Question 1

Does Thioridazine have a black box warning?

Accepted Answer

Yes. 5 FDA-approved labels for Thioridazine carry a boxed warning, and its subject is thioridazine has been shown to prolong the qtc interval in a dose related manner, and drugs with this potential, including.... A boxed warning is the strongest warning the FDA requires on a prescription label, and it is applied to the drug, not to any individual taking it.

Question 2

What does the Thioridazine boxed warning say?

Accepted Answer

The wording is set by each manufacturer within FDA requirements, so it varies. In the version quoted on this page, taken from a label effective 02 March 2026, the warning concerns thioridazine has been shown to prolong the qtc interval in a dose related manner, and drugs with this potential, including.... The full text is linked so the exact version can be read rather than summarised.

Question 3

Does the Thioridazine boxed warning mean the drug is unsafe or being withdrawn?

Accepted Answer

No. It means the FDA requires the risk of thioridazine has been shown to prolong the qtc interval in a dose related manner, and drugs with this potential, including... to be communicated prominently so prescribers weigh it explicitly. Thioridazine remains FDA-approved and is dispensed under 5 current labels. A boxed warning is a disclosure requirement, not a judgement that a drug should not be used.

Question 4

Will a Thioridazine refill from another manufacturer show different warning text?

Accepted Answer

Probably not, and that makes it unusual. Each manufacturer writes its own label within the FDA's requirements, so most drugs carry several wordings of the same warning. All 5 Thioridazine labels sampled here used identical wording, so the text on a refill should read the same as the last one.

Question 5

Should I stop taking Thioridazine because of this warning?

Accepted Answer

This page does not answer that and cannot. The warning about thioridazine has been shown to prolong the qtc interval in a dose related manner, and drugs with this potential, including... is written for a prescriber deciding whether Thioridazine suits a particular patient, and stopping a prescribed medicine carries its own risks that this page knows nothing about. Raise it with the prescriber or a pharmacist, who can see the whole picture.

Does Thioridazine have a black box warning?

What the warning says