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This page presents data from the FDA Adverse Event Reporting System (FAERS) and the FDA-approved drug label. A report submitted to FAERS does not prove a drug caused the reported event. Always consult a healthcare provider about medications.

Sodium Chloride

Last updated: August 28, 2026
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Sodium Chloride is a medication. According to the FDA-approved label, This sterile, nonpyrogenic electrolyte solution is indicated for all general irrigation, washing, rinsing and dilution purposes including blood cell washing (when used in conjunction with automated intraoperative blood salvaging equipment). FAERS contains 78,532 submissions naming this drug from 1998 through 2026; the top three reactions cited are nausea, myelosuppression, and dyspnoea.

Most-Reported Reactions

Counts of the reactions most often cited in FAERS submissions that named Sodium Chloride. Inclusion here does not establish causation - submitters describe what was observed, not what was confirmed. One submission can list several reactions, so the totals exceed the report count.

NAUSEA 5,628 (7.2%) MYELOSUPPRESSION 5,180 (6.6%) DYSPNOEA 4,957 (6.3%) OFF LABEL USE 4,929 (6.3%) HEADACHE 4,496 (5.7%) PYREXIA 4,389 (5.6%) FATIGUE 4,312 (5.5%) VOMITING 3,990 (5.1%) DIARRHOEA 3,853 (4.9%) PNEUMONIA 3,534 (4.5%) PAIN 3,151 (4.0%) WHITE BLOOD CELL COUNT DECREASED 2,886 (3.7%) DRUG INEFFECTIVE 2,789 (3.6%) COUGH 2,707 (3.4%) DIZZINESS 2,634 (3.4%)

Patient Demographics

Patient sex and age across the FAERS submissions that named Sodium Chloride. Percentages here are computed only from submissions where these fields were filled in - many leave them blank.

By Sex

Female Male Unknown

By Age Group

0-17 18-44 45-64 65+

Severity Outcomes

Severity flags recorded across the 78,532 FAERS submissions that named Sodium Chloride. Each bar shows the count of those reports carrying that flag. A single case can carry more than one (a hospitalization that became life-threatening, for example), so these bars are independent rates - they don't sum to 100%. Inclusion of a case under any flag does not establish that the drug caused the outcome.

DEATH 6,830 (8.7%) HOSPITALIZATION 35,123 (44.7%) LIFE-THREATENING 5,366 (6.8%) DISABLING 1,807 (2.3%)

Submissions Per Quarter

Quarterly count of FAERS submissions that named Sodium Chloride. Ups and downs on this chart can track prescribing volume, news cycles, or shifts in how reports get filed, rather than the drug becoming safer or more dangerous.

1998 1999 2001 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026

From the FDA-Approved Label

Excerpts from the official FDA-approved prescribing information for Sodium Chloride. This is the authoritative source on indications, warnings, and known adverse reactions.

Indications

This sterile, nonpyrogenic electrolyte solution is indicated for all general irrigation, washing, rinsing and dilution purposes including blood cell washing (when used in conjunction with automated intraoperative blood salvaging equipment).

Warnings

FOR IRRIGATION ONLY. NOT FOR INJECTION. Entry of a hypotonic solution into the circulation may cause hemolysis. Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, each of these irrigations must be regarded as a systemic drug. Absorption of large amounts can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions. Do not heat over 66° C (150° F).

Adverse Reactions (from label)

Possible adverse effects arising from the irrigation of body cavities, tissues, cells or indwelling catheters and tubes are usually avoidable when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. Accidental contamination from careless technique may transmit infection. Should any adverse reaction occur, discontinue the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

FDA label effective date: 2025-10-31

Disclaimer

AdverseEvent.ai is not affiliated with the FDA. Adverse-event counts come from the FDA Adverse Event Reporting System (FAERS). Drug labels come from the FDA drug label dataset. A report submitted to FAERS does not prove a drug caused the reported event — always consult a healthcare provider about medications. This site is for informational purposes only and is not medical advice.