Yes. 73 FDA-approved labels for Levofloxacin carry a boxed warning, and its subject is serious adverse reactions including tendinitis, tendon rupture, peripheral neuropathy, central nervous system effects. 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 Levofloxacin warning opens on one specific label, identified underneath it. Of the 25 Levofloxacin labels sampled, 12 carried materially different wordings and this was the most common, used by 7 of them.
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS • Fluoroquinolones, including levofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see Warnings and Precautions ( 5.1 )], including: o Tendinitis and tendon rupture [see Warnings and Precautions ( 5.2 )] o Peripheral neuropathy [see Warnings and Precautions ( 5.3)] o Central nervous system effects [see Warnings and Precautions (5.4)] Discontinue levofloxacin immediately and avoid the use of fluoroquinolones, including levofloxacin, in patients who...
LEVOFLOXACIN, A-S Medication Solutions, label version effective 31 July 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 Levofloxacin labels sampled for this page, 12 carried materially different wordings of the same warning, and the version quoted above was used by 7 of them.
The hazard does not change between those 12 versions. Only the sentences do, which is why a refill from a different manufacturer can carry warning text that reads differently without anything about Levofloxacin or its risks having changed.
Levofloxacin is dispensed under 73 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 Levofloxacin have a black box warning?
Yes. 73 FDA-approved labels for Levofloxacin carry a boxed warning, and its subject is serious adverse reactions including tendinitis, tendon rupture, peripheral neuropathy, central nervous system effects. 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 Levofloxacin 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 31 July 2025, the warning concerns serious adverse reactions including tendinitis, tendon rupture, peripheral neuropathy, central nervous system effects. The full text is linked so the exact version can be read rather than summarised.
Does the Levofloxacin boxed warning mean the drug is unsafe or being withdrawn?
No. It means the FDA requires the risk of serious adverse reactions including tendinitis, tendon rupture, peripheral neuropathy, central nervous system effects to be communicated prominently so prescribers weigh it explicitly. Levofloxacin remains FDA-approved and is dispensed under 73 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 Levofloxacin labels sampled here, 12 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 Levofloxacin because of this warning?
This page does not answer that and cannot. The warning about serious adverse reactions including tendinitis, tendon rupture, peripheral neuropathy, central nervous system effects is written for a prescriber deciding whether Levofloxacin 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 Levofloxacin label, linked below by its DailyMed set identifier so the exact version can be opened rather than taken on trust. The figure of 73 labels, and the count of 12 distinct wordings among 25 sampled, were computed from the openFDA labelling API on 30 August 2026.
- LEVOFLOXACIN prescribing information, A-S Medication Solutions, effective 31 July 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.