85/100 · Critical
Manufactured by Granules India Ltd
High Safety Concerns with Potassium Chloride Extended-Release
192,836 FDA adverse event reports analyzed
Last updated: 2026-05-12
POTASSIUM CHLORIDE EXTENDED RELEASE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Granules India Ltd. Based on analysis of 192,836 FDA adverse event reports, POTASSIUM CHLORIDE EXTENDED RELEASE 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 EXTENDED RELEASE 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 EXTENDED RELEASE.
Potassium Chloride Extended-Release 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 192,836 adverse event reports for this medication, which is primarily manufactured by Granules India Ltd.
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. Serious adverse events, including death, respiratory failure, and cardiac arrest, are common.
A wide range of reactions, including gastrointestinal issues, respiratory problems, and cardiovascular events, are reported. The drug is frequently associated with electrolyte imbalances and kidney issues.
Patients taking Potassium Chloride Extended-Release 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 side effects, including respiratory failure and cardiac issues. Warnings are issued for patients with pre-existing heart conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Potassium Chloride Extended-Release received a safety concern score of 85/100 (high concern). This is based on a 75.3% serious event ratio across 88,320 classified reports. The score accounts for 192,836 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: 51,790, Male: 31,629, Unknown: 76. The most frequently reported age groups are age 71 (1,866 reports), age 69 (1,858 reports), age 70 (1,827 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 88,320 classified reports for POTASSIUM CHLORIDE EXTENDED RELEASE:
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 side effects, including respiratory failure and cardiac issues. Warnings are issued for patients with pre-existing heart conditions.
If you are taking Potassium Chloride Extended-Release, 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 closely for signs of electrolyte imbalances and respiratory issues, especially in elderly patients. Follow prescribed dosages and do not alter the regimen without consulting a healthcare provider. 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 safety concerns, particularly in elderly patients and those with pre-existing conditions.
The FDA has received approximately 192,836 adverse event reports associated with Potassium Chloride Extended-Release. 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 Extended-Release include Diarrhoea, Dyspnoea, Nausea, Fatigue, Death. By volume, the top reported reactions are: Diarrhoea (6,424 reports), Dyspnoea (6,334 reports), Nausea (6,195 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 Extended-Release.
Out of 88,320 classified reports, 66,499 (75.3%) were classified as serious and 21,821 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 Extended-Release break down by patient sex as follows: Female: 51,790, Male: 31,629, Unknown: 76. 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 Extended-Release adverse events are: age 71: 1,866 reports, age 69: 1,858 reports, age 70: 1,827 reports, age 72: 1,821 reports, age 67: 1,779 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 Extended-Release adverse event reports is Granules India Ltd. 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 Extended-Release 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 Extended-Release 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 Extended-Release 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. Serious adverse events, including death, respiratory failure, and cardiac arrest, are common.
Key safety signals identified in Potassium Chloride Extended-Release's adverse event data include: Death reports are significant, with 4411 cases reported.. Respiratory failure and cardiac arrest are among the more severe reactions.. Electrolyte imbalances, particularly hypokalemia and hyperkalemia, are common.. 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 side effects, including respiratory failure and cardiac issues. Warnings are issued for patients with pre-existing heart conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Potassium Chloride Extended-Release.
Monitor closely for signs of electrolyte imbalances and respiratory issues, especially in elderly patients. Follow prescribed dosages and do not alter the regimen without consulting a healthcare provider.
Potassium Chloride Extended-Release has 192,836 adverse event reports on file with the FDA. A wide range of reactions, including gastrointestinal issues, respiratory problems, and cardiovascular events, are reported. The volume of reports for Potassium Chloride Extended-Release reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors this drug due to its high safety concerns, particularly in elderly patients and those with pre-existing conditions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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