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Study · Observational study · 2026

6 results

Based on the FDA Adverse Event Reporting System Database, a Study on Signal Mining of Adverse Events for Guanylate Cyclase-C Receptor Agonists.

Lei D, Guo C, Zhao S

Hospital pharmacy9 Oct 2025

PMID41098936 (opens in a new tab)PMCIDPMC12518259 (opens in a new tab)DOI10.1177/00185787251378702 (opens in a new tab)PepBankPUB-41098936
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanObservational studySafety outcome

    In FAERS reports from Q1 2013 to Q4 2023, plecanatide had 811 adverse drug event reports and 2230 adverse drug event signals across 19 System Organ Classes.

    In plain wordsIn US adverse event reports (FAERS) from 2013 to 2023, plecanatide had 811 reports and 2230 flagged signals across 19 body-system classes.

    Peptide
    Plecanatide
    Outcome
    Not applicableAdverse event reports
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Measurements

    Adverse event reports
    811 reports
    plecanatide
    Adverse event signals
    2230 signals
    plecanatide
    System Organ Classes with signals
    19 System Organ Classes
    plecanatide

    Source sentences

    Summary
    A total of 12 275 ADE reports for Linaclotide and 811 for Plecanatide were retrieved, resulting in 28 123 and 2230 ADE signals, respectively, across 24 and 19 System Organ Classes (SOCs).
    2 context sentences
    Summary · context
    Data on adverse reactions associated with Linaclotide and Plecanatide were extracted from the FDA Adverse Event Reporting System (FAERS) for the period from Q1 2013 to Q4 2023.
    Summary · context
    Signal detection was performed using the Reporting Odds Ratio (ROR) and the Proportional Reporting Ratio (PRR).
  2. 02HumanObservational studySafety outcome

    In FAERS data, 811 plecanatide ADE reports yielded 2230 ADE signals across 19 System Organ Classes.

    In plain wordsIn FAERS records, 811 plecanatide reports gave 2230 adverse event signals across 19 organ classes.

    Peptide
    Plecanatide
    Outcome
    Not applicableAdverse event signals
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Measurements

    ADE reports
    811 reports
    plecanatide
    Adverse event signals
    2230 signals
    plecanatide
    System Organ Classes
    19 classes
    plecanatide

    Source sentences

    Summary
    A total of 12 275 ADE reports for Linaclotide and 811 for Plecanatide were retrieved, resulting in 28 123 and 2230 ADE signals, respectively, across 24 and 19 System Organ Classes (SOCs).
    2 context sentences
    Summary · context
    Data on adverse reactions associated with Linaclotide and Plecanatide were extracted from the FDA Adverse Event Reporting System (FAERS) for the period from Q1 2013 to Q4 2023.
    Summary · context
    Signal detection was performed using the Reporting Odds Ratio (ROR) and the Proportional Reporting Ratio (PRR).
  3. 03HumanObservational studySafety outcome

    In FAERS data, plecanatide predominantly showed gastrointestinal adverse event signals, including abdominal pain, bloating, and diarrhea.

    In plain wordsIn FAERS records, plecanatide was linked mainly to gastrointestinal side effects, including abdominal pain, bloating, and diarrhea.

    Peptide
    Plecanatide
    Outcome
    Not applicableGastrointestinal adverse events, including abdominal pain, bloating, and diarrhea
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Both drugs predominantly exhibited gastrointestinal ADEs, including abdominal pain, bloating, and diarrhea.
    2 context sentences
    Summary · context
    Data on adverse reactions associated with Linaclotide and Plecanatide were extracted from the FDA Adverse Event Reporting System (FAERS) for the period from Q1 2013 to Q4 2023.
    Summary · context
    Signal detection was performed using the Reporting Odds Ratio (ROR) and the Proportional Reporting Ratio (PRR).
  4. 04HumanObservational studySafety outcome

    In FAERS data, plecanatide showed a muscle spasm signal absent from its instructions.

    In plain wordsIn FAERS records, plecanatide was linked to a muscle spasm signal absent from its instructions.

    Peptide
    Plecanatide
    Outcome
    Not applicableMuscle spasms
    Study

    n: not reported in source

    Outcome group
    Adverse events · Musculoskeletal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Plecanatide demonstrated signals for muscle spasms and sleep disorders, also absent from its instructions.
    2 context sentences
    Summary · context
    Data on adverse reactions associated with Linaclotide and Plecanatide were extracted from the FDA Adverse Event Reporting System (FAERS) for the period from Q1 2013 to Q4 2023.
    Summary · context
    Signal detection was performed using the Reporting Odds Ratio (ROR) and the Proportional Reporting Ratio (PRR).
  5. 05HumanObservational studySafety outcome

    In FAERS data, plecanatide showed a sleep disorder signal absent from its instructions.

    In plain wordsIn FAERS records, plecanatide was linked to a sleep disorder signal absent from its instructions.

    Peptide
    Plecanatide
    Outcome
    Not applicableSleep disorders
    Study

    n: not reported in source

    Outcome group
    Adverse events · Sleep
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Plecanatide demonstrated signals for muscle spasms and sleep disorders, also absent from its instructions.
    2 context sentences
    Summary · context
    Data on adverse reactions associated with Linaclotide and Plecanatide were extracted from the FDA Adverse Event Reporting System (FAERS) for the period from Q1 2013 to Q4 2023.
    Summary · context
    Signal detection was performed using the Reporting Odds Ratio (ROR) and the Proportional Reporting Ratio (PRR).
  6. 06HumanObservational studySafety outcome

    In FAERS data, plecanatide showed signals related to water and electrolyte disorders.

    In plain wordsIn FAERS records, plecanatide was linked to signals for water and electrolyte disorders.

    Peptide
    Plecanatide
    Outcome
    Not applicableWater and electrolyte disorders
    Study

    n: not reported in source

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Additionally, both drugs revealed signals related to water and electrolyte disorders.
    2 context sentences
    Summary · context
    Data on adverse reactions associated with Linaclotide and Plecanatide were extracted from the FDA Adverse Event Reporting System (FAERS) for the period from Q1 2013 to Q4 2023.
    Summary · context
    Signal detection was performed using the Reporting Odds Ratio (ROR) and the Proportional Reporting Ratio (PRR).

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 3Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 2

    27 Oct 2026, 16:37 UTC

    Study data updated · source update from Europe PMC

  3. Version 1

    27 Oct 2026, 16:34 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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