Yes. 103 FDA-approved labels for Olanzapine carry a boxed warning, and its subject is increased mortality in elderly patients with dementia-related psychosis. A boxed warning is the most serious warning the FDA requires on a prescription label. It is applied to the drug and to the situations in which it is used, not to any particular person taking it.
What the warning says
Below is how the Olanzapine warning opens on one specific label, identified underneath it. Of the 25 Olanzapine labels sampled, 3 carried materially different wordings and this was the most common, used by 23 of them.
WARNING: 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.
OLANZAPINE, Lannett Company, Inc., label version effective 10 July 2023. Opening of the warning; read the full label on DailyMed.Why the wording differs between manufacturers
There is no single official text of a boxed warning. The FDA sets what a warning must cover, and each manufacturer writes its own label within that. Of the 25 Olanzapine labels sampled for this page, 3 carried materially different wordings of the same warning, and the version quoted above was used by 23 of them.
The hazard does not change between those 3 versions. Only the sentences do, which is why a refill from a different manufacturer can carry warning text that reads differently without anything about Olanzapine or its risks having changed.
Olanzapine is dispensed under 103 current FDA labels despite this warning, which is the point worth holding onto: a boxed warning is a disclosure requirement, not a verdict. What a boxed warning does and does not mean sets out the distinction.
Common questions
Does Olanzapine have a black box warning?
Yes. 103 FDA-approved labels for Olanzapine carry a boxed warning, and its subject is increased mortality in elderly patients with dementia-related psychosis. 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.
What does the Olanzapine boxed warning say?
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 10 July 2023, the warning concerns increased mortality in elderly patients with dementia-related psychosis. The full text is linked so the exact version can be read rather than summarised.
Does the Olanzapine boxed warning mean the drug is unsafe or being withdrawn?
No. It means the FDA requires the risk of increased mortality in elderly patients with dementia-related psychosis to be communicated prominently so prescribers weigh it explicitly. Olanzapine remains FDA-approved and is dispensed under 103 current labels. A boxed warning is a disclosure requirement, not a judgement that a drug should not be used.
Why do different pharmacies show different warning text for the same drug?
Because each manufacturer writes its own label within the FDA's requirements. Of 25 Olanzapine labels sampled here, 3 carried materially different wordings of the same warning. The hazard described is the same; the sentences are not. This is a common source of confusion when a prescription is refilled with a different manufacturer's product.
Should I stop taking Olanzapine because of this warning?
This page does not answer that and cannot. The warning about increased mortality in elderly patients with dementia-related psychosis is written for a prescriber deciding whether Olanzapine 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.
Where this page's information comes from
The quotation above is from one Olanzapine label, linked below by its DailyMed set identifier so the exact version can be opened rather than taken on trust. The figure of 103 labels, and the count of 3 distinct wordings among 25 sampled, were computed from the openFDA labelling API on 30 August 2026.
- OLANZAPINE prescribing information, Lannett Company, Inc., effective 10 July 2023.
- openFDA drug labelling API, the source of the label counts and variant counts on this page.
Labels are revised over time. The version linked above is the one this page was written against, and a newer revision may differ. Counts reflect the labels present in openFDA on the retrieval date.