85/100 · Critical
Manufactured by Vantive US Healthcare LLC
High Safety Concerns with Icodextrin-Based Peritoneal Dialysis Solution
40,763 FDA adverse event reports analyzed
Last updated: 2026-05-12
ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Vantive US Healthcare LLC. Based on analysis of 40,763 FDA adverse event reports, ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM 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 ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE include DEATH, PERITONITIS, PERITONEAL DIALYSIS COMPLICATION, PERITONITIS BACTERIAL, HYPOTENSION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE.
Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium 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 40,763 adverse event reports for this medication, which is primarily manufactured by Vantive Us Healthcare Llc.
The most commonly reported adverse events include Death, Peritonitis, Peritoneal Dialysis Complication. Of classified reports, 83.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The drug is associated with a high number of serious adverse events, including death, peritonitis, and myocardial infarction.
A wide range of reactions, including infections, fluid overload, and cardiac disorders, are reported. The majority of adverse events are serious, with a serious event rate of 83.6%.
Patients taking Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions with other medications and peritoneal dialysis procedures should be carefully monitored, and patients should be warned about the potential for serious adverse events. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride received a safety concern score of 85/100 (high concern). This is based on a 83.6% serious event ratio across 30,482 classified reports. The score accounts for 40,763 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: Male: 17,247, Female: 11,657, Unknown: 190. The most frequently reported age groups are age 62 (446 reports), age 65 (427 reports), age 60 (412 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 30,482 classified reports for ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM 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.
Interactions with other medications and peritoneal dialysis procedures should be carefully monitored, and patients should be warned about the potential for serious adverse events.
If you are taking Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride, here are important things to know. The most commonly reported side effects include death, peritonitis, peritoneal dialysis complication, peritonitis bacterial, hypotension. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should be closely monitored for signs of infection, fluid overload, and cardiovascular issues. Healthcare providers should ensure proper administration techniques to minimize the risk of complications. 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 the safety profile of this drug, and healthcare providers should be vigilant in managing patients on this therapy.
The FDA has received approximately 40,763 adverse event reports associated with Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium 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 Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride include Death, Peritonitis, Peritoneal Dialysis Complication, Peritonitis Bacterial, Hypotension. By volume, the top reported reactions are: Death (5,981 reports), Peritonitis (1,843 reports), Peritoneal Dialysis Complication (1,459 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride.
Out of 30,482 classified reports, 25,480 (83.6%) were classified as serious and 5,002 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 Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride break down by patient sex as follows: Male: 17,247, Female: 11,657, Unknown: 190. 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 Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride adverse events are: age 62: 446 reports, age 65: 427 reports, age 60: 412 reports, age 64: 403 reports, age 66: 393 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 Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride adverse event reports is Vantive Us Healthcare 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 Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride include: Pneumonia, Myocardial Infarction, Infection, Sepsis, Fluid Overload. 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 Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium 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.
Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium 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 drug is associated with a high number of serious adverse events, including death, peritonitis, and myocardial infarction.
Key safety signals identified in Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride's adverse event data include: Multiple reports of death and severe infections (peritonitis, sepsis) indicate significant risks.. Cardiovascular issues, including myocardial infarction and cardiac failure, are frequently reported.. Fluid-related complications such as fluid overload and dehydration 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 medications and peritoneal dialysis procedures should be carefully monitored, and patients should be warned about the potential for serious adverse events. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride.
Patients should be closely monitored for signs of infection, fluid overload, and cardiovascular issues. Healthcare providers should ensure proper administration techniques to minimize the risk of complications.
Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride has 40,763 adverse event reports on file with the FDA. A wide range of reactions, including infections, fluid overload, and cardiac disorders, are reported. The volume of reports for Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA should continue to monitor the safety profile of this drug, and healthcare providers should be vigilant in managing patients on this therapy. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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