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Lanreotide Injection

Lanreotide Injection is a somatostatin analog used to treat acromegaly, certain gastroenteropancreatic neuroendocrine tumors, and carcinoid syndrome in adults.

Brand names Somatuline DepotSomatuline
Drug class Somatostatin Analog
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 4 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 8, 2026 🚨Recall on record · 2
Lanreotide Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Lanreotide is an injection that mimics the hormone somatostatin to suppress excess hormone release. It is used for acromegaly (too much growth hormone), certain neuroendocrine tumors of the gut and pancreas, and carcinoid syndrome, and it is a specialist mainstay, around since about 2007 and available as a generic. Most people tolerate it well, and loose stools, belly cramps, nausea and a sore lump at the injection site are the usual complaints. The one to watch is gallstones, since it slows the gallbladder, so report severe belly pain, fever or yellowing skin or eyes promptly. Blood sugar can swing either way and heart rate can slow, so expect both to be checked.

Clinical pearls

  • Each dose is a deep injection into the upper outer buttock, usually given in a clinic, alternating left and right sides.
  • If you take a beta-blocker or another heart-rate-slowing drug, tell every prescriber, since lanreotide can slow your pulse further.
  • On insulin or diabetes medicines, check your sugars more often after starting, because doses may need adjusting in either direction.
  • Oily stools, bloating or weight loss can signal poor fat absorption, so report them rather than dismissing them as routine diarrhea.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asInjection
Earliest FDA record2007
Companies listing it with the FDA4
FDA label last updatedSep 1, 2024
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Lanreotide Injection, written from its FDA label.

What Lanreotide Injection is used for

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Lanreotide Injection is approved for three distinct uses in adults:

  • Acromegaly: Long-term treatment for patients whose growth hormone levels remain too high after surgery and/or radiation, or who cannot undergo those treatments. The goal is to bring growth hormone (GH) and IGF-1 levels back to normal.
  • Gastroenteropancreatic neuroendocrine tumors (GEP-NETs): Treatment of adults with unresectable (cannot be surgically removed), well- or moderately-differentiated, locally advanced or metastatic GEP-NETs, to slow tumor progression and improve progression-free survival.
  • Carcinoid syndrome: Treatment of adults with carcinoid syndrome to reduce how frequently short-acting somatostatin analog rescue medications are needed. If a patient is already receiving Lanreotide Injection for GEP-NETs, no additional dose is given for carcinoid syndrome.

How Lanreotide Injection works

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Lanreotide is a synthetic octapeptide — a small protein — that mimics the action of somatostatin, a natural hormone in your body that acts as a brake on many other hormones. It binds with high affinity to somatostatin receptors SSTR2 and SSTR5, which are found on certain cells, including those that produce growth hormone and hormones in neuroendocrine tumors. By activating these receptors, lanreotide suppresses excess growth hormone and IGF-1 (a related growth factor) in acromegaly, and helps slow abnormal hormone secretion in GEP-NETs and carcinoid syndrome.

It also inhibits the secretion of several gut and pancreatic hormones (such as gastrin, glucagon, and pancreatic enzymes) and reduces gallbladder contractions — effects that explain both its therapeutic benefits and some of its side effects.

Lanreotide Injection dosage

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Lanreotide Injection is given by deep subcutaneous injection — a shot under the skin in the upper outer buttock — typically once every 4 weeks. It is intended to be administered by a healthcare provider. The injection site is alternated between the right and left side each time.

  • Acromegaly: Dosing is adjusted over time based on GH and IGF-1 blood levels and symptom control; patients who are well-controlled may be eligible for less frequent dosing (every 6 to 8 weeks) at their doctor's discretion. Lower starting doses are recommended for patients with moderate or severe kidney or liver disease.
  • GEP-NETs and carcinoid syndrome: The standard schedule is once every 4 weeks, with no additional dose given for carcinoid syndrome if the patient is already receiving lanreotide for GEP-NETs.

Never adjust your dose or schedule on your own — your doctor will monitor your response and make any necessary changes.

