What the label lists and what reports show
Thiothixene side effects
Thiothixene's FDA label lists its adverse reactions in its own words. FAERS holds 218 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 diabetes mellitus (25 reports).
- Generic listed
- Boxed warning
Check it at the source: the thiothixene FDA label on DailyMed (effective November 16, 2024, Amneal Pharmaceuticals NY LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsNOTE : Not all of the following adverse reactions have been reported with thiothixene. However, since thiothixene has certain chemical and pharmacologic similarities to the phenothiazines, all of the known side effects and toxicity associated with phenothiazine therapy should be borne in mind when thiothixene is used. Cardiovascular Effects Tachycardia, hypotension, lightheadedness, and syncope. In the event hypotension occurs, epinephrine should not be used as a pressor agent since a paradoxical further lowering of blood pressure may result. Nonspecific EKG changes have been observed in some patients receiving thiothixene. These changes are usually reversible and frequently disappear on continued thiothixene therapy. The incidence of these changes is lower than that observed with some phenothiazines. The clinical significance of these changes is not known. …
Source: FDA drug label, Amneal Pharmaceuticals NY LLC, effective November 16, 2024 (SPL set 81c40311-7dc4-4332-8920-a39a8466aea6), via openFDA; the full label on DailyMed
What do FAERS reports show?
218 reports list thiothixene among the medicines taken, each a report of something that happened, not proof the medicine caused it; 21 are coded as a death and 77 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, 9 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.
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?
- Thiothixene: 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