TRIAL RESULTS · SIDE EFFECTS
Linaclotide side effects
ANSWER
In 14 placebo-controlled trials with posted results, the most common side effects of Linaclotide were diarrhea 14.0% (placebo 4.6%). Read from ClinicalTrials.gov on 2026-10-03. Not medical advice.
Trial register
Trials with posted results
18
with an arm on Linaclotide, of 62 registered
Against placebo
14
placebo-controlled trials
People in those trials
5,648
on Linaclotide · 4,308 on placebo
Read
2026-10-03
ClinicalTrials.gov
VS PLACEBO
Most common side effects, Linaclotide beside placebo
Diarrhea14.0%4.6%
Share of people with each side effect in 14 placebo-controlled trials with posted results: 5,648 people on Linaclotide (all doses), 4,308 on placebo, same trials. Listed only when reported for at least half of the people on Linaclotide. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
ALL TRIALS
The 100 most reported of 212 side effects reported
Every trial with posted results and an arm on Linaclotide (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 | Linaclotide | Placebo | Trials |
|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 26.2% (888 of 3,386) | 4.1% | 6 |
| Diarrhea | Gastrointestinal disorders | 14.0% (597 of 4,277) | 4.6% | 9 |
| Upper respiratory tract infection | Infections and infestations | 5.4% (186 of 3,439) | 5.0% | 6 |
| Abdominal pain | Gastrointestinal disorders | 4.6% (185 of 4,012) | 2.3% | 7 |
| Sinusitis | Infections and infestations | 5.6% (127 of 2,270) | 5.4% | 3 |
| Urinary tract infection | Infections and infestations | 4.2% (119 of 2,856) | 1.8% | 4 |
| Nausea | Gastrointestinal disorders | 4.7% (117 of 2,466) | 5.8% | 4 |
| Headache | Nervous system disorders | 3.7% (103 of 2,800) | 1.1% | 4 |
| Abdominal distension | Gastrointestinal disorders | 3.8% (72 of 1,890) | 5.9% | 2 |
| Flatulence | Gastrointestinal disorders | 4.5% (67 of 1,484) | 6.0% | 3 |
| DIARRHOEA | Gastrointestinal disorders | 5.2% (43 of 821) | 2.2% | 3 |
| Nasopharyngitis | Infections and infestations | 2.4% (19 of 779) | 2.5% | 2 |
| INFLUENZA | Infections and infestations | 2.2% (12 of 547) | 0.0% | 2 |
| COVID-19 | Infections and infestations | 2.3% (10 of 440) | 2.2% | 2 |
| Angina pectoris | Cardiac disorders | 0.2% (6 of 2,799) | 0.5% | 3 |
| Cholelithiasis | Hepatobiliary disorders | 0.3% (6 of 1,973) | 0.5% | 2 |
| Vomiting | Gastrointestinal disorders | 0.2% (5 of 2,073) | 0.1% | 3 |
| CONSTIPATION | Gastrointestinal disorders | 0.6% (5 of 821) | 0.0% | 3 |
| Cholecystitis | Hepatobiliary disorders | 0.3% (5 of 1,973) | 0.0% | 2 |
| Non-cardiac chest pain | General disorders | 0.3% (5 of 1,971) | 0.2% | 2 |
| PYREXIA | General disorders | 3.0% (5 of 166) | 0.0% | 1 |
| NASOPHARYNGITIS | Infections and infestations | 3.0% (5 of 166) | 1.6% | 1 |
| Syncope | Nervous system disorders | 0.3% (4 of 1,555) | - | 1 |
| EAR INFECTION | Infections and infestations | 2.4% (4 of 166) | 0.0% | 1 |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | 2.4% (4 of 166) | 0.0% | 1 |
| Pneumonia | Infections and infestations | 0.1% (3 of 3,701) | 0.4% | 5 |
| Bronchitis | Infections and infestations | 0.1% (3 of 2,989) | 0.2% | 4 |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.1% (3 of 2,817) | 0.1% | 4 |
| Ectopic pregnancy | Reproductive system and breast disorders | 0.1% (3 of 2,585) | 0.0% | 3 |
| Nephrolithiasis | Renal and urinary disorders | 0.1% (3 of 2,825) | 0.0% | 3 |
| Cerebrovascular accident | Nervous system disorders | 0.1% (3 of 2,169) | 0.0% | 2 |
| Goitre | Endocrine disorders | 0.2% (3 of 1,973) | 0.5% | 2 |
| Neck pain | Musculoskeletal and connective tissue disorders | 0.1% (3 of 2,381) | - | 2 |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 0.1% (3 of 2,381) | - | 2 |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.2% (3 of 1,999) | 0.1% | 2 |
| Ileus | Gastrointestinal disorders | 0.1% (3 of 2,381) | - | 2 |
| Ovarian cyst | Reproductive system and breast disorders | 0.2% (3 of 1,555) | - | 1 |
| ABDOMINAL PAIN | Gastrointestinal disorders | 1.1% (3 of 274) | 1.2% | 1 |
| URINARY TRACT INFECTION | Infections and infestations | 1.8% (3 of 166) | 0.0% | 1 |
| Faecaloma | Gastrointestinal disorders | 0.5% (2 of 409) | 0.0% | 2 |
| Chest pain | Cardiac disorders | 0.1% (2 of 2,169) | 0.0% | 2 |
| Dehydration | Metabolism and nutrition disorders | 0.2% (2 of 1,244) | 0.0% | 2 |
| Diverticulitis | Gastrointestinal disorders | 0.1% (2 of 1,973) | 0.0% | 2 |
| Small intestinal obstruction | Gastrointestinal disorders | 0.1% (2 of 1,973) | 0.0% | 2 |
| Depression | Psychiatric disorders | 0.1% (2 of 2,381) | - | 2 |
| Fall | Injury, poisoning and procedural complications | 0.1% (2 of 1,729) | 1.3% | 2 |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 0.1% (2 of 2,381) | - | 2 |
| Abdominal pain upper | Gastrointestinal disorders | 0.1% (2 of 2,381) | - | 2 |
| Anaemia | Blood and lymphatic system disorders | 0.1% (2 of 1,999) | 0.0% | 2 |
| Appendicitis | Infections and infestations | 0.1% (2 of 1,957) | 0.0% | 2 |
| Colitis | Gastrointestinal disorders | 0.2% (2 of 1,238) | 0.1% | 2 |
| Hypotension | Vascular disorders | 0.1% (2 of 1,648) | 0.0% | 2 |
| Peptic ulcer | Gastrointestinal disorders | 0.1% (2 of 1,648) | 0.0% | 2 |
| Back pain | Musculoskeletal and connective tissue disorders | 0.1% (2 of 1,555) | - | 1 |
| Bladder prolapse | Renal and urinary disorders | 0.1% (2 of 1,555) | - | 1 |
| Uterine prolapse | Reproductive system and breast disorders | 0.1% (2 of 1,555) | - | 1 |
| Adenomyosis | Reproductive system and breast disorders | 0.1% (2 of 1,555) | - | 1 |
| Hypertension | Vascular disorders | 0.1% (2 of 1,555) | - | 1 |
| Cystocele | Reproductive system and breast disorders | 0.1% (2 of 1,555) | - | 1 |
| Atrial fibrillation | Cardiac disorders | 0.1% (1 of 854) | 0.6% | 2 |
| Gastroenteritis viral | Infections and infestations | 0.0% (1 of 2,169) | 0.2% | 2 |
| Cellulitis | Infections and infestations | 0.1% (1 of 1,032) | 0.1% | 2 |
| Vertigo | Ear and labyrinth disorders | 0.1% (1 of 1,957) | 0.2% | 2 |
| Sepsis | Infections and infestations | 0.0% (1 of 2,021) | 1.5% | 2 |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | 0.1% (1 of 1,971) | 0.2% | 2 |
| Ankle fracture | Injury, poisoning and procedural complications | 0.1% (1 of 1,729) | 1.3% | 2 |
| Asthma | Respiratory, thoracic and mediastinal disorders | 0.1% (1 of 1,386) | 0.1% | 2 |
| Gastroenteritis | Gastrointestinal disorders | 0.1% (1 of 1,030) | 0.1% | 2 |
| Constipation | Gastrointestinal disorders | 0.1% (1 of 1,648) | 0.2% | 2 |
| Haematemesis | Gastrointestinal disorders | 0.1% (1 of 900) | - | 2 |
| Diverticulum intestinal hemorrhagic | Gastrointestinal disorders | 0.2% (1 of 614) | 0.0% | 1 |
| Drug toxicity | Injury, poisoning and procedural complications | 0.2% (1 of 418) | 0.0% | 1 |
| Endometriosis | Reproductive system and breast disorders | 0.2% (1 of 418) | 0.0% | 1 |
| Lymphoma | Blood and lymphatic system disorders | 0.2% (1 of 418) | 0.0% | 1 |
| Orthostatic hypotension | Vascular disorders | 0.2% (1 of 418) | 0.0% | 1 |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.2% (1 of 418) | 0.0% | 1 |
| Postoperative wound infection | Injury, poisoning and procedural complications | 0.2% (1 of 418) | 0.0% | 1 |
| Abdominal abscess | Infections and infestations | 0.1% (1 of 1,555) | - | 1 |
