Yes. 19 FDA-approved labels for Misoprostol carry a boxed warning, and its subject is misoprostol administration to women who are pregnant can cause birth defects, abortion, premature birth. 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 Misoprostol warning opens on one specific label, identified underneath it. Of the 19 Misoprostol labels sampled, 5 carried materially different wordings, and this was the most common, used by 11 of them.
WARNINGS MISOPROSTOL ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE BIRTH DEFECTS, ABORTION, PREMATURE BIRTH OR UTERINE RUPTURE. UTERINE RUPTURE HAS BEEN REPORTED WHEN MISOPROSTOL WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION. THE RISK OF UTERINE RUPTURE INCREASES WITH ADVANCING GESTATIONAL AGES AND WITH PRIOR UTERINE SURGERY, INCLUDING CESAREAN DELIVERY (See also PRECAUTIONS and LABOR AND DELIVERY ). MISOPROSTOL SHOULD NOT BE TAKEN BY PREGNANT WOMEN TO REDUCE THE RISK OF ULCERS INDUCED BY NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDs) (See CONTRAINDICATIONS , WARNINGS , and PRECAUTIONS ).
MISOPROSTOL, ANI Pharmaceuticals, Inc., label version effective 23 October 2025. 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 19 Misoprostol labels sampled for this page, 5 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 5 versions. Only the sentences do, which is why a refill from a different manufacturer can carry warning text that reads differently without anything about Misoprostol or its risks having changed.
Misoprostol is dispensed under 19 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 Misoprostol have a black box warning?
Yes. 19 FDA-approved labels for Misoprostol carry a boxed warning, and its subject is misoprostol administration to women who are pregnant can cause birth defects, abortion, premature birth. 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 Misoprostol 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 23 October 2025, the warning concerns misoprostol administration to women who are pregnant can cause birth defects, abortion, premature birth. The full text is linked so the exact version can be read rather than summarised.
Does the Misoprostol boxed warning mean the drug is unsafe or being withdrawn?
No. It means the FDA requires the risk of misoprostol administration to women who are pregnant can cause birth defects, abortion, premature birth to be communicated prominently so prescribers weigh it explicitly. Misoprostol remains FDA-approved and is dispensed under 19 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 19 Misoprostol labels sampled here, 5 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 Misoprostol because of this warning?
This page does not answer that and cannot. The warning about misoprostol administration to women who are pregnant can cause birth defects, abortion, premature birth is written for a prescriber deciding whether Misoprostol 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 Misoprostol label, linked below by its DailyMed set identifier so the exact version can be opened rather than taken on trust. The figure of 19 labels, and the count of 5 distinct wordings among 19 sampled, were computed from the openFDA labelling API on 30 August 2026.
- MISOPROSTOL prescribing information, ANI Pharmaceuticals, Inc., effective 23 October 2025.
- 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.