that improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials performed with Sandostatin Injection, and that these trials were not optimally designed to detect such effects.
The most useful sentence on this record, and it is in an approved label rather than an enforcement document. Read it precisely, because it can be over-read in both directions. It is NOT a statement that the drug does not work — the approved indications stand, and the label's own clinical studies describe hormonal and symptomatic control. It IS a statement that a specific class of benefit was not demonstrated, together with FDA's reason: the trials were not designed to detect it. Absence of a finding is not a negative finding, and the label says which one this is. This is the same distinction the site draws when FDA declines to reach a question — the difference between 'we looked and it was not there' and 'we did not look'.
SANDOSTATIN (octreotide acetate) injection — Prescribing Information (SPL) — FDA, 22 July 2026“Improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials performed with Sandostatin Injection; these trials were not optimally designed to detect such effects.”
Checked against the source on .The FDA-approved labeling for Sandostatin LAR Depot states that in patients with carcinoid syndrome and VIPomas, the effect of Sandostatin Injection and Sandostatin LAR Depot on tumor size, rate of growth and development of metastases has not been determined.
The second label saying the same thing about the same gap, which is why it is recorded separately rather than folded into a note on the first. A claim about two labels needs two labels. Note the scope difference: this one is confined to carcinoid syndrome and VIPomas, and it names three distinct undetermined endpoints — size, growth rate and development of metastases. Section 14 of the same label separately reports median reductions in tumour volume in two open-label studies in previously untreated acromegalic patients, which is a different disease, a different endpoint and an uncontrolled design. Those two facts are not in conflict; conflating them would be the error.
SANDOSTATIN LAR DEPOT (octreotide acetate) for injectable suspension — Prescribing Information (SPL) — FDA, 22 December 2025“In patients with carcinoid syndrome and VIPomas, the effect of Sandostatin Injection and SANDOSTATIN LAR DEPOT on tumor size, rate of growth and development of metastases, has not been determined.”
Checked against the source on .Sandostatin LAR Depot is not approved as an initial treatment. Its FDA-approved labeling indicates it in patients in whom initial treatment with Sandostatin Injection has been shown to be effective and tolerated.
Recorded because product-level gating is invisible if you only know the molecule. Both of the convenience formulations are downstream products by label design — this one requires prior response to the subcutaneous injection, and Mycapssa requires prior response to octreotide or lanreotide. The label's clinical trials match that design: they were performed in patients who had already been receiving Sandostatin Injection.
SANDOSTATIN LAR DEPOT (octreotide acetate) for injectable suspension — Prescribing Information (SPL) — FDA, 22 December 2025“SANDOSTATIN LAR DEPOT 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with Sandostatin Injection has been shown to be effective and tolerated.”
Checked against the source on .Mycapssa, the oral delayed-release octreotide capsule, is approved only for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. Its labeling carries no carcinoid or VIPoma indication.
The narrowest approval of the four, and the one most likely to be over-read as 'oral octreotide is approved'. It is approved for one disease, in one population, defined by prior response to an injectable somatostatin analogue. The injectable products carry three indications; this one carries a fragment of the first. Same molecule, materially different label.
MYCAPSSA (octreotide) delayed-release capsules, for oral use — Prescribing Information (SPL) — FDA, 24 July 2025“MYCAPSSA is indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.”
Checked against the source on .Octreotide appears in none of Categories 1, 2 or 3 of FDA's list of bulk drug substances nominated for use in compounding under section 503A, updated 2026-05-14.
Recorded to close a misreading, not to assert a status — which is why this record has no `compoundingStatus` field at all. Verified by downloading the document with a browser user-agent and text-extracting it locally on 2026-08-02: 'octreotide' returns 0 hits and 'somatostatin' returns 0 hits. This absence means something entirely different from BPC-157's absence. BPC-157 was nominated and left Category 2 when the nominators withdrew. Octreotide was never in this system: a 503A bulks nomination is a route for substances WITHOUT an approved product, and octreotide has seventeen approved applications. Categorical silence here is neither permission nor a safety finding, and it says nothing at all about what a pharmacy may lawfully do with an approved octreotide drug product. SCOPE LIMIT: this record makes no claim about the separate 503B bulks list. That document was not read for this compound, and a blank is honest.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026Checked against the source on .FDA's approval letter for Bynfezia Pen (NDA 213224), filed in the 2024 approval-letter directory, acknowledges receipt of an amendment dated March 29, 2024 that constituted a complete response to FDA's May 19, 2021 action letter, and approves the application for the acromegaly, carcinoid tumor and VIPoma indications.
