Prescription medication · Guanylate Cyclase-C Agonist
linaclotide
Also sold as Linzess. Linzess is used to treat irritable bowel syndrome with constipation (IBS-C) in adults and children ages 7 and older.
Data updated 2026-05-15
- 24,979
- FDA reportsModerately reported
- $17.30
- Brand price (NADAC)
linaclotide (Linzess) is a prescription Guanylate Cyclase-C Agonist. Linzess is used to treat irritable bowel syndrome with constipation (IBS-C) in adults and children ages 7 and older.
Linzess is a medicine that helps treat certain bowel problems. It works by helping your bowels move more regularly.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$17.30/unit
Generic Available
No
ABBVIE
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Linzess is used to treat irritable bowel syndrome with constipation (IBS-C) in adults and children ages 7 and older.
Common side effects
Diarrhea, Abdominal pain, Gas
Key warnings
Linzess can cause serious dehydration in children under 2 years old.
The sections below are summarized in plain English from linaclotide's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Linzess is a guanylate cyclase-C agonist. It works by increasing fluid in your intestines. This helps to soften stool and make bowel movements easier.
Side Effects (from patient reports)
Based on 24,979 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for linaclotide, by number of reports
- Diarrhoea
Diarrhoea
4,502 reports
- Constipation
Constipation
1,862 reports
- Nausea 1,373
Nausea
1,373 reports
- Fatigue 1,111
Fatigue
1,111 reports
- Abdominal Distension 1,100
Abdominal Distension
1,100 reports
- Abdominal Pain 1,009
Abdominal Pain
1,009 reports
- Headache 982
Headache
982 reports
- Pain 896
Pain
896 reports
- Abdominal Pain Upper 884
Abdominal Pain Upper
884 reports
- Dizziness 796
Dizziness
796 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for linaclotide each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where linaclotide sits
linaclotide has more FDA adverse-event reports than 60% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is linaclotide; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 24,979 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2012–2025.
Total Reports
24,979
Reports Mentioning Death
988
4.0% of reports — not proof of cause
Hospitalization Reports
3,610
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DIARRHOEA | 4,502 |
| 4 | CONSTIPATION | 1,862 |
| 5 | NAUSEA | 1,373 |
| 6 | FATIGUE | 1,111 |
| 7 | ABDOMINAL DISTENSION | 1,100 |
| 8 | ABDOMINAL PAIN | 1,009 |
| 9 | HEADACHE | 982 |
| 10 | PAIN | 896 |
| 11 | ABDOMINAL PAIN UPPER | 884 |
| 12 | DIZZINESS | 796 |
| 13 | INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION | 727 |
| 14 | FLATULENCE | 675 |
| 15 | FALL | 648 |
| 16 | MALAISE | 634 |
| 17 | DYSPNOEA | 633 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Linzess can cause serious dehydration in children under 2 years old. Do not give Linzess to children under 2 years old. It is also not for people with a known or suspected blockage in their intestines.
Common Questions
Can I crush or chew the Linzess capsule?
What should I do if I have severe diarrhea while taking Linzess?
Can I take Linzess with food?
Is Linzess safe to use during pregnancy?
Can I give Linzess to my child?
What if I can't swallow the capsule?
How long does it take for Linzess to work?
Can I take Linzess if I have a bowel obstruction?
What are the most common side effects of Linzess?
How should I store Linzess?
What are the common side effects of linaclotide?
What drug class is linaclotide?
What pregnancy or breastfeeding source fields are listed for linaclotide?
Related Medications in Guanylate Cyclase-C Agonist
Other drugs grouped near linaclotide - same-class peers and common alternatives.
alosetron
Lotronex
Alosetron (Lotronex) is a medicine for women with severe diarrhea-predominant irritable bowel syndrome (IBS).
Compare with linaclotide →
aprepitant
Emend
Aprepitant (Emend) is a medicine that helps prevent nausea and vomiting.
Compare with linaclotide →
bisacodyl
Dulcolax
Bisacodyl is a medicine that helps you have a bowel movement.
Compare with linaclotide →
bismuth subsalicylate
Pepto-Bismol
Bismuth subsalicylate (Pepto-Bismol) is a medicine that can treat diarrhea and upset stomach.
Compare with linaclotide →
cimetidine
Tagamet
Cimetidine (Tagamet) reduces stomach acid.
Compare with linaclotide →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for linaclotide: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 24,979.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 3.96%.
- desonide Δ 0.01 pts · 4,709 reports · Topical Corticosteroid 3.95%death share
- oxaprozin Δ 0.05 pts · 2,050 reports · Nonsteroidal Anti-Inflammatory Drug (NSAID) 3.90%death share
- esketamine Δ 0.09 pts · 15,846 reports · NMDA Receptor Antagonist (Nasal Spray) 4.05%death share
- mefenamic acid Δ 0.11 pts · 2,104 reports · Nonsteroidal Anti-Inflammatory Drug (NSAID) 3.85%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for linaclotide
The FDA label for linaclotide (sold under brand names such as Linzess) classifies it as a prescription-only medication in the Guanylate Cyclase-C Agonist class. Linzess is used to treat irritable bowel syndrome with constipation (IBS-C) in adults and children ages 7 and older. Official labeling lists 6 commonly reported side effects, including Diarrhea, Abdominal pain, Gas.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 24,979 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: November 4, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages