Yes. 13 FDA-approved labels for Metoclopramide carry a boxed warning, and its subject is tardive dyskinesia. 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 Metoclopramide warning opens on one specific label, identified underneath it. Of the 13 Metoclopramide labels sampled, 7 carried materially different wordings, and this was the most common, used by 6 of them.
WARNING: TARDIVE DYSKINESIA Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose. Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped. Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.
METOCLOPRAMIDE HYDROCHLORIDE, ATLANTIC BIOLOGICALS CORP., label version effective 10 July 2026. 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 13 Metoclopramide labels sampled for this page, 7 carried materially different wordings of the same warning, and the version quoted above was used by 6 of them.
The hazard does not change between those 7 versions. Only the sentences do, which is why a refill from a different manufacturer can carry warning text that reads differently without anything about Metoclopramide or its risks having changed.
Metoclopramide is dispensed under 13 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 Metoclopramide have a black box warning?
Yes. 13 FDA-approved labels for Metoclopramide carry a boxed warning, and its subject is tardive dyskinesia. 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 Metoclopramide 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 2026, the warning concerns tardive dyskinesia. The full text is linked so the exact version can be read rather than summarised.
Does the Metoclopramide boxed warning mean the drug is unsafe or being withdrawn?
No. It means the FDA requires the risk of tardive dyskinesia to be communicated prominently so prescribers weigh it explicitly. Metoclopramide remains FDA-approved and is dispensed under 13 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 13 Metoclopramide labels sampled here, 7 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 Metoclopramide because of this warning?
This page does not answer that and cannot. The warning about tardive dyskinesia is written for a prescriber deciding whether Metoclopramide 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 Metoclopramide label, linked below by its DailyMed set identifier so the exact version can be opened rather than taken on trust. The figure of 13 labels, and the count of 7 distinct wordings among 13 sampled, were computed from the openFDA labelling API on 30 August 2026.
- METOCLOPRAMIDE HYDROCHLORIDE prescribing information, ATLANTIC BIOLOGICALS CORP., effective 10 July 2026.
- 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.