What the label lists and what reports show
Lanreotide side effects
Lanreotide's FDA label: “Most common adverse reactions are: Acromegaly (>5%): diarrhea, cholelithiasis, abdominal pain, nausea and injection site reactions.” FAERS holds 7,795 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (1,415 reports).
- Generic listed
Check it at the source: the lanreotide FDA label on DailyMed (effective October 11, 2024, Ipsen Biopharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of SOMATULINE DEPOT?SOMATULINE DEPOT may cause serious side effects, including: Gallstones (cholelithiasis) and complications that can happen if you have gallstones. Gallstones are a serious but common side effect in people who take SOMATULINE DEPOT and have acromegaly and GEP-NET. Your healthcare provider may check your gallbladder before and during treatment with SOMATULINE DEPOT. Possible complications of gallstones include inflammation and infection of the gall bladder, and pancreatitis. Tell your healthcare provider if you get any symptoms of gallstones, including: sudden pain in your upper right stomach area (abdomen) yellowing of your skin and whites of your eyes nausea sudden pain in your right shoulder or between your shoulder blades fever with chills Fatty stool. SOMATULINE DEPOT may cause your body to have issues absorbing dietary fats. […]
Source: FDA drug label, Ipsen Biopharmaceuticals, Inc., effective October 11, 2024 (SPL set 6e4a41fd-a753-4362-87ee-8cc56ed3660d), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions are: Acromegaly (>5%): diarrhea, cholelithiasis, abdominal pain, nausea and injection site reactions.
Table 1: Adverse Reactions at an Incidence of Greater than 5% with SOMATULINE DEPOT Overall and Occurring at Higher Rate than Placebo: Placebo-Controlled and Fixed-Dose Phase of Study 1 By Dose
| Body System Preferred Term | Placebo (N=25) N (%) | SOMATULINE DEPOT Overall (N=83) N (%) | SOMATULINE DEPOT 60 mg (N=34) N (%) | SOMATULINE DEPOT 90 mg (N=36) N (%) | SOMATULINE DEPOT 120 mg (N=37) N (%) | SOMATULINE DEPOT Overall (N=107) N (%) |
|---|---|---|---|---|---|---|
| Gastrointestinal System Disorders | 1 (4%) | 30 (36%) | 12 (35%) | 21 (58%) | 27 (73%) | 60 (56%) |
| Diarrhea | 0 | 26 (31%) | 9 (26%) | 15 (42%) | 24 (65%) | 48 (45%) |
| Abdominal pain | 1 (4%) | 6 (7%) | 3 (9%) | 6 (17%) | 7 (19%) | 16 (15%) |
| Flatulence | 0 | 5 (6%) | 0 (0%) | 3 (8%) | 5 (14%) | 8 (7%) |
| Application Site Disorders | 0 (0%) | 5 (6%) | 3 (9%) | 4 (11%) | 8 (22%) | 15 (14%) |
| Liver and Biliary System Disorders | 1 (4%) | 3 (4%) | 9 (26%) | 7 (19%) | 4 (11%) | 20 (19%) |
| Cholelithiasis | 0 | 2 (2%) | 5 (15%) | 6 (17%) | 3 (8%) | 14 (13%) |
| Heart Rate & Rhythm Disorders | 0 | 8 (10%) | 7 (21%) | 2 (6%) | 5 (14%) | 14 (13%) |
| Bradycardia | 0 | 7 (8%) | 6 (18%) | 2 (6%) | 2 (5%) | 10 (9%) |
| Red Blood Cell Disorders | 0 | 6 (7%) | 2 (6%) | 5 (14%) | 2 (5%) | 9 (8%) |
| Anemia | 0 | 6 (7%) | 2 (6%) | 5 (14%) | 2 (5%) | 9 (8%) |
| Metabolic & Nutritional Disorders | 3 (12%) | 13 (16%) | 8 (24%) | 9 (25%) | 4 (11%) | 21 (20%) |
| Weight decrease | 0 | 7 (8%) | 3 (9%) | 4 (11%) | 2 (5%) | 9 (8%) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions to SOMATULINE DEPOT are discussed in greater detail in other sections of the labeling: Cholelithiasis and Complications of Cholelithiasis [see Warnings and Precautions (5.1) ] Hyperglycemia and Hypoglycemia [see Warnings and Precautions (5.2) ] Cardiovascular Abnormalities [see Warnings and Precautions (5.3) ] Thyroid Function Abnormalities [see Warnings and Precautions (5.4) ] Steatorrhea and Malabsorption of Dietary Fats [see Warnings and Precautions (5.6) ] Most common adverse reactions are: Acromegaly (>5%): diarrhea, cholelithiasis, abdominal pain, nausea and injection site reactions. ( 6.1 ) GEP-NET (>10%): abdominal pain, musculoskeletal pain, vomiting, headache, injection site reaction, hyperglycemia, hypertension, and cholelithiasis. ( 6.1 ) Carcinoid Syndrome: (≥5% and at least 5% greater than placebo): headache, dizziness and muscle spasm. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, 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?
7,795 reports list lanreotide among the medicines taken, 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. Of the 21 reactions below, 13 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Lanreotide: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions