TRIAL RESULTS · SIDE EFFECTS
Terlipressin side effects
ANSWER
In 2 placebo-controlled trials with posted results, the most common side effects of Terlipressin were abdominal pain 21.8% (placebo 13.4%), diarrhoea 16.4% (placebo 5.7%), nausea 15.0% (placebo 11.3%). Read from ClinicalTrials.gov on 2026-10-03. Not medical advice.
Trial register
Trials with posted results
5
with an arm on Terlipressin, of 118 registered
Against placebo
2
placebo-controlled trials
People in those trials
293
on Terlipressin · 194 on placebo
Read
2026-10-03
ClinicalTrials.gov
VS PLACEBO
Most common side effects, Terlipressin beside placebo
Share of people with each side effect in 2 placebo-controlled trials with posted results: 293 people on Terlipressin (all doses), 194 on placebo, same trials. Listed only when reported for at least half of the people on Terlipressin. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
ALL TRIALS
The 100 most reported of 229 side effects reported
Every trial with posted results and an arm on Terlipressin (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 | Terlipressin | Placebo | Trials |
|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | 19.6% (71 of 363) | 13.4% | 4 |
| Diarrhoea | Gastrointestinal disorders | 17.3% (54 of 313) | 5.7% | 3 |
| Nausea | Gastrointestinal disorders | 15.0% (44 of 293) | 11.3% | 2 |
| Hypotension | Vascular disorders | 10.5% (36 of 343) | 6.7% | 3 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 12.3% (36 of 293) | 6.7% | 2 |
| Vomiting | Gastrointestinal disorders | 8.6% (27 of 313) | 7.2% | 3 |
| Hypokalaemia | Metabolism and nutrition disorders | 8.9% (26 of 293) | 6.2% | 2 |
| Hepatic encephalopathy | Nervous system disorders | 8.0% (25 of 313) | 11.3% | 3 |
| Fluid overload | Metabolism and nutrition disorders | 8.2% (24 of 293) | 4.1% | 2 |
| Anaemia | Blood and lymphatic system disorders | 7.8% (23 of 293) | 7.7% | 2 |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 8.8% (22 of 250) | 3.0% | 2 |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | 7.2% (21 of 293) | 4.6% | 2 |
| Bradycardia | Cardiac disorders | 6.5% (19 of 293) | 1.0% | 2 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 6.1% (18 of 293) | 2.1% | 2 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 5.1% (15 of 293) | 1.0% | 2 |
| Sepsis | Infections and infestations | 4.8% (14 of 293) | 1.5% | 2 |
| Chronic hepatic failure | Hepatobiliary disorders | 7.0% (14 of 200) | 8.1% | 1 |
| Multiple Organ Dysfunction Syndrome | General disorders | 12.9% (12 of 93) | 6.3% | 1 |
| Ascites | Gastrointestinal disorders | 3.5% (11 of 313) | 3.1% | 3 |
| Metabolic acidosis | Metabolism and nutrition disorders | 3.8% (11 of 293) | 4.1% | 2 |
| Tachycardia | Cardiac disorders | 4.4% (11 of 250) | 8.1% | 2 |
| Chest pain | General disorders | 5.5% (11 of 200) | 3.0% | 1 |
| Multiple organ dysfunction syndrome | General disorders | 5.5% (11 of 200) | 5.1% | 1 |
| Hepatic failure | Hepatobiliary disorders | 5.5% (11 of 200) | 10.1% | 1 |
| Pyrexia | General disorders | 3.4% (10 of 293) | 6.2% | 2 |
| Urinary tract infection | Infections and infestations | 3.4% (10 of 293) | 6.2% | 2 |
| Mental status changes | Psychiatric disorders | 3.1% (9 of 293) | 0.5% | 2 |
| Lethargy | Nervous system disorders | 9.7% (9 of 93) | 3.2% | 1 |
| Chronic Hepatic Failure | Hepatobiliary disorders | 9.7% (9 of 93) | 8.4% | 1 |
| AKI | Renal and urinary disorders | 18.0% (9 of 50) | - | 1 |
| Acute kidney injury | Renal and urinary disorders | 2.7% (8 of 293) | 2.1% | 2 |
| Asterixis | Nervous system disorders | 8.6% (8 of 93) | 4.2% | 1 |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 4.0% (8 of 200) | 0.0% | 1 |
| Hepatic cirrhosis | Hepatobiliary disorders | 4.0% (8 of 200) | 3.0% | 1 |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 4.0% (8 of 200) | 2.0% | 1 |
| Abdominal distension | Gastrointestinal disorders | 2.4% (7 of 293) | 2.1% | 2 |
| Oedema peripheral | General disorders | 2.4% (7 of 293) | 4.1% | 2 |
| Hyperglycaemia | Metabolism and nutrition disorders | 2.4% (7 of 293) | 1.0% | 2 |
| Headache | Nervous system disorders | 6.2% (7 of 113) | 5.3% | 2 |
| Hepatorenal Syndrome | Hepatobiliary disorders | 7.5% (7 of 93) | 2.1% | 1 |
| Septic shock | Infections and infestations | 3.5% (7 of 200) | 0.0% | 1 |
| Pneumonia | Infections and infestations | 2.0% (6 of 293) | 4.1% | 2 |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 6.5% (6 of 93) | 0.0% | 1 |
| Anxiety | Psychiatric disorders | 6.5% (6 of 93) | 3.2% | 1 |
| Insomnia | Psychiatric disorders | 6.5% (6 of 93) | 3.2% | 1 |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | 6.5% (6 of 93) | 0.0% | 1 |
| Ecchymosis | Skin and subcutaneous tissue disorders | 6.5% (6 of 93) | 3.2% | 1 |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | 6.5% (6 of 93) | 1.1% | 1 |
| Altered Mental Status (including hepatic encephalopathy) | Nervous system disorders | 12.0% (6 of 50) | - | 1 |
| Coagulopathy | Blood and lymphatic system disorders | 1.7% (5 of 293) | 2.6% | 2 |
| Hepatorenal syndrome | Hepatobiliary disorders | 1.7% (5 of 293) | 6.2% | 2 |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 1.7% (5 of 293) | 1.0% | 2 |
| Hyperphosphataemia | Metabolism and nutrition disorders | 5.4% (5 of 93) | 5.3% | 1 |
| Hypophosphataemia | Metabolism and nutrition disorders | 5.4% (5 of 93) | 2.1% | 1 |
| Abdominal Pain | Gastrointestinal disorders | 5.4% (5 of 93) | 1.1% | 1 |
| Cirrhosis alcoholic | Hepatobiliary disorders | 2.5% (5 of 200) | 3.0% | 1 |
| Shock | Vascular disorders | 2.5% (5 of 200) | 3.0% | 1 |
| worsening ascites | Hepatobiliary disorders | 10.0% (5 of 50) | - | 1 |
| diarrhea | Gastrointestinal disorders | 1.5% (4 of 261) | - | 1 |
| Hepatic Failure | Hepatobiliary disorders | 4.3% (4 of 93) | 6.3% | 1 |
| Septic Shock | Infections and infestations | 4.3% (4 of 93) | 2.1% | 1 |
| Renal failure | Renal and urinary disorders | 2.0% (4 of 200) | 0.0% | 1 |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | 2.0% (4 of 200) | 0.0% | 1 |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | 1.4% (3 of 220) | 2.0% | 2 |
| Renal Failure | Renal and urinary disorders | 3.2% (3 of 93) | 4.2% | 1 |
| Renal Impairment | Renal and urinary disorders | 3.2% (3 of 93) | 0.0% | 1 |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | 3.2% (3 of 93) | 3.2% | 1 |
| Hypertension | Vascular disorders | 15.0% (3 of 20) | - | 1 |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | 1.5% (3 of 200) | 2.0% | 1 |
| Liver failure | Hepatobiliary disorders | 6.0% (3 of 50) | - | 1 |
| Thrombocytopenia | Blood and lymphatic system disorders | 1.4% (2 of 143) | 0.0% | 2 |
| Urosepsis | Infections and infestations | 0.7% (2 of 293) | 0.0% | 2 |
| Hyperkalaemia | Metabolism and nutrition disorders | 0.7% (2 of 293) | 0.5% | 2 |
| Encephalopathy | Nervous system disorders | 0.7% (2 of 293) | 0.0% | 2 |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 2.2% (2 of 93) | 5.3% | 1 |
| Cardio-Respiratory Arrest | Cardiac disorders | 2.2% (2 of 93) | 1.1% | 1 |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | 2.2% (2 of 93) | 1.1% | 1 |
| Intestinal Ischaemia | Gastrointestinal disorders | 2.2% (2 of 93) | 0.0% | 1 |
| Oesophageal Varices Haemorrhage | Gastrointestinal disorders | 2.2% (2 of 93) | 1.1% | 1 |
| Asthenia | General disorders | 2.2% (2 of 93) | 1.1% | 1 |
| Hepatorenal Failure | Hepatobiliary disorders | 2.2% (2 of 93) | 1.1% | 1 |
| Enterococcal Infection | Infections and infestations | 2.2% (2 of 93) | 0.0% | 1 |
| Peritonitis Bacterial | Infections and infestations | 2.2% (2 of 93) | 0.0% | 1 |
| Acute Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | 2.2% (2 of 93) | 1.1% | 1 |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | 2.2% (2 of 93) | 2.1% | 1 |
| Vascular Skin Disorder | Skin and subcutaneous tissue disorders | 2.2% (2 of 93) | 0.0% | 1 |
| Oliguria | Renal and urinary disorders | 2.2% (2 of 93) | 0.0% | 1 |
| Cardiac arrest | Cardiac disorders | 1.0% (2 of 200) | 1.0% | 1 |
| Pulseless electrical activity | Cardiac disorders | 1.0% (2 of 200) | 1.0% | 1 |
| Intestinal ischaemia | Gastrointestinal disorders | 1.0% (2 of 200) | 0.0% | 1 |
| Hepatitis alcoholic | Hepatobiliary disorders | 1.0% (2 of 200) | 1.0% | 1 |
| Acidosis | Metabolism and nutrition disorders | 1.0% (2 of 200) | 0.0% | 1 |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | 1.0% (2 of 200) | 0.0% | 1 |
| Electrolyte abnormality | Renal and urinary disorders | 4.0% (2 of 50) | - | 1 |
| Spontaneous Bacterial Peritonitis | Infections and infestations | 4.0% (2 of 50) | - | 1 |
| Leukocytosis | Blood and lymphatic system disorders | 0.3% (1 of 293) | 0.5% | 2 |
| Cellulitis | Infections and infestations | 0.9% (1 of 113) | 1.1% | 2 |
| Death | General disorders | 0.3% (1 of 293) | 1.5% | 2 |
| Liver disorder | Hepatobiliary disorders | 0.3% (1 of 293) | 0.5% | 2 |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.3% (1 of 293) | 0.5% | 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
Terlivaz NDA022231 · label of 2026-06-19 Regulator
The most common adverse reactions (≥10%) include abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea.
QUESTIONS
Does terlipressin cause abdominal pain?
In 2 placebo-controlled trials with posted results, 21.8% of people on terlipressin reported abdominal pain, against 13.4% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does terlipressin cause diarrhoea?
In 2 placebo-controlled trials with posted results, 16.4% of people on terlipressin reported diarrhoea, against 5.7% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does terlipressin cause nausea?
In 2 placebo-controlled trials with posted results, 15.0% of people on terlipressin reported nausea, against 11.3% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does terlipressin cause dyspnoea?
In 2 placebo-controlled trials with posted results, 12.3% of people on terlipressin reported dyspnoea, against 6.7% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does terlipressin cause hypotension?
In 2 placebo-controlled trials with posted results, 11.3% of people on terlipressin reported hypotension, against 6.7% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
REGISTERED STUDIES
118 registered clinical trials of Terlipressin
The 10 most recently updated are listed.
| NCT07252401 | Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Variceal Bleeding and Renal Dysfunction Status: NOT_YET_RECRUITING · Updated 2026-08-27 |
|---|---|
| NCT07746349 | Terlipressin vs Placebo to Reduce Bleeding in Fibroid Surgery Status: NOT_YET_RECRUITING · Updated 2026-08-05 |
| NCT07719933 | Intraoperative Continuous Terlipressin Infusion is Associated With Reduced Severe Postoperative Complications After Laparoscopic Hepatectomy: a Prospective Propensity Score-matched Cohort Study Status: COMPLETED · Updated 2026-07-28 |
| NCT02473341 | Efficacy Of Bovine Colostrum In The Treatment Of Severe Alcohol-Associated Hepatitis: A Randomized Controlled Trial Status: ACTIVE_NOT_RECRUITING · Updated 2026-07-21 |
| NCT06855758 | Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation Status: ACTIVE_NOT_RECRUITING · Updated 2026-07-13 |
| NCT02970175 | Interest of in Situ Terlipressin Administration Before the Realisation of Bronchial Biopsy Status: COMPLETED · Updated 2026-06-08 |
| NCT07304466 | Effects of Terlipressin and Somatostatin on Portal Pressure in Patients Undergoing Living Donor Liver Transplantation Status: RECRUITING · Updated 2026-04-29 |
| NCT04961528 | ACid Tranexamic or Terlipressin for Initial Emergency Treatment of Mild to seVere hEmoptysis: a Randomized Trial. Status: COMPLETED · Updated 2026-04-23 |
| NCT06256432 | Endothelin Receptor Antagonism With Ambrisentan to Treat Hepatorenal Syndrome Status: ACTIVE_NOT_RECRUITING · Updated 2026-04-13 |
| NCT07178366 | Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial) Status: NOT_YET_RECRUITING · Updated 2026-03-25 |
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