Yes. 5 FDA-approved labels for Mifepristone carry a boxed warning, and its subject is termination of pregnancy. 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 Mifepristone warning opens on one specific label, identified underneath it. Of the 5 Mifepristone labels sampled, 3 carried materially different wordings, and this was the most common, used by 2 of them.
WARNING: TERMINATION OF PREGNANCY Mifepristone is a potent antagonist of progesterone and cortisol via the progesterone and glucocorticoid (GR-II) receptors, respectively. The antiprogestational effects will result in the termination of pregnancy. Pregnancy must therefore be excluded before the initiation of treatment with mifepristone and prevented during treatment and for one month after stopping treatment by the use of a non-hormonal medically acceptable method of contraception unless the patient has had a surgical sterilization, in which case no additional contraception is needed.
MIFEPRISTONE, Actavis Pharma, Inc., label version effective 01 February 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 5 Mifepristone labels sampled for this page, 3 carried materially different wordings of the same warning, and the version quoted above was used by 2 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 Mifepristone or its risks having changed.
Mifepristone is dispensed under 5 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 Mifepristone have a black box warning?
Yes. 5 FDA-approved labels for Mifepristone carry a boxed warning, and its subject is termination of pregnancy. 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 Mifepristone 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 February 2022, the warning concerns termination of pregnancy. The full text is linked so the exact version can be read rather than summarised.
Does the Mifepristone boxed warning mean the drug is unsafe or being withdrawn?
No. It means the FDA requires the risk of termination of pregnancy to be communicated prominently so prescribers weigh it explicitly. Mifepristone remains FDA-approved and is dispensed under 5 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 5 Mifepristone 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 Mifepristone because of this warning?
This page does not answer that and cannot. The warning about termination of pregnancy is written for a prescriber deciding whether Mifepristone 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 Mifepristone label, linked below by its DailyMed set identifier so the exact version can be opened rather than taken on trust. The figure of 5 labels, and the count of 3 distinct wordings among 5 sampled, were computed from the openFDA labelling API on 30 August 2026.
- MIFEPRISTONE prescribing information, Actavis Pharma, Inc., effective 01 February 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.