85/100 · Critical
Manufactured by Upsher-Smith Laboratories, LLC
Potassium Chloride Adverse Events Show High Seriousness and Diverse Reactions
236,469 FDA adverse event reports analyzed
Last updated: 2026-05-12
POTASSIUM CHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Upsher-Smith Laboratories, LLC. Based on analysis of 236,469 FDA adverse event reports, POTASSIUM CHLORIDE 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 POTASSIUM CHLORIDE 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.
Potassium Chloride 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 236,469 adverse event reports for this medication, which is primarily manufactured by Upsher-Smith Laboratories, Llc.
The most commonly reported adverse events include Diarrhoea, Dyspnoea, Nausea. Of classified reports, 73.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are serious, with over 79,900 serious reports out of 109,019 total reports.
A wide range of reactions are reported, including respiratory, cardiovascular, and gastrointestinal issues. Death is a notable adverse event, with 5,490 reports.
Patients taking Potassium Chloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Potassium Chloride can interact with other drugs, leading to potential adverse effects such as hypokalemia or hyperkalemia. Warnings are present for drug interactions and the risk of respiratory issues. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Potassium Chloride received a safety concern score of 85/100 (high concern). This is based on a 73.3% serious event ratio across 109,019 classified reports. The score accounts for 236,469 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: 65,195, Male: 38,024, Unknown: 89. The most frequently reported age groups are age 69 (2,299 reports), age 71 (2,294 reports), age 72 (2,256 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 109,019 classified reports for POTASSIUM CHLORIDE:
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.
Potassium Chloride can interact with other drugs, leading to potential adverse effects such as hypokalemia or hyperkalemia. Warnings are present for drug interactions and the risk of respiratory issues.
If you are taking Potassium Chloride, 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. Monitor patients closely for signs of respiratory distress, especially in elderly patients. Be cautious when Potassium Chloride is used in combination with other medications that affect potassium levels. 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 the safety of Potassium Chloride, and any new serious adverse events should be reported to the FDA's MedWatch program.
The FDA has received approximately 236,469 adverse event reports associated with Potassium Chloride. 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 include Diarrhoea, Dyspnoea, Nausea, Fatigue, Death. By volume, the top reported reactions are: Diarrhoea (7,865 reports), Dyspnoea (7,763 reports), Nausea (7,563 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.
Out of 109,019 classified reports, 79,900 (73.3%) were classified as serious and 29,119 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 break down by patient sex as follows: Female: 65,195, Male: 38,024, Unknown: 89. 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 adverse events are: age 69: 2,299 reports, age 71: 2,294 reports, age 72: 2,256 reports, age 70: 2,219 reports, age 67: 2,190 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 adverse event reports is Upsher-Smith Laboratories, 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 Potassium Chloride include: Pneumonia, Asthenia, Headache, Dizziness, 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 Potassium Chloride 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 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. The majority of adverse events are serious, with over 79,900 serious reports out of 109,019 total reports.
Key safety signals identified in Potassium Chloride's adverse event data include: High number of serious adverse events (79,900 out of 109,019 total reports). Diverse reactions including respiratory, cardiovascular, and gastrointestinal issues. Death reported in 5,490 cases. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Potassium Chloride can interact with other drugs, leading to potential adverse effects such as hypokalemia or hyperkalemia. Warnings are present for drug interactions and the risk of respiratory issues. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Potassium Chloride.
Monitor patients closely for signs of respiratory distress, especially in elderly patients. Be cautious when Potassium Chloride is used in combination with other medications that affect potassium levels.
Potassium Chloride has 236,469 adverse event reports on file with the FDA. A wide range of reactions are reported, including respiratory, cardiovascular, and gastrointestinal issues. The volume of reports for Potassium Chloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Potassium Chloride, and any new serious adverse events should be reported 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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