85/100 · Critical
Manufactured by Amneal Pharmaceuticals LLC
High Serious Adverse Reactions with Prochlorperazine Edisylate
2,682 FDA adverse event reports analyzed
Last updated: 2026-05-12
PROCHLORPERAZINE EDISYLATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals LLC. Based on analysis of 2,682 FDA adverse event reports, PROCHLORPERAZINE EDISYLATE 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 PROCHLORPERAZINE EDISYLATE include NAUSEA, FATIGUE, DIARRHOEA, OFF LABEL USE, VOMITING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PROCHLORPERAZINE EDISYLATE.
Prochlorperazine Edisylate 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 2,682 adverse event reports for this medication, which is primarily manufactured by Amneal Pharmaceuticals Llc.
The most commonly reported adverse events include Nausea, Fatigue, Diarrhoea. Of classified reports, 71.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Severe reactions such as death, pneumonia, and sepsis are common.
Significant gastrointestinal issues like nausea and diarrhea are frequent. Serious infections and respiratory issues are notable safety concerns. The drug is associated with a high rate of serious adverse events (71.5%).
Patients taking Prochlorperazine Edisylate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Prochlorperazine Edisylate can interact with other drugs, potentially exacerbating side effects. Warnings include monitoring for serious infections and respiratory issues. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Prochlorperazine Edisylate received a safety concern score of 85/100 (high concern). This is based on a 71.5% serious event ratio across 1,160 classified reports. The score accounts for 2,682 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: 638, Male: 426. The most frequently reported age groups are age 64 (30 reports), age 68 (28 reports), age 71 (28 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 1,160 classified reports for PROCHLORPERAZINE EDISYLATE:
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.
Prochlorperazine Edisylate can interact with other drugs, potentially exacerbating side effects. Warnings include monitoring for serious infections and respiratory issues.
If you are taking Prochlorperazine Edisylate, here are important things to know. The most commonly reported side effects include nausea, fatigue, diarrhoea, off label use, vomiting. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any severe symptoms to their healthcare provider immediately. Follow prescribed dosages and do not alter the regimen without medical advice. 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 closely monitors this drug due to its high rate of serious adverse events. Healthcare providers should be vigilant in managing patient care.
The FDA has received approximately 2,682 adverse event reports associated with Prochlorperazine Edisylate. 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 Prochlorperazine Edisylate include Nausea, Fatigue, Diarrhoea, Off Label Use, Vomiting. By volume, the top reported reactions are: Nausea (149 reports), Fatigue (124 reports), Diarrhoea (100 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Prochlorperazine Edisylate.
Out of 1,160 classified reports, 829 (71.5%) were classified as serious and 331 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 Prochlorperazine Edisylate break down by patient sex as follows: Female: 638, Male: 426. 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 Prochlorperazine Edisylate adverse events are: age 64: 30 reports, age 68: 28 reports, age 71: 28 reports, age 66: 27 reports, age 72: 27 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 Prochlorperazine Edisylate adverse event reports is Amneal Pharmaceuticals Llc. 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 Prochlorperazine Edisylate include: Death, Asthenia, Dyspnoea, Dehydration, Drug Ineffective. 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 Prochlorperazine Edisylate 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.
Prochlorperazine Edisylate 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. Severe reactions such as death, pneumonia, and sepsis are common.
Key safety signals identified in Prochlorperazine Edisylate's adverse event data include: Death reports: 70. Pneumonia: 46. Sepsis: 27. Drug hypersensitivity: 41. Acute kidney injury: 21. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Prochlorperazine Edisylate can interact with other drugs, potentially exacerbating side effects. Warnings include monitoring for serious infections and respiratory issues. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Prochlorperazine Edisylate.
Patients should report any severe symptoms to their healthcare provider immediately. Follow prescribed dosages and do not alter the regimen without medical advice.
Prochlorperazine Edisylate has 2,682 adverse event reports on file with the FDA. Significant gastrointestinal issues like nausea and diarrhea are frequent. The volume of reports for Prochlorperazine Edisylate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors this drug due to its high rate of serious adverse events. Healthcare providers should be vigilant in managing patient care. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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