Yes. 12 FDA-approved labels for Ketoconazole carry a boxed warning, and its subject is because ketoconazole tablets have been associated with serious adverse reactions, ketoconazole tablets are.... 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 Ketoconazole warning opens on one specific label, identified underneath it. Of the 12 Ketoconazole labels sampled, 3 carried materially different wordings, and this was the most common, used by 10 of them.
WARNING Because ketoconazole tablets have been associated with serious adverse reactions (see WARNINGS section), ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections. Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. Hepatotoxicity Serious hepatotoxicity, including cases with a fatal outcome or requiring liver transplantation has occurred with the use of oral ketoconazole. Some patients had no obvious risk factors for liver disease.
KETOCONAZOLE, Amerisyn LLC, label version effective 10 August 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 12 Ketoconazole labels sampled for this page, 3 carried materially different wordings of the same warning, and the version quoted above was used by 10 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 Ketoconazole or its risks having changed.
Ketoconazole is dispensed under 12 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 Ketoconazole have a black box warning?
Yes. 12 FDA-approved labels for Ketoconazole carry a boxed warning, and its subject is because ketoconazole tablets have been associated with serious adverse reactions, ketoconazole tablets are.... 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 Ketoconazole 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 August 2026, the warning concerns because ketoconazole tablets have been associated with serious adverse reactions, ketoconazole tablets are.... The full text is linked so the exact version can be read rather than summarised.
Does the Ketoconazole boxed warning mean the drug is unsafe or being withdrawn?
No. It means the FDA requires the risk of because ketoconazole tablets have been associated with serious adverse reactions, ketoconazole tablets are... to be communicated prominently so prescribers weigh it explicitly. Ketoconazole remains FDA-approved and is dispensed under 12 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 12 Ketoconazole 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 Ketoconazole because of this warning?
This page does not answer that and cannot. The warning about because ketoconazole tablets have been associated with serious adverse reactions, ketoconazole tablets are... is written for a prescriber deciding whether Ketoconazole 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 Ketoconazole label, linked below by its DailyMed set identifier so the exact version can be opened rather than taken on trust. The figure of 12 labels, and the count of 3 distinct wordings among 12 sampled, were computed from the openFDA labelling API on 30 August 2026.
- KETOCONAZOLE prescribing information, Amerisyn LLC, effective 10 August 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.