Prescription medicine
Lanreotide Brand names: Somatuline; first approved as Somatuline Depot
Lanreotide (Somatuline) is a prescription medicine with an FDA approval on record since 2007. FDA's NDC Directory lists it from 3 generic labelers.
- Generic listed
Check it at the source: the lanreotide FDA label on DailyMed (effective October 11, 2024, Ipsen Biopharmaceuticals, Inc.); the NDA 22074 record on Drugs@FDA; every lanreotide label on DailyMed.
Highlights of the record
FDA label of October 11, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageSOMATULINE DEPOT is a somatostatin analog indicated for: the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy.
Forms and strengths
- 60 mg/.2ml
- 90 mg/.3ml
- 120 mg/.5ml
Injection.
On the market
- Earliest approval on file
- August 30, 2007 Somatuline Depot, Ipsen Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first May 21, 2024; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 3 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2026 0 Class I among all firms' recalls; latest March 13, 2026
- FAERS reports
- 7,795 through July 30, 2026
What is lanreotide used for?
From the label: indications and usageSOMATULINE DEPOT is a somatostatin analog indicated for: the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. ( 1.1 ) the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. ( 1.2 ) the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy. […]
FDA pharmacologic class: Somatostatin Analog.
Source: FDA drug label (SOMATULINE DEPOT), Ipsen Biopharmaceuticals, Inc., effective October 11, 2024 (SPL set 6e4a41fd-a753-4362-87ee-8cc56ed3660d), via openFDA; the full label on DailyMed
What does the patient leaflet for lanreotide say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while receiving SOMATULINE DEPOT?SOMATULINE DEPOT can cause dizziness. If you have dizziness, do not drive a car or operate machinery.
Source: FDA drug label (SOMATULINE DEPOT), Ipsen Biopharmaceuticals, Inc., effective October 11, 2024 (SPL set 6e4a41fd-a753-4362-87ee-8cc56ed3660d), via openFDA; the full label on DailyMed
Is there a generic for lanreotide (Somatuline)?
The FDA approved the first generic lanreotide on May 21, 2024. 2 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists lanreotide from 3 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2007 earliest approval on file
- 2024 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has lanreotide been recalled?
The FDA's Enforcement Report lists 3 recalls naming lanreotide since 2026: 0 Class I (the most serious), 3 Class II, 0 Class III; 3 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 13, 2026 | Class II | 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. |
| January 2, 2026 | Class II | Cipla USA, Inc. | Presence of Particulate Matter. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the lanreotide label say about other medicines?
The lanreotide label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name lanreotide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Bromocriptine | drug interactions | Dosage adjustment of cyclosporine may be needed. ( 7.2 ) Bromocriptine: SOMATULINE DEPOT may increase the absorption of bromocriptine. ( 7.3 ) Bradycardia-Inducing Drugs (e.g., beta-blockers): |
| Cyclosporine | drug interactions | DRUG INTERACTIONS Cyclosporine: SOMATULINE DEPOT may decrease the absorption of cyclosporine. |
| Glucagon | drug interactions | Insulin and Oral Hypoglycemic Drugs Lanreotide, like somatostatin and other somatostatin analogs, inhibits the secretion of insulin and glucagon. |
| Quinidine | drug interactions | Since it cannot be excluded that SOMATULINE DEPOT may have this effect, avoid other drugs mainly metabolized by CYP3A4 and which have a low therapeutic index (e.g., quinidine, terfenadine). |
Other labels that name lanreotide
Source: FDA drug label (SOMATULINE DEPOT), Ipsen Biopharmaceuticals, Inc., effective October 11, 2024 (SPL set 6e4a41fd-a753-4362-87ee-8cc56ed3660d), via openFDA; the full label on DailyMed
What do FAERS reports show for lanreotide?
The FDA Adverse Event Reporting System holds 7,795 reports that list lanreotide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,422 are coded as a death and 1,586 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other somatostatin analogs
- the pharmacologic class, with prices and generics
- Lanreotide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other