85/100 · Critical
Manufactured by ANI Pharmaceuticals, Inc.
Metoclopramide Hydrochloride: High Risk of Serious Adverse Reactions
206,778 FDA adverse event reports analyzed
Last updated: 2026-05-12
METOCLOPRAMIDE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. Based on analysis of 206,778 FDA adverse event reports, METOCLOPRAMIDE HYDROCHLORIDE 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 HYDROCHLORIDE include TARDIVE DYSKINESIA, EXTRAPYRAMIDAL DISORDER, NERVOUS SYSTEM DISORDER, DYSTONIA, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for METOCLOPRAMIDE HYDROCHLORIDE.
Metoclopramide Hydrochloride 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 206,778 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, 89.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Metoclopramide Hydrochloride is associated with a high incidence of serious adverse reactions, particularly extrapyramidal disorders and tardive dyskinesia.
The drug is frequently reported to cause neurological and gastrointestinal issues, including nausea, vomiting, and pain. There is a significant risk of drug interactions, particularly with other antipsychotics and drugs that affect the central nervous system.
Patients taking Metoclopramide Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Metoclopramide Hydrochloride can cause serious drug interactions, particularly with other antipsychotics and drugs that affect the central nervous system. Healthcare providers should be cautious when prescribing this drug in combination with other me This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Metoclopramide Hydrochloride received a safety concern score of 85/100 (high concern). This is based on a 89.5% serious event ratio across 74,994 classified reports. The score accounts for 206,778 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: 42,931, Male: 24,879, Unknown: 1,594. The most frequently reported age groups are age 67 (1,107 reports), age 66 (1,069 reports), age 69 (1,056 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 74,994 classified reports for METOCLOPRAMIDE HYDROCHLORIDE:
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 Hydrochloride can cause serious drug interactions, particularly with other antipsychotics and drugs that affect the central nervous system. Healthcare providers should be cautious when prescribing this drug in combination with other me
If you are taking Metoclopramide Hydrochloride, here are important things to know. The most commonly reported side effects include tardive dyskinesia, extrapyramidal disorder, nervous system disorder, dystonia, nausea. 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 or history of drug-induced movement disorders before starting Metoclopramide Hydrochloride. Regular follow-up appointments are essential to monitor for signs of serious adverse reactions, 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 has issued warnings about the potential for serious adverse reactions with Metoclopramide Hydrochloride, particularly in elderly patients. Regular monitoring and dose adjustments are recommended to minimize risk.
The FDA has received approximately 206,778 adverse event reports associated with Metoclopramide Hydrochloride. 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 Hydrochloride include Tardive Dyskinesia, Extrapyramidal Disorder, Nervous System Disorder, Dystonia, Nausea. By volume, the top reported reactions are: Tardive Dyskinesia (16,216 reports), Extrapyramidal Disorder (12,906 reports), Nervous System Disorder (7,523 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 Hydrochloride.
Out of 74,994 classified reports, 67,131 (89.5%) were classified as serious and 7,863 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 Hydrochloride break down by patient sex as follows: Female: 42,931, Male: 24,879, Unknown: 1,594. 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 Hydrochloride adverse events are: age 67: 1,107 reports, age 66: 1,069 reports, age 69: 1,056 reports, age 65: 1,033 reports, age 61: 1,032 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 Hydrochloride 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 Hydrochloride include: Pain, Vomiting, Anxiety, Economic Problem, Diarrhoea. 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 Hydrochloride 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 Hydrochloride 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 Hydrochloride is associated with a high incidence of serious adverse reactions, particularly extrapyramidal disorders and tardive dyskinesia.
Key safety signals identified in Metoclopramide Hydrochloride's adverse event data include: Tardive dyskinesia and extrapyramidal disorders are key safety signals, with high report counts.. Neurological and gastrointestinal issues are frequently reported, indicating a broad range of potential adverse effects.. Serious reactions such as death, pneumonia, and renal failure are also common, highlighting the severity of potential side effects.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Metoclopramide Hydrochloride can cause serious drug interactions, particularly with other antipsychotics and drugs that affect the central nervous system. Healthcare providers should be cautious when prescribing this drug in combination with other me Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Metoclopramide Hydrochloride.
Patients should inform their healthcare provider about any existing neurological conditions or history of drug-induced movement disorders before starting Metoclopramide Hydrochloride. Regular follow-up appointments are essential to monitor for signs of serious adverse reactions, especially in elderly patients.
Metoclopramide Hydrochloride has 206,778 adverse event reports on file with the FDA. The drug is frequently reported to cause neurological and gastrointestinal issues, including nausea, vomiting, and pain. The volume of reports for Metoclopramide Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has issued warnings about the potential for serious adverse reactions with Metoclopramide Hydrochloride, particularly in elderly patients. Regular monitoring and dose adjustments are recommended to minimize risk. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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