A deliberate wrinkle, recorded rather than smoothed over. Drugs@FDA lists the ORIG approval action for NDA 213224 as 2024-09-27 with submission class 'Type 5 - New Formulation or New Manufacturer'. But accessdata.fda.gov also serves an approval letter for the same submission (213224Orig1s000ltr.pdf) under the 2020 directory, referring to the same application dated and received March 28, 2019 and to a January 28, 2020 final printed labeling submission. Both PDFs were downloaded and text-extracted on 2026-08-02. The 2024 letter's reference to a complete response to a May 19, 2021 action letter is what makes the sequence non-obvious. This record therefore does NOT state a single clean 'Bynfezia was approved in year X' — it states what each document says. Anyone needing the definitive approval history should read both letters and the Drugs@FDA submission table rather than trust a one-line date.
NDA 213224 Approval Letter — Bynfezia Pen (octreotide acetate) injection, for subcutaneous use — FDA, 27 September 2024“We acknowledge receipt of your amendment dated March 29, 2024, which constituted a complete response to our May 19, 2021, action letter.”
Checked against the source on .Drugs@FDA lists seventeen applications with the generic name octreotide: four NDAs — Sandostatin (NDA 019667), Sandostatin LAR Depot (NDA 021008), Mycapssa (NDA 208232) and Bynfezia Pen (NDA 213224) — and thirteen abbreviated new drug applications for generic octreotide acetate, from sponsors including Fresenius Kabi, Meitheal, Hikma/West-Ward, Heritage, Mylan, Teva, Gland and Sun.
Recorded because the count is the answer to a question people actually ask — whether generic octreotide exists — and because it is the field-query check this library once got wrong on sermorelin. The query above searches `openfda.generic_name`; `products.active_ingredients.name` was checked as well and agrees. Marketing status varies application by application and product by product within an application; a listed ANDA is not by itself evidence that a given presentation is currently marketed.
Drugs@FDA — applications with generic name octreotide (openFDA drug/drugsfda) — FDA, 31 July 2026Checked against the source on .
Documented safety signals
Cholelithiasis and complications of cholelithiasis. The Sandostatin Injection label states the drug may inhibit gallbladder contractility and decrease bile secretion, which may lead to gallbladder abnormalities or sludge, and that acute cholecystitis, ascending cholangitis, biliary obstruction, cholestatic hepatitis or pancreatitis have been reported with therapy. In clinical trials, primarily in patients with acromegaly or psoriasis, the incidence of biliary tract abnormalities was 63% — 27% gallstones, 24% sludge without stones and 12% biliary duct dilatation. One patient developed ascending cholangitis during therapy and died.
The dominant safety signal on this molecule and the one with a real denominator behind it — a trial population, not a spontaneous-report count. The label also reports that the incidence of stones or sludge in patients who received Sandostatin Injection for 12 months or longer was 52%, and that fewer than 2% of patients treated for one month or less developed gallstones, so exposure duration is doing most of the work. The same warning appears in the Sandostatin LAR Depot and Mycapssa labels, both of which note postmarketing reports of cholelithiasis resulting in complications including cholecystitis, cholangitis, pancreatitis and requiring cholecystectomy.
SANDOSTATIN (octreotide acetate) injection — Prescribing Information (SPL) — FDA, 22 July 2026“In clinical trials (primarily patients with acromegaly or psoriasis), the incidence of biliary tract abnormalities was 63% (27% gallstones, 24% sludge without stones, 12% biliary duct dilatation).”
Checked against the source on .Cardiac function abnormalities. The Sandostatin Injection label states that patients receiving the drug intravenously may be at increased risk for higher degree atrioventricular blocks, and that complete atrioventricular block was reported in postmarketing reports in patients receiving it intravenously during surgical procedures. In acromegalic patients, the label reports bradycardia developed in 25%, conduction abnormalities occurred in 10% and arrhythmias occurred in 9% during therapy.
Route-dependent, which is the part that gets lost. The label states that in the majority of the complete-AV-block reports the drug was given at higher than recommended amounts and/or as a continuous intravenous infusion, and adds that the safety of continuous intravenous infusion has not been established for the approved indications. It also records QT prolongation, axis shifts, early repolarization, low voltage, R/S transition and early R-wave progression among observed ECG changes, while noting these changes are not uncommon in acromegalic patients — a confounder the label names itself. One acromegalic patient with severe congestive heart failure worsened on initiation and improved on discontinuation, confirmed by a positive rechallenge.
SANDOSTATIN (octreotide acetate) injection — Prescribing Information (SPL) — FDA, 22 July 2026“Patients who receive Sandostatin Injection intravenously may be at increased risk for higher degree atrioventricular blocks. In postmarketing reports, complete atrioventricular block was reported in patients receiving IV Sandostatin Injection during surgical procedures.”
Checked against the source on .Hyperglycemia and hypoglycemia. The Sandostatin Injection label states the drug alters the balance between the counter-regulatory hormones insulin, glucagon and growth hormone, which may result in hypoglycemia or hyperglycemia, and that this may result in overt diabetes mellitus. Hypoglycemia and hyperglycemia occurred in 3% and 16% of acromegalic patients respectively. Severe hyperglycemia, subsequent pneumonia and death following initiation of therapy was reported in one patient with no history of hyperglycemia.
Recorded with the fatality because the label records it, and because the patient had no prior history — the risk is not confined to people already known to be dysglycaemic. The Mycapssa label reports the corresponding rates from its own trials as increased blood glucose 7%, hypoglycemia 4% and diabetes mellitus 1%. Different products, different populations, different trials; the numbers are not comparable and are recorded as what each label says rather than merged.
SANDOSTATIN (octreotide acetate) injection — Prescribing Information (SPL) — FDA, 22 July 2026“Severe hyperglycemia, subsequent pneumonia, and death following initiation of Sandostatin Injection therapy was reported in one patient with no history of hyperglycemia.”
Checked against the source on .Thyroid function abnormalities. The Sandostatin Injection label states that octreotide suppresses secretion of thyroid stimulating hormone, which may result in hypothyroidism, and recommends baseline and periodic assessment of thyroid function during chronic therapy. In acromegalic patients the label reports biochemical hypothyroidism alone in 12%, goiter in 8%, and 4% requiring initiation of thyroid replacement therapy.
A mechanism-level effect on a second endocrine axis, which is what a somatostatin analogue does — somatostatin inhibits more than growth hormone. The label notes that in patients without acromegaly, hypothyroidism has only been reported in several isolated patients and goiter has not been reported, so the population matters.
SANDOSTATIN (octreotide acetate) injection — Prescribing Information (SPL) — FDA, 22 July 2026“Octreotide suppresses secretion of thyroid stimulating hormone (TSH), which may result in hypothyroidism.”
Checked against the source on .Steatorrhea, malabsorption of dietary fats, and changes in vitamin B12 levels. The Sandostatin Injection label states that somatostatin analogs reversibly inhibit secretion of pancreatic enzymes and bile acids, which may result in malabsorption of dietary fats and subsequent symptoms of steatorrhea, loose stools, abdominal bloating and weight loss, and directs evaluation for potential pancreatic exocrine insufficiency. It also states that depressed vitamin B12 levels and abnormal Schilling's tests have been observed in some patients receiving therapy.
Worth reading because weight loss appears here as an ADVERSE finding attributable to fat malabsorption, not as a benefit. The label frames it as a symptom to be evaluated for pancreatic exocrine insufficiency. The same warning is carried in the Sandostatin LAR Depot and Mycapssa labels, which describe it as a somatostatin-analog class effect.
