Yes. 28 FDA-approved labels for Amiodarone carry a boxed warning, and its subject is pulmonary, hepatic and cardiac toxicity. 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 Amiodarone warning opens on one specific label, identified underneath it. Of the 25 Amiodarone labels sampled, 7 carried materially different wordings and this was the most common, used by 6 of them.
WARNING: PULMONARY, HEPATIC and CARDