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Study · Observational study · n = 861 · 2024

10 results

Assessing real-world safety of plecanatide: a pharmacovigilance study based on the FDA adverse event reporting system.

Zhang Z, Yao Y, Zhu L

Frontiers in pharmacology25 Nov 2024Cited by 6 (Europe PMC)

PMID39654622 (opens in a new tab)PMCIDPMC11625541 (opens in a new tab)DOI10.3389/fphar.2024.1500810 (opens in a new tab)PepBankPUB-39654622
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Summary

BackgroundPlecanatide is a selective gastrointestinal peptide used for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Given its widespread use, understanding the long-term safety of plecanatide in real-world settings is essential.MethodsData for this study were sourced from the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from the first quarter of 2017 to the second quarter of 2024. Disproportionality analysis methods were employed to quantify adverse event signals associated with plecanatide. Additionally, a Weibull distribution analysis was conducted to assess changes in adverse events over time. Sensitivity analyses were performed to enhance the robustness of the findings.ResultsA total of 861 cases associated with plecanatide were identified, including 2057 adverse event reports. Common positive adverse events included diarrhea, constipation, abdominal distension, dissatisfaction with treatment, rectal tenesmus, increased fecal volume, abnormal gastrointestinal sounds, and gastrointestinal motility disorders. The majority of adverse events related to plecanatide occurred within the first 7 days of treatment. Findings were consistent across sensitivity analyses.ConclusionThis study preliminarily explores the safety of plecanatide in real-world applications, revealing significant new adverse event signals. These findings provide important safety references for clinicians prescribing plecanatide for CIC and IBS-C.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

  1. 01HumanObservational studySafety outcome

    FAERS contained 861 plecanatide-associated cases and 2057 adverse event reports.

    In plain wordsFAERS contained 861 plecanatide-associated cases and 2057 adverse event reports.

    Peptide
    Plecanatide
    Outcome
    Not applicableAdverse event reports
    Study

    n = 861

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

    Measurements

    Cases
    861 cases
    FAERS
    Adverse event reports
    2057 reports
    FAERS

    Source sentences

    Summary
    A total of 861 cases associated with plecanatide were identified, including 2057 adverse event reports.
    2 context sentences
    Summary · context
    Data for this study were sourced from the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from the first quarter of 2017 to the second quarter of 2024.
    Summary · context
    Disproportionality analysis methods were employed to quantify adverse event signals associated with plecanatide.
  2. 02HumanObservational studySafety outcome

    Plecanatide reports showed a positive diarrhea signal in FAERS.

    In plain wordsPlecanatide reports showed a positive diarrhea signal in FAERS.

    Peptide
    Plecanatide
    Outcome
    IncreaseDiarrhea signal
    Study

    n: not reported in source

    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Common positive adverse events included diarrhea, constipation, abdominal distension, dissatisfaction with treatment, rectal tenesmus, increased fecal volume, abnormal gastrointestinal sounds, and gastrointestinal motility disorders.
    2 context sentences
    Summary · context
    Data for this study were sourced from the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from the first quarter of 2017 to the second quarter of 2024.
    Summary · context
    Disproportionality analysis methods were employed to quantify adverse event signals associated with plecanatide.
  3. 03HumanObservational studySafety outcome

    Plecanatide reports showed a positive constipation signal in FAERS.

    In plain wordsPlecanatide reports showed a positive constipation signal in FAERS.

    Peptide
    Plecanatide
    Outcome
    IncreaseConstipation signal
    Study

    n: not reported in source

    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Common positive adverse events included diarrhea, constipation, abdominal distension, dissatisfaction with treatment, rectal tenesmus, increased fecal volume, abnormal gastrointestinal sounds, and gastrointestinal motility disorders.
    2 context sentences
    Summary · context
    Data for this study were sourced from the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from the first quarter of 2017 to the second quarter of 2024.
    Summary · context
    Disproportionality analysis methods were employed to quantify adverse event signals associated with plecanatide.
  4. 04HumanObservational studySafety outcome

    Plecanatide reports showed a positive abdominal distension signal in FAERS.

    In plain wordsPlecanatide reports showed a positive abdominal swelling signal in FAERS.

    Peptide
    Plecanatide
    Outcome
    IncreaseAbdominal distension signal
    Study

    n: not reported in source

    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Common positive adverse events included diarrhea, constipation, abdominal distension, dissatisfaction with treatment, rectal tenesmus, increased fecal volume, abnormal gastrointestinal sounds, and gastrointestinal motility disorders.
    2 context sentences
    Summary · context
    Data for this study were sourced from the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from the first quarter of 2017 to the second quarter of 2024.
    Summary · context
    Disproportionality analysis methods were employed to quantify adverse event signals associated with plecanatide.
  5. 05HumanObservational studySafety outcome

    Plecanatide reports showed a positive treatment dissatisfaction signal in FAERS.

    In plain wordsPlecanatide reports showed a positive treatment dissatisfaction signal in FAERS.

    Peptide
    Plecanatide
    Outcome
    IncreaseTreatment dissatisfaction signal
    Study

    n: not reported in source

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

    Source sentences

    Summary
    Common positive adverse events included diarrhea, constipation, abdominal distension, dissatisfaction with treatment, rectal tenesmus, increased fecal volume, abnormal gastrointestinal sounds, and gastrointestinal motility disorders.
    2 context sentences
    Summary · context
    Data for this study were sourced from the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from the first quarter of 2017 to the second quarter of 2024.
    Summary · context
    Disproportionality analysis methods were employed to quantify adverse event signals associated with plecanatide.
  6. 06HumanObservational studySafety outcome

    Plecanatide reports showed a positive rectal tenesmus signal in FAERS.

    In plain wordsPlecanatide reports showed a positive rectal tenesmus signal in FAERS.

    Peptide
    Plecanatide
    Outcome
    IncreaseRectal tenesmus signal
    Study

    n: not reported in source

    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Common positive adverse events included diarrhea, constipation, abdominal distension, dissatisfaction with treatment, rectal tenesmus, increased fecal volume, abnormal gastrointestinal sounds, and gastrointestinal motility disorders.
    2 context sentences
    Summary · context
    Data for this study were sourced from the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from the first quarter of 2017 to the second quarter of 2024.
    Summary · context
    Disproportionality analysis methods were employed to quantify adverse event signals associated with plecanatide.
  7. 07HumanObservational studySafety outcome

    Plecanatide reports showed a positive increased fecal volume signal in FAERS.

    In plain wordsPlecanatide reports showed a positive increased stool volume signal in FAERS.

    Peptide
    Plecanatide
    Outcome
    IncreaseIncreased fecal volume signal
    Study

    n: not reported in source

    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Common positive adverse events included diarrhea, constipation, abdominal distension, dissatisfaction with treatment, rectal tenesmus, increased fecal volume, abnormal gastrointestinal sounds, and gastrointestinal motility disorders.
    2 context sentences
    Summary · context
    Data for this study were sourced from the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from the first quarter of 2017 to the second quarter of 2024.
    Summary · context
    Disproportionality analysis methods were employed to quantify adverse event signals associated with plecanatide.
  8. 08HumanObservational studySafety outcome

    Plecanatide reports showed a positive abnormal gastrointestinal sounds signal in FAERS.

    In plain wordsPlecanatide reports showed a positive abnormal gut sounds signal in FAERS.

    Peptide
    Plecanatide
    Outcome
    IncreaseAbnormal gastrointestinal sounds signal
    Study

    n: not reported in source

    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Common positive adverse events included diarrhea, constipation, abdominal distension, dissatisfaction with treatment, rectal tenesmus, increased fecal volume, abnormal gastrointestinal sounds, and gastrointestinal motility disorders.
    2 context sentences
    Summary · context
    Data for this study were sourced from the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from the first quarter of 2017 to the second quarter of 2024.
    Summary · context
    Disproportionality analysis methods were employed to quantify adverse event signals associated with plecanatide.
  9. 09HumanObservational studySafety outcome

    Plecanatide reports showed a positive gastrointestinal motility disorders signal in FAERS.

    In plain wordsPlecanatide reports showed a positive gut movement disorder signal in FAERS.

    Peptide
    Plecanatide
    Outcome
    IncreaseGastrointestinal motility disorders signal
    Study

    n: not reported in source

    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Common positive adverse events included diarrhea, constipation, abdominal distension, dissatisfaction with treatment, rectal tenesmus, increased fecal volume, abnormal gastrointestinal sounds, and gastrointestinal motility disorders.
    2 context sentences
    Summary · context
    Data for this study were sourced from the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from the first quarter of 2017 to the second quarter of 2024.
    Summary · context
    Disproportionality analysis methods were employed to quantify adverse event signals associated with plecanatide.
  10. 10HumanObservational studySafety outcome

    Most plecanatide-associated adverse events occurred within the first 7 days of treatment.

    In plain wordsMost plecanatide-associated adverse events occurred within the first 7 days of treatment.

    Peptide
    Plecanatide
    Outcome
    Not applicableAdverse event onset
    Study

    n: not reported in source

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

    Measurements

    Window containing most adverse event onsets
    ≤ 7 days
    plecanatide-associated adverse events, FAERS

    Source sentences

    Summary
    The majority of adverse events related to plecanatide occurred within the first 7 days of treatment.
    2 context sentences
    Summary · context
    Data for this study were sourced from the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from the first quarter of 2017 to the second quarter of 2024.
    Summary · context
    Disproportionality analysis methods were employed to quantify adverse event signals associated with plecanatide.

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 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:37 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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