TRIAL RESULTS · SIDE EFFECTS
Teduglutide side effects
ANSWER
In 1 placebo-controlled trial with posted results, the most common side effects of Teduglutide were abdominal pain 31.0% (placebo 23.3%), nausea 28.6% (placebo 18.6%), gastrointestinal stoma complication 23.8% (placebo 7.0%). Read from ClinicalTrials.gov on 2026-10-03. Not medical advice.
Trial register
Trials with posted results
5
with an arm on Teduglutide, of 51 registered
Against placebo
1
placebo-controlled trials
People in those trials
42
on Teduglutide · 43 on placebo
Read
2026-10-03
ClinicalTrials.gov
VS PLACEBO
Most common side effects, Teduglutide beside placebo
Share of people with each side effect in 1 placebo-controlled trial with posted results: 42 people on Teduglutide (all doses), 43 on placebo, same trials. Listed only when reported for at least half of the people on Teduglutide. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
ALL TRIALS
The 100 most reported of 281 side effects reported
Every trial with posted results and an arm on Teduglutide (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 | Teduglutide | Placebo | Trials |
|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | 17.8% (60 of 337) | 9.3% | 5 |
| Abdominal pain | Gastrointestinal disorders | 16.9% (57 of 337) | 23.3% | 5 |
| Nausea | Gastrointestinal disorders | 13.4% (45 of 337) | 18.6% | 5 |
| Headache | Nervous system disorders | 13.2% (39 of 295) | - | 4 |
| Pyrexia | General disorders | 18.2% (38 of 209) | 9.3% | 4 |
| Nasopharyngitis | Infections and infestations | 15.8% (33 of 209) | 0.0% | 4 |
| Cough | Respiratory, thoracic and mediastinal disorders | 19.2% (32 of 167) | - | 3 |
| Upper respiratory tract infection | Infections and infestations | 26.0% (26 of 100) | - | 2 |
| Diarrhoea | Gastrointestinal disorders | 24.0% (24 of 100) | - | 2 |
| Abdominal distension | Gastrointestinal disorders | 8.5% (23 of 270) | 2.3% | 4 |
| Urinary tract infection | Infections and infestations | 9.6% (20 of 209) | 9.3% | 4 |
| Device related infection | Infections and infestations | 19.0% (19 of 100) | - | 2 |
| Alanine aminotransferase increased | Investigations | 19.0% (19 of 100) | - | 2 |
| Influenza | Infections and infestations | 8.6% (18 of 209) | 0.0% | 4 |
| Fatigue | General disorders | 11.3% (18 of 159) | 7.0% | 3 |
| Viral infection | Infections and infestations | 10.6% (15 of 142) | 0.0% | 3 |
| Abdominal pain upper | Gastrointestinal disorders | 13.0% (13 of 100) | - | 2 |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 13.0% (13 of 100) | - | 2 |
| Rash | Skin and subcutaneous tissue disorders | 13.0% (13 of 100) | - | 2 |
| Injection site bruising | General disorders | 10.3% (12 of 117) | - | 2 |
| Injection site erythema | General disorders | 6.2% (12 of 195) | - | 2 |
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | 13.0% (12 of 92) | 7.0% | 2 |
| Device breakage | Injury, poisoning and procedural complications | 7.7% (11 of 142) | 2.3% | 3 |
| Injection site pain | General disorders | 5.6% (11 of 195) | - | 2 |
| Rhinitis | Infections and infestations | 11.0% (11 of 100) | - | 2 |
| Dizziness | Nervous system disorders | 3.4% (10 of 295) | - | 4 |
| Dehydration | Metabolism and nutrition disorders | 7.0% (10 of 142) | 0.0% | 3 |
| Catheter sepsis | Infections and infestations | 8.3% (9 of 109) | 0.0% | 2 |
| Ear infection | Infections and infestations | 9.0% (9 of 100) | - | 2 |
| Aspartate aminotransferase increased | Investigations | 9.0% (9 of 100) | - | 2 |
| Device occlusion | Product Issues | 9.0% (9 of 100) | - | 2 |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 9.0% (9 of 100) | - | 2 |
| abdominal distension | Gastrointestinal disorders | 13.4% (9 of 67) | - | 1 |
| Catheter site infection | Infections and infestations | 4.8% (8 of 167) | - | 3 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 4.8% (8 of 167) | - | 3 |
| Flatulence | Gastrointestinal disorders | 8.7% (8 of 92) | 7.0% | 2 |
| Blood bicarbonate decreased | Investigations | 8.0% (8 of 100) | - | 2 |
| Metabolic acidosis | Metabolism and nutrition disorders | 8.0% (8 of 100) | - | 2 |
| C-reactive protein increased | Investigations | 16.0% (8 of 50) | - | 1 |
| Pain | General disorders | 6.0% (7 of 117) | - | 2 |
| Central line systemic infections | Infections and infestations | 16.7% (7 of 42) | 16.3% | 1 |
| Edema peripheral | General disorders | 16.7% (7 of 42) | 4.7% | 1 |
| Gastroenteritis viral | Infections and infestations | 6.0% (6 of 100) | - | 2 |
| Gastrointestinal bacterial overgrowth | Infections and infestations | 6.0% (6 of 100) | - | 2 |
| Respiratory tract infection | Infections and infestations | 6.0% (6 of 100) | - | 2 |
| Acidosis | Metabolism and nutrition disorders | 6.0% (6 of 100) | - | 2 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 6.0% (6 of 100) | - | 2 |
| Hypokalaemia | Metabolism and nutrition disorders | 6.0% (6 of 100) | - | 2 |
| Abdominal Pain Upper | Gastrointestinal disorders | 9.0% (6 of 67) | - | 1 |
| Intestinal stoma complications | Injury, poisoning and procedural complications | 9.0% (6 of 67) | - | 1 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 4.3% (5 of 117) | - | 2 |
| Lymphadenopathy | Blood and lymphatic system disorders | 5.0% (5 of 100) | - | 2 |
| Ear pain | Ear and labyrinth disorders | 5.0% (5 of 100) | - | 2 |
| Device related sepsis | Infections and infestations | 5.0% (5 of 100) | - | 2 |
| Blood urea increased | Investigations | 5.0% (5 of 100) | - | 2 |
| Asthenia | General disorders | 7.5% (5 of 67) | - | 1 |
| Catheter-related infection | Infections and infestations | 11.9% (5 of 42) | 2.3% | 1 |
| Contusion | Injury, poisoning and procedural complications | 10.0% (5 of 50) | - | 1 |
| Decreased appetite | Metabolism and nutrition disorders | 10.0% (5 of 50) | - | 1 |
| Pneumonia | Infections and infestations | 1.9% (4 of 209) | 0.0% | 4 |
| Cellulitis | Infections and infestations | 4.0% (4 of 100) | - | 2 |
| Otitis media | Infections and infestations | 4.0% (4 of 100) | - | 2 |
| Viral upper respiratory tract infection | Infections and infestations | 4.0% (4 of 100) | - | 2 |
| Catheter related complications | General disorders | 6.0% (4 of 67) | - | 1 |
| Conjunctivitis | Infections and infestations | 8.0% (4 of 50) | - | 1 |
| Haematochezia | Gastrointestinal disorders | 8.0% (4 of 50) | - | 1 |
| Gastrostomy tube site complication | Injury, poisoning and procedural complications | 8.0% (4 of 50) | - | 1 |
| Laceration | Injury, poisoning and procedural complications | 8.0% (4 of 50) | - | 1 |
| Skin abrasion | Injury, poisoning and procedural complications | 8.0% (4 of 50) | - | 1 |
| Gamma-glutamyltransferase increased | Investigations | 8.0% (4 of 50) | - | 1 |
| Haemoglobin decreased | Investigations | 8.0% (4 of 50) | - | 1 |
| Lipase increased | Investigations | 8.0% (4 of 50) | - | 1 |
| Device dislocation | Injury, poisoning and procedural complications | 2.1% (3 of 142) | 4.7% | 3 |
| Sepsis | Infections and infestations | 2.6% (3 of 117) | - | 2 |
| Blood triglycerides increased | Investigations | 3.0% (3 of 100) | - | 2 |
| Otitis media acute | Infections and infestations | 3.0% (3 of 100) | - | 2 |
| diahrrea | Gastrointestinal disorders | 4.5% (3 of 67) | - | 1 |
| Dyspepsia | Gastrointestinal disorders | 4.5% (3 of 67) | - | 1 |
| Back pain | Musculoskeletal and connective tissue disorders | 4.5% (3 of 67) | - | 1 |
| Catheter related complication | General disorders | 4.5% (3 of 67) | - | 1 |
| Diarrhea | Gastrointestinal disorders | 7.1% (3 of 42) | 11.6% | 1 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 7.1% (3 of 42) | 0.0% | 1 |
| Weight increased | Investigations | 7.1% (3 of 42) | 7.0% | 1 |
| Seasonal allergy | Immune system disorders | 6.0% (3 of 50) | - | 1 |
| Tachycardia | Cardiac disorders | 6.0% (3 of 50) | - | 1 |
| Constipation | Gastrointestinal disorders | 6.0% (3 of 50) | - | 1 |
| Anastomotic ulcer | Injury, poisoning and procedural complications | 6.0% (3 of 50) | - | 1 |
| Blood urine present | Investigations | 6.0% (3 of 50) | - | 1 |
| Body temperature increased | Investigations | 6.0% (3 of 50) | - | 1 |
| Crystal urine present | Investigations | 6.0% (3 of 50) | - | 1 |
| International normalised ratio increased | Investigations | 6.0% (3 of 50) | - | 1 |
| Prothrombin time prolonged | Investigations | 6.0% (3 of 50) | - | 1 |
| White blood cells urine positive | Investigations | 6.0% (3 of 50) | - | 1 |
| Hyperchloraemia | Metabolism and nutrition disorders | 6.0% (3 of 50) | - | 1 |
| Hyponatraemia | Metabolism and nutrition disorders | 6.0% (3 of 50) | - | 1 |
| Lethargy | Nervous system disorders | 6.0% (3 of 50) | - | 1 |
| Haematuria | Renal and urinary disorders | 6.0% (3 of 50) | - | 1 |
| Vessel puncture site pain | General disorders | 2.3% (3 of 128) | - | 1 |
| Cholecystitis acute | Hepatobiliary disorders | 1.8% (2 of 109) | 0.0% | 2 |
| Infectious mononucleosis | Infections and infestations | 1.7% (2 of 117) | - | 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
Gattex NDA203441 · label of 2025-09-05 Regulator
Most common adverse reactions (≥10%) are: abdominal pain, nausea, upper respiratory tract infection, abdominal distension, injection site reaction, vomiting, fluid overload, and hypersensitivity.
Serious reactions the label warns about: Acceleration of Neoplastic Growth, Intestinal Obstruction, Biliary and Pancreatic Disease, Fluid Imbalance and Fluid Overload.
QUESTIONS
Does teduglutide cause abdominal pain?
In 1 placebo-controlled trial with posted results, 31.0% of people on teduglutide reported abdominal pain, against 23.3% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does teduglutide cause nausea?
In 1 placebo-controlled trial with posted results, 28.6% of people on teduglutide reported nausea, against 18.6% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does teduglutide cause gastrointestinal stoma complication?
In 1 placebo-controlled trial with posted results, 23.8% of people on teduglutide reported gastrointestinal stoma complication, against 7.0% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does teduglutide cause abdominal distension?
In 1 placebo-controlled trial with posted results, 21.4% of people on teduglutide reported abdominal distension, against 2.3% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does teduglutide cause central line systemic infections?
In 1 placebo-controlled trial with posted results, 16.7% of people on teduglutide reported central line systemic infections, against 16.3% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
REGISTERED STUDIES
51 registered clinical trials of Teduglutide
The 10 most recently updated are listed.
| NCT06973304 | A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome Status: ACTIVE_NOT_RECRUITING · Updated 2026-09-08 |
|---|---|
| NCT05023382 | A Study of Teduglutide in Japanese People With Short Bowel Syndrome Status: COMPLETED · Updated 2026-08-07 |
| NCT07537686 | Glucagon-like Peptide 2 (GLP-2) in Undernourished Women Improving From Histology-Confirmed Environmental Enteric Dysfunction (EED) Status: NOT_YET_RECRUITING · Updated 2026-04-17 |
| NCT07319832 | A Study of Teduglutide in Chinese Children and Teenagers With Short Bowel Syndrome Status: RECRUITING · Updated 2026-03-13 |
| NCT07400783 | TED_ORG: Study on Short Bowel Syndrome Status: RECRUITING · Updated 2026-02-10 |
| NCT05561647 | A Survey to Assess Participants' and Physicians' Knowledge When Using GATTEX (Knowledge Assessment Survey) Status: RECRUITING · Updated 2026-01-26 |
| NCT01990040 | Registry for Participants With Short Bowel Syndrome Status: ACTIVE_NOT_RECRUITING · Updated 2025-10-10 |
| NCT03562130 | Characterization of the Long-term Safety, Efficacy, and Pharmacodynamics Revestive® in the Management of Short Bowel Syndrome Pediatric Patients Status: COMPLETED · Updated 2025-09-11 |
| NCT05371028 | A Study of Teduglutide (Revestive®) in Participants With Short Bowel Syndrome (SBS) in Canada Status: COMPLETED · Updated 2025-04-06 |
| NCT02954458 | Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS) Status: COMPLETED · Updated 2025-03-28 |
WEEKLY
Register Watch, weekly
New trials, approvals and enforcement actions. One email a week.