Difelikefalin-associated adverse drug event signals: a real-world pharmacovigilance study from the FAERS database.

Zhao J, Qiu Q, Zhang J, Tan J

Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association22 Jun 2026

PMID42329786DOI10.1093/ndt/gfag144PepBankPUB-42329786

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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 study11

11 results from studies that gave the peptide. 11 results from people.

01HumanObservational studySafety outcome
Among difelikefalin-related FAERS reports, 46.01% listed 'other serious' outcomes.
In plain wordsDifelikefalin FAERS reports included other serious outcomes. These reports do not establish causation.
Peptide
Difelikefalin
Outcome
Not applicableOther serious event reports
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated
Measurements
Other serious outcomes
46.01%
reports
Source sentences
Summary
Clinically, the most frequent outcomes were 'other serious' events (46.01%), hospitalization (33.46%), and death (15.59%).
2 context sentences(design, population, supporting numbers)
Summary · context
ADE reports related to difelikefalin were extracted from the FAERS database (2022-2025).
Summary · context
Disproportionality analyses, including the reporting odds ratio (ROR) and proportional reporting ratio (PRR), were employed to detect ADE signals.
Report a problemFND-4232978601
02HumanObservational studySafety outcome
Among difelikefalin-related FAERS reports, 33.46% listed hospitalization.
In plain wordsDifelikefalin FAERS reports included hospitalization. These reports do not establish causation.
Peptide
Difelikefalin
Outcome
Not applicableHospitalization reports
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated
Measurements
Hospitalization
33.46%
reports
Source sentences
Summary
Clinically, the most frequent outcomes were 'other serious' events (46.01%), hospitalization (33.46%), and death (15.59%).
2 context sentences(design, population, supporting numbers)
Summary · context
ADE reports related to difelikefalin were extracted from the FAERS database (2022-2025).
Summary · context
Disproportionality analyses, including the reporting odds ratio (ROR) and proportional reporting ratio (PRR), were employed to detect ADE signals.
Report a problemFND-4232978602
03HumanObservational studySafety outcome
Among difelikefalin-related FAERS reports, 15.59% listed death.
In plain wordsDifelikefalin FAERS reports included deaths. These reports do not establish causation.
Peptide
Difelikefalin
Outcome
Not applicableDeath reports
Study
n: not reported in source
Outcome group
Mortality · Whole body
Studied dose
Dose not stated
Measurements
Death
15.59%
reports
Source sentences
Summary
Clinically, the most frequent outcomes were 'other serious' events (46.01%), hospitalization (33.46%), and death (15.59%).
2 context sentences(design, population, supporting numbers)
Summary · context
ADE reports related to difelikefalin were extracted from the FAERS database (2022-2025).
Summary · context
Disproportionality analyses, including the reporting odds ratio (ROR) and proportional reporting ratio (PRR), were employed to detect ADE signals.
Report a problemFND-4232978603
04HumanObservational studySafety outcome
Difelikefalin FAERS reports showed a nervous system disorder signal with a reporting odds ratio of 3.4.
In plain wordsDifelikefalin was linked to disproportionate reporting of nervous system disorders in FAERS.
Peptide
Difelikefalin
Outcome
IncreaseNervous system disorder reporting signal
Study
n: not reported in source
Outcome group
Adverse events · Nervous system and cognition
Studied dose
Dose not stated
Measurements
ROR
3.4
reported result
Source sentences
Summary
At the System Organ Class (SOC) level, Nervous system disorders (ROR = 3.4) and Psychiatric disorders (ROR = 2.99) showed the strongest ADE signals.
2 context sentences(design, population, supporting numbers)
Summary · context
ADE reports related to difelikefalin were extracted from the FAERS database (2022-2025).
Summary · context
Disproportionality analyses, including the reporting odds ratio (ROR) and proportional reporting ratio (PRR), were employed to detect ADE signals.
Report a problemFND-4232978604
05HumanObservational studySafety outcome
Difelikefalin FAERS reports showed a psychiatric disorder signal with a reporting odds ratio of 2.99.
In plain wordsDifelikefalin was linked to disproportionate reporting of psychiatric disorders in FAERS.
Peptide
Difelikefalin
Outcome
IncreasePsychiatric disorder reporting signal
Study
n: not reported in source
Outcome group
Adverse events · Mental health and mood
Studied dose
Dose not stated
Measurements
ROR
2.99
reported result
Source sentences
Summary
At the System Organ Class (SOC) level, Nervous system disorders (ROR = 3.4) and Psychiatric disorders (ROR = 2.99) showed the strongest ADE signals.
2 context sentences(design, population, supporting numbers)
Summary · context
ADE reports related to difelikefalin were extracted from the FAERS database (2022-2025).
Summary · context
Disproportionality analyses, including the reporting odds ratio (ROR) and proportional reporting ratio (PRR), were employed to detect ADE signals.
Report a problemFND-4232978605
06HumanObservational studySafety outcome
Difelikefalin FAERS reports showed a mental status change signal with a reporting odds ratio of 85.65.
In plain wordsDifelikefalin was linked to disproportionate reporting of mental status changes in FAERS.
Peptide
Difelikefalin
Outcome
IncreaseMental status change reporting signal
Study
n: not reported in source
Outcome group
Adverse events · Nervous system and cognition
Studied dose
Dose not stated
Measurements
ROR
85.65
reported result
Source sentences
Summary
At the Preferred Term (PT) level, high-risk signals included mental status changes (ROR = 85.65), disorientation (ROR = 33.62), electric shock sensation (ROR = 32.09), somnolence (ROR = 16.25), fall (ROR = 8.46), and fracture (ROR = 21.06).
2 context sentences(design, population, supporting numbers)
Summary · context
ADE reports related to difelikefalin were extracted from the FAERS database (2022-2025).
Summary · context
Disproportionality analyses, including the reporting odds ratio (ROR) and proportional reporting ratio (PRR), were employed to detect ADE signals.
Report a problemFND-4232978606
07HumanObservational studySafety outcome
Difelikefalin FAERS reports showed a disorientation signal with a reporting odds ratio of 33.62.
In plain wordsDifelikefalin was linked to disproportionate reporting of disorientation in FAERS.
Peptide
Difelikefalin
Outcome
IncreaseDisorientation reporting signal
Study
n: not reported in source
Outcome group
Adverse events · Nervous system and cognition
Studied dose
Dose not stated
Measurements
ROR
33.62
reported result
Source sentences
Summary
At the Preferred Term (PT) level, high-risk signals included mental status changes (ROR = 85.65), disorientation (ROR = 33.62), electric shock sensation (ROR = 32.09), somnolence (ROR = 16.25), fall (ROR = 8.46), and fracture (ROR = 21.06).
2 context sentences(design, population, supporting numbers)
Summary · context
ADE reports related to difelikefalin were extracted from the FAERS database (2022-2025).
Summary · context
Disproportionality analyses, including the reporting odds ratio (ROR) and proportional reporting ratio (PRR), were employed to detect ADE signals.
Report a problemFND-4232978607
08HumanObservational studySafety outcome
Difelikefalin FAERS reports showed an electric shock sensation signal with a reporting odds ratio of 32.09.
In plain wordsDifelikefalin was linked to disproportionate reporting of electric shock sensations in FAERS.
Peptide
Difelikefalin
Outcome
IncreaseElectric shock sensation reporting signal
Study
n: not reported in source
Outcome group
Adverse events · Nervous system and cognition
Studied dose
Dose not stated
Measurements
ROR
32.09
reported result
Source sentences
Summary
At the Preferred Term (PT) level, high-risk signals included mental status changes (ROR = 85.65), disorientation (ROR = 33.62), electric shock sensation (ROR = 32.09), somnolence (ROR = 16.25), fall (ROR = 8.46), and fracture (ROR = 21.06).
2 context sentences(design, population, supporting numbers)
Summary · context
ADE reports related to difelikefalin were extracted from the FAERS database (2022-2025).
Summary · context
Disproportionality analyses, including the reporting odds ratio (ROR) and proportional reporting ratio (PRR), were employed to detect ADE signals.
Report a problemFND-4232978608
09HumanObservational studySafety outcome
Difelikefalin FAERS reports showed a somnolence signal with a reporting odds ratio of 16.25.
In plain wordsDifelikefalin was linked to disproportionate reporting of sleepiness in FAERS.
Peptide
Difelikefalin
Outcome
IncreaseSomnolence reporting signal
Study
n: not reported in source
Outcome group
Adverse events · Nervous system and cognition
Studied dose
Dose not stated
Measurements
ROR
16.25
reported result
Source sentences
Summary
At the Preferred Term (PT) level, high-risk signals included mental status changes (ROR = 85.65), disorientation (ROR = 33.62), electric shock sensation (ROR = 32.09), somnolence (ROR = 16.25), fall (ROR = 8.46), and fracture (ROR = 21.06).
2 context sentences(design, population, supporting numbers)
Summary · context
ADE reports related to difelikefalin were extracted from the FAERS database (2022-2025).
Summary · context
Disproportionality analyses, including the reporting odds ratio (ROR) and proportional reporting ratio (PRR), were employed to detect ADE signals.
Report a problemFND-4232978609
10HumanObservational studySafety outcome
Difelikefalin FAERS reports showed a fall signal with a reporting odds ratio of 8.46.
In plain wordsDifelikefalin was linked to disproportionate reporting of falls in FAERS.
Peptide
Difelikefalin
Outcome
IncreaseFall reporting signal
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated
Measurements
ROR
8.46
reported result
Source sentences
Summary
At the Preferred Term (PT) level, high-risk signals included mental status changes (ROR = 85.65), disorientation (ROR = 33.62), electric shock sensation (ROR = 32.09), somnolence (ROR = 16.25), fall (ROR = 8.46), and fracture (ROR = 21.06).
2 context sentences(design, population, supporting numbers)
Summary · context
ADE reports related to difelikefalin were extracted from the FAERS database (2022-2025).
Summary · context
Disproportionality analyses, including the reporting odds ratio (ROR) and proportional reporting ratio (PRR), were employed to detect ADE signals.
Report a problemFND-4232978610
11HumanObservational studySafety outcome
Difelikefalin FAERS reports showed a fracture signal with a reporting odds ratio of 21.06.
In plain wordsDifelikefalin was linked to disproportionate reporting of fractures in FAERS.
Peptide
Difelikefalin
Outcome
IncreaseFracture reporting signal
Study
n: not reported in source
Outcome group
Adverse events · Musculoskeletal
Studied dose
Dose not stated
Measurements
ROR
21.06
reported result
Source sentences
Summary
At the Preferred Term (PT) level, high-risk signals included mental status changes (ROR = 85.65), disorientation (ROR = 33.62), electric shock sensation (ROR = 32.09), somnolence (ROR = 16.25), fall (ROR = 8.46), and fracture (ROR = 21.06).
2 context sentences(design, population, supporting numbers)
Summary · context
ADE reports related to difelikefalin were extracted from the FAERS database (2022-2025).
Summary · context
Disproportionality analyses, including the reporting odds ratio (ROR) and proportional reporting ratio (PRR), were employed to detect ADE signals.
Report a problemFND-4232978611

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.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:35 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

Journal Article

Keywords

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