Yes. 117 FDA-approved labels for Ketorolac carry a boxed warning, and its subject is ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (nsaid), is indicated for the short-term (up to 5 days in adults).... 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 Ketorolac warning opens on one specific label, identified underneath it. Of the 25 Ketorolac labels sampled, 7 carried materially different wordings and this was the most common, used by 11 of them.
WARNING Ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. Oral ketorolac tromethamine is indicated only as continuation treatment following intravenous or intramuscular dosing of ketorolac tromethamine, if necessary. The total combined duration of use of oral ketorolac tromethamine and ketorolac tromethamine injection should not exceed 5 days. Ketorolac tromethamine is not indicated for use in pediatric patients and it is NOT indicated for minor or chronic painful conditions.
KETOROLAC TROMETHAMINE, Asclemed USA, Inc., label version effective 12 October 2022. 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 Ketorolac labels sampled for this page, 7 carried materially different wordings of the same warning, and the version quoted above was used by 11 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 Ketorolac or its risks having changed.
Ketorolac is dispensed under 117 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 Ketorolac have a black box warning?
Yes. 117 FDA-approved labels for Ketorolac carry a boxed warning, and its subject is ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (nsaid), is indicated for the short-term (up to 5 days in adults).... 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 Ketorolac 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 12 October 2022, the warning concerns ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (nsaid), is indicated for the short-term (up to 5 days in adults).... The full text is linked so the exact version can be read rather than summarised.
Does the Ketorolac boxed warning mean the drug is unsafe or being withdrawn?
No. It means the FDA requires the risk of ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (nsaid), is indicated for the short-term (up to 5 days in adults)... to be communicated prominently so prescribers weigh it explicitly. Ketorolac remains FDA-approved and is dispensed under 117 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 Ketorolac 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 Ketorolac because of this warning?
This page does not answer that and cannot. The warning about ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (nsaid), is indicated for the short-term (up to 5 days in adults)... is written for a prescriber deciding whether Ketorolac 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 Ketorolac label, linked below by its DailyMed set identifier so the exact version can be opened rather than taken on trust. The figure of 117 labels, and the count of 7 distinct wordings among 25 sampled, were computed from the openFDA labelling API on 30 August 2026.
- KETOROLAC TROMETHAMINE prescribing information, Asclemed USA, Inc., effective 12 October 2022.
- 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.