78/100 · Elevated
Manufactured by ANI Pharmaceuticals, Inc.
High Serious Adverse Events with Prochlorperazine Maleate
20,380 FDA adverse event reports analyzed
Last updated: 2026-05-12
PROCHLORPERAZINE MALEATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. Based on analysis of 20,380 FDA adverse event reports, PROCHLORPERAZINE MALEATE has a safety score of 78 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 MALEATE include NAUSEA, FATIGUE, DIARRHOEA, DEATH, VOMITING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PROCHLORPERAZINE MALEATE.
Prochlorperazine Maleate has a safety concern score of 78 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 20,380 adverse event reports for this medication, which is primarily manufactured by Ani Pharmaceuticals, Inc..
The most commonly reported adverse events include Nausea, Fatigue, Diarrhoea. Of classified reports, 66.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Significant number of serious adverse events, including death and respiratory issues.
Common gastrointestinal issues like nausea and diarrhea reported. Multiple cases of hematological abnormalities and infections.
Patients taking Prochlorperazine Maleate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Prochlorperazine Maleate can interact with other drugs, potentially affecting its efficacy or causing adverse reactions. Warnings include monitoring for interactions with anticholinergic agents and other central nervous system depressants. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Prochlorperazine Maleate received a safety concern score of 78/100 (high concern). This is based on a 66.5% serious event ratio across 8,721 classified reports. The score accounts for 20,380 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: 4,625, Male: 3,387, Unknown: 6. The most frequently reported age groups are age 70 (212 reports), age 66 (181 reports), age 61 (180 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 8,721 classified reports for PROCHLORPERAZINE MALEATE:
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 Maleate can interact with other drugs, potentially affecting its efficacy or causing adverse reactions. Warnings include monitoring for interactions with anticholinergic agents and other central nervous system depressants.
If you are taking Prochlorperazine Maleate, here are important things to know. The most commonly reported side effects include nausea, fatigue, diarrhoea, death, 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 inform their healthcare provider of any pre-existing conditions, especially those related to the heart, liver, or kidneys. Regular monitoring of blood counts and liver function is advised, 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 closely monitors adverse events for Prochlorperazine Maleate. Healthcare providers should report any serious adverse events to the FDA's MedWatch program.
The FDA has received approximately 20,380 adverse event reports associated with Prochlorperazine Maleate. 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 Maleate include Nausea, Fatigue, Diarrhoea, Death, Vomiting. By volume, the top reported reactions are: Nausea (1,225 reports), Fatigue (1,208 reports), Diarrhoea (907 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 Maleate.
Out of 8,721 classified reports, 5,800 (66.5%) were classified as serious and 2,921 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 Maleate break down by patient sex as follows: Female: 4,625, Male: 3,387, Unknown: 6. 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 Maleate adverse events are: age 70: 212 reports, age 66: 181 reports, age 61: 180 reports, age 69: 179 reports, age 71: 178 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 Maleate 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 Prochlorperazine Maleate include: Asthenia, Decreased Appetite, Constipation, Off Label Use, Pain. 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 Maleate 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 Maleate has a safety concern score of 78 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. Significant number of serious adverse events, including death and respiratory issues.
Key safety signals identified in Prochlorperazine Maleate's adverse event data include: High number of reports of death (663).. Multiple hematological issues including decreased platelet count, anemia, and neutropenia.. Respiratory issues such as pneumonia and dyspnea are frequently reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Prochlorperazine Maleate can interact with other drugs, potentially affecting its efficacy or causing adverse reactions. Warnings include monitoring for interactions with anticholinergic agents and other central nervous system depressants. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Prochlorperazine Maleate.
Patients should inform their healthcare provider of any pre-existing conditions, especially those related to the heart, liver, or kidneys. Regular monitoring of blood counts and liver function is advised, especially in elderly patients.
Prochlorperazine Maleate has 20,380 adverse event reports on file with the FDA. Common gastrointestinal issues like nausea and diarrhea reported. The volume of reports for Prochlorperazine Maleate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors adverse events for Prochlorperazine Maleate. Healthcare providers should report any serious 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.
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