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What the label lists and what reports show

Linaclotide side effects

Linaclotide's FDA label: “Most common adverse reactions (≥2%) reported in adult patients with IBS-C or CIC are: diarrhea, abdominal pain, flatulence and abdominal distension.” FAERS holds 26,525 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (4,703 reports).

  • No generic listed
  • Boxed warning

Check it at the source: the linaclotide FDA label on DailyMed (effective May 21, 2026, Allergan, Inc.); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of LINZESS?

LINZESS can cause serious side effects, including: See “ What is the most important information I should know about LINZESS? ” Diarrhea is the most common side effect of LINZESS, and it can sometimes be severe. ◦ Diarrhea often begins within the first 2 weeks of LINZESS treatment. ◦ Stop taking LINZESS and call your healthcare provider right away if you get severe diarrhea during treatment with LINZESS . Other common side effects of LINZESS in people with IBS-C and CIC include: gas stomach-area (abdomen) pain swelling, or a feeling of fullness or pressure in your abdomen (distention) C all your healthcare provider or go to the nearest hospital emergency room right away, if you develop unusual or severe stomach-area (abdomen) pain, especially if you also have bright red, bloody stools or black stools that look like tar. These are not all the possible side effects of LINZESS. […]

Source: FDA drug label, NDA202811 (Abbvie), as published by Allergan, Inc., effective May 21, 2026 (SPL set 09beda19-56d6-4a56-afdc-9a77b70b2ef3), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

Most common adverse reactions (≥2%) reported in adult patients with IBS-C or CIC are: diarrhea, abdominal pain, flatulence and abdominal distension.

From the label: adverse reactions, continued

Most common adverse reactions (≥2%) reported in adult patients with IBS-C or CIC are: diarrhea, abdominal pain, flatulence and abdominal distension. ( 6.1 ) Most common adverse reaction (≥2%) reported in pediatric patients 7 to 17 years of age with IBS-C and 6 to 17 years of age with FC is diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie, Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Demographic characteristics were comparable between treatment groups in all studies [see Clinical Studies ( 14.1 , 14.2 , 14.3 , 14.4 , 14.5 )]. Irritable Bowel Syndrome with Constipation (IBS-C) in Adults Most Common Adverse Reactions The data described below reflect exposure to LINZESS in the two placebo-controlled clinical trials involving 1605 adult patients with IBS-C (Trials 1 and 2) [see Clinical Studies ( 14.1 )]. Patients were randomized to receive placebo or 290 mcg LINZESS once daily on an empty stomach for up to 26 weeks. …

Source: FDA drug label, NDA202811 (Abbvie), as published by Allergan, Inc., effective May 21, 2026 (SPL set 09beda19-56d6-4a56-afdc-9a77b70b2ef3), via openFDA; the full label on DailyMed

What do FAERS reports show?

26,525 reports list linaclotide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,064 are coded as a death and 3,921 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Diarrhoea (named in the label)4,703
  • Drug Ineffective (a use or a product term, not a reaction)4,516
  • Off Label Use (a use or a product term, not a reaction)3,345
  • Constipation (a use or a product term, not a reaction)1,998
  • Nausea (named in the label)1,476
  • Fatigue1,171
  • Abdominal Distension (named in the label)1,170
  • Abdominal Pain (named in the label)1,063
  • Headache (named in the label)1,040
  • Pain965
  • Abdominal Pain Upper942
  • Dizziness (named in the label)859
  • Inappropriate Schedule Of Product Administration (a use or a product term, not a reaction)775
  • Fall718
  • Flatulence (named in the label)703
  • Dyspnoea677
  • Malaise665
  • Vomiting (named in the label)650
  • Asthenia643
  • Product Dose Omission Issue (a use or a product term, not a reaction)579
  • Death (an outcome recorded in the report)538
  • Intentional Product Misuse (a use or a product term, not a reaction)522
  • Weight Decreased522
  • Rash (named in the label)484
  • Anxiety477

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Linaclotide: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions