What the label lists and what reports show
Sorbitol side effects
Sorbitol's FDA label lists its adverse reactions in its own words. FAERS holds 598 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 (43 reports).
- No generic listed
Check it at the source: the sorbitol FDA label on DailyMed (effective December 31, 2019, Baxter Healthcare Corporation); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsLife threatening adverse reactions with intravenous sorbitol infusions have been reported in patients with fructose intolerance. The literature reports occasional adverse reactions for intravenous sorbitol infusions. These include disturbances such as acidosis, electrolyte loss, marked diuresis, urinary retention, edema, dryness of mouth and thirst, and dehydration; cardiovascular/pulmonary disorders such as pulmonary congestion, hypotension, tachycardia, angina-like pains, and other general reactions such as blurred vision, convulsions, nausea, vomiting, diarrhea, rhinitis, chills, vertigo, and backache. Allergic reactions reported to occur from sorbitol include urticaria. Should adverse reactions occur, discontinue the irrigant and reevaluate the clinical status of the patient. …
Source: FDA drug label, Baxter Healthcare Corporation, effective December 31, 2019 (SPL set aea0b5a1-444b-4330-a3ce-26485dbbfe75), via openFDA; the full label on DailyMed
What do FAERS reports show?
598 reports list sorbitol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 115 are coded as a death and 326 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 23 reactions below, 3 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Sorbitol: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions