Yes. 16 FDA-approved labels for Clozapine carry a boxed warning, and its subject is severe neutropenia; orthostatic hypotension, bradycardia, and syncope; seizure; myocarditi. 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 Clozapine warning opens on one specific label, identified underneath it. Of the 16 Clozapine labels sampled, 10 carried materially different wordings and this was the most common, used by 4 of them.
WARNING: SEVERE NEUTROPENIA; ORTHOSTATIC HYPOTENSION, BRADYCARDIA, AND SYNCOPE; SEIZURE; MYOCARDITIS, PERICARDITIS, AND CARDIOMYOPATHY; INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Severe Neutropenia Clozapine has caused severe neutropenia which is associated with an increased risk of serious and potentially fatal infections. Prior to initiating clozapine treatment, obtain baseline ANC(s). Clozapine initiation is not recommended in patients with a baseline ANC less than 1500/μL (less than 1000/μL for those with Benign Ethnic Neutropenia (also known as Duffy-null associated neutrophil count)).
CLOZAPINE, Aurobindo Pharma Limited, label version effective 17 December 2025. 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 16 Clozapine labels sampled for this page, 10 carried materially different wordings of the same warning, and the version quoted above was used by 4 of them.
The hazard does not change between those 10 versions. Only the sentences do, which is why a refill from a different manufacturer can carry warning text that reads differently without anything about Clozapine or its risks having changed.
Clozapine is dispensed under 16 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 Clozapine have a black box warning?
Yes. 16 FDA-approved labels for Clozapine carry a boxed warning, and its subject is severe neutropenia; orthostatic hypotension, bradycardia, and syncope; seizure; myocarditi. 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 Clozapine 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 17 December 2025, the warning concerns severe neutropenia; orthostatic hypotension, bradycardia, and syncope; seizure; myocarditi. The full text is linked so the exact version can be read rather than summarised.
Does the Clozapine boxed warning mean the drug is unsafe or being withdrawn?
No. It means the FDA requires the risk of severe neutropenia; orthostatic hypotension, bradycardia, and syncope; seizure; myocarditi to be communicated prominently so prescribers weigh it explicitly. Clozapine remains FDA-approved and is dispensed under 16 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 16 Clozapine labels sampled here, 10 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 Clozapine because of this warning?
This page does not answer that and cannot. The warning about severe neutropenia; orthostatic hypotension, bradycardia, and syncope; seizure; myocarditi is written for a prescriber deciding whether Clozapine 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 Clozapine label, linked below by its DailyMed set identifier so the exact version can be opened rather than taken on trust. The figure of 16 labels, and the count of 10 distinct wordings among 16 sampled, were computed from the openFDA labelling API on 30 August 2026.
- CLOZAPINE prescribing information, Aurobindo Pharma Limited, effective 17 December 2025.
- 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.