TRIAL RESULTS · SIDE EFFECTS
Lixisenatide side effects
ANSWER
In 11 placebo-controlled trials with posted results, the most common side effects of Lixisenatide were nausea 24.8% (placebo 6.5%), hypoglycaemia 18.4% (placebo 16.4%), vomiting 10.3% (placebo 2.6%). Read from ClinicalTrials.gov on 2026-10-03. Not medical advice.
Trial register
Trials with posted results
23
with an arm on Lixisenatide, of 75 registered
Against placebo
11
placebo-controlled trials
People in those trials
7,147
on Lixisenatide · 5,297 on placebo
Read
2026-10-03
ClinicalTrials.gov
VS PLACEBO
Most common side effects, Lixisenatide beside placebo
Share of people with each side effect in 11 placebo-controlled trials with posted results: 7,147 people on Lixisenatide (all doses), 5,297 on placebo, same trials. Listed only when reported for at least half of the people on Lixisenatide. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
ALL TRIALS
The 100 most reported of 862 side effects reported
Every trial with posted results and an arm on Lixisenatide (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 | Lixisenatide | Placebo | Trials |
|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | 22.7% (2,295 of 10,111) | 6.5% | 23 |
| Hypoglycaemia | Metabolism and nutrition disorders | 16.7% (1,382 of 8,285) | 16.4% | 16 |
| Headache | Nervous system disorders | 9.0% (889 of 9,915) | 6.8% | 22 |
| Vomiting | Gastrointestinal disorders | 9.7% (873 of 8,976) | 2.6% | 19 |
| Diarrhoea | Gastrointestinal disorders | 9.9% (836 of 8,460) | 8.1% | 18 |
| Nasopharyngitis | Infections and infestations | 8.9% (832 of 9,322) | 9.0% | 20 |
| Dizziness | Nervous system disorders | 8.1% (608 of 7,524) | 6.3% | 13 |
| Hypertension | Vascular disorders | 3.9% (313 of 8,022) | 4.9% | 12 |
| Influenza | Infections and infestations | 4.5% (309 of 6,821) | 2.4% | 10 |
| Upper respiratory tract infection | Infections and infestations | 3.9% (281 of 7,290) | 2.3% | 10 |
| Back pain | Musculoskeletal and connective tissue disorders | 4.1% (261 of 6,384) | 2.0% | 9 |
| Dyspepsia | Gastrointestinal disorders | 2.9% (190 of 6,465) | 0.2% | 11 |
| Angina pectoris | Cardiac disorders | 3.9% (181 of 4,615) | 5.5% | 6 |
| Urinary tract infection | Infections and infestations | 2.3% (159 of 6,783) | 1.7% | 8 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 2.8% (158 of 5,733) | 1.6% | 7 |
| Bronchitis | Infections and infestations | 2.2% (147 of 6,542) | 2.1% | 8 |
| Non-cardiac chest pain | General disorders | 2.9% (145 of 5,067) | 5.1% | 6 |
| Blood glucose decreased | Investigations | 8.5% (119 of 1,396) | 3.6% | 4 |
| Fatigue | General disorders | 4.7% (96 of 2,031) | 1.9% | 7 |
| Gastroenteritis | Infections and infestations | 1.8% (89 of 4,987) | 1.1% | 5 |
| Constipation | Gastrointestinal disorders | 1.7% (85 of 4,915) | 0.6% | 8 |
| Pharyngitis | Infections and infestations | 4.9% (85 of 1,733) | 5.2% | 3 |
| Abdominal pain | Gastrointestinal disorders | 1.4% (80 of 5,560) | 0.7% | 7 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 1.6% (76 of 4,856) | 0.6% | 4 |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 1.1% (71 of 6,546) | 0.6% | 9 |
| Abdominal pain upper | Gastrointestinal disorders | 1.4% (65 of 4,486) | 0.6% | 5 |
| Cough | Respiratory, thoracic and mediastinal disorders | 1.3% (57 of 4,374) | 0.7% | 3 |
| Decreased appetite | Metabolism and nutrition disorders | 1.4% (53 of 3,879) | 0.0% | 7 |
| Asthenia | General disorders | 1.3% (53 of 4,157) | 0.7% | 4 |
| Pneumonia | Infections and infestations | 0.6% (49 of 7,682) | 1.4% | 11 |
| Gastritis | Gastrointestinal disorders | 0.8% (40 of 5,269) | 0.3% | 4 |
| Atrial fibrillation | Cardiac disorders | 0.5% (32 of 6,453) | 0.9% | 9 |
| Tremor | Nervous system disorders | 5.6% (31 of 551) | 2.6% | 2 |
| Oedema peripheral | General disorders | 0.7% (29 of 3,998) | 0.7% | 3 |
| Hypertensive crisis | Vascular disorders | 0.5% (23 of 4,381) | 0.4% | 4 |
| Renal failure acute | Renal and urinary disorders | 0.5% (22 of 4,079) | 0.6% | 4 |
| Abdominal discomfort | Gastrointestinal disorders | 9.9% (22 of 223) | 0.6% | 2 |
