Pharmacologic class (EPC) · 3 drug pages

Guanylate Cyclase-C agonist: adverse event reports filed with FDA

16,496 reports list a drug in this class as a suspect or interacting product, 2012–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

16,496
reports across the class: 0.1% of all reports; 1,375
reports, 12 months to June 2026: 1,087 in the 12 months before; 20.3%
marked serious by the reporter: 57.4% across all reports; 3
drugs with a page: brand and generic names counted separately

Guanylate Cyclase-C agonist is a pharmacologic class (an FDA Established Pharmacologic Class) with 3 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 16,496 adverse event reports received by FDA, 0.1% of the database, from August 2012 to June 2026.

1,375 reports arrived in the 12 months to June 2026, up 26% from 1,087 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 20.3% of the class's reports are marked serious, 2.5% record death among the outcomes and 5.4% record hospitalisation, as reported.

Across the class the reactions recorded most often are diarrhoea (28.4%), drug ineffective (24.5%) and off label use (16.5%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
LinzessLinaclotide	brand	14,346	1,034	17.9%	Diarrhoea
Linaclotide	generic	1,131	274	48.9%	Diarrhoea
Plecanatide	generic	1,019	67	21.5%	Diarrhoea

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Diarrhoealoose or frequent stools28.4%4,687
Drug ineffectivethe medicine did not work as expected24.5%4,042
Off label useused for a purpose or in a way not on the label16.5%2,727
Constipationconstipation8.2%1,357
Abdominal distensiona bloated abdomen6.6%1,096
Abdominal painstomach or belly pain5.5%902
Abdominal pain upperupper stomach pain4.5%736
Flatulencewind4.3%709
Nauseafeeling sick3.6%599
Inappropriate schedule of product administrationthe product was taken at the wrong times3.5%578
Intentional product misusedeliberate use not as intended2.8%465
Dizzinesslight-headedness or unsteadiness2.4%402
Product storage errorthe product was stored wrongly2.3%382
Inappropriate schedule of drug administrationthe medicine was taken at the wrong times2.2%355
Abdominal discomfortstomach discomfort2%327
Incorrect dose administeredthe wrong dose was given1.9%317
Headachehead pain1.9%308
Wrong technique in product usage processthe product was used in the wrong way1.8%294
Painpain, site not specified1.7%278
Malaisegeneral feeling of being unwell1.7%273
Fatiguetiredness1.6%264
Muscle spasmsmuscle cramps1.6%262
Astheniaweakness or lack of energy1.6%260
Product dispensing error1.5%254
Drug dose omissiona dose was missed1.4%232

Solid bar: share of all class reports. Hollow bar: the median share across the 3 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death2.5%417

Life-threatening0.5%76

Hospitalisation (initial or prolonged)5.4%899

Disability0.8%134

Congenital anomaly0%3

Other serious14.7%2,431

Not serious79.7%13,155

Patient age

Under 20%3

2 to 110.1%23

12 to 171.1%184

18 to 444.3%702

45 to 6410.1%1,669

65 to 749%1,489

75 and over12%1,976

Age not given63.3%10,450

Who reported

Physician7.1%1,179

Pharmacist3.6%594

Other health professional6.1%1,006

Lawyer0%3

Consumer or non-health professional80.7%13,308

Not given2.5%406

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Guanylate Cyclase-C agonist reports

Which drugs are in the Guanylate Cyclase-C agonist class on this site?

Linzess, Linaclotide and Plecanatide. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

16,496 reports through June 2026, 1,375 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

diarrhoea (28.4%), drug ineffective (24.5%), off label use (16.5%), constipation (8.2%) and abdominal distension (6.6%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.