Page last updated: 2024-11-01

ondansetron and Adverse Drug Event

ondansetron has been researched along with Adverse Drug Event in 20 studies

Ondansetron: A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties.

Research Excerpts

ExcerptRelevanceReference
"The primary aim of this study was to compare the effectiveness of olanzapine, palonosetron and ondansetron infusion (standard of care) for the treatment of breakthrough chemotherapy-induced nausea and vomiting (CINV) in patients undergoing hematopoietic stem cell transplantation (HSCT)."9.24A randomized trial of olanzapine versus palonosetron versus infused ondansetron for the treatment of breakthrough chemotherapy-induced nausea and vomiting in patients undergoing hematopoietic stem cell transplantation. ( Barras, M; Butler, JP; Curley, C; Kennedy, GA; Nakagaki, M, 2017)
"Palonosetron has shown efficacy in the prevention of chemotherapy-induced nausea and vomiting in adults undergoing moderately or highly emetogenic chemotherapy."9.22Palonosetron versus ondansetron for prevention of chemotherapy-induced nausea and vomiting in paediatric patients with cancer receiving moderately or highly emetogenic chemotherapy: a randomised, phase 3, double-blind, double-dummy, non-inferiority study. ( Basharova, EV; Kabickova, E; Kovács, G; Nicolas, P; Spinelli, T; Wachtel, AE, 2016)
"The neurokinin-1 receptor antagonist aprepitant, plus a 5HT3 antagonist and corticosteroid is well-tolerated and effective in preventing chemotherapy-induced nausea and vomiting in adults but has not been formally assessed in adolescents."9.14Aprepitant in adolescent patients for prevention of chemotherapy-induced nausea and vomiting: a randomized, double-blind, placebo-controlled study of efficacy and tolerability. ( Carides, AD; Chawla, S; Chua, V; Devandry, S; Evans, JK; Gore, L; Hemenway, M; Oxenius, B; Petrilli, A; Schissel, D; Taylor, A; Valentine, J, 2009)
"At several out-of-hours services primary care, a single dose of ondansetron was compared with standard care (oral rehydration solution (ORS)) in young children with gastroenteritis and persistent vomiting."8.12[No place for ondansetron in young children with gastroenteritis and persistent vomiting]. ( Wichers, IM, 2022)
"The primary aim of this study was to compare the effectiveness of olanzapine, palonosetron and ondansetron infusion (standard of care) for the treatment of breakthrough chemotherapy-induced nausea and vomiting (CINV) in patients undergoing hematopoietic stem cell transplantation (HSCT)."5.24A randomized trial of olanzapine versus palonosetron versus infused ondansetron for the treatment of breakthrough chemotherapy-induced nausea and vomiting in patients undergoing hematopoietic stem cell transplantation. ( Barras, M; Butler, JP; Curley, C; Kennedy, GA; Nakagaki, M, 2017)
"Palonosetron has shown efficacy in the prevention of chemotherapy-induced nausea and vomiting in adults undergoing moderately or highly emetogenic chemotherapy."5.22Palonosetron versus ondansetron for prevention of chemotherapy-induced nausea and vomiting in paediatric patients with cancer receiving moderately or highly emetogenic chemotherapy: a randomised, phase 3, double-blind, double-dummy, non-inferiority study. ( Basharova, EV; Kabickova, E; Kovács, G; Nicolas, P; Spinelli, T; Wachtel, AE, 2016)
"The neurokinin-1 receptor antagonist aprepitant, plus a 5HT3 antagonist and corticosteroid is well-tolerated and effective in preventing chemotherapy-induced nausea and vomiting in adults but has not been formally assessed in adolescents."5.14Aprepitant in adolescent patients for prevention of chemotherapy-induced nausea and vomiting: a randomized, double-blind, placebo-controlled study of efficacy and tolerability. ( Carides, AD; Chawla, S; Chua, V; Devandry, S; Evans, JK; Gore, L; Hemenway, M; Oxenius, B; Petrilli, A; Schissel, D; Taylor, A; Valentine, J, 2009)
"Ondansetron has shown good efficacy in the prevention of acute nausea and vomiting in children receiving moderately or highly emetogenic chemotherapy and/or irradiation, particularly when combined with dexamethasone."4.81Ondansetron: a review of its use as an antiemetic in children. ( Bhana, N; Culy, CR; Plosker, GL, 2001)
"At several out-of-hours services primary care, a single dose of ondansetron was compared with standard care (oral rehydration solution (ORS)) in young children with gastroenteritis and persistent vomiting."4.12[No place for ondansetron in young children with gastroenteritis and persistent vomiting]. ( Wichers, IM, 2022)
"Postoperative pain was treated successfully in both groups."2.78Ondansetron does not attenuate the analgesic efficacy of nefopam. ( Chen, J; Chen, Y; Li, MG; Lu, KZ; Shen, H; Tian, GP, 2013)
"Ondansetron exposure was equivalent in regimens B and C."2.74Impact of casopitant, a novel NK-1 antagonist, on the pharmacokinetics of ondansetron and dexamethasone. ( Adams, L; Blum, R; Johnson, B; Lates, C; Lebowitz, P; Lu, E; Zhang, K, 2009)
"Pioglitazone was further assessed as a mechanism-based inhibitor."1.40Domperidone interacts with pioglitazone but not with ondansetron via common CYP metabolism in vitro. ( Nagar, S; Parkman, HP; Youssef, AS, 2014)
"5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects."1.32Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling. ( Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004)

Research

Studies (20)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's3 (15.00)18.2507
2000's6 (30.00)29.6817
2010's8 (40.00)24.3611
2020's3 (15.00)2.80

Authors

AuthorsStudies
Matthews, EJ1
Kruhlak, NL1
Weaver, JL1
Benz, RD1
Contrera, JF1
Liu, Z1
Shi, Q1
Ding, D1
Kelly, R1
Fang, H1
Tong, W1
Morgan, RE1
van Staden, CJ1
Chen, Y2
Kalyanaraman, N1
Kalanzi, J1
Dunn, RT1
Afshari, CA1
Hamadeh, HK1
Wichers, IM1
Mansour, M2
Nasr, M2
Ahmed-Farid, OAH2
Ahmed, RF2
Osman, AAM1
Elhassan, MMA1
AbdElrahim, BHA1
Ahmed, FHA1
Yousif, JBH1
Ahmed, MAM1
Abdelhafeez, RHA1
Ahmed, UMY1
Darpo, B1
Benson, C1
Brown, R1
Dota, C1
Ferber, G1
Ferry, J1
Jarugula, V1
Keirns, J1
Ortemann-Renon, C1
Pham, T1
Riley, S1
Sarapa, N1
Ticktin, M1
Zareba, W1
Couderc, JP1
Lu, KZ1
Shen, H1
Li, MG1
Tian, GP1
Chen, J1
Youssef, AS1
Parkman, HP1
Nagar, S1
Kovács, G1
Wachtel, AE1
Basharova, EV1
Spinelli, T1
Nicolas, P1
Kabickova, E1
Nakagaki, M1
Barras, M1
Curley, C1
Butler, JP1
Kennedy, GA1
Bell, GC1
Caudle, KE1
Whirl-Carrillo, M1
Gordon, RJ1
Hikino, K1
Prows, CA1
Gaedigk, A1
Agundez, J1
Sadhasivam, S1
Klein, TE1
Schwab, M1
Gore, L1
Chawla, S1
Petrilli, A1
Hemenway, M1
Schissel, D1
Chua, V1
Carides, AD1
Taylor, A1
Devandry, S1
Valentine, J1
Evans, JK1
Oxenius, B1
Johnson, B1
Adams, L1
Lu, E1
Zhang, K1
Lebowitz, P1
Lates, C1
Blum, R1
Nathan, PC1
Tomlinson, G1
Dupuis, LL1
Greenberg, ML1
Ota, S1
Bartels, U1
Feldman, BM1
Dłuzniewska, A1
Balwierz, W1
Armata, J1
Eliasińska, A1
Thavaraj, V1
Arya, LS1
McCune, JS1
Oertel, MD1
Pfeifer, D1
Houston, SA1
Bingham, A1
Sawyer, WT1
Lindley, CM1
Culy, CR1
Bhana, N1
Plosker, GL1

Clinical Trials (5)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Clinical ECG Study to Evaluate Electrophysiological Effects of Potential QT Prolonging Drugs With Novel ECG Biomarkers With Exposure-Response Analysis[NCT05716854]Phase 144 participants (Actual)Interventional2023-03-21Completed
A Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Two Different Doses of Palonosetron Compared to Ondansetron in the Prevention of CINV in Pediatric Patients Undergoing Single and Repeated Cycles of MEC o[NCT01442376]Phase 3502 participants (Actual)Interventional2011-09-30Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated W[NCT00080444]Phase 350 participants (Actual)Interventional2004-04-30Completed
A Study to Evaluate the Safety and Efficacy of Aprepitant (MK0869) for Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients[NCT01757210]20 participants (Actual)Observational2012-09-30Completed
An Open-Label, Phase I Study to Assess the Pharmacokinetic Interaction Between Repeat Doses of Oral Casopitant and Intravenous and Oral Doses of Dexamethasone and Intravenous and Oral Doses of Ondansetron When Administered in Healthy Adult Subjects[NCT00437229]Phase 137 participants (Actual)Interventional2007-02-19Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Proportion of Patients With Complete Response >24 to 120 Hours (Delayed Phase) in Cycle 1

Complete Response (CR) was defined as no vomiting, no retching, and no use of antiemetic rescue medication from >24 to 120 hours (delayed phase) after T0 (start of administration of the most emetogenic chemotherapy) during first cycle. (NCT01442376)
Timeframe: from >24 to 120 hours (delayed phase) after T0

Interventionpercentage of patients (Number)
Palonosetron 10 mcg/kg28.9
Palonosetron 20 mcg/kg38.8
Ondansetron28.4

Proportion of Patients With Complete Response 0 to 24 Hours (Acute Phase) in Cycle 1

Complete Response (CR) was defined as no vomiting, no retching, and no use of antiemetic rescue medication from 0 to 24 hours (acute phase) after T0 (start of administration of the most emetogenic chemotherapy) during first cycle. Time 0 (T0) is defined as the time when the patient starts the first cycle of chemotherapy. (NCT01442376)
Timeframe: 0 to 24 hours after T0

Interventionpercentage of patients (Number)
Palonosetron 10 mcg/kg54.2
Palonosetron 20 mcg/kg59.4
Ondansetron58.6

Reviews

3 reviews available for ondansetron and Adverse Drug Event

ArticleYear
Clinical Pharmacogenetics Implementation Consortium (CPIC) guideline for CYP2D6 genotype and use of ondansetron and tropisetron.
    Clinical pharmacology and therapeutics, 2017, Volume: 102, Issue:2

    Topics: Antiemetics; Cytochrome P-450 CYP2D6; Drug-Related Side Effects and Adverse Reactions; Genetic Testi

2017
Ondansetron.
    Indian pediatrics, 1995, Volume: 32, Issue:8

    Topics: Administration, Oral; Adult; Antiemetics; Child; Child, Preschool; Clinical Trials as Topic; Drug-Re

1995
Ondansetron: a review of its use as an antiemetic in children.
    Paediatric drugs, 2001, Volume: 3, Issue:6

    Topics: Adolescent; Antiemetics; Child; Clinical Trials as Topic; Dexamethasone; Drug-Related Side Effects a

2001

Trials

7 trials available for ondansetron and Adverse Drug Event

ArticleYear
Evaluation of the Effect of 5 QT-Positive Drugs on the JTpeak Interval - An Analysis of ECGs From the IQ-CSRC Study.
    Journal of clinical pharmacology, 2020, Volume: 60, Issue:1

    Topics: Arrhythmias, Cardiac; Biomarkers; Cetirizine; Drug-Related Side Effects and Adverse Reactions; Elect

2020
Ondansetron does not attenuate the analgesic efficacy of nefopam.
    International journal of medical sciences, 2013, Volume: 10, Issue:12

    Topics: Adult; Aged; Analgesics; Drug Combinations; Drug-Related Side Effects and Adverse Reactions; Female;

2013
Palonosetron versus ondansetron for prevention of chemotherapy-induced nausea and vomiting in paediatric patients with cancer receiving moderately or highly emetogenic chemotherapy: a randomised, phase 3, double-blind, double-dummy, non-inferiority study.
    The Lancet. Oncology, 2016, Volume: 17, Issue:3

    Topics: Adolescent; Antiemetics; Antineoplastic Agents; Child; Child, Preschool; Confidence Intervals; Dose-

2016
A randomized trial of olanzapine versus palonosetron versus infused ondansetron for the treatment of breakthrough chemotherapy-induced nausea and vomiting in patients undergoing hematopoietic stem cell transplantation.
    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2017, Volume: 25, Issue:2

    Topics: Adolescent; Adult; Aged; Antiemetics; Antineoplastic Combined Chemotherapy Protocols; Benzodiazepine

2017
Aprepitant in adolescent patients for prevention of chemotherapy-induced nausea and vomiting: a randomized, double-blind, placebo-controlled study of efficacy and tolerability.
    Pediatric blood & cancer, 2009, Volume: 52, Issue:2

    Topics: Adolescent; Antineoplastic Agents; Aprepitant; Area Under Curve; Child; Dexamethasone; Double-Blind

2009
Aprepitant in adolescent patients for prevention of chemotherapy-induced nausea and vomiting: a randomized, double-blind, placebo-controlled study of efficacy and tolerability.
    Pediatric blood & cancer, 2009, Volume: 52, Issue:2

    Topics: Adolescent; Antineoplastic Agents; Aprepitant; Area Under Curve; Child; Dexamethasone; Double-Blind

2009
Aprepitant in adolescent patients for prevention of chemotherapy-induced nausea and vomiting: a randomized, double-blind, placebo-controlled study of efficacy and tolerability.
    Pediatric blood & cancer, 2009, Volume: 52, Issue:2

    Topics: Adolescent; Antineoplastic Agents; Aprepitant; Area Under Curve; Child; Dexamethasone; Double-Blind

2009
Aprepitant in adolescent patients for prevention of chemotherapy-induced nausea and vomiting: a randomized, double-blind, placebo-controlled study of efficacy and tolerability.
    Pediatric blood & cancer, 2009, Volume: 52, Issue:2

    Topics: Adolescent; Antineoplastic Agents; Aprepitant; Area Under Curve; Child; Dexamethasone; Double-Blind

2009
Impact of casopitant, a novel NK-1 antagonist, on the pharmacokinetics of ondansetron and dexamethasone.
    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2009, Volume: 17, Issue:9

    Topics: Adolescent; Adult; Antiemetics; Dexamethasone; Drug Therapy, Combination; Drug-Related Side Effects

2009
A pilot study of ondansetron plus metopimazine vs. ondansetron monotherapy in children receiving highly emetogenic chemotherapy: a Bayesian randomized serial N-of-1 trials design.
    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2006, Volume: 14, Issue:3

    Topics: Antiemetics; Antineoplastic Agents; Bayes Theorem; Brain Neoplasms; Child; Child, Preschool; Cisplat

2006

Other Studies

10 other studies available for ondansetron and Adverse Drug Event

ArticleYear
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
    Current drug discovery technologies, 2004, Volume: 1, Issue:4

    Topics: Adverse Drug Reaction Reporting Systems; Artificial Intelligence; Computers; Databases, Factual; Dru

2004
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
    PLoS computational biology, 2011, Volume: 7, Issue:12

    Topics: Animals; Anti-Infective Agents; Anti-Inflammatory Agents; Chemical and Drug Induced Liver Injury; Da

2011
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
    Toxicological sciences : an official journal of the Society of Toxicology, 2013, Volume: 136, Issue:1

    Topics: Animals; ATP Binding Cassette Transporter, Subfamily B; ATP Binding Cassette Transporter, Subfamily

2013
[No place for ondansetron in young children with gastroenteritis and persistent vomiting].
    Nederlands tijdschrift voor geneeskunde, 2022, 03-02, Volume: 166

    Topics: Administration, Oral; Antiemetics; Child; Child, Preschool; Diarrhea; Double-Blind Method; Drug-Rela

2022
Intranasal ondansetron microemulsion counteracting the adverse effects of cisplatin: animal study.
    Pharmacological reports : PR, 2023, Volume: 75, Issue:1

    Topics: Animals; Antiemetics; Cisplatin; Drug-Related Side Effects and Adverse Reactions; Ondansetron; Rats;

2023
Intranasal ondansetron microemulsion counteracting the adverse effects of cisplatin: animal study.
    Pharmacological reports : PR, 2023, Volume: 75, Issue:1

    Topics: Animals; Antiemetics; Cisplatin; Drug-Related Side Effects and Adverse Reactions; Ondansetron; Rats;

2023
Intranasal ondansetron microemulsion counteracting the adverse effects of cisplatin: animal study.
    Pharmacological reports : PR, 2023, Volume: 75, Issue:1

    Topics: Animals; Antiemetics; Cisplatin; Drug-Related Side Effects and Adverse Reactions; Ondansetron; Rats;

2023
Intranasal ondansetron microemulsion counteracting the adverse effects of cisplatin: animal study.
    Pharmacological reports : PR, 2023, Volume: 75, Issue:1

    Topics: Animals; Antiemetics; Cisplatin; Drug-Related Side Effects and Adverse Reactions; Ondansetron; Rats;

2023
Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting: A Comparative Study From Sudan.
    Journal of global oncology, 2018, Volume: 4

    Topics: Adult; Aged; Antiemetics; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Therap

2018
Domperidone interacts with pioglitazone but not with ondansetron via common CYP metabolism in vitro.
    Xenobiotica; the fate of foreign compounds in biological systems, 2014, Volume: 44, Issue:9

    Topics: Antiemetics; Chromatography, Liquid; Cytochrome P-450 CYP3A; Domperidone; Drug Interactions; Drug-Re

2014
[Evaluation of +ondansetron (Zolfiran) in prevention of vomiting in children treated with cytostatics].
    Pediatria polska, 1995, Volume: 70, Issue:1

    Topics: Adolescent; Child; Child, Preschool; Drug-Related Side Effects and Adverse Reactions; Female; Humans

1995
Reports from the University Hospital Consortium (UHC) Technology Advancement Center.
    International journal of technology assessment in health care, 1995,Winter, Volume: 11, Issue:1

    Topics: Academic Medical Centers; Drug-Related Side Effects and Adverse Reactions; Multicenter Studies as To

1995
Evaluation of outcomes in converting from intravenous ondansetron to oral granisetron: an observational study.
    The Annals of pharmacotherapy, 2001, Volume: 35, Issue:1

    Topics: Administration, Oral; Adolescent; Adult; Antiemetics; Child; Constipation; Diarrhea; Drug Utilizatio

2001