Dosing details from the FDA-approved label

From the Lanreotide Injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Acromegaly
    • 90 mg given via the deep subcutaneous route at 4-week intervals for 3 months (starting dosage)
    • After 3 months, adjust: GH greater than 1 ng/mL to less than or equal to 2.5 ng/mL, IGF-1 normal, and clinical symptoms controlled: maintain 90 mg every 4 weeks
    • GH greater than 2.5 ng/mL, IGF-1 elevated, and/or clinical symptoms uncontrolled: increase to 120 mg e
    • GH and IGF-1 levels should be obtained 6 weeks after a change to an extended dosing interval
  • Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
    • 120 mg administered every 4 weeks by deep subcutaneous injection
  • Carcinoid Syndrome
    • 120 mg administered every 4 weeks by deep subcutaneous injection
    • If patients are already being treated with Lanreotide Injection for GEP-NETs, do not administer an additional dose for the treatment of carcinoid syndrome
  • Acromegaly in patients with moderate or severe renal impairment (creatinine clearance (CLcr) less than 60 mL/min)
    • 60 mg via the deep subcutaneous route at 4-week intervals for 3 months (starting dosage), followed by dosage adjustment
    • Renal impairment starting dosage
  • Acromegaly in patients with moderate or severe hepatic impairment (Child-Pugh Class B or C)
    • 60 mg via the deep subcutaneous route at 4-week intervals for 3 months (starting dosage), followed by dosage adjustment
    • Hepatic impairment starting dosage
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Administration ( 2.1 ): For deep subcutaneous injection only. Intended for administration by a healthcare provider. Administer in the superior external quadrant of the buttock. Alternate injection sites. Recommended Dosage ( 2.1 ) Acromegaly : 90 mg every 4 weeks for 3 months. Adjust thereafter based on GH and/or IGF-1 levels. See full prescribing information for titration regimen. GEP-NETs : 120 mg every 4 weeks. Carcinoid Syndrome : 120 mg every 4 weeks. If patients are already being treated with Lanreotide Injection for GEP-NET, do not administer an additional dose for carcinoid syndrome. Dosage Adjustment : See full prescribing information for dosage adjustment in patients with acromegaly and renal or hepatic impairment. ( 2.2 , 2.3 ) 2.1 Recommended Dosage Acromegaly The recommended starting dosage of Lanreotide Injection is 90 mg given via the deep subcutaneous route, at 4-week intervals for 3 months. After 3 months, the Lanreotide injection dosage may be adjusted as follows: GH greater than 1 ng/mL to less than or equal to 2.5 ng/mL, IGF-1 normal, and clinical symptoms controlled: maintain dosage at 90 mg every 4 weeks. GH greater than 2.5 ng/mL, IGF-1 elevated, and/or clinical symptoms uncontrolled: increase dosage to 120 mg every 4 weeks. GH less than or equal to 1 ng/mL, IGF-1 normal, and clinical symptoms controlled: reduce dosage to 60 mg every 4 weeks. Thereafter, the dosage should be adjusted according to the response of the patient as judged by a reduction in serum GH and/or IGF-1 levels; and/or changes in symptoms of acromegaly. Patients who are controlled on Lanreotide Injection 60 or 90 mg may be considered for an extended dosing interval of Lanreotide Injection 120 mg every 6 or 8 weeks. GH and IGF-1 levels should be obtained 6 weeks after this change in dosing regimen to evaluate persistence of patient response. Continued monitoring of patient response with dosage adjustments for biochemical and clinical symptom control, as necessary, is recommended. Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) The recommended dosage of Lanreotide Injection is 120 mg administered every 4 weeks by deep subcutaneous injection. Carcinoid Syndrome The recommended dosage of Lanreotide Injection is 120 mg administered every 4 weeks by deep subcutaneous injection.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Lanreotide Injection side effects

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The most commonly reported side effects with Lanreotide Injection include:

Common side effects

  • Diarrhea
  • Abdominal (stomach) pain
  • Nausea
  • Gallstones (cholelithiasis)
  • Injection site pain, swelling, or nodule
  • Headache
  • Musculoskeletal (muscle and joint) pain
  • High blood sugar (hyperglycemia)
  • Nausea and vomiting
  • Injection site reactions — pain, swelling, a lump, or itching at the injection spot
  • Headache and dizziness (reported in carcinoid syndrome trials)

When to get medical help

  • Call your doctor if you have severe stomach pain, fever, or yellowing of the skin or eyes — these could be signs of gallstone complications such as cholecystitis or pancreatitis
  • Tell your doctor right away if your heart rate feels very slow or you feel faint — lanreotide can lower heart rate (bradycardia)
  • Monitor blood sugar closely — lanreotide can cause both high and low blood sugar, especially if you take diabetes medicines
  • Report new or worsening symptoms like oily/loose stools, weight loss, or bloating — this may signal fat malabsorption or pancreatic enzyme problems
  • Contact your doctor if you notice signs of a serious allergic reaction such as swelling of the face or throat, or difficulty breathing

Most gastrointestinal side effects are mild to moderate and tend to settle over time. However, if you develop severe stomach pain, signs of jaundice (yellowing of skin or eyes), very slow heartbeat, or significant changes in blood sugar, contact your doctor right away — these can signal more serious problems.

Lanreotide Injection warnings and precautions

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  • Gallstones and gallbladder complications: Lanreotide slows gallbladder movement and can lead to gallstone formation. Serious complications — including gallbladder infection (cholecystitis), bile duct infection (cholangitis), and pancreatitis — have been reported. Some patients required gallbladder removal. Periodic monitoring may be needed, and the drug should be stopped if complications are suspected.
  • Blood sugar changes: Lanreotide affects insulin and glucagon secretion, which can cause both high and low blood sugar. Blood glucose monitoring is recommended when starting, stopping, or changing the dose, and diabetes medications may need adjustment.
  • Slow heart rate (bradycardia): Lanreotide can lower heart rate, especially in patients with pre-existing heart conditions or those taking other drugs that slow the heart. Seek medical attention if you feel faint, dizzy, or notice an unusually slow heartbeat.
  • Thyroid function: Slight decreases in thyroid hormone levels can occur, though clinical hypothyroidism is rare. Testing is recommended when clinically indicated.
  • Fat malabsorption (steatorrhea): New or worsening oily/loose stools, bloating, or unexplained weight loss may signal that lanreotide is interfering with pancreatic enzyme release and fat digestion. Report these symptoms to your doctor.

Lanreotide Injection interactions

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Lanreotide Injection can interact with several medications — tell your prescriber and pharmacist about everything you take:

  • Insulin and oral diabetes drugs: Lanreotide affects blood sugar by altering insulin and glucagon secretion; your diabetes treatment may need to be adjusted.
  • Cyclosporine (immune suppressant): Lanreotide may reduce the absorption of cyclosporine, potentially lowering its levels in the blood — dose adjustment and monitoring may be needed.
  • Bromocriptine: Lanreotide may increase how much bromocriptine is absorbed into the body.
  • Beta-blockers and other heart-rate-lowering drugs: Combining these with lanreotide can have an additive effect on slowing the heart rate; dose adjustments of the co-administered drug may be necessary.
  • Drugs metabolized by CYP3A4 with a narrow safety window (e.g., quinidine, terfenadine): Lanreotide may slow the breakdown of these drugs, raising their levels in the blood — use with caution or avoid.

Interactions listed in the FDA-approved label

From the Lanreotide Injection prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Insulin and oral hypoglycemic drugs: Lanreotide, like somatostatin and other somatostatin analogs, inhibits the secretion of insulin and glucagon. Monitor blood glucose levels when Lanreotide Injection treatment is initiated or when the dose is altered, and adjust antidiabetic treatment accordingly.
  • Cyclosporine: Concomitant administration with Lanreotide Injection may decrease the absorption of cyclosporine. May necessitate adjustment of cyclosporine dose to maintain therapeutic drug concentrations.
  • Bromocriptine: Limited published data indicate that concomitant administration of a somatostatin analog and bromocriptine may increase the absorption of bromocriptine.
  • Bradycardia-inducing drugs (e.g., beta-blockers): May have an additive effect on the reduction of heart rate associated with lanreotide. Dosage adjustments of concomitant drugs may be necessary.
  • Drugs metabolized by cytochrome P450 enzymes (e.g., quinidine, terfenadine): Somatostatin analogs may decrease the metabolic clearance of compounds metabolized by cytochrome P450 enzymes; drugs metabolized by the liver may be metabolized more slowly during Lanreotide Injection treatment. Avoid other drugs mainly metabolized by CYP3A4 and which have a low therapeutic index (e.g., quinidine, terfenadine); dose reductions of concomitantly administered medications should be considered.
Read the label’s full interactions text

