Skip to content

Study · Observational study · n = 49 · 2025

2 results

A pharmacovigilance study of the association between linaclotide/plecanatide and muscle spasms based on food and drug administration adverse event reporting system.

Fan X, Li Y, Lin X

Frontiers in pharmacology6 Aug 2025Cited by 2 (Europe PMC)

PMID40843382 (opens in a new tab)PMCIDPMC12364702 (opens in a new tab)DOI10.3389/fphar.2025.1635792 (opens in a new tab)PepBankPUB-40843382
Download PDFPubMedAsk about this study
Jump to 2 results

Summary

BackgroundLinaclotide and plecanatide, as guanylate cyclase-C agonists, are effective treatments for irritable bowel syndrome with constipation and chronic idiopathic constipation. While their therapeutic benefits are well-established, the potential association between these drugs and the adverse reaction of muscle spasms remains understudied and controversial.AimTo evaluate the potential association between muscle spasms and linaclotide or plecanatide using real-world pharmacovigilance data.MethodCases of muscle spasms linked to linaclotide or plecanatide as primary suspected drugs were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS). Disproportionality analyses, including reporting odds ratio and information component, were employed to detect safety signals. Temporal patterns were assessed using Weibull distribution analysis.ResultsA total of 231 muscle spasms cases were identified (linaclotide: 182; plecanatide: 49). Females accounted for 72.3% of the cases (n = 167), indicating a higher susceptibility. Disproportionality analysis revealed significant safety signals for both drugs, with plecanatide showing a stronger association (ROR = 6.12, 95% CI: 4.61-8.11) compared to linaclotide (ROR = 1.88, 95% CI: 1.63-2.18). Weibull analysis demonstrated an early failure-type curve (β < 1), suggesting a higher incidence shortly after treatment initiation.ConclusionThis study identifies a significant association between linaclotide/plecanatide and muscle spasms. The findings highlight the need for vigilance in high-risk populations and call for further investigation into the underlying mechanisms.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study2

2 results from studies that gave the peptide. 2 results from people.

  1. 01HumanObservational studySafety outcome

    FAERS contained 49 muscle spasm reports naming plecanatide as a primary suspected drug.

    In plain wordsFAERS contained 49 muscle spasm reports linked to suspected plecanatide exposure.

    Peptide
    Plecanatide
    Outcome
    Not applicableMuscle spasm reports
    Study

    n = 49

    Outcome group
    Adverse events · Musculoskeletal
    Studied dose
    Dose not stated

    Measurements

    Muscle spasm reports
    49 cases
    plecanatide

    Source sentences

    Summary
    A total of 231 muscle spasms cases were identified (linaclotide: 182; plecanatide: 49).
    2 context sentences
    Summary · context
    Cases of muscle spasms linked to linaclotide or plecanatide as primary suspected drugs were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS).
    Summary · context
    Disproportionality analyses, including reporting odds ratio and information component, were employed to detect safety signals.
  2. 02HumanObservational studySafety outcome

    Plecanatide showed a muscle spasm safety signal in FAERS (ROR = 6.12, 95% CI: 4.61-8.11).

    In plain wordsPlecanatide was linked to a muscle spasm reporting signal in FAERS.

    Peptide
    Plecanatide
    Outcome
    IncreaseMuscle spasm reporting signal
    Study

    n: not reported in source

    Outcome group
    Adverse events · Musculoskeletal
    Studied dose
    Dose not stated

    Measurements

    ROR
    6.12 ratio
    plecanatide
    95% CI
    4.61 to 8.11 ratio
    plecanatide

    Source sentences

    Summary
    Disproportionality analysis revealed significant safety signals for both drugs, with plecanatide showing a stronger association (ROR = 6.12, 95% CI: 4.61-8.11) compared to linaclotide (ROR = 1.88, 95% CI: 1.63-2.18).
    2 context sentences
    Summary · context
    Cases of muscle spasms linked to linaclotide or plecanatide as primary suspected drugs were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS).
    Summary · context
    Disproportionality analyses, including reporting odds ratio and information component, were employed to detect safety signals.

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.

PepBank is a research reference. Talk to a doctor before you use any peptide.