What the label lists and what reports show
Tromethamine side effects
Tromethamine's FDA label lists its adverse reactions in its own words. FAERS holds 178 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 (23 reports).
- Generic listed
Check it at the source: the tromethamine FDA label on DailyMed (effective May 27, 2026, Hospira, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsGenerally, side effects have been infrequent. Respiratory: Although the incidence of ventilatory depression is low, it is important to keep in mind that such depression may occur. Respiratory depression may be more likely to occur in patients who have chronic hypoventilation or those who have been treated with drugs which depress respiration. In patients with associated respiratory acidosis, tromethamine should be administered with mechanical assistance to ventilation. Vascular: Extreme care should be taken to avoid perivascular infiltration. Local tissue damage and subsequent sloughing may occur if extravasation occurs. Chemical phlebitis and venospasm also have been reported. Hematologic: Transient depression of blood glucose may occur. Hepatic: Infusion via low-lying umbilical venous catheters has been associated with hepatocellular necrosis. …
Source: FDA drug label, Hospira, Inc., effective May 27, 2026 (SPL set 4af52118-c12b-4ad5-30bb-959848357e8a), via openFDA; the full label on DailyMed
What do FAERS reports show?
178 reports list tromethamine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 14 are coded as a death and 57 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, 1 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Tromethamine: 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