Skip to main content
PlainMeds

What the label lists and what reports show

Sodium chloride side effects

Sodium chloride's FDA label lists its adverse reactions in its own words. FAERS holds 78,656 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (5,633 reports).

  • Generic listed
  • A presentation discontinued

Check it at the source: the sodium chloride FDA label on DailyMed (effective June 30, 2025, Baxter Healthcare Corporation); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Post-Marketing Adverse Reactions The following adverse reactions have been identified during post approval use of Sodium Chloride Injection, USP. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been reported in the post-marketing experience during use of 0.9% Sodium Chloride Injection, USP and include the following: General disorders and administration site conditions: Infusion site erythema, injection site streaking, burning sensation, and infusion site urticaria Hypersensitivity reactions: Hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus. Metabolism and nutrition disorders: Hypernatremia, hyponatremia, hyperchloremic metabolic acidosis. …

Source: FDA drug label, Baxter Healthcare Corporation, effective June 30, 2025 (SPL set 958d35f0-6834-43be-a700-fa58f38b4c19), via openFDA; the full label on DailyMed

What do FAERS reports show?

78,656 reports list sodium chloride among the medicines taken, each a report of something that happened, not proof the medicine caused it; 6,849 are coded as a death and 35,162 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Nausea (named in the label)5,633
  • Myelosuppression5,180
  • Dyspnoea (named in the label)4,962
  • Off Label Use (a use or a product term, not a reaction)4,930
  • Headache (named in the label)4,497
  • Pyrexia (named in the label)4,391
  • Fatigue4,313
  • Vomiting (named in the label)3,994
  • Diarrhoea3,856
  • Pneumonia3,537
  • Pain3,152
  • White Blood Cell Count Decreased2,888
  • Drug Ineffective (a use or a product term, not a reaction)2,792
  • Cough2,706
  • Dizziness2,640
  • Asthenia2,423
  • Malaise2,285
  • Pruritus (named in the label)2,208
  • Rash (named in the label)2,170
  • Product Dose Omission Issue (a use or a product term, not a reaction)2,153
  • Weight Decreased2,042
  • Fall2,034
  • Death (an outcome recorded in the report)2,032
  • Covid-191,979
  • Sinusitis1,931

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Sodium chloride: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions