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Comparative safety of prescribed Esketamine and ketamine in relation to renal and urinary disorders: A pharmacovigilance perspective

S. Chiappini, Amira Guirguis Orcid Logo, N. Schifano, J.M. Corkery, F. Semeraro, A. Mosca, G. D’Andrea, G. Duccio Papanti, D. Arillotta, G. Floresta, G. Martinotti, F. Schifano

Progress in Neuro-Psychopharmacology and Biological Psychiatry, Volume: 136, Start page: 111213

Swansea University Author: Amira Guirguis Orcid Logo

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DOI (Published version): 10.1016/j.pnpbp.2024.111213

Abstract

Intranasal esketamine, approved with oral antidepressants for adults with treatment-resistant depression (TRD), is the S-enantiomer of ketamine and has higher potency and affinity for N-Methyl-d-Aspartate receptors. Administered intranasally, it offers rapid absorption and onset, essential for sever...

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Published in: Progress in Neuro-Psychopharmacology and Biological Psychiatry
ISSN: 0278-5846 1878-4216
Published: Elsevier BV 2025
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Comparative studies on esketamine and ketamine's urological safety profiles show esketamine has lower or comparable risks of renal and urinary disorders. Ketamine, however, has documented cases of nephrotoxicity and severe urological issues in recreational users.The study aims to further evaluate and compare these profiles against other antidepressants and antipsychotics using the Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) data. ADR cases were reported to the FDA up to May 12, 2024, being drugs listed including esketamine, ketamine, quetiapine, aripiprazole, olanzapine, risperidone, citalopram, escitalopram, paroxetine, fluoxetine, sertraline, duloxetine, venlafaxine, amitriptyline, and clomipramine.Risperidone showed the highest ADRs (107,418) and serious cases (71,515), with significant renal and urinary disorders reported, including acute kidney injury and urinary incontinence. Olanzapine, quetiapine, and aripiprazole also had high serious ADRs. Venlafaxine and fluoxetine were notable among antidepressants for acute kidney injury. Esketamine and ketamine were associated with lower urinary tract symptoms and nephrolithiasis. Disproportionality analysis revealed ketamine had higher odds of renal and urinary disorders compared to other drug classes, while esketamine had lower or comparable odds.The data suggest a relatively favorable tolerability profile for these drugs, especially esketamine. 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spelling 2025-02-13T14:30:42.3736051 v2 68306 2024-11-20 Comparative safety of prescribed Esketamine and ketamine in relation to renal and urinary disorders: A pharmacovigilance perspective b49270b9a0d580cf4f31f9a1b6c93f87 0000-0001-8255-0660 Amira Guirguis Amira Guirguis true false 2024-11-20 MEDS Intranasal esketamine, approved with oral antidepressants for adults with treatment-resistant depression (TRD), is the S-enantiomer of ketamine and has higher potency and affinity for N-Methyl-d-Aspartate receptors. Administered intranasally, it offers rapid absorption and onset, essential for severe depressive symptoms or suicidal impulses. Comparative studies on esketamine and ketamine's urological safety profiles show esketamine has lower or comparable risks of renal and urinary disorders. Ketamine, however, has documented cases of nephrotoxicity and severe urological issues in recreational users.The study aims to further evaluate and compare these profiles against other antidepressants and antipsychotics using the Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) data. ADR cases were reported to the FDA up to May 12, 2024, being drugs listed including esketamine, ketamine, quetiapine, aripiprazole, olanzapine, risperidone, citalopram, escitalopram, paroxetine, fluoxetine, sertraline, duloxetine, venlafaxine, amitriptyline, and clomipramine.Risperidone showed the highest ADRs (107,418) and serious cases (71,515), with significant renal and urinary disorders reported, including acute kidney injury and urinary incontinence. Olanzapine, quetiapine, and aripiprazole also had high serious ADRs. Venlafaxine and fluoxetine were notable among antidepressants for acute kidney injury. Esketamine and ketamine were associated with lower urinary tract symptoms and nephrolithiasis. Disproportionality analysis revealed ketamine had higher odds of renal and urinary disorders compared to other drug classes, while esketamine had lower or comparable odds.The data suggest a relatively favorable tolerability profile for these drugs, especially esketamine. However, the results highlight the necessity for more extensive studies to evaluate long-term safety and optimize treatment protocols. Journal Article Progress in Neuro-Psychopharmacology and Biological Psychiatry 136 111213 Elsevier BV 0278-5846 1878-4216 Esketamine, Ketamine, Urological safety, Pharmacovigilance 10 1 2025 2025-01-10 10.1016/j.pnpbp.2024.111213 COLLEGE NANME Medical School COLLEGE CODE MEDS Swansea University SU Library paid the OA fee (TA Institutional Deal) This research received no external funding. 2025-02-13T14:30:42.3736051 2024-11-20T14:00:54.2654834 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Pharmacy S. Chiappini 1 Amira Guirguis 0000-0001-8255-0660 2 N. Schifano 3 J.M. Corkery 4 F. Semeraro 5 A. Mosca 6 G. D’Andrea 7 G. Duccio Papanti 8 D. Arillotta 9 G. Floresta 10 G. Martinotti 11 F. Schifano 12 68306__33325__97c200ee9af948a6862d85e652d5b31e.pdf 68306.VoR.pdf 2025-01-14T11:43:28.7318585 Output 840219 application/pdf Version of Record true © 2024 The Authors. This is an open access article under the CC BY-NC license. true eng http://creativecommons.org/licenses/by-nc/4.0/
title Comparative safety of prescribed Esketamine and ketamine in relation to renal and urinary disorders: A pharmacovigilance perspective
spellingShingle Comparative safety of prescribed Esketamine and ketamine in relation to renal and urinary disorders: A pharmacovigilance perspective
Amira Guirguis
title_short Comparative safety of prescribed Esketamine and ketamine in relation to renal and urinary disorders: A pharmacovigilance perspective
title_full Comparative safety of prescribed Esketamine and ketamine in relation to renal and urinary disorders: A pharmacovigilance perspective
title_fullStr Comparative safety of prescribed Esketamine and ketamine in relation to renal and urinary disorders: A pharmacovigilance perspective
title_full_unstemmed Comparative safety of prescribed Esketamine and ketamine in relation to renal and urinary disorders: A pharmacovigilance perspective
title_sort Comparative safety of prescribed Esketamine and ketamine in relation to renal and urinary disorders: A pharmacovigilance perspective
author_id_str_mv b49270b9a0d580cf4f31f9a1b6c93f87
author_id_fullname_str_mv b49270b9a0d580cf4f31f9a1b6c93f87_***_Amira Guirguis
author Amira Guirguis
author2 S. Chiappini
Amira Guirguis
N. Schifano
J.M. Corkery
F. Semeraro
A. Mosca
G. D’Andrea
G. Duccio Papanti
D. Arillotta
G. Floresta
G. Martinotti
F. Schifano
format Journal article
container_title Progress in Neuro-Psychopharmacology and Biological Psychiatry
container_volume 136
container_start_page 111213
publishDate 2025
institution Swansea University
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doi_str_mv 10.1016/j.pnpbp.2024.111213
publisher Elsevier BV
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hierarchy_top_title Faculty of Medicine, Health and Life Sciences
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hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Pharmacy{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Pharmacy
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description Intranasal esketamine, approved with oral antidepressants for adults with treatment-resistant depression (TRD), is the S-enantiomer of ketamine and has higher potency and affinity for N-Methyl-d-Aspartate receptors. Administered intranasally, it offers rapid absorption and onset, essential for severe depressive symptoms or suicidal impulses. Comparative studies on esketamine and ketamine's urological safety profiles show esketamine has lower or comparable risks of renal and urinary disorders. Ketamine, however, has documented cases of nephrotoxicity and severe urological issues in recreational users.The study aims to further evaluate and compare these profiles against other antidepressants and antipsychotics using the Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) data. ADR cases were reported to the FDA up to May 12, 2024, being drugs listed including esketamine, ketamine, quetiapine, aripiprazole, olanzapine, risperidone, citalopram, escitalopram, paroxetine, fluoxetine, sertraline, duloxetine, venlafaxine, amitriptyline, and clomipramine.Risperidone showed the highest ADRs (107,418) and serious cases (71,515), with significant renal and urinary disorders reported, including acute kidney injury and urinary incontinence. Olanzapine, quetiapine, and aripiprazole also had high serious ADRs. Venlafaxine and fluoxetine were notable among antidepressants for acute kidney injury. Esketamine and ketamine were associated with lower urinary tract symptoms and nephrolithiasis. Disproportionality analysis revealed ketamine had higher odds of renal and urinary disorders compared to other drug classes, while esketamine had lower or comparable odds.The data suggest a relatively favorable tolerability profile for these drugs, especially esketamine. However, the results highlight the necessity for more extensive studies to evaluate long-term safety and optimize treatment protocols.
published_date 2025-01-10T05:21:36Z
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