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What the label lists and what reports show

Dextrose and sodium chloride side effects

Dextrose and sodium chloride's FDA label lists its adverse reactions in its own words. FAERS holds 165 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 vomiting (39 reports).

  • Generic listed

Check it at the source: the dextrose and sodium chloride FDA label on DailyMed (effective November 2, 2025, ICU Medical Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

Source: FDA drug label, NDA017606 (Otsuka Icu Medcl), as published by ICU Medical Inc., effective November 2, 2025 (SPL set 4555b1bf-6d97-4798-a63d-6d34291c85ce), via openFDA; the full label on DailyMed

What do FAERS reports show?

165 reports list dextrose and sodium chloride among the medicines taken, each a report of something that happened, not proof the medicine caused it; 56 are coded as a death and 107 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 22 reactions below, none is 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.

The 25 most reported reactions

  • Vomiting39
  • Nausea33
  • Hyponatraemia27
  • Ascites26
  • Constipation26
  • Sepsis26
  • Abdominal Distension25
  • Abdominal Pain25
  • Off Label Use (a use or a product term, not a reaction)25
  • General Physical Health Deterioration24
  • Anaemia23
  • Appendicitis23
  • Appendicolith23
  • Cardiogenic Shock23
  • Ventricular Fibrillation23
  • Multiple Organ Dysfunction Syndrome21
  • Stress21
  • Blood Phosphorus Increased20
  • Somnolence20
  • Condition Aggravated (a use or a product term, not a reaction)18
  • Dyspnoea18
  • Dry Mouth17
  • Pyrexia17
  • Blood Cholesterol Increased16
  • Death (an outcome recorded in the report)16

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

What next?

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