TRIAL RESULTS · SIDE EFFECTS
Plecanatide side effects
ANSWER
In 8 placebo-controlled trials with posted results, the most common side effects of Plecanatide were diarrhoea 5.8% (placebo 1.2%), headache 2.3% (placebo 1.6%). Read from ClinicalTrials.gov on 2026-10-03. Not medical advice.
Trial register
Trials with posted results
10
with an arm on Plecanatide, of 15 registered
Against placebo
8
placebo-controlled trials
People in those trials
4,622
on Plecanatide · 2,068 on placebo
Read
2026-10-03
ClinicalTrials.gov
VS PLACEBO
Most common side effects, Plecanatide beside placebo
Diarrhoea5.8%1.2%
Headache2.3%1.6%
Share of people with each side effect in 8 placebo-controlled trials with posted results: 4,622 people on Plecanatide (all doses), 2,068 on placebo, same trials. Listed only when reported for at least half of the people on Plecanatide. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
ALL TRIALS
The 100 most reported of 140 side effects reported
Every trial with posted results and an arm on Plecanatide (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 | Plecanatide | Placebo | Trials |
|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 6.5% (498 of 7,655) | 1.2% | 7 |
| Headache | Nervous system disorders | 1.9% (117 of 6,196) | 1.6% | 8 |
| Nausea | Gastrointestinal disorders | 1.8% (75 of 4,180) | 1.8% | 5 |
| Urinary tract infection | Infections and infestations | 2.1% (72 of 3,409) | 1.1% | 3 |
| Diarrhea | Gastrointestinal disorders | 4.0% (64 of 1,609) | 1.0% | 3 |
| Nasopharyngitis | Infections and infestations | 1.5% (61 of 3,994) | 0.9% | 4 |
| Urinary Tract Infection | Infections and infestations | 1.9% (56 of 2,984) | 2.5% | 2 |
| Upper Respiratory Tract Infection | Infections and infestations | 1.9% (52 of 2,770) | 0.7% | 3 |
| Sinusitis | Infections and infestations | 1.0% (33 of 3,203) | 0.4% | 2 |
| Abdominal Pain | Gastrointestinal disorders | 3.5% (30 of 869) | 3.7% | 2 |
| Flatulence | Gastrointestinal disorders | 2.9% (25 of 869) | 2.0% | 2 |
| Abdominal Distension | Gastrointestinal disorders | 3.4% (24 of 712) | 2.1% | 1 |
| Upper Respiratory tract infection | Infections and infestations | 2.8% (20 of 712) | 2.1% | 1 |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | 0.3% (12 of 4,237) | 0.1% | 3 |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | 1.4% (7 of 498) | 1.4% | 2 |
| Back pain | Musculoskeletal and connective tissue disorders | 2.1% (7 of 341) | 0.0% | 1 |
| Fatigue | General disorders | 2.1% (7 of 341) | 0.0% | 1 |
| Alanine Aminotransferase Increased | Investigations | 0.3% (6 of 2,272) | - | 1 |
| Diverticulitis | Infections and infestations | 0.1% (5 of 5,573) | 0.2% | 3 |
| Aspartate Aminotransferase Increased | Investigations | 0.2% (5 of 2,272) | - | 1 |
| Aspartate aminotransferase increased | Investigations | 0.1% (3 of 4,394) | 0.1% | 4 |
| Non-cardiac chest pain | General disorders | 0.1% (3 of 4,018) | 0.3% | 3 |
| Cholelithiasis | Hepatobiliary disorders | 0.1% (3 of 5,573) | 0.0% | 3 |
| Transaminases increased | Investigations | 0.4% (3 of 791) | 0.0% | 2 |
| Alanine aminotransferase increased | Investigations | 0.0% (2 of 4,161) | 0.3% | 4 |
| Gastroenteritis | Infections and infestations | 0.0% (2 of 4,013) | 0.1% | 3 |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | 0.0% (2 of 4,018) | 0.3% | 3 |
| Appendicitis | Infections and infestations | 0.1% (2 of 2,711) | 0.0% | 2 |
| Cholecystitis acute | Hepatobiliary disorders | 0.2% (2 of 1,039) | 0.0% | 2 |
| Bile duct stone | Hepatobiliary disorders | 0.1% (2 of 2,711) | 0.0% | 2 |
| Ankle fracture | Injury, poisoning and procedural complications | 0.1% (2 of 3,301) | 0.0% | 2 |
| Vomiting | Gastrointestinal disorders | 0.1% (2 of 2,527) | 0.0% | 2 |
| Cardiac failure congestive | Cardiac disorders | 0.1% (2 of 3,306) | 0.0% | 2 |
| Cholecystitis | Hepatobiliary disorders | 0.1% (2 of 3,306) | 0.0% | 2 |
| Chest Pain | General disorders | 0.1% (2 of 2,429) | 0.0% | 2 |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 0.1% (2 of 2,370) | - | 1 |
| Atrial fibrillation | Cardiac disorders | 0.1% (2 of 2,370) | - | 1 |
| Intestinal obstruction | Gastrointestinal disorders | 0.2% (2 of 931) | 0.0% | 1 |
| Liver function test abnormal | Investigations | 0.2% (2 of 936) | 0.0% | 1 |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 0.2% (2 of 936) | 0.0% | 1 |
| Road Traffic Accident | Injury, poisoning and procedural complications | 0.1% (2 of 2,272) | - | 1 |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | 0.1% (2 of 2,272) | - | 1 |
| Non-Cardiac Chest Pain | General disorders | 0.1% (2 of 2,272) | - | 1 |
| Asthma | Respiratory, thoracic and mediastinal disorders | 0.1% (1 of 1,466) | 0.2% | 2 |
| Femoral neck fracture | Injury, poisoning and procedural complications | 0.0% (1 of 3,306) | 0.2% | 2 |
| Nephrolithiasis | Renal and urinary disorders | 0.0% (1 of 3,306) | 0.2% | 2 |
| Psychotic disorder | Psychiatric disorders | 0.0% (1 of 3,068) | 0.3% | 2 |
| Pneumonia | Infections and infestations | 0.0% (1 of 3,203) | 0.2% | 2 |
| Suicidal ideation | Psychiatric disorders | 0.1% (1 of 1,452) | 0.1% | 2 |
| Asthenia | General disorders | 0.1% (1 of 712) | 0.0% | 1 |
| Endometriosis | Reproductive system and breast disorders | 0.1% (1 of 712) | 0.0% | 1 |
| Cholecystitis Acute | Hepatobiliary disorders | 0.1% (1 of 712) | 0.0% | 1 |
| Hypoaesthesia | Nervous system disorders | 0.1% (1 of 712) | 0.0% | 1 |
| Supraventricular tachycardia | Cardiac disorders | 0.3% (1 of 341) | 0.0% | 1 |
| Clostridium difficile colitis | Infections and infestations | 0.0% (1 of 2,370) | - | 1 |
| Liver abscess | Infections and infestations | 0.0% (1 of 2,370) | - | 1 |
| Patella fracture | Injury, poisoning and procedural complications | 0.0% (1 of 2,370) | - | 1 |
| Rib fracture | Injury, poisoning and procedural complications | 0.0% (1 of 2,370) | - | 1 |
| Tendon injury | Injury, poisoning and procedural complications | 0.0% (1 of 2,370) | - | 1 |
| Aspartate aminotransferase abnormal | Investigations | 0.0% (1 of 2,370) | - | 1 |
| Electrocardiogram change | Investigations | 0.0% (1 of 2,370) | - | 1 |
| Abdominal pain | Gastrointestinal disorders | 0.0% (1 of 2,370) | - | 1 |
| Myocardial infarction | Cardiac disorders | 0.0% (1 of 2,370) | - | 1 |
| Calculus ureteric | Renal and urinary disorders | 0.0% (1 of 2,370) | - | 1 |
| Hydronephrosis | Renal and urinary disorders | 0.0% (1 of 2,370) | - | 1 |
| Renal failure acute | Renal and urinary disorders | 0.0% (1 of 2,370) | - | 1 |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.0% (1 of 2,370) | - | 1 |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.0% (1 of 2,370) | - | 1 |
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.0% (1 of 2,370) | - | 1 |
| Hypotension | Vascular disorders | 0.0% (1 of 2,370) | - | 1 |
| Thrombosis | Vascular disorders | 0.0% (1 of 2,370) | - | 1 |
| Drug hypersensitivity | Immune system disorders | 0.0% (1 of 2,370) | - | 1 |
| Ischaemic stroke | Nervous system disorders | 0.0% (1 of 2,370) | - | 1 |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 0.0% (1 of 2,370) | - | 1 |
| Cerebral infarction | Nervous system disorders | 0.1% (1 of 931) | 0.0% | 1 |
| Staphylococcal infection | Infections and infestations | 0.1% (1 of 931) | 0.0% | 1 |
| Vertigo positional | Ear and labyrinth disorders | 0.1% (1 of 936) | 0.0% | 1 |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.1% (1 of 936) | 0.0% | 1 |
| Convulsion | Nervous system disorders | 0.1% (1 of 936) | 0.0% | 1 |
| Affective disorder | Psychiatric disorders | 0.1% (1 of 698) | 0.0% | 1 |
| Lymphadenitis | Blood and lymphatic system disorders | 0.1% (1 of 698) | 0.0% | 1 |
| Drowning | General disorders | 0.1% (1 of 698) | 0.0% | 1 |
| Hepatitis C | Infections and infestations | 0.1% (1 of 698) | 0.0% | 1 |
| Viral infection | Infections and infestations | 0.1% (1 of 754) | 0.0% | 1 |
| LFT abnormal | Investigations | 0.1% (1 of 754) | 0.0% | 1 |
| Costochondritis | Musculoskeletal and connective tissue disorders | 0.1% (1 of 754) | 0.0% | 1 |
| Liver Function Test Abnormal | Investigations | 0.0% (1 of 2,272) | - | 1 |
| Transaminases Increased | Investigations | 0.0% (1 of 2,272) | - | 1 |
| Bacterial Pyelonephritis | Infections and infestations | 0.0% (1 of 2,272) | - | 1 |
| Cellulitis | Infections and infestations | 0.0% (1 of 2,272) | - | 1 |
| Clostridial Infection | Infections and infestations | 0.0% (1 of 2,272) | - | 1 |
| Meningitis Viral | Infections and infestations | 0.0% (1 of 2,272) | - | 1 |
| Periorbital Cellulitis | Infections and infestations | 0.0% (1 of 2,272) | - | 1 |
| Pyelonephritis Acute | Infections and infestations | 0.0% (1 of 2,272) | - | 1 |
| Subcutaneous Abscess | Infections and infestations | 0.0% (1 of 2,272) | - | 1 |
| Viral Infection | Infections and infestations | 0.0% (1 of 2,272) | - | 1 |
| Ankle Fracture | Injury, poisoning and procedural complications | 0.0% (1 of 2,272) | - | 1 |
| Forearm Fracture | Injury, poisoning and procedural complications | 0.0% (1 of 2,272) | - | 1 |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | 0.0% (1 of 2,272) | - | 1 |
| Acute Myocardial Infarction | Cardiac disorders | 0.0% (1 of 2,272) | - | 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
Trulance Immediate release NDA208745 · label of 2024-04-04 Regulator
Most Common Adverse Reactions Table 1 provides the incidence of adverse reactions reported in at least 2% of CIC patients in the TRULANCE-treated group and at an incidence that was greater than in the placebo group.
QUESTIONS
Does plecanatide cause diarrhoea?
In 8 placebo-controlled trials with posted results, 5.8% of people on plecanatide reported diarrhoea, against 1.2% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does plecanatide cause headache?
In 8 placebo-controlled trials with posted results, 2.3% of people on plecanatide reported headache, against 1.6% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
REGISTERED STUDIES
15 registered clinical trials of Plecanatide
The 10 most recently updated are listed.
| NCT07723924 | This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC Status: RECRUITING · Updated 2026-10-02 |
|---|---|
| NCT05107219 | GCC Agonist Signal in the Small Intestine Status: COMPLETED · Updated 2026-04-07 |
| NCT03596905 | Efficacy and Safety of Plecanatide in Children 6 to <18 Years With Irritable Bowel Syndrome With Constipation (IBS-C) Status: COMPLETED · Updated 2025-12-31 |
| NCT05151328 | Efficacy and Safety of Plecanatide Comparing With Placebo in the Treatment of Functional Constipation Status: COMPLETED · Updated 2024-07-11 |
| NCT02706483 | Long Term Safety Study of Plecanatide Status: COMPLETED · Updated 2020-08-18 |
| NCT01053962 | SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation Status: COMPLETED · Updated 2020-01-02 |
| NCT01982240 | 12-Week Study of Plecanatide for CIC (The CIC3 Study) Status: COMPLETED · Updated 2019-12-26 |
| NCT03551873 | A Postmarketing Study of Plecanatide in Breast Milk of Lactating Women Treated With TRULANCE® Status: COMPLETED · Updated 2019-11-22 |
| NCT03120520 | An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation Status: COMPLETED · Updated 2019-10-04 |
| NCT01919697 | Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC) Status: COMPLETED · Updated 2019-07-02 |
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