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Thioridazine Hydrochloride

Also known as: Thioridazine Hydrochloride

Route: Oral

Check Thioridazine Hydrochloride Interactions →

5 interactions on record⛔ Black Box Warning

Thioridazine Hydrochloride has 5 known drug interactions based on U.S. FDA drug labeling data. Of these, 5 are contraindicated combinations that should be avoided entirely. Notable interactions include combinations with Fluoxetine, Fluvoxamine, Paroxetine. Patients taking Thioridazine Hydrochloride should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 5
Contraindicated: 5

Contraindicated (5)

Thioridazine Hydrochloride + Fluoxetine— Inhibits CYP450 2D6, elevating thioridazine levels and augmenting QTc prolongation, risking serious cardiac arrhythmias …
Thioridazine Hydrochloride + Fluvoxamine— Increases thioridazine and active metabolites (mesoridazine, sulforidazine) 3-fold. Should not be coadministered.
Thioridazine Hydrochloride + Paroxetine— Inhibits CYP450 2D6, elevating thioridazine levels and augmenting QTc prolongation, risking serious cardiac arrhythmias …
Thioridazine Hydrochloride + Pindolol— Produces moderate, dose-related increases in thioridazine and metabolite serum levels, with elevated pindolol levels. Sh…
Thioridazine Hydrochloride + Propranolol— Increases plasma thioridazine levels by 50-400% and metabolites by 80-300%. Should not be coadministered.

Thioridazine Hydrochloride + Fluoxetine⛔Contraindicated

Inhibits CYP450 2D6, elevating thioridazine levels and augmenting QTc prolongation, risking serious cardiac arrhythmias including Torsades de pointes.

Thioridazine Hydrochloride + Fluvoxamine⛔Contraindicated

Increases thioridazine and active metabolites (mesoridazine, sulforidazine) 3-fold. Should not be coadministered.

Thioridazine Hydrochloride + Paroxetine⛔Contraindicated

Inhibits CYP450 2D6, elevating thioridazine levels and augmenting QTc prolongation, risking serious cardiac arrhythmias including Torsades de pointes.

Thioridazine Hydrochloride + Pindolol⛔Contraindicated

Produces moderate, dose-related increases in thioridazine and metabolite serum levels, with elevated pindolol levels. Should not be coadministered.

Thioridazine Hydrochloride + Propranolol⛔Contraindicated

Increases plasma thioridazine levels by 50-400% and metabolites by 80-300%. Should not be coadministered.

⛔ FDA Black Box Warning

WARNING Thioridazine has been shown to prolong the QTc interval in a dose related manner, and drugs with this potential, including thioridazine, have been associated with Torsades de pointes type arrhythmias and sudden death. Due to its potential for significant, possibly life threatening, proarrhythmic effects, thioridazine should be reserved for use in the treatment of schizophrenic patients who fail to show an acceptable response to adequate courses of treatment with other antipsychotic drugs, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs (see WARNINGS , CONTRAINDICATIONS , and INDICATIONS ). Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Thioridazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS ).

Contraindications

CONTRAINDICATIONS Thioridazine hydrochloride tablet use should be avoided in combination with other drugs that are known to prolong the QTc interval and in patients with congenital long QT syndrome or a history of cardiac arrhythmias. Reduced cytochrome P450 2D6 isozyme activity drugs that inhibit this isozyme (e.g., fluoxetine and paroxetine) and certain other drugs (e.g., fluvoxamine, propranolol, and pindolol) appear to appreciably inhibit the metabolism of thioridazine. The resulting elevated levels of thioridazine would be expected to augment the prolongation of the QTc interval associated with thioridazine and may increase the risk of serious, potentially fatal, cardiac arrhythmias, such as Torsades de pointes type arrhythmias. Such an increased risk may result also from the additive effect of coadministering thioridazine with other agents that prolong the QTc interval. Therefore, thioridazine is contraindicated with these drugs as well as in patients, comprising about 7% of the normal population, who are known to have a genetic defect leading to reduced levels of activity of P450 2D6 (see WARNINGS and PRECAUTIONS ). In common with other phenothiazines, thioridazine is contraindicated in severe central nervous system depression or comatose states from any cause including drug induced central nervous system depression (see WARNINGS ). It should also be noted that hypertensive or hypotensive heart disease of extreme degree is a contraindication of phenothiazine administration.

Pregnancy & Breastfeeding

Pregnancy Nonteratogenic Effects Neonates exposed to antipsychotic drugs, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. Thioridazine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.