82/100 · Critical
Manufactured by ANI Pharmaceuticals, Inc.
High Seriousness in Adverse Reactions for Potassium Chloride, Dextrose Monohydrate
192,813 FDA adverse event reports analyzed
Last updated: 2026-05-12
POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. Based on analysis of 192,813 FDA adverse event reports, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE has a safety score of 82 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 POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE include DIARRHOEA, DYSPNOEA, NAUSEA, FATIGUE, DEATH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE.
Potassium Chloride, Dextrose Monohydrate has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 192,813 adverse event reports for this medication, which is primarily manufactured by Ani Pharmaceuticals, Inc..
The most commonly reported adverse events include Diarrhoea, Dyspnoea, Nausea. Of classified reports, 75.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. A high percentage of serious adverse reactions (75.3%) indicates significant safety concerns.
The most common reactions include diarrhea, dyspnea, and nausea, suggesting gastrointestinal and respiratory issues. A wide range of reactions (100 distinct) indicates diverse potential side effects.
Patients taking Potassium Chloride, Dextrose Monohydrate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions with other drugs can lead to serious adverse effects, such as drug interactions and hypokalemia/hyperkalemia. Patients should be monitored closely. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Potassium Chloride, Dextrose Monohydrate received a safety concern score of 82/100 (high concern). This is based on a 75.3% serious event ratio across 88,276 classified reports. The score accounts for 192,813 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: 51,762, Male: 31,616, Unknown: 75. The most frequently reported age groups are age 71 (1,866 reports), age 69 (1,856 reports), age 70 (1,827 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 88,276 classified reports for POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE:
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.
Interactions with other drugs can lead to serious adverse effects, such as drug interactions and hypokalemia/hyperkalemia. Patients should be monitored closely.
If you are taking Potassium Chloride, Dextrose Monohydrate, here are important things to know. The most commonly reported side effects include diarrhoea, dyspnoea, nausea, fatigue, death. 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 new or worsening 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 should continue to monitor this drug due to the high number of serious adverse events. Healthcare providers should be vigilant about potential interactions and monitor patients closely.
The FDA has received approximately 192,813 adverse event reports associated with Potassium Chloride, Dextrose Monohydrate. 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 Potassium Chloride, Dextrose Monohydrate include Diarrhoea, Dyspnoea, Nausea, Fatigue, Death. By volume, the top reported reactions are: Diarrhoea (6,424 reports), Dyspnoea (6,331 reports), Nausea (6,194 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Potassium Chloride, Dextrose Monohydrate.
Out of 88,276 classified reports, 66,494 (75.3%) were classified as serious and 21,782 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 Potassium Chloride, Dextrose Monohydrate break down by patient sex as follows: Female: 51,762, Male: 31,616, Unknown: 75. 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 Potassium Chloride, Dextrose Monohydrate adverse events are: age 71: 1,866 reports, age 69: 1,856 reports, age 70: 1,827 reports, age 72: 1,819 reports, age 67: 1,778 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 Potassium Chloride, Dextrose Monohydrate 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 Potassium Chloride, Dextrose Monohydrate include: Pneumonia, Asthenia, Vomiting, Headache, Off Label Use. 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 Potassium Chloride, Dextrose Monohydrate 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.
Potassium Chloride, Dextrose Monohydrate has a safety concern score of 82 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. A high percentage of serious adverse reactions (75.3%) indicates significant safety concerns.
Key safety signals identified in Potassium Chloride, Dextrose Monohydrate's adverse event data include: Death reports are a key safety signal, with 4,411 cases reported.. Acute kidney injury and chronic kidney disease are frequent, indicating potential renal toxicity.. Cardiac failure and arrhythmias (atrial fibrillation, myocardial infarction) are significant safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions with other drugs can lead to serious adverse effects, such as drug interactions and hypokalemia/hyperkalemia. Patients should be monitored closely. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Potassium Chloride, Dextrose Monohydrate.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow prescribed dosages and do not alter the regimen without medical advice.
Potassium Chloride, Dextrose Monohydrate has 192,813 adverse event reports on file with the FDA. The most common reactions include diarrhea, dyspnea, and nausea, suggesting gastrointestinal and respiratory issues. The volume of reports for Potassium Chloride, Dextrose Monohydrate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA should continue to monitor this drug due to the high number of serious adverse events. Healthcare providers should be vigilant about potential interactions and monitor patients closely. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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