85/100 · Critical
Manufactured by ANI Pharmaceuticals, Inc.
Metoclopramide Adverse Events: High Seriousness and Diverse Reactions
156,854 FDA adverse event reports analyzed
Last updated: 2026-05-12
METOCLOPRAMIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. Based on analysis of 156,854 FDA adverse event reports, METOCLOPRAMIDE has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for METOCLOPRAMIDE include TARDIVE DYSKINESIA, EXTRAPYRAMIDAL DISORDER, NERVOUS SYSTEM DISORDER, DYSTONIA, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for METOCLOPRAMIDE.
Metoclopramide has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 156,854 adverse event reports for this medication, which is primarily manufactured by Ani Pharmaceuticals, Inc..
The most commonly reported adverse events include Tardive Dyskinesia, Extrapyramidal Disorder, Nervous System Disorder. Of classified reports, 94.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Metoclopramide is associated with a high number of serious adverse events, particularly Tardive Dyskinesia and Extrapyramidal Disorder.
The drug has a wide range of reactions, including neurological, gastrointestinal, and systemic effects. Report volume is substantial, with over 150,000 total reports, indicating widespread use and potential for adverse events.
Patients taking Metoclopramide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Metoclopramide can cause serious neurological side effects such as Tardive Dyskinesia and Extrapyramidal Disorder. It is important to monitor patients for these conditions, especially those with prolonged use. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Metoclopramide received a safety concern score of 85/100 (high concern). This is based on a 94.5% serious event ratio across 53,273 classified reports. The score accounts for 156,854 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 30,007, Male: 18,699, Unknown: 1,348. The most frequently reported age groups are age 69 (803 reports), age 67 (775 reports), age 66 (758 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 53,273 classified reports for METOCLOPRAMIDE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Metoclopramide can cause serious neurological side effects such as Tardive Dyskinesia and Extrapyramidal Disorder. It is important to monitor patients for these conditions, especially those with prolonged use.
If you are taking Metoclopramide, here are important things to know. The most commonly reported side effects include tardive dyskinesia, extrapyramidal disorder, nervous system disorder, dystonia, pain. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should inform their healthcare provider about any existing neurological conditions before starting Metoclopramide. Regular monitoring for signs of Tardive Dyskinesia and Extrapyramidal Disorder is recommended, especially in elderly patients. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor Metoclopramide for safety, particularly for serious neurological and gastrointestinal side effects. Healthcare providers should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 156,854 adverse event reports associated with Metoclopramide. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Metoclopramide include Tardive Dyskinesia, Extrapyramidal Disorder, Nervous System Disorder, Dystonia, Pain. By volume, the top reported reactions are: Tardive Dyskinesia (13,206 reports), Extrapyramidal Disorder (11,629 reports), Nervous System Disorder (7,175 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Metoclopramide.
Out of 53,273 classified reports, 50,338 (94.5%) were classified as serious and 2,935 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Metoclopramide break down by patient sex as follows: Female: 30,007, Male: 18,699, Unknown: 1,348. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Metoclopramide adverse events are: age 69: 803 reports, age 67: 775 reports, age 66: 758 reports, age 61: 757 reports, age 71: 732 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Metoclopramide adverse event reports is Ani Pharmaceuticals, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Metoclopramide include: Nausea, Economic Problem, Anxiety, Vomiting, Movement Disorder. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Metoclopramide to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Metoclopramide has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Metoclopramide is associated with a high number of serious adverse events, particularly Tardive Dyskinesia and Extrapyramidal Disorder.
Key safety signals identified in Metoclopramide's adverse event data include: Tardive Dyskinesia and Extrapyramidal Disorder are key safety signals, with high counts and serious nature.. Multiple serious reactions, including death, pneumonia, and renal failure, are reported.. A diverse range of reactions, including neurological, gastrointestinal, and systemic effects, are observed.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Metoclopramide can cause serious neurological side effects such as Tardive Dyskinesia and Extrapyramidal Disorder. It is important to monitor patients for these conditions, especially those with prolonged use. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Metoclopramide.
Patients should inform their healthcare provider about any existing neurological conditions before starting Metoclopramide. Regular monitoring for signs of Tardive Dyskinesia and Extrapyramidal Disorder is recommended, especially in elderly patients.
Metoclopramide has 156,854 adverse event reports on file with the FDA. The drug has a wide range of reactions, including neurological, gastrointestinal, and systemic effects. The volume of reports for Metoclopramide reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Metoclopramide for safety, particularly for serious neurological and gastrointestinal side effects. Healthcare providers should report any adverse events to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by ANI Pharmaceuticals, Inc. and compare their safety profiles:
The following drugs share commonly reported adverse reactions with METOCLOPRAMIDE:
Drugs related to METOCLOPRAMIDE based on therapeutic use, drug class, or shared indications: