Descriptive Analysis of Reported Adverse Events Associated with Metoclopramide Using FDA Adverse Event Reporting System Databases

Metoclopramide has been approved by the Food and Drug Administration (FDA) for the treatment of nausea and vomiting in patients with gastroesophageal reflux disease (GERD) who are unresponsive to standard therapies, as well as for managing diabetic gastroparesis by enhancing gastric motility. This study aims to analyze and describe the adverse events associated with metoclopramide using the Food and Drug Administration Adverse Event Reporting System databases. The study encompassed all reports of metoclopramide submitted by healthcare providers or other stakeholders up until January 01, 2025. The data were analyzed using descriptive statistics, and the results were presented as both raw numbers and percentages. A total of 22,381 reports were submitted to FAERS before January 01, 2025. The majority of patients were female, accounting for 67.90%, and most of them were between the ages of 18 and 64. The most commonly reported events were tardive dyskinesia (59.74%), extrapyramidal disorder (52.83%), nervous system disorder (32.31%), and dystonia (30.35%). While metoclopramide remains an effective treatment for conditions like nausea and vomiting, healthcare providers must be vigilant in managing its potential adverse reactions.

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Publication Details

Journal
Clinical Pharmacy Connect
Published
2025-06-17
DOI
https://doi.org/10.69709/cpc.2025.193994
Primary Topic
Nausea and vomiting management
Type
article
Field-Weighted Citation Impact
0.00

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article

Descriptive Analysis of Reported Adverse Events Associated with Metoclopramide Using FDA Adverse Event Reporting System Databases

Nehad J. Ahmed
2 links
Clinical Pharmacy Connect
Nausea and vomiting management
article

Descriptive Analysis of Reported Adverse Events Associated with Metoclopramide Using FDA Adverse Event Reporting System Databases

Nehad J. Ahmed
article en

Abstract

Metoclopramide has been approved by the Food and Drug Administration (FDA) for the treatment of nausea and vomiting in patients with gastroesophageal reflux disease (GERD) who are unresponsive to standard therapies, as well as for managing diabetic gastroparesis by enhancing gastric motility. This study aims to analyze and describe the adverse events associated with metoclopramide using the Food and Drug Administration Adverse Event Reporting System databases. The study encompassed all reports of metoclopramide submitted by healthcare providers or other stakeholders up until January 01, 2025. The data were analyzed using descriptive statistics, and the results were presented as both raw numbers and percentages. A total of 22,381 reports were submitted to FAERS before January 01, 2025. The majority of patients were female, accounting for 67.90%, and most of them were between the ages of 18 and 64. The most commonly reported events were tardive dyskinesia (59.74%), extrapyramidal disorder (52.83%), nervous system disorder (32.31%), and dystonia (30.35%). While metoclopramide remains an effective treatment for conditions like nausea and vomiting, healthcare providers must be vigilant in managing its potential adverse reactions.

Clinical Pharmacy ConnectVol. 1(1)
Prince Sattam Bin Abdulaziz University (SA)
Prince Sattam bin Abdulaziz University
Openalex Percentile: Top 76%
Nausea and vomiting management
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