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.
How to Take It
Take Linzess on an empty stomach, at least 30 minutes before a meal. Try to take it around the same time each day. Swallow the capsule whole; do not crush or chew it. If you have trouble swallowing, you can open the capsule and mix the contents with applesauce or water.
This is a plain-language summary of linaclotide's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
It is not expected that Linzess will harm your unborn baby. Linaclotide was not found in breast milk, so it is not expected to harm a breastfeeding baby.
This is a plain-language summary of linaclotide's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, skip it and take your next dose at the regular time. Do not take two doses at the same time.
This is a plain-language summary of linaclotide's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store Linzess at room temperature (between 59°F and 86°F) in its original container, protected from moisture.
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
- Diarrhea
Diarrhea
4,502 reports
- Constipation
Constipation
1,862 reports
- Feeling sick to your stomach 1,373
Feeling sick to your stomach
1,373 reports
- Feeling tired 1,111
Feeling tired
1,111 reports
- Bloating 1,100
Bloating
1,100 reports
- Stomach pain 1,009
Stomach pain
1,009 reports
- Headache 982
Headache
982 reports
- Pain 896
Pain
896 reports
- Upper stomach pain 884
Upper stomach pain
884 reports
- Feeling dizzy 796
Feeling dizzy
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) 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?
Is linaclotide safe during pregnancy?
Related Medications in Guanylate Cyclase-C Agonist
Other drugs grouped near linaclotide - same-class peers and common alternatives.
alosetron
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Alosetron (Lotronex) is a medicine for women with severe diarrhea-predominant irritable bowel syndrome (IBS).
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aprepitant
Emend
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bisacodyl
Dulcolax
Bisacodyl is a medicine that helps you have a bowel movement.
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bismuth subsalicylate
Pepto-Bismol
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cimetidine
Tagamet
Cimetidine (Tagamet) reduces stomach acid.
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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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: November 4, 2025
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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