TRIAL RESULTS · SIDE EFFECTS
Octreotide side effects
ANSWER
In 5 placebo-controlled trials with posted results, the most common side effects of Octreotide were diarrhoea 46.2% (placebo 31.7%), oedema peripheral 34.9% (placebo 19.6%), asthenia 33.3% (placebo 20.9%). Read from ClinicalTrials.gov on 2026-10-03. Not medical advice.
Trial register
Trials with posted results
24
with an arm on Octreotide, of 344 registered
Against placebo
5
placebo-controlled trials
People in those trials
442
on Octreotide · 444 on placebo
Read
2026-10-03
ClinicalTrials.gov
VS PLACEBO
Most common side effects, Octreotide beside placebo
Share of people with each side effect in 5 placebo-controlled trials with posted results: 442 people on Octreotide (all doses), 444 on placebo, same trials. Listed only when reported for at least half of the people on Octreotide. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
ALL TRIALS
The 100 most reported of 1114 side effects reported
Every trial with posted results and an arm on Octreotide (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 | Octreotide | Placebo | Trials |
|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | 23.9% (520 of 2,172) | 21.2% | 17 |
| Fatigue | General disorders | 30.6% (460 of 1,503) | 27.7% | 16 |
| Diarrhoea | Gastrointestinal disorders | 32.0% (455 of 1,424) | 31.7% | 12 |
| Headache | Nervous system disorders | 20.7% (356 of 1,718) | 18.5% | 15 |
| Hypertension | Vascular disorders | 17.6% (349 of 1,986) | 19.4% | 13 |
| Abdominal pain | Gastrointestinal disorders | 18.1% (322 of 1,780) | 21.9% | 16 |
| Diarrhea | Gastrointestinal disorders | 30.8% (267 of 868) | 40.0% | 7 |
| Vomiting | Gastrointestinal disorders | 12.2% (264 of 2,172) | 13.0% | 17 |
| Asthenia | General disorders | 20.2% (250 of 1,240) | 20.9% | 10 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 13.5% (213 of 1,573) | 13.8% | 12 |
| Oedema peripheral | General disorders | 13.7% (187 of 1,361) | 19.6% | 11 |
| Decreased appetite | Metabolism and nutrition disorders | 15.2% (170 of 1,122) | 15.2% | 9 |
| Aspartate aminotransferase increased | Investigations | 12.3% (158 of 1,285) | 3.2% | 11 |
| Dizziness | Nervous system disorders | 7.6% (152 of 2,012) | 8.5% | 14 |
| Constipation | Gastrointestinal disorders | 8.5% (146 of 1,710) | 9.8% | 13 |
| Anaemia | Blood and lymphatic system disorders | 14.0% (144 of 1,029) | 9.1% | 9 |
| Cough | Respiratory, thoracic and mediastinal disorders | 15.5% (143 of 924) | 15.2% | 8 |
| Back pain | Musculoskeletal and connective tissue disorders | 10.9% (141 of 1,289) | 16.6% | 13 |
| Stomatitis | Gastrointestinal disorders | 42.5% (137 of 322) | 11.8% | 3 |
| Rash | Skin and subcutaneous tissue disorders | 26.0% (131 of 504) | 14.1% | 5 |
| Hyperglycaemia | Metabolism and nutrition disorders | 13.0% (126 of 967) | 4.5% | 8 |
| Weight decreased | Investigations | 11.9% (126 of 1,060) | 9.1% | 8 |
| Alanine aminotransferase increased | Investigations | 9.6% (123 of 1,285) | 2.3% | 11 |
| Hyperglycemia | Metabolism and nutrition disorders | 52.8% (122 of 231) | - | 3 |
| Flatulence | Gastrointestinal disorders | 6.9% (113 of 1,643) | 11.1% | 13 |
| Platelet count decreased | Investigations | 19.5% (110 of 563) | - | 5 |
| Abdominal distension | Gastrointestinal disorders | 7.3% (107 of 1,470) | 5.7% | 11 |
| Insomnia | Psychiatric disorders | 8.7% (106 of 1,215) | 6.6% | 11 |
| Pyrexia | General disorders | 7.2% (100 of 1,396) | 7.0% | 10 |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 20.7% (97 of 469) | 2.4% | 4 |
| Abdominal pain upper | Gastrointestinal disorders | 6.9% (96 of 1,392) | 10.0% | 10 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 14.1% (96 of 681) | 9.1% | 6 |
| Cholelithiasis | Hepatobiliary disorders | 10.2% (95 of 935) | 0.4% | 7 |
| Mucositis oral | Gastrointestinal disorders | 61.9% (91 of 147) | - | 1 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 7.7% (88 of 1,143) | 11.3% | 10 |
| Anemia | Blood and lymphatic system disorders | 37.7% (87 of 231) | - | 3 |
| Alopecia | Skin and subcutaneous tissue disorders | 8.9% (86 of 969) | 1.9% | 6 |
| Nasopharyngitis | Infections and infestations | 9.1% (85 of 930) | 12.6% | 7 |
| Hypokalaemia | Metabolism and nutrition disorders | 10.1% (85 of 842) | 2.6% | 7 |
| Pruritus | Skin and subcutaneous tissue disorders | 13.6% (85 of 627) | 5.7% | 4 |
| Dysgeusia | Nervous system disorders | 12.8% (74 of 576) | 5.7% | 5 |
| Proteinuria | Renal and urinary disorders | 12.4% (74 of 595) | - | 3 |
| Fatigue (asthenia, lethargy, malaise) | General disorders | 18.9% (74 of 391) | - | 1 |
| Hypertriglyceridemia | Metabolism and nutrition disorders | 49.7% (73 of 147) | - | 1 |
| Urinary tract infection | Infections and infestations | 5.1% (71 of 1,395) | 4.5% | 13 |
| Anorexia | Gastrointestinal disorders | 10.3% (70 of 679) | 3.1% | 5 |
| Weight loss | General disorders | 27.3% (70 of 256) | - | 3 |
| Thrombocytopenia | Blood and lymphatic system disorders | 7.6% (67 of 879) | 0.8% | 8 |
| Glucose, serum-high (hyperglycemia) | Investigations | 14.7% (67 of 455) | - | 2 |
| Dyspepsia | Gastrointestinal disorders | 5.1% (66 of 1,294) | 1.7% | 11 |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | 7.4% (65 of 873) | 7.4% | 8 |
| Dry skin | Skin and subcutaneous tissue disorders | 12.3% (65 of 528) | 2.4% | 5 |
| Cholesterol high | Investigations | 43.5% (64 of 147) | - | 1 |
| Alkaline phosphatase increased | Investigations | 32.8% (63 of 192) | - | 2 |
| Neutrophil count decreased | Investigations | 13.7% (62 of 451) | - | 4 |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 42.2% (62 of 147) | - | 1 |
| Myalgia | Musculoskeletal and connective tissue disorders | 6.8% (58 of 852) | 6.6% | 7 |
| Anxiety | Psychiatric disorders | 5.8% (56 of 961) | 7.4% | 10 |
| Upper respiratory tract infection | Infections and infestations | 6.3% (55 of 867) | 5.9% | 6 |
| Dehydration | Metabolism and nutrition disorders | 4.6% (51 of 1,119) | 5.7% | 9 |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | 11.0% (50 of 455) | - | 2 |
| Flushing | Vascular disorders | 6.2% (49 of 790) | 9.5% | 6 |
| Lymphocyte count decreased | Investigations | 8.7% (49 of 563) | - | 5 |
| Pain | General disorders | 5.5% (47 of 851) | 1.5% | 9 |
| White blood cell decreased | Investigations | 19.9% (46 of 231) | - | 3 |
| Edema limbs | General disorders | 19.9% (46 of 231) | - | 3 |
| Chills | General disorders | 6.0% (45 of 753) | 4.1% | 7 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 8.2% (45 of 546) | 2.8% | 4 |
| Gamma-glutamyltransferase increased | Investigations | 6.9% (44 of 635) | 10.7% | 5 |
| Mucosal inflammation | General disorders | 22.8% (44 of 193) | 13.1% | 2 |
| Neutropenia | Blood and lymphatic system disorders | 4.6% (43 of 940) | 1.4% | 7 |
| Blood bilirubin increased | Investigations | 4.6% (41 of 900) | - | 8 |
| Dry mouth | Gastrointestinal disorders | 7.2% (41 of 571) | 2.8% | 6 |
| Blood creatinine increased | Investigations | 4.7% (41 of 867) | 2.4% | 6 |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 4.6% (40 of 867) | 6.2% | 6 |
| Injection site pain | Skin and subcutaneous tissue disorders | 7.6% (40 of 523) | - | 4 |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | 8.8% (40 of 455) | - | 2 |
| Hypoalbuminemia | Metabolism and nutrition disorders | 20.8% (40 of 192) | - | 2 |
| AST,SGOT | Investigations | 62.5% (40 of 64) | - | 1 |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 5.2% (39 of 743) | 9.6% | 7 |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 9.6% (39 of 407) | 0.9% | 3 |
| Hemoglobin | Blood and lymphatic system disorders | 8.6% (39 of 455) | - | 2 |
| Hypocalcemia | Metabolism and nutrition disorders | 20.3% (39 of 192) | - | 2 |
| Influenza | Infections and infestations | 3.9% (38 of 975) | 0.3% | 6 |
| COVID-19 | Infections and infestations | 11.0% (38 of 345) | 2.3% | 2 |
| Mucositis/stomatitis (functional/symptomatic) | Gastrointestinal disorders | 59.4% (38 of 64) | - | 1 |
| Sinusitis | Infections and infestations | 4.9% (35 of 710) | 3.8% | 6 |
| Depression | Psychiatric disorders | 7.1% (35 of 490) | 5.2% | 5 |
| Aphthous stomatitis | Gastrointestinal disorders | 13.1% (34 of 260) | 1.4% | 2 |
| Pain - Abdomen NOS | Gastrointestinal disorders | 8.7% (34 of 391) | - | 1 |
| Hyponatremia | Metabolism and nutrition disorders | 6.7% (33 of 496) | - | 3 |
| Hypophosphatemia | Metabolism and nutrition disorders | 22.4% (33 of 147) | - | 1 |
| Creatinine increased | Investigations | 13.4% (31 of 231) | - | 3 |
| Injection site reaction | Skin and subcutaneous tissue disorders | 30.1% (31 of 103) | - | 2 |
| Triglyceride, serum-high (hypertriglyceridemia) | Investigations | 6.8% (31 of 455) | - | 2 |
| Blood creatine phosphokinase increased | Investigations | 11.3% (31 of 275) | - | 2 |
| Hypoglycaemia | Metabolism and nutrition disorders | 3.1% (30 of 964) | 0.6% | 6 |
| Hypokalemia | Metabolism and nutrition disorders | 13.0% (30 of 231) | - | 3 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 12.6% (29 of 231) | - | 3 |
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | 10.7% (29 of 272) | 3.1% | 2 |
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
Sandostatin NDA019667 · label of 2026-07-22 Regulator
Most common adverse reactions (incidence > 10%) in patients with acromegaly are gallbladder abnormalities, sinus bradycardia, diarrhea, loose stools, nausea, abdominal discomfort, hyperglycemia, and hypothyroidism.
Octreotide Acetate ANDA216839 · label of 2026-01-30 Regulator
Most common adverse reactions (incidence > 10%) in patients with acromegaly are gallbladder abnormalities, sinus bradycardia, diarrhea, loose stools, nausea, abdominal discomfort, hyperglycemia, and hypothyroidism.
Sandostatin LAR Depot NDA021008 · label of 2025-12-22 Regulator
The most common adverse reactions, occurring in ≥ 20% of patients are: Acromegaly: diarrhea, cholelithiasis, abdominal pain, flatulence.
QUESTIONS
Does octreotide cause diarrhoea?
In 5 placebo-controlled trials with posted results, 46.2% of people on octreotide reported diarrhoea, against 31.7% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does octreotide cause oedema peripheral?
In 5 placebo-controlled trials with posted results, 34.9% of people on octreotide reported oedema peripheral, against 19.6% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does octreotide cause asthenia?
In 5 placebo-controlled trials with posted results, 33.3% of people on octreotide reported asthenia, against 20.9% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does octreotide cause nausea?
In 5 placebo-controlled trials with posted results, 30.8% of people on octreotide reported nausea, against 21.2% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does octreotide cause fatigue?
In 5 placebo-controlled trials with posted results, 29.8% of people on octreotide reported fatigue, against 27.7% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
REGISTERED STUDIES
344 registered clinical trials of Octreotide
The 10 most recently updated are listed.
| NCT02019706 | Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome Status: RECRUITING · Updated 2026-10-02 |
|---|---|
| NCT00569127 | Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor Status: ACTIVE_NOT_RECRUITING · Updated 2026-10-01 |
| NCT07583563 | An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly Status: RECRUITING · Updated 2026-09-25 |
| 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 |
| 2023-507443-10-00 | A phase III multi-center, randomized, open-label study to evaluate the efficacy and safety of Lutathera in patients with Grade 2 and Grade 3 advanced GEP-NET (NETTER-2) Status: UNKNOWN · Updated 2026-09-18 |
| 2024-519667-18-00 | Preventing postoperative complications in patients undergoing high-risk pancreatoduodenectomy with a bundle approach including hydrocortisone, ocreotide, and teres ligament patch (PANENCA): an international randomized controlled multicenter trial Status: UNKNOWN · Updated 2026-09-17 |
| NCT06878664 | Randomized Interval Assessment Trial of Lu177-Dotatate in Slowly Progressive G1-2 Advanced Midgut Neuroendocrine Tumors Status: RECRUITING · Updated 2026-09-16 |
| NCT07663318 | A Phase 1 Study to Evaluate the Relative Bioavailability of Octreotide Acetate Tablets(T25) Compared to MYCAPSSA® and The Food Effect on Pharmacokinetics Of Octreotide Acetate Tablets(T25) Status: COMPLETED · Updated 2026-09-16 |
| NCT06784752 | Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET Status: RECRUITING · Updated 2026-09-11 |
| NCT07814651 | A Clinical Trial to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Octreotide Long-acting Injection in Patients With Acromegaly Status: COMPLETED · Updated 2026-09-11 |
WEEKLY
Register Watch, weekly
New trials, approvals and enforcement actions. One email a week.