| Cellulitis | Infections and infestations | 0.4% (20 of 5,484) | 0.6% | 8 |
| Syncope | Nervous system disorders | 0.5% (17 of 3,551) | 0.5% | 3 |
| Hyperuricaemia | Metabolism and nutrition disorders | 2.0% (17 of 840) | 3.5% | 2 |
| Coronary artery disease | Cardiac disorders | 0.2% (15 of 6,872) | 0.3% | 9 |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 0.4% (15 of 3,733) | 0.5% | 2 |
| Acute myocardial infarction | Cardiac disorders | 0.3% (14 of 5,347) | 0.5% | 12 |
| Angina unstable | Cardiac disorders | 0.4% (14 of 3,784) | 0.4% | 9 |
| Cholelithiasis | Hepatobiliary disorders | 0.3% (14 of 4,625) | 0.2% | 3 |
| Cholecystitis acute | Hepatobiliary disorders | 0.2% (13 of 5,803) | 0.3% | 7 |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.2% (13 of 5,271) | 0.2% | 5 |
| Cholecystitis | Hepatobiliary disorders | 0.2% (13 of 5,587) | 0.2% | 5 |
| Diabetic nephropathy | Renal and urinary disorders | 2.5% (13 of 524) | 3.9% | 2 |
| Fall | Injury, poisoning and procedural complications | 0.2% (12 of 4,871) | 0.2% | 4 |
| Myalgia | Musculoskeletal and connective tissue disorders | 0.3% (12 of 3,675) | 0.5% | 2 |
| Cerebral infarction | Nervous system disorders | 0.3% (11 of 3,362) | 0.1% | 7 |
| Abdominal distension | Gastrointestinal disorders | 0.3% (11 of 3,225) | 0.0% | 4 |
| Inguinal hernia | Gastrointestinal disorders | 0.2% (10 of 5,013) | 0.1% | 4 |
| Sepsis | Infections and infestations | 0.3% (10 of 3,349) | 0.3% | 2 |
| Peripheral arterial occlusive disease | Vascular disorders | 0.2% (9 of 5,076) | 0.2% | 4 |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | 0.2% (9 of 3,733) | 0.6% | 2 |
| Ventricular tachycardia | Cardiac disorders | 0.3% (9 of 3,031) | 0.3% | 1 |
| Transient ischaemic attack | Nervous system disorders | 0.1% (8 of 5,357) | 0.1% | 7 |
| Contusion | Injury, poisoning and procedural complications | 0.2% (8 of 4,125) | 0.0% | 4 |
| Nephrolithiasis | Renal and urinary disorders | 0.2% (8 of 4,209) | 0.3% | 3 |
| Anaemia | Blood and lymphatic system disorders | 0.3% (8 of 3,146) | 0.3% | 2 |
| Diabetic foot | Skin and subcutaneous tissue disorders | 0.3% (8 of 3,031) | 0.1% | 1 |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.1% (7 of 5,096) | 0.1% | 6 |
| Hypoglycaemic unconsciousness | Metabolism and nutrition disorders | 0.2% (7 of 4,421) | 0.1% | 6 |
| Appendicitis | Infections and infestations | 0.2% (7 of 4,316) | 0.1% | 4 |
| Cataract | Eye disorders | 0.2% (7 of 4,002) | 0.1% | 4 |
| Renal failure | Renal and urinary disorders | 0.2% (7 of 3,815) | 0.2% | 4 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 0.2% (7 of 4,024) | 0.1% | 4 |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 0.2% (7 of 3,354) | 0.2% | 2 |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | 0.1% (6 of 4,238) | 0.1% | 5 |
| Goitre | Endocrine disorders | 0.1% (6 of 4,481) | 0.0% | 4 |
| Urticaria | Skin and subcutaneous tissue disorders | 0.1% (6 of 4,120) | 0.0% | 4 |
| Rib fracture | Injury, poisoning and procedural complications | 0.1% (6 of 5,023) | 0.1% | 4 |
| Deep vein thrombosis | Vascular disorders | 0.2% (6 of 3,582) | 0.1% | 3 |
| Erysipelas | Infections and infestations | 0.1% (6 of 4,031) | 0.2% | 3 |
| Bronchopneumonia | Infections and infestations | 0.2% (6 of 3,031) | 0.1% | 1 |
| Respiratory tract infection | Infections and infestations | 0.2% (6 of 3,031) | 0.1% | 1 |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.2% (6 of 3,031) | 0.1% | 1 |
| Renal failure chronic | Renal and urinary disorders | 0.2% (6 of 3,031) | 0.1% | 1 |
| Myocardial infarction | Cardiac disorders | 0.1% (5 of 3,951) | 0.5% | 10 |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.1% (5 of 6,043) | 0.1% | 6 |
| Cardiac failure congestive | Cardiac disorders | 0.2% (5 of 3,182) | 0.2% | 6 |
| Haemorrhoids | Gastrointestinal disorders | 0.1% (5 of 5,166) | 0.0% | 5 |
| Vitreous haemorrhage | Eye disorders | 0.1% (5 of 4,948) | 0.1% | 4 |
| Carotid artery stenosis | Nervous system disorders | 0.1% (5 of 3,677) | 0.2% | 3 |
| Anaphylactic shock | Immune system disorders | 0.1% (5 of 3,801) | 0.0% | 3 |