7 DRUG INTERACTIONS Cyclosporine : Lanreotide Injection may decrease the absorption of cyclosporine. Dosage adjustment of cyclosporine may be needed. ( 7.2 ) Bromocriptine : Lanreotide Injection may increase the absorption of bromocriptine. ( 7.3 ) Bradycardia-Inducing Drugs (e.g., beta-blockers) : Lanreotide Injection may decrease heart rate. Dosage adjustment of the coadministered drug may be necessary. ( 7.3 ) 7.1 Insulin and Oral Hypoglycemic Drugs Lanreotide, like somatostatin and other somatostatin analogs, inhibits the secretion of insulin and glucagon. Therefore, blood glucose levels should be monitored when Lanreotide Injection treatment is initiated or when the dose is altered, and antidiabetic treatment should be adjusted accordingly [see Warnings and Precautions ( 5.2 )] . 7.2 Cyclosporine Concomitant administration of cyclosporine with Lanreotide Injection may decrease the absorption of cyclosporine, and therefore, may necessitate adjustment of cyclosporine dose to maintain therapeutic drug concentrations. [see Clinical Pharmacology ( 12.3 )] 7.3 Bromocriptine Limited published data indicate that concomitant administration of a somatostatin analog and bromocriptine may increase the absorption of bromocriptine [see Clinical Pharmacology ( 12.3 )] . 7.4 Bradycardia-Inducing Drugs Concomitant administration of bradycardia-inducing drugs (e.g., beta-blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Dosage adjustments of concomitant drugs may be necessary. 7.5 Drug Metabolism Interactions The limited published data available indicate that somatostatin analogs may decrease the metabolic clearance of compounds known to be metabolized by cytochrome P450 enzymes, which may be due to the suppression of growth hormone. Since it cannot be excluded that Lanreotide Injection may have this effect, avoid other drugs mainly metabolized by CYP3A4 and which have a low therapeutic index (e.g., quinidine, terfenadine).

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿13 supplements and herbs with documented Lanreotide Injection interactions, ranked by severity Check Lanreotide Injection against a supplement or herb →

Before taking Lanreotide Injection

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  • Allergy to lanreotide: Lanreotide Injection is contraindicated (must not be used) if you have ever had a serious allergic reaction to lanreotide, including anaphylaxis or severe swelling (angioedema).
  • Gallbladder problems: Tell your doctor if you have a history of gallstones — you may need closer monitoring.
  • Diabetes or blood sugar problems: Blood glucose monitoring is recommended when treatment starts or the dose changes.
  • Heart conditions or slow heart rate: Use with caution; tell your doctor about any cardiac history before starting.
  • Moderate or severe kidney impairment: A lower starting dose is recommended for acromegaly patients; caution applies to extended dosing intervals.
  • Moderate or severe liver impairment: A lower starting dose is recommended for acromegaly patients; GEP-NET patients with hepatic impairment have not been well-studied.
  • Pregnancy: Animal studies showed reduced fetal survival and fetal abnormalities. There is not enough human data to rule out harm. Discuss the risks carefully with your doctor.
  • Breastfeeding: Do not breastfeed during treatment or for 6 months after the last dose — the drug may pass into breast milk and could cause serious harm to a nursing infant.
  • Women who may become pregnant: Animal studies suggest lanreotide may reduce fertility in females.
  • Children: Safety and effectiveness in pediatric patients have not been established.
  • Older adults: No major overall differences in safety or effectiveness have been found compared to younger patients, but extra caution is advised given higher rates of kidney, liver, and heart concerns in older individuals.

