TRIAL RESULTS · SIDE EFFECTS
Lanreotide side effects
ANSWER
In 5 placebo-controlled trials with posted results, the most common side effects of Lanreotide were diarrhoea 19.5% (placebo 23.6%), abdominal pain 16.8% (placebo 15.9%), fatigue 12.2% (placebo 14.6%). Read from ClinicalTrials.gov on 2026-10-03. Not medical advice.
Trial register
Trials with posted results
18
with an arm on Lanreotide, of 125 registered
Against placebo
5
placebo-controlled trials
People in those trials
437
on Lanreotide · 258 on placebo
Read
2026-10-03
ClinicalTrials.gov
VS PLACEBO
Most common side effects, Lanreotide beside placebo
Share of people with each side effect in 5 placebo-controlled trials with posted results: 437 people on Lanreotide (all doses), 258 on placebo, same trials. Listed only when reported for at least half of the people on Lanreotide. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
ALL TRIALS
The 100 most reported of 553 side effects reported
Every trial with posted results and an arm on Lanreotide (n ≥ 20), all phases, by people affected. Placebo is shown where placebo-controlled trials reported the same event. Comparator arms are not counted.
| Side effect | Organ system | Lanreotide | Placebo | Trials |
|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 32.3% (321 of 995) | 23.6% | 13 |
| Abdominal pain | Gastrointestinal disorders | 16.4% (168 of 1,026) | 15.9% | 14 |
| Nausea | Gastrointestinal disorders | 13.7% (141 of 1,026) | 12.0% | 14 |
| Headache | Nervous system disorders | 13.2% (111 of 841) | 9.4% | 11 |
| Fatigue | General disorders | 12.1% (109 of 898) | 14.6% | 13 |
| Cholelithiasis | Hepatobiliary disorders | 12.6% (90 of 717) | 6.4% | 8 |
| Constipation | Gastrointestinal disorders | 9.0% (87 of 963) | 9.7% | 14 |
| Vomiting | Gastrointestinal disorders | 9.6% (83 of 868) | 7.8% | 12 |
| Abdominal pain upper | Gastrointestinal disorders | 9.3% (79 of 846) | 8.1% | 11 |
| Dizziness | Nervous system disorders | 8.3% (66 of 795) | 2.1% | 9 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 8.0% (64 of 805) | 8.2% | 10 |
| Abdominal distension | Gastrointestinal disorders | 17.5% (63 of 360) | 6.8% | 5 |
| Weight decreased | Investigations | 7.7% (59 of 767) | 6.4% | 9 |
| Hypertension | Vascular disorders | 7.0% (58 of 834) | 5.6% | 11 |
| Back pain | Musculoskeletal and connective tissue disorders | 7.2% (55 of 765) | 10.3% | 11 |
| Decreased appetite | Metabolism and nutrition disorders | 7.2% (55 of 760) | 8.6% | 9 |
| Nasopharyngitis | Infections and infestations | 7.1% (53 of 743) | 11.6% | 8 |
| Upper respiratory tract infection | Infections and infestations | 9.9% (53 of 538) | 4.7% | 5 |
| Hyperglycaemia | Metabolism and nutrition disorders | 7.3% (51 of 701) | 2.3% | 8 |
| Asthenia | General disorders | 7.0% (48 of 684) | 6.6% | 9 |
| Flatulence | Gastrointestinal disorders | 6.8% (48 of 701) | 6.5% | 7 |
| Anaemia | Blood and lymphatic system disorders | 5.0% (43 of 859) | 1.7% | 10 |
| Urinary tract infection | Infections and infestations | 5.1% (40 of 791) | 7.3% | 10 |
| Alopecia | Skin and subcutaneous tissue disorders | 7.6% (40 of 525) | 3.9% | 6 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 5.0% (32 of 642) | 5.2% | 8 |
| Cough | Respiratory, thoracic and mediastinal disorders | 4.9% (31 of 627) | 4.3% | 8 |
| Pyrexia | General disorders | 4.1% (30 of 723) | 4.3% | 9 |
| Injection site pain | General disorders | 6.7% (28 of 418) | 4.0% | 5 |
| Oedema peripheral | General disorders | 4.3% (26 of 598) | 5.2% | 7 |
| Abdominal discomfort | Gastrointestinal disorders | 5.3% (25 of 468) | 3.4% | 6 |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 4.5% (25 of 554) | 2.7% | 6 |
| Blood glucose increased | Investigations | 10.8% (24 of 222) | 0.0% | 3 |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 5.5% (23 of 418) | 2.2% | 4 |
| Injection site induration | General disorders | 10.3% (23 of 224) | - | 2 |
| Flushing | Vascular disorders | 3.6% (22 of 618) | 4.3% | 8 |
| Anxiety | Psychiatric disorders | 4.6% (22 of 477) | 1.2% | 6 |
| Sinus bradycardia | Cardiac disorders | 9.8% (22 of 224) | - | 2 |
| Insomnia | Psychiatric disorders | 5.1% (21 of 412) | 2.7% | 8 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 3.5% (20 of 576) | 2.2% | 7 |
| Rash | Skin and subcutaneous tissue disorders | 7.7% (18 of 234) | 4.0% | 4 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 3.8% (16 of 418) | 4.5% | 5 |
| Dyspepsia | Gastrointestinal disorders | 6.3% (16 of 254) | 2.7% | 5 |
| Disease progression | General disorders | 5.6% (15 of 268) | 0.0% | 2 |
| Influenza like illness | General disorders | 3.2% (14 of 439) | 1.2% | 5 |
| Hypokalaemia | Metabolism and nutrition disorders | 3.4% (13 of 388) | 3.0% | 8 |
| Gamma-glutamyltransferase increased | Investigations | 3.3% (13 of 397) | 0.0% | 4 |
| Diabetes mellitus | Metabolism and nutrition disorders | 5.4% (13 of 239) | 5.3% | 3 |
| Aspartate aminotransferase increased | Investigations | 3.2% (12 of 372) | 0.0% | 5 |
| Renal cyst | Renal and urinary disorders | 5.4% (12 of 224) | - | 2 |
| Injection Site Pain | General disorders | 20.3% (12 of 59) | - | 1 |
| Gastrointestinal sounds abnormal | Gastrointestinal disorders | 9.4% (12 of 128) | - | 1 |
| Pruritus | Skin and subcutaneous tissue disorders | 4.3% (11 of 256) | 5.1% | 5 |
| Hypothyroidism | Endocrine disorders | 4.5% (11 of 246) | - | 3 |
| Alanine aminotransferase increased | Investigations | 10.5% (11 of 105) | - | 3 |
| Thyroid mass | Endocrine disorders | 8.6% (11 of 128) | - | 1 |
| Injection site nodule | General disorders | 4.6% (10 of 217) | 6.4% | 4 |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 7.1% (10 of 141) | 7.7% | 3 |
| Abdominal Pain | Gastrointestinal disorders | 11.6% (10 of 86) | 4.0% | 2 |
| Hepatic cyst | Hepatobiliary disorders | 4.5% (10 of 224) | - | 2 |
| Toothache | Gastrointestinal disorders | 6.0% (10 of 168) | - | 2 |
| Rectal tenesmus | Gastrointestinal disorders | 5.6% (10 of 179) | 3.8% | 2 |
| Blood bilirubin increased | Investigations | 10.6% (10 of 94) | 0.0% | 2 |
| Gastrointestinal disorder | Gastrointestinal disorders | 11.1% (10 of 90) | - | 1 |
| Hypotension | Vascular disorders | 3.5% (9 of 259) | 3.8% | 5 |
| Sciatica | Nervous system disorders | 2.0% (9 of 453) | 1.2% | 5 |
| Depression | Psychiatric disorders | 3.3% (9 of 275) | 0.0% | 5 |
| Bronchitis | Infections and infestations | 4.8% (9 of 189) | 9.6% | 3 |
| Blood triglycerides increased | Investigations | 2.9% (9 of 307) | 0.0% | 3 |
| Abdominal Pain Upper | Gastrointestinal disorders | 15.3% (9 of 59) | - | 1 |
| Dyslipidaemia | Metabolism and nutrition disorders | 9.4% (9 of 96) | - | 1 |
| Hypoglycaemia | Metabolism and nutrition disorders | 1.5% (8 of 541) | 1.4% | 6 |
| Dehydration | Metabolism and nutrition disorders | 2.5% (8 of 320) | 0.8% | 5 |
| Myalgia | Musculoskeletal and connective tissue disorders | 2.7% (8 of 298) | 5.5% | 5 |
| Lower respiratory tract infection | Infections and infestations | 3.0% (8 of 266) | 0.0% | 2 |
| Chest discomfort | General disorders | 4.5% (8 of 179) | 0.0% | 2 |
| White blood cell count decreased | Investigations | 9.6% (8 of 83) | - | 2 |
| Back Pain | Musculoskeletal and connective tissue disorders | 13.6% (8 of 59) | - | 1 |
| Anorexia | Metabolism and nutrition disorders | 36.4% (8 of 22) | - | 1 |
| Clinically significant postoperative pancreatic fistula | Surgical and medical procedures | 8.2% (8 of 98) | - | 1 |
| Death NOS | General disorders | 15.7% (8 of 51) | - | 1 |
| Bilirubin conjugated increased | Investigations | 18.6% (8 of 43) | - | 1 |
| Pneumonia | Infections and infestations | 2.1% (7 of 332) | 1.7% | 6 |
| Gastroenteritis | Infections and infestations | 2.2% (7 of 320) | 3.1% | 4 |
| Chest pain | General disorders | 3.0% (7 of 237) | 3.8% | 4 |
| Dry mouth | Gastrointestinal disorders | 4.2% (7 of 165) | 3.8% | 4 |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | 1.9% (7 of 363) | 1.2% | 3 |
| Injection site swelling | General disorders | 3.1% (7 of 224) | - | 2 |
| Gallbladder enlargement | Hepatobiliary disorders | 5.5% (7 of 128) | - | 1 |
| Protein urine present | Investigations | 5.5% (7 of 128) | - | 1 |
| Intestinal obstruction | Gastrointestinal disorders | 1.3% (6 of 461) | 1.4% | 5 |
| Steatorrhoea | Gastrointestinal disorders | 2.7% (6 of 225) | 6.8% | 4 |
| Neutropenia | Blood and lymphatic system disorders | 3.2% (6 of 188) | - | 3 |
| Pollakiuria | Renal and urinary disorders | 3.0% (6 of 199) | 0.0% | 3 |
| Palpitations | Cardiac disorders | 4.9% (6 of 123) | 0.0% | 3 |
| Ear infection | Infections and infestations | 6.7% (6 of 90) | - | 2 |
| Thrombocytopenia | Blood and lymphatic system disorders | 6.5% (6 of 92) | - | 2 |
| Blood cholesterol increased | Investigations | 6.6% (6 of 91) | 0.0% | 2 |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | 6.6% (6 of 91) | 7.7% | 2 |
| Glycosylated haemoglobin increased | Investigations | 7.2% (6 of 83) | - | 2 |
| Pancreatic enzymes decreased | Investigations | 5.9% (6 of 101) | 0.0% | 1 |
Source: ClinicalTrials.gov posted results, read 2026-10-03. A trial lists events above its own reporting threshold, so a rare event may be missing from some trials. Not medical advice.
FDA LABEL
What the FDA label says
LANREOTIDE ACETATE ANDA217193 · label of 2025-02-01 Regulator
Most common adverse reactions are: Acromegaly (>5%): diarrhea, cholelithiasis, abdominal pain, nausea and injection site reactions.
SOMATULINE DEPOT NDA022074 · label of 2024-10-11 Regulator
Most common adverse reactions are: Acromegaly (>5%): diarrhea, cholelithiasis, abdominal pain, nausea and injection site reactions.
QUESTIONS
Does lanreotide cause diarrhoea?
In 5 placebo-controlled trials with posted results, 19.5% of people on lanreotide reported diarrhoea, against 23.6% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does lanreotide cause abdominal pain?
In 5 placebo-controlled trials with posted results, 16.8% of people on lanreotide reported abdominal pain, against 15.9% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does lanreotide cause fatigue?
In 5 placebo-controlled trials with posted results, 12.2% of people on lanreotide reported fatigue, against 14.6% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does lanreotide cause nausea?
In 5 placebo-controlled trials with posted results, 11.0% of people on lanreotide reported nausea, against 12.0% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does lanreotide cause vomiting?
In 5 placebo-controlled trials with posted results, 10.8% of people on lanreotide reported vomiting, against 7.8% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
REGISTERED STUDIES
125 registered clinical trials of Lanreotide
The 10 most recently updated are listed.
| 2024-516616-24-00 | A Phase 3 randomized 3-arm trial (double-blind Debio 4126, placebo control, and open-label Debio 4126), to assess the efficacy and safety of Debio 4126, a 12-week octreotide formulation, in patients with acromegaly previously treated with somatostatin analogs. Status: UNKNOWN · Updated 2026-09-23 |
|---|---|
| NCT06878664 | Randomized Interval Assessment Trial of Lu177-Dotatate in Slowly Progressive G1-2 Advanced Midgut Neuroendocrine Tumors Status: RECRUITING · Updated 2026-09-16 |
| 2023-509334-19-00 | Trial title: Phase 1b/3 global, randomized, controlled, open-label trial comparing treatment with RYZ101 to standard of care (SoC) therapy in subjects with inoperable, advanced, somatostatin receptor expressing (SSTR+), well-differentiated gastro-enteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following prior 177Lu-labelled somatostatin analogue (177Lu-SSA) therapy (ACTION-1) Status: UNKNOWN · Updated 2026-08-31 |
| 2023-508723-12-00 | A randomized, multi-center, open-label, active-controlled Phase 3 trial to assess the efficacy and safety of octreotide subcutaneous depot (CAM2029) versus octreotide LAR or lanreotide ATG in patients with gastroenteropancreatic neuroendocrine tumors Status: UNKNOWN · Updated 2026-08-10 |
| NCT07087054 | Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen Status: RECRUITING · Updated 2026-08-04 |
| NCT05050942 | A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET Status: ACTIVE_NOT_RECRUITING · Updated 2026-07-28 |
| 2023-505884-35-00 | Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with long-acting Somatostatin Analogues - ATSA trial Status: UNKNOWN · Updated 2026-06-17 |
| NCT07534371 | Analysis of Optimal Treatment Sequencing of Surufatinib and Somatostatin Analogs in Neuroendocrine Tumors: A Retrospective Cohort Study Status: ACTIVE_NOT_RECRUITING · Updated 2026-04-16 |
| NCT05048901 | Cabozantinib and Lanreotide as Treatment for Gastroenteropancreatic Neuroendocrine Tumors Status: RECRUITING · Updated 2026-04-09 |
| NCT02127437 | Lanreotide In Polycystic Kidney Disease Study Status: COMPLETED · Updated 2026-04-08 |
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