Yes. 78 FDA-approved labels for Clindamycin carry a boxed warning, and its subject is clostridioides difficile -associated diarrhea (cdad) has been reported with use of nearly all antibacterial agents, including.... 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 Clindamycin warning opens on one specific label, identified underneath it. Of the 25 Clindamycin labels sampled, 4 carried materially different wordings and this was the most common, used by 10 of them.
WARNING Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin hydrochloride and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C. difficile. Because clindamycin hydrochloride therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS AND USAGE section.
CLINDAMYCIN HYDROCHLORIDE, A-S Medication Solutions, label version effective 07 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 25 Clindamycin labels sampled for this page, 4 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 4 versions. Only the sentences do, which is why a refill from a different manufacturer can carry warning text that reads differently without anything about Clindamycin or its risks having changed.
Clindamycin is dispensed under 78 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 Clindamycin have a black box warning?
Yes. 78 FDA-approved labels for Clindamycin carry a boxed warning, and its subject is clostridioides difficile -associated diarrhea (cdad) has been reported with use of nearly all antibacterial agents, including.... 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 Clindamycin 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 07 October 2025, the warning concerns clostridioides difficile -associated diarrhea (cdad) has been reported with use of nearly all antibacterial agents, including.... The full text is linked so the exact version can be read rather than summarised.
Does the Clindamycin boxed warning mean the drug is unsafe or being withdrawn?
No. It means the FDA requires the risk of clostridioides difficile -associated diarrhea (cdad) has been reported with use of nearly all antibacterial agents, including... to be communicated prominently so prescribers weigh it explicitly. Clindamycin remains FDA-approved and is dispensed under 78 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 Clindamycin labels sampled here, 4 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 Clindamycin because of this warning?
This page does not answer that and cannot. The warning about clostridioides difficile -associated diarrhea (cdad) has been reported with use of nearly all antibacterial agents, including... is written for a prescriber deciding whether Clindamycin 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 Clindamycin label, linked below by its DailyMed set identifier so the exact version can be opened rather than taken on trust. The figure of 78 labels, and the count of 4 distinct wordings among 25 sampled, were computed from the openFDA labelling API on 30 August 2026.
- CLINDAMYCIN HYDROCHLORIDE prescribing information, A-S Medication Solutions, effective 07 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.