| Presyncope | Nervous system disorders | 0.1% (5 of 3,520) | 0.0% | 3 |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 0.1% (5 of 4,061) | 0.1% | 3 |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | 0.1% (5 of 3,582) | 0.1% | 3 |
| Lobar pneumonia | Infections and infestations | 0.1% (5 of 3,877) | 0.0% | 3 |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.1% (5 of 3,836) | 0.0% | 3 |
| Anal abscess | Infections and infestations | 0.1% (5 of 4,051) | 0.1% | 2 |
| Lipase increased | Investigations | 0.6% (5 of 904) | - | 2 |
| Early satiety | General disorders | 7.2% (5 of 69) | - | 1 |
| Hyperkalaemia | Metabolism and nutrition disorders | 0.2% (5 of 3,031) | 0.1% | 1 |
| Hyponatraemia | Metabolism and nutrition disorders | 0.2% (5 of 3,031) | 0.1% | 1 |
| Peripheral artery stenosis | Vascular disorders | 0.2% (5 of 3,031) | 0.1% | 1 |
| Myocardial ischaemia | Cardiac disorders | 0.1% (4 of 4,821) | 0.1% | 6 |
| Cholecystitis chronic | Hepatobiliary disorders | 0.1% (4 of 4,739) | 0.0% | 5 |
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
Soliqua 100/33 BLA208673 · label of 2026-03-18 Regulator
The most common adverse reactions, reported in ≥5% of patients treated with SOLIQUA 100/33 include hypoglycemia, nausea, nasopharyngitis, diarrhea, upper respiratory tract infection, and headache.
QUESTIONS
Does lixisenatide cause nausea?
In 11 placebo-controlled trials with posted results, 24.8% of people on lixisenatide reported nausea, against 6.5% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does lixisenatide cause hypoglycaemia?
In 11 placebo-controlled trials with posted results, 18.4% of people on lixisenatide reported hypoglycaemia, against 16.4% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does lixisenatide cause vomiting?
In 11 placebo-controlled trials with posted results, 10.3% of people on lixisenatide reported vomiting, against 2.6% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does lixisenatide cause diarrhoea?
In 11 placebo-controlled trials with posted results, 10.1% of people on lixisenatide reported diarrhoea, against 8.1% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does lixisenatide cause headache?
In 11 placebo-controlled trials with posted results, 9.6% of people on lixisenatide reported headache, against 6.8% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
REGISTERED STUDIES
75 registered clinical trials of Lixisenatide
The 10 most recently updated are listed.
| NCT05220917 | Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study Status: ACTIVE_NOT_RECRUITING · Updated 2026-08-13 |
|---|---|
| NCT06716424 | A Study to Investigate Safety and Efficacy of iGlarLixi in Adult Patients With Type 2 Diabetes Mellitus Status: COMPLETED · Updated 2026-07-10 |
| NCT07307235 | Efficacy and Safety of iGlarLixi Versus Standard of Care in a Real-world Adult China Population With Uncontrolled Type 2 Diabetes on Oral Agents Status: RECRUITING · Updated 2026-07-07 |
| NCT06671587 | iGlarLixi CGM Study in Chinese T2D Individuals After OADs Status: RECRUITING · Updated 2026-03-17 |
| NCT07173712 | Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes Status: NOT_YET_RECRUITING · Updated 2026-02-06 |
| NCT03439943 | Study to Evaluate the Effect of Lixisenatide in Patient With Parkinson's Disease Status: COMPLETED · Updated 2025-11-28 |
| NCT05413369 | iGlarLixi vs IDegAsp in Chinese Participants After OAD(s) Status: COMPLETED · Updated 2025-09-24 |
| NCT07188545 | Using Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic Health (CKMH) Outcomes in Real-world Settings (DASH-CKMH) Status: ACTIVE_NOT_RECRUITING · Updated 2025-09-23 |
| NCT07117240 | Evaluation of the Efficacy and Safety of GLP-1 Receptor Agonist Therapy In Steroid-Induced Diabetes Status: ENROLLING_BY_INVITATION · Updated 2025-09-19 |
| NCT05114590 | Effect of Soliqua 100/33 on Time in Range From Continuous Glucose Monitoring in Insulin-naive Patients With Very Uncontrolled Type 2 Diabetes Mellitus Status: COMPLETED · Updated 2025-09-09 |
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