Reglanmetoclopramide
According to the FDA label: The use of Metoclopramide Oral Solution is recommended for adults only. Therapy should not exceed 12 weeks in duration. Symptomatic Gastroesophageal Reflux Metoclopramide Oral Solution is indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy. The principal effect of metoclopramide is on symptoms of post-prandial and daytime heartburn with less observed effect on nocturnal symptoms.
25,753 adverse event reports submitted to the FDA (1997–2026)
Top Reported Adverse Events
The most frequently reported events in association with Reglan in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
- Tardive Dyskinesia 6,602 reports
Extrapyramidal Disorder 3,949 reports
A group of movement problems, such as stiffness, tremor, or restlessness, that can be associated with certain medications.
Full definition in the glossary →Dystonia 2,528 reports
Involuntary muscle contractions that cause twisting movements or abnormal postures.
Full definition in the glossary →Nausea 2,416 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Vomiting 1,685 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 1,319 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Pain 1,306 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Incorrect Drug Administration Duration 1,264 reports
A report that a medication was taken for a longer or shorter time than directed. This is a usage category.
Full definition in the glossary →Fatigue 1,250 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Dyspnoea 1,182 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Asthenia 1,025 reports
Physical weakness or lack of strength.
Full definition in the glossary →Headache 1,000 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 974 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Anxiety 899 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →Abdominal Pain 895 reports
Pain in the belly or stomach area.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 15,176 |
| Male | 7,206 |
| Unknown | 1,364 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 420 |
| 18-34 | 1,332 |
| 35-49 | 2,362 |
| 50-64 | 4,296 |
| 65-74 | 2,739 |
| 75+ | 1,567 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Reglan. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 11,102 |
| Hospitalization | 8,960 |
| Disability | 5,152 |
| Non-Serious | 4,656 |
| Death | 2,723 |
| Life-Threatening | 1,212 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Reglan. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 1997 | 1 |
| 1999 | 1 |
| 2001 | 1 |
| 2003 | 4 |
| 2004 | 524 |
| 2005 | 571 |
| 2006 | 565 |
| 2007 | 564 |
| 2008 | 594 |
| 2009 | 832 |
| 2010 | 1,178 |
| 2011 | 4,038 |
| 2012 | 3,769 |
| 2013 | 1,211 |
| 2014 | 934 |
| 2015 | 843 |
| 2016 | 980 |
| 2017 | 1,061 |
| 2018 | 915 |
| 2019 | 1,027 |
| 2020 | 964 |
| 2021 | 924 |
| 2022 | 1,158 |
| 2023 | 1,044 |
| 2024 | 974 |
| 2025 | 902 |
| 2026 (partial) | 174 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Reglan
In FDA adverse event reports that mention Reglan, these medications appeared most often in the same report.
- Acetaminophen (3,092 reports)
- Omeprazole (3,010 reports)
- Furosemide (2,936 reports)
- Aspirin (2,537 reports)
- Pantoprazole (2,519 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026