SANDOSTATIN (octreotide acetate) injection — Prescribing Information (SPL) — FDA, 22 July 2026“Somatostatin analogs reversibly inhibit secretion of pancreatic enzymes and bile acids, which may result in malabsorption of dietary fats and subsequent symptoms of steatorrhea, loose stools, abdominal bloating, and weight loss.”
Checked against the source on .The oral product carries the same class warnings as the injections. The Mycapssa label carries warnings and precautions for cholelithiasis and complications of cholelithiasis, hypoglycemia or hyperglycemia, thyroid function abnormalities, cardiac function abnormalities, steatorrhea and malabsorption of dietary fats, and changes in vitamin B12 levels.
Recorded on its own because the oral route invites the opposite intuition. Mycapssa is a capsule and it carries the same six warning categories as the injectable products. Route of administration is not the risk axis here. The label reports bradycardia 2%, conduction abnormalities 1% and arrhythmias/tachycardia 2% in its own trials, and notes these ECG changes may occur in patients with acromegaly independently.
MYCAPSSA (octreotide) delayed-release capsules, for oral use — Prescribing Information (SPL) — FDA, 24 July 2025“MYCAPSSA may inhibit gallbladder contractility and decrease bile secretion, which may lead to gallbladder abnormalities or sludge.”
Checked against the source on .No FDA-approved octreotide product reviewed for this record carries a boxed warning. The Structured Product Labeling for Sandostatin Injection, Sandostatin LAR Depot, Mycapssa and Bynfezia Pen contains no boxed warning section.
Recorded as an explicit negative so that the absence is a checked fact rather than an oversight. Verified 2026-08-02 by querying the `boxed_warning` field of the openFDA `drug/label` records for all four NDAs: empty in every one. The absence of a boxed warning is not a safety endorsement — the six warnings above are in the same labels — and it is recorded here only because a reader comparing this record with the GLP-1 records will notice the difference and should know it was looked at.
SANDOSTATIN (octreotide acetate) injection — Prescribing Information (SPL) — FDA, 22 July 2026Checked against the source on .
Questions people actually ask
Every answer cites the document behind it. Where the honest answer is “nobody knows”, that is the answer you will get.
- Is octreotide FDA-approved?
Yes. Octreotide is approved under four FDA new drug applications — Sandostatin Injection (NDA 019667), Sandostatin LAR Depot (NDA 021008), Mycapssa delayed-release oral capsules (NDA 208232) and Bynfezia Pen (NDA 213224) — and Drugs@FDA additionally lists thirteen abbreviated new drug applications for generic octreotide acetate, from sponsors including Fresenius Kabi, Meitheal, Hikma/West-Ward, Heritage, Mylan, Teva, Gland and Sun. Drugs@FDA records the original approval action for NDA 019667 as 21 October 1988, under priority review, classified Type 1 — New Molecular Entity. Approval is per application and per product, not per molecule: marketing status varies across the seventeen applications, and two Sandostatin Injection strengths are individually listed as Discontinued, each carrying the Drugs@FDA annotation that the product was not discontinued or withdrawn for safety or effectiveness reasons.
Drugs@FDA — applications with generic name octreotide (openFDA drug/drugsfda) — FDA, 31 July 2026Checked against the source on .- What is octreotide approved to treat?
Three things, and they are narrower than the molecule's reputation. The FDA-approved labeling for Sandostatin Injection indicates it to reduce blood levels of growth hormone and IGF-1 'in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses'; for treatment of severe diarrhea and flushing episodes associated with metastatic carcinoid tumors; and for treatment of the profuse watery diarrhea associated with vasoactive intestinal peptide tumors (VIPomas). Read the gating: the acromegaly indication is written as a second-line one. Anything outside these three indications is off-label use, which is a decision for a licensed prescriber and is not something this label supports.
SANDOSTATIN (octreotide acetate) injection — Prescribing Information (SPL) — FDA, 22 July 2026“Sandostatin Injection is indicated for treatment of severe diarrhea and flushing episodes associated with metastatic carcinoid tumors.”
Checked against the source on .- Does octreotide shrink tumors?
The FDA-approved labeling does not claim it does, and says so explicitly. Sandostatin Injection's label carries an Important Limitations of Use section reading: 'Improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials performed with Sandostatin Injection; these trials were not optimally designed to detect such effects.' The Sandostatin LAR Depot label states separately that in patients with carcinoid syndrome and VIPomas, the effect on tumor size, rate of growth and development of metastases has not been determined. Read the reason FDA gives, because it changes the meaning: these are statements that the question was not adequately studied, not findings that the drug failed. Absence of a finding is not a negative finding. Separately, section 14 of the LAR label reports median reductions in tumour volume in two open-label studies in previously untreated acromegalic patients — a different disease and an uncontrolled design, which is why the Limitations of Use paragraph still stands.
SANDOSTATIN (octreotide acetate) injection — Prescribing Information (SPL) — FDA, 22 July 2026“Improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials performed with Sandostatin Injection; these trials were not optimally designed to detect such effects.”
Checked against the source on .- Is there an oral form of octreotide?
Yes — Mycapssa (NDA 208232) is an FDA-approved delayed-release octreotide capsule for oral use, but its approval is much narrower than the injections'. Its labeling indicates it 'for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide'. It carries no carcinoid indication and no VIPoma indication, and by the terms of the indication it is not a starting treatment — the label describes patients who have already responded to an injectable somatostatin analogue. Its efficacy was established in a 9-month randomised, double-blind, placebo-controlled study of 56 patients with acromegaly (NCT03252353), in which 58% of patients treated with Mycapssa versus 19% of patients treated with placebo maintained the biochemical response defined as IGF-1 at or below the upper limit of normal; 25% of patients treated with Mycapssa required discontinuation and treatment with another somatostatin analog at some point during the study.
MYCAPSSA (octreotide) delayed-release capsules, for oral use — Prescribing Information (SPL) — FDA, 24 July 2025“MYCAPSSA is indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.”
Checked against the source on .- What are the main risks of octreotide?
The FDA-approved labeling's leading concern is the gallbladder. The Sandostatin Injection label states the drug may inhibit gallbladder contractility and decrease bile secretion, which may lead to gallbladder abnormalities or sludge, and reports that in clinical trials — primarily in patients with acromegaly or psoriasis — 'the incidence of biliary tract abnormalities was 63% (27% gallstones, 24% sludge without stones, 12% biliary duct dilatation)', rising to 52% for stones or sludge among patients treated for 12 months or longer. The label also records that one patient developed ascending cholangitis during therapy and died. Beyond the gallbladder, the same label carries warnings for cardiac function abnormalities including complete atrioventricular block reported with intravenous administration during surgical procedures, hyperglycemia and hypoglycemia, thyroid function abnormalities from suppression of thyroid stimulating hormone, steatorrhea and malabsorption of dietary fats, and depressed vitamin B12 levels. No FDA-approved octreotide product reviewed here carries a boxed warning.
SANDOSTATIN (octreotide acetate) injection — Prescribing Information (SPL) — FDA, 22 July 2026“In clinical trials (primarily patients with acromegaly or psoriasis), the incidence of biliary tract abnormalities was 63% (27% gallstones, 24% sludge without stones, 12% biliary duct dilatation).”
Checked against the source on .- Is octreotide on FDA's 503A compounding list?
No. Octreotide appears in none of Categories 1, 2 or 3 of FDA's list of bulk drug substances nominated for use in compounding under section 503A, updated 14 May 2026 — the document was downloaded and text-extracted on 2 August 2026 and returns zero hits for both 'octreotide' and 'somatostatin'. Read what that absence does and does not mean. It is not a safety finding and it is not permission. It also means something different from BPC-157's absence from the same list: BPC-157 was nominated and left Category 2 when the nominators withdrew, whereas a 503A bulks nomination is a route for substances without an approved drug product, and octreotide has seventeen approved applications in Drugs@FDA. That is why this record carries no 503A compounding status at all rather than recording octreotide as 'never nominated' — the list can establish absence, not the reason for it.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026Checked against the source on .