85/100 · Critical
Manufactured by ANI Pharmaceuticals, Inc.
High Safety Concerns with Potassium Chloride Oral
192,817 FDA adverse event reports analyzed
Last updated: 2026-05-12
POTASSIUM CHLORIDE ORAL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. Based on analysis of 192,817 FDA adverse event reports, POTASSIUM CHLORIDE ORAL 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 ORAL 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 ORAL.
Potassium Chloride Oral 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 192,817 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. Serious adverse events such as death, acute kidney injury, and respiratory failure are common.
A wide range of reactions, including gastrointestinal issues and cardiovascular events, are reported. The majority of reported reactions are serious, indicating a high risk profile.
Patients taking Potassium Chloride Oral should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Potassium Chloride Oral can interact with other medications, potentially leading to serious side effects such as hyperkalemia or hypokalemia. Warnings are issued for patients with renal impairment. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Potassium Chloride Oral received a safety concern score of 85/100 (high concern). This is based on a 75.3% serious event ratio across 88,277 classified reports. The score accounts for 192,817 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: 31,617, 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 88,277 classified reports for POTASSIUM CHLORIDE ORAL:
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 Oral can interact with other medications, potentially leading to serious side effects such as hyperkalemia or hypokalemia. Warnings are issued for patients with renal impairment.
If you are taking Potassium Chloride Oral, 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 any signs of serious adverse reactions, especially in elderly patients. Follow prescribed dosages and consult a healthcare provider if side effects occur. 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 Potassium Chloride Oral, and regulatory actions may be taken based on the severity and frequency of reported issues.
The FDA has received approximately 192,817 adverse event reports associated with Potassium Chloride Oral. 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 Oral 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 Oral.
Out of 88,277 classified reports, 66,495 (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 Oral break down by patient sex as follows: Female: 51,762, Male: 31,617, 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 Oral 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 Oral 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 Oral 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 Oral 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 Oral 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 such as death, acute kidney injury, and respiratory failure are common.
Key safety signals identified in Potassium Chloride Oral's adverse event data include: Death reports are significant, with 4,411 cases reported.. Acute kidney injury and respiratory failure are among the most serious reactions.. Cardiac issues, including atrial fibrillation and myocardial infarction, are also frequently reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Potassium Chloride Oral can interact with other medications, potentially leading to serious side effects such as hyperkalemia or hypokalemia. Warnings are issued for patients with renal impairment. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Potassium Chloride Oral.
Monitor closely for any signs of serious adverse reactions, especially in elderly patients. Follow prescribed dosages and consult a healthcare provider if side effects occur.
Potassium Chloride Oral has 192,817 adverse event reports on file with the FDA. A wide range of reactions, including gastrointestinal issues and cardiovascular events, are reported. The volume of reports for Potassium Chloride Oral reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors adverse events for Potassium Chloride Oral, and regulatory actions may be taken based on the severity and frequency of reported issues. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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