What Lanreotide Injection does in the body

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Lanreotide primarily works by reducing growth hormone (GH) and IGF-1 levels in patients with acromegaly — a single injection can lower GH levels rapidly and keep them suppressed for at least 28 days. In carcinoid syndrome, it reduces levels of urinary 5-HIAA, a marker of excess serotonin activity. Beyond its hormonal effects, lanreotide inhibits the release of several gut and pancreatic hormones (including gastrin, glucagon, motilin, and pancreatic polypeptide), reduces gallbladder contractility, slows meal-stimulated pancreatic secretions, and can transiently affect blood sugar by suppressing both insulin and glucagon secretion.

How your body processes Lanreotide Injection

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When injected deep under the skin, lanreotide forms a drug depot (a slow-release reservoir) at the injection site. The drug then gradually diffuses into surrounding tissue and enters the bloodstream — giving it a long half-life of 23 to 30 days, which is why it only needs to be injected once a month. Bioavailability (the portion that reaches the bloodstream) after a single subcutaneous dose is approximately 70–78%. Meaningful drug levels are maintained throughout the full 28-day dosing period at the recommended doses.

How to store Lanreotide Injection

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Store SOMATULINE DEPOT in the refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in the original package.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

13

Supplements & herbs that interact with Lanreotide Injection

13 supplements and herbal products have documented interactions with Lanreotide Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Moderate · 12
  • Minor · 1
ADRAFINIL Moderate CANNABIDIOL (CBD) Moderate CANNABINOL (CBN) Moderate CANNABIS Moderate DELTA-9-TETRAHYDROCANNABINOL (THC) Moderate ERGOT Moderate EVODIA Moderate FEVER BARK Moderate +5 more
Every supplement checked against Lanreotide Injection — ranked by severity The full interaction hub: 12 moderate · 1 minor · every one linked to its full report. Check Lanreotide Injection against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Lanreotide Injection: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Lanreotide Injection — the kind of thing our pharmacy team would talk through with you at the counter.

What is lanreotide actually doing for my condition?

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That depends on why you're taking it. If you have acromegaly, it's working to lower your growth hormone and IGF-1 levels back toward normal — which helps ease symptoms like enlarged hands, feet, or facial features, and reduces long-term health risks. If you have a neuroendocrine tumor, it's helping to slow tumor growth. And for carcinoid syndrome, it helps control the excess hormones the tumor puts out, so you need your rescue medication less often.

How is this injection given, and do I have to give it to myself?

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Lanreotide Injection is given as a deep shot under the skin in the upper outer area of the buttock — and it's meant to be given by a healthcare provider, not typically at home. You'll come in roughly once every four weeks for your dose. The provider will alternate the injection site between your right and left side each visit to prevent buildup at one spot. The injection is given slowly over about 20 seconds because the medication is quite thick.

What side effects should I expect, and which ones should make me call my doctor?

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The most common ones are stomach-related — diarrhea, abdominal pain, and nausea. You may also notice some soreness, swelling, or a small lump at the injection site, especially early in treatment. Those usually improve with time. Call your doctor right away if you have severe stomach pain with fever, yellowing of the skin or eyes, a very slow or irregular heartbeat, feeling faint, or significant changes in your blood sugar. These can signal more serious problems like gallstone complications or heart rate changes that need attention.

Will this affect my blood sugar?

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It can, yes. Lanreotide affects the hormones that regulate blood sugar — both insulin and glucagon — so your levels might go up or down. Your doctor will want to monitor your blood sugar when you start treatment or if your dose changes. If you're on diabetes medications, your prescriber may need to adjust them. Let your care team know if you notice symptoms of high or low blood sugar.

Is it safe to take lanreotide if I'm pregnant or breastfeeding?

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There isn't enough human data to say it's safe during pregnancy, and animal studies did show harm to developing fetuses. If you're pregnant, planning to become pregnant, or breastfeeding, talk to your doctor right away. You should not breastfeed while taking this medication or for 6 months after your last dose, because the drug could potentially harm a nursing baby.

Are there any medications I should let my doctor know about before starting lanreotide?

▾
Definitely share your full medication list. A few key ones to flag: if you take cyclosporine (an immune suppressant), lanreotide can reduce how well it's absorbed, so your levels may need to be checked. If you take beta-blockers or other medications that slow your heart rate, combining them with lanreotide can slow your heart even more. And if you have diabetes and take insulin or other blood sugar medications, those doses may need adjusting. Your doctor or pharmacist can review everything with you.

Is Lanreotide Injection available over the counter?

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No. Lanreotide Injection is a prescription medicine: every Lanreotide Injection product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Lanreotide Injection first available?

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The earliest FDA record we hold for Lanreotide Injection is from 2007: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Lanreotide Injection was first used.

Who makes Lanreotide Injection?

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4 companies currently list Lanreotide Injection products in the FDA's NDC Directory, including Cipla USA Inc., Exelan Pharmaceuticals, Inc., Ipsen Biopharmaceuticals, Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Lanreotide Injection on HelloPharmacist

📊Lanreotide Injection supplement interactions13 checked — ranked by severity 🌿Drug & Supplement CheckerLanreotide Injection vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Lanreotide Injection NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Lanreotide Injection Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Lanreotide Injection forms and strengths (how it comes)

Lanreotide Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Lanreotide Injection inactive ingredients by manufacturer.

Injection

By injection · Under the skin
Brands Somatuline Depot
How this form is used
What it may be used for
  • Used for long-term treatment of acromegaly in patients who have not responded adequately to surgery and/or radiation, or for whom those options are not available
  • Used to improve progression-free survival in adults with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
  • Used to treat carcinoid syndrome in adults, reducing the need for short-acting rescue therapy
Important instructions
  • Lanreotide Acetate and Somatuline Depot are given by deep subcutaneous injection into the upper outer area of the buttock — this should be done by a healthcare provider
  • Alternate the injection site between the right and left buttock with each dose
  • Remove the pre-filled syringe from the refrigerator 30 minutes before injection; the sealed pouch may be kept at room temperature (not above 104°F/40°C) for up to 72 hours and returned to the refrigerator if unused
  • Inject the medication slowly over 20 seconds — do not rush, as the medication is thick and pushing too fast may cause discomfort
Available strengths 3 strengths
60 mg/0.2 mL 90 mg/0.3 mL 120 mg/0.5 mL
29 FDA-listed product records ⓘ

Lanreotide Injection on the U.S. market: products, makers and brands

How Lanreotide Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

4 companies list 13 Lanreotide Injection product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 2007. Brand names on the directory include Somatuline Depot, Somatuline; the rest are generics.

1
Dose forms ⓘ
4
Labelers (makers, repackagers, distributors)
2
Brand names
13
FDA-listed product records ⓘ
2007
Earliest FDA record ⓘ
Cipla USA Inc.46%
Exelan Pharmaceuticals, Inc.23%
Ipsen Biopharmaceuticals, Inc.23%
Amneal Pharmaceuticals LLC8%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Lanreotide Injection is used (Medicaid data)

A general measure of how commonly Lanreotide Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Lanreotide Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

4,864
Medicaid prescriptions filled (Q1–Q4 2025)
$24.5M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Lanreotide Injection prescribed? Of the 1,601 medications we measure, Lanreotide Injection ranks #1,050 by Medicaid prescriptions — more than 34% of them.

Where Lanreotide Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,050 of 1,601
#1,045 Tetrabenazine 5,050 Rx #1,046 Lanthanum 4,990 Rx #1,047 Avacincaptad Pegol 4,978 Rx #1,048 Acalabrutinib 4,921 Rx #1,049 Ciprofloxacin Injectio... 4,872 Rx #1,050 Lanreotide Injection 4,864 Rx #1,051 Alcohol 4,861 Rx #1,052 Temozolomide 4,846 Rx #1,053 Hydralazine / Isosorbi... 4,770 Rx #1,054 Teduglutide Injection 4,744 Rx #1,055 Rifapentine 4,737 Rx

Utilization by Lanreotide Injection product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 0.5 mL / 240 mg/mL prefilled syringe is the most-dispensed Lanreotide Injection product — about 97% of these Medicaid prescriptions.

0.5 ML lanreotide 240 MG/ML Prefilled Syringe Most dispensed

4,719 Medicaid prescriptions (Q1–Q4 2025) 97% of Lanreotide Injection prescriptions shown $23.7M gross reimbursement (before rebates) ≈ $5,012 per prescription (gross)

Summed across the 3 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 749814

0.2 ML lanreotide 300 MG/ML Prefilled Syringe

103 Medicaid prescriptions (Q1–Q4 2025) 2% of Lanreotide Injection prescriptions shown $526,121 gross reimbursement (before rebates) ≈ $5,108 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 749811

0.3 ML lanreotide 300 MG/ML Prefilled Syringe

42 Medicaid prescriptions (Q1–Q4 2025) <1% of Lanreotide Injection prescriptions shown $343,191 gross reimbursement (before rebates) ≈ $8,171 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 749817

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Lanreotide Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 5 of 15 listed Lanreotide Injection NDCs with Medicaid activity.

Compare Lanreotide Injection products

A representative set of FDA-listed product records for Lanreotide Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 13 of 13 products — FDA National Drug Code Directory. See every product, package size and price: browse all 13 Lanreotide Injection NDCs →

Lanreotide Injection recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 2 Lanreotide recalls since July 2021, covering 3 product listings. Both are still ongoing or began in the last six months. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Mar 13, 2026 · Cipla USA, Inc.
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
  • Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for: Cipla USA, Inc.,… Lots: Lot, expiry: 4401699IR1, Exp. 5/31/2026; 4401699IR2, Exp. 5/31/2026; 4401700IR1, Exp. 5/31/2026; 4401701IR1, Exp. 5/31/2026; 4401702IR1, Exp. 5/31/2026; 4401722IR1, Exp. 5/31/2026; 4401723IR1, Exp. 5/31/2026; 4401724IR1, Exp. 5/31/2026; 44… FDA record D-0423-2026 →
  • Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured f… Lots: Lot, expiry: 4401666IR1, Exp 8/31/2027; 4401703IR1, Exp 9/30/2027; 4401703IR2, EXP 9/30/2027; 4401704IR1, Exp 9/30/2027; 4401705IR1, Exp 9/30/2027; 4401706IR1, Exp 9/30/2027; 4401720IR1, Exp 9/30/2027; 4401721IR1, Exp 9/30/2027; 4401733IR1… FDA record D-0422-2026 →
Ongoing Class II Jan 2, 2026 · Cipla USA, Inc.
Presence of Particulate Matter.
  • Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059… Lots: Lot, expiry: 4301954IR1 , exp 31/10/2026 ; 4301994IR1 , exp 31/10/2026 ; 4301995IR1 , exp 31/10/2026 ; 4301996IR1 , exp 31/10/2026 ; 4400005IR1 , exp 30/11/2026 ; 4400006IR1 , exp 30/11/2026 ; 4400007IR1 , exp 30/11/2026 ; 4400124IR1 , exp… FDA record D-0290-2026 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Lanreotide Injection RxCUI 68092 1 dose form · 3 strengths

Look up RxCUI 68092 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Lanreotide Injection brand names

Lanreotide Injection is sold under 2 brand names in the FDA directory — Somatuline Depot, Somatuline. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Somatuline Depot Somatuline

Who makes Lanreotide Injection: manufacturers and labelers

4 companies list Lanreotide Injection products with the FDA. By number of product records, the largest are Cipla USA Inc., Exelan Pharmaceuticals, Inc., Ipsen Biopharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Cipla USA Inc. 6 Exelan Pharmaceuticals, Inc. 3 Ipsen Biopharmaceuticals, Inc. 3 Amneal Pharmaceuticals LLC 1

Lanreotide Injection drug class (RxNorm)

Lanreotide Injection belongs to the Somatostatin Analog class.

Pharmacologic class Somatostatin Analog
Drug family (ATC) Somatostatin and analogues
How it works Somatostatin Receptor Agonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Lanreotide Injection page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Sep 1, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Lanreotide Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Lanreotide Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
4
Finished products in the current FDA directory
13
Companies listing them (makers, repackagers, distributors)
4
FDA labeler codes behind them ⓘ
4
Linked representative label ⓘ
Cipla USA Inc.
Linked label effective
Sep 1, 2024
Composite sections available
21
Linked SPL Set ID
11da176a-99bc-4ada-8b3f-6bd2b37a6313
Linked SPL Document ID
fd205110-15eb-4707-82b2-185e5bbf616b
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Cipla USA Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →