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Study · Observational study · 2023

10 results

A real-world pharmacovigilance study of abaloparatide based on the FDA Adverse Event Reporting System (FAERS).

Shi X, Cheng Q, Zhao YZ, Zou SP, Sun MH

Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA18 Aug 2023Cited by 8 (Europe PMC)

PMID37594595 (opens in a new tab)DOI10.1007/s00198-023-06877-6 (opens in a new tab)PepBankPUB-37594595
Publisher pagePubMedAsk about this study
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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 study10

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

  1. 01HumanObservational studySafety outcome

    In FAERS abaloparatide reports, 99 safety signals met all four algorithms, including 35 unexpected signals.

    In plain wordsIn adverse event reports for abaloparatide, researchers detected 99 signals, including 35 unexpected signals.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    Not applicableDetected safety signals
    Study

    Homo sapiensn: not reported in source

    FDA Adverse Event Reporting System clinical adverse event reports
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Measurements

    Signals
    99 signals
    all four algorithms
    Unexpected signals
    35 signals
    abaloparatide

    Source sentences

    Summary
    A total 99 signals simultaneously conforming to four algorithms were detected, among which, 35 signals were identified as unexpected signals.
    1 context sentence
    Summary · context
    We evaluated abaloparatide-associated safety signals by data mining of the FDA pharmacovigilance database.
  2. 02HumanObservational studySafety outcome

    In FAERS, abaloparatide was linked to an unexpected growing-pains signal with 13 reports.

    In plain wordsIn adverse event reports, abaloparatide was linked to a growing-pains signal involving 13 reports.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    Not applicableGrowing pains
    Study

    Homo sapiensn: not reported in source

    FDA Adverse Event Reporting System clinical adverse event reports
    Outcome group
    Adverse events · Musculoskeletal
    Studied dose
    Dose not stated

    Measurements

    Reports
    13 reports
    growing pains

    Source sentences

    Summary
    Such as growing pains (n=13), waist circumference increased (n=21), sensory disturbance (n=103), tinnitus (n=65), visual acuity reduced (n=54), blood alkaline phosphatase increased (n=61), and hair growth abnormal (n=13).
    2 context sentences
    Summary · context
    A total 99 signals simultaneously conforming to four algorithms were detected, among which, 35 signals were identified as unexpected signals.
    Summary · context
    We evaluated abaloparatide-associated safety signals by data mining of the FDA pharmacovigilance database.
  3. 03HumanObservational studySafety outcome

    In FAERS, abaloparatide was linked to an unexpected increased-waist-circumference signal with 21 reports.

    In plain wordsIn adverse event reports, abaloparatide was linked to an increased-waist-circumference signal involving 21 reports.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    Not applicableIncreased waist circumference
    Study

    Homo sapiensn: not reported in source

    FDA Adverse Event Reporting System clinical adverse event reports
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    Reports
    21 reports
    waist circumference increased

    Source sentences

    Summary
    Such as growing pains (n=13), waist circumference increased (n=21), sensory disturbance (n=103), tinnitus (n=65), visual acuity reduced (n=54), blood alkaline phosphatase increased (n=61), and hair growth abnormal (n=13).
    2 context sentences
    Summary · context
    A total 99 signals simultaneously conforming to four algorithms were detected, among which, 35 signals were identified as unexpected signals.
    Summary · context
    We evaluated abaloparatide-associated safety signals by data mining of the FDA pharmacovigilance database.
  4. 04HumanObservational studySafety outcome

    In FAERS, abaloparatide was linked to an unexpected sensory-disturbance signal with 103 reports.

    In plain wordsIn adverse event reports, abaloparatide was linked to a sensory-disturbance signal involving 103 reports.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    Not applicableSensory disturbance
    Study

    Homo sapiensn: not reported in source

    FDA Adverse Event Reporting System clinical adverse event reports
    Outcome group
    Adverse events · Nervous system and cognition
    Studied dose
    Dose not stated

    Measurements

    Reports
    103 reports
    sensory disturbance

    Source sentences

    Summary
    Such as growing pains (n=13), waist circumference increased (n=21), sensory disturbance (n=103), tinnitus (n=65), visual acuity reduced (n=54), blood alkaline phosphatase increased (n=61), and hair growth abnormal (n=13).
    2 context sentences
    Summary · context
    A total 99 signals simultaneously conforming to four algorithms were detected, among which, 35 signals were identified as unexpected signals.
    Summary · context
    We evaluated abaloparatide-associated safety signals by data mining of the FDA pharmacovigilance database.
  5. 05HumanObservational studySafety outcome

    In FAERS, abaloparatide was linked to an unexpected tinnitus signal with 65 reports.

    In plain wordsIn adverse event reports, abaloparatide was linked to a tinnitus signal involving 65 reports.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    Not applicableTinnitus
    Study

    Homo sapiensn: not reported in source

    FDA Adverse Event Reporting System clinical adverse event reports
    Outcome group
    Adverse events · Nervous system and cognition
    Studied dose
    Dose not stated

    Measurements

    Reports
    65 reports
    tinnitus

    Source sentences

    Summary
    Such as growing pains (n=13), waist circumference increased (n=21), sensory disturbance (n=103), tinnitus (n=65), visual acuity reduced (n=54), blood alkaline phosphatase increased (n=61), and hair growth abnormal (n=13).
    2 context sentences
    Summary · context
    A total 99 signals simultaneously conforming to four algorithms were detected, among which, 35 signals were identified as unexpected signals.
    Summary · context
    We evaluated abaloparatide-associated safety signals by data mining of the FDA pharmacovigilance database.
  6. 06HumanObservational studySafety outcome

    In FAERS, abaloparatide was linked to an unexpected reduced-visual-acuity signal with 54 reports.

    In plain wordsIn adverse event reports, abaloparatide was linked to a reduced-vision signal involving 54 reports.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    Not applicableReduced visual acuity
    Study

    Homo sapiensn: not reported in source

    FDA Adverse Event Reporting System clinical adverse event reports
    Outcome group
    Adverse events · Eye
    Studied dose
    Dose not stated

    Measurements

    Reports
    54 reports
    visual acuity reduced

    Source sentences

    Summary
    Such as growing pains (n=13), waist circumference increased (n=21), sensory disturbance (n=103), tinnitus (n=65), visual acuity reduced (n=54), blood alkaline phosphatase increased (n=61), and hair growth abnormal (n=13).
    2 context sentences
    Summary · context
    A total 99 signals simultaneously conforming to four algorithms were detected, among which, 35 signals were identified as unexpected signals.
    Summary · context
    We evaluated abaloparatide-associated safety signals by data mining of the FDA pharmacovigilance database.
  7. 07HumanObservational studySafety outcome

    In FAERS, abaloparatide was linked to an unexpected increased-blood-alkaline-phosphatase signal with 61 reports.

    In plain wordsIn adverse event reports, abaloparatide was linked to an increased blood alkaline phosphatase signal involving 61 reports.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    Not applicableIncreased blood alkaline phosphatase
    Study

    Homo sapiensn: not reported in source

    FDA Adverse Event Reporting System clinical adverse event reports
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Measurements

    Reports
    61 reports
    blood alkaline phosphatase increased

    Source sentences

    Summary
    Such as growing pains (n=13), waist circumference increased (n=21), sensory disturbance (n=103), tinnitus (n=65), visual acuity reduced (n=54), blood alkaline phosphatase increased (n=61), and hair growth abnormal (n=13).
    2 context sentences
    Summary · context
    A total 99 signals simultaneously conforming to four algorithms were detected, among which, 35 signals were identified as unexpected signals.
    Summary · context
    We evaluated abaloparatide-associated safety signals by data mining of the FDA pharmacovigilance database.
  8. 08HumanObservational studySafety outcome

    In FAERS, abaloparatide was linked to an unexpected abnormal-hair-growth signal with 13 reports.

    In plain wordsIn adverse event reports, abaloparatide was linked to an abnormal-hair-growth signal involving 13 reports.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    Not applicableAbnormal hair growth
    Study

    Homo sapiensn: not reported in source

    FDA Adverse Event Reporting System clinical adverse event reports
    Outcome group
    Adverse events · Skin and wound
    Studied dose
    Dose not stated

    Measurements

    Reports
    13 reports
    hair growth abnormal

    Source sentences

    Summary
    Such as growing pains (n=13), waist circumference increased (n=21), sensory disturbance (n=103), tinnitus (n=65), visual acuity reduced (n=54), blood alkaline phosphatase increased (n=61), and hair growth abnormal (n=13).
    2 context sentences
    Summary · context
    A total 99 signals simultaneously conforming to four algorithms were detected, among which, 35 signals were identified as unexpected signals.
    Summary · context
    We evaluated abaloparatide-associated safety signals by data mining of the FDA pharmacovigilance database.
  9. 09HumanObservational studySafety outcome

    In FAERS abaloparatide reports, patient age might be associated with increased adverse event severity.

    In plain wordsIn abaloparatide adverse event reports, patient age might be linked to greater adverse event severity.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    Direction not reportedAge association with adverse event severity
    Study

    Homo sapiensn: not reported in source

    FDA Adverse Event Reporting System clinical adverse event reports
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Measurements

    p value for patient age
    < 0.001
    patient age and adverse event severity

    Source sentences

    Summary
    Patient age (p < 0.001) might be associated with an increased risk of AEs severity.
    1 context sentence
    Summary · context
    We evaluated abaloparatide-associated safety signals by data mining of the FDA pharmacovigilance database.
  10. 10HumanObservational studySafety outcome

    In FAERS abaloparatide reports, the most common adverse event onset window was 0-7 days.

    In plain wordsIn abaloparatide reports, adverse events most commonly started within 0-7 days.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    Not applicableAdverse event onset
    Study

    Homo sapiensn: not reported in source

    FDA Adverse Event Reporting System clinical adverse event reports
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Measurements

    Most common onset window
    0 to 7 days
    abaloparatide adverse events

    Source sentences

    Summary
    The most common timeframe for AE occurrence was 0-7 days.
    1 context sentence
    Summary · context
    We evaluated abaloparatide-associated safety signals by data mining of the FDA pharmacovigilance database.

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

    22 Oct 2026, 02:25 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

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