| Biliary dyskinesia | Hepatobiliary disorders | 0.1% (1 of 1,555) | - | 1 |
| Bunion | Surgical and medical procedures | 0.1% (1 of 1,555) | - | 1 |
| Chest discomfort | General disorders | 0.1% (1 of 1,555) | - | 1 |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.1% (1 of 1,555) | - | 1 |
| Groin pain | Musculoskeletal and connective tissue disorders | 0.1% (1 of 1,555) | - | 1 |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.1% (1 of 1,555) | - | 1 |
| Pancreatitis acute | Gastrointestinal disorders | 0.1% (1 of 1,555) | - | 1 |
| Post procedural infection | Infections and infestations | 0.1% (1 of 1,555) | - | 1 |
| Rectal prolapse | Gastrointestinal disorders | 0.1% (1 of 1,555) | - | 1 |
| Scoliosis | Musculoskeletal and connective tissue disorders | 0.1% (1 of 1,555) | - | 1 |
| Spigelian hernia | Gastrointestinal disorders | 0.1% (1 of 1,555) | - | 1 |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | 0.1% (1 of 1,555) | - | 1 |
| Tibia fracture | Injury, poisoning and procedural complications | 0.1% (1 of 1,555) | - | 1 |
| Suicide attempt | Psychiatric disorders | 0.1% (1 of 1,555) | - | 1 |
| Supraventricular tachycardia | Cardiac disorders | 0.1% (1 of 1,555) | - | 1 |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.1% (1 of 1,555) | - | 1 |
| Transient ischaemic attack | Vascular disorders | 0.1% (1 of 1,555) | - | 1 |
| Umbilical hernia | Gastrointestinal disorders | 0.1% (1 of 1,555) | - | 1 |
| Urinary retention postoperative | Injury, poisoning and procedural complications | 0.1% (1 of 1,555) | - | 1 |
| Uterovaginal prolapse | Reproductive system and breast disorders | 0.1% (1 of 1,555) | - | 1 |
| Ventricular tachycardia | Cardiac disorders | 0.1% (1 of 1,555) | - | 1 |
| Vestibular neuronitis | Infections and infestations | 0.1% (1 of 1,555) | - | 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
Linzess NDA202811 · label of 2026-05-21 Regulator
Most common adverse reactions (≥2%) reported in adult patients with IBS-C or CIC are: diarrhea, abdominal pain, flatulence and abdominal distension.
QUESTIONS
Does linaclotide cause diarrhea?
In 14 placebo-controlled trials with posted results, 14.0% of people on linaclotide reported diarrhea, against 4.6% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
REGISTERED STUDIES
62 registered clinical trials of Linaclotide
The 10 most recently updated are listed.
| NCT07780344 | MRI Parameters as Biomarkers in Cystic Fibrosis (FEMPTO) Status: NOT_YET_RECRUITING · Updated 2026-08-21 |
|---|---|
| NCT05796388 | A Study of Virtual Reality and Linaclotide for IBS-C Status: RECRUITING · Updated 2026-07-29 |
| NCT03796884 | Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer Status: ACTIVE_NOT_RECRUITING · Updated 2026-07-22 |
| NCT05652205 | A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation Status: COMPLETED · Updated 2026-05-14 |
| NCT07569419 | Proof of Principle Study for an Efficacy Trial of Linaclotide for Cystic Fibrosis Status: RECRUITING · Updated 2026-05-06 |
| NCT05107219 | GCC Agonist Signal in the Small Intestine Status: COMPLETED · Updated 2026-04-07 |
| NCT03119584 | Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation Status: ACTIVE_NOT_RECRUITING · Updated 2026-04-03 |
| NCT07431957 | "Efficacy and Safety of Linaclotide in Chronic Constipation" Status: NOT_YET_RECRUITING · Updated 2026-02-25 |
| NCT06692673 | Linaclotide for Colonoscopy Bowel Prep Status: RECRUITING · Updated 2026-01-23 |
| NCT04166058 | Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C Status: COMPLETED · Updated 2026-01-06 |
WEEKLY
Register Watch, weekly
New trials, approvals and enforcement actions. One email a week.