Yes. 42 FDA-approved labels for Tacrolimus carry a boxed warning, and its subject is malignancies and serious infections. 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 Tacrolimus warning opens on one specific label, identified underneath it. Of the 25 Tacrolimus labels sampled, 14 carried materially different wordings, and this was the most common, used by 8 of them.
WARNING: MALIGNANCIES and SERIOUS INFECTIONS Increased risk for developing serious infections and malignancies with tacrolimus or other immunosuppressants that may lead to hospitalization or death. ( 5.1 , 5.2 ) WARNING: MALIGNANCIES and SERIOUS INFECTIONS See full prescribing information for complete boxed warning. Increased risk for developing serious infections and malignancies with tacrolimus or other immunosuppressants that may lead to hospitalization or death. ( 5.1 , 5.2 )
TACROLIMUS, Proficient Rx LP, label version effective 01 October 2023. 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 Tacrolimus labels sampled for this page, 14 carried materially different wordings of the same warning, and the version quoted above was used by 8 of them.
The hazard does not change between those 14 versions. Only the sentences do, which is why a refill from a different manufacturer can carry warning text that reads differently without anything about Tacrolimus or its risks having changed.
Tacrolimus is dispensed under 42 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 Tacrolimus have a black box warning?
Yes. 42 FDA-approved labels for Tacrolimus carry a boxed warning, and its subject is malignancies and serious infections. 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 Tacrolimus 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 01 October 2023, the warning concerns malignancies and serious infections. The full text is linked so the exact version can be read rather than summarised.
Does the Tacrolimus boxed warning mean the drug is unsafe or being withdrawn?
No. It means the FDA requires the risk of malignancies and serious infections to be communicated prominently so prescribers weigh it explicitly. Tacrolimus remains FDA-approved and is dispensed under 42 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 Tacrolimus labels sampled here, 14 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 Tacrolimus because of this warning?
This page does not answer that and cannot. The warning about malignancies and serious infections is written for a prescriber deciding whether Tacrolimus 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 Tacrolimus label, linked below by its DailyMed set identifier so the exact version can be opened rather than taken on trust. The figure of 42 labels, and the count of 14 distinct wordings among 25 sampled, were computed from the openFDA labelling API on 30 August 2026.
- TACROLIMUS prescribing information, Proficient Rx LP, effective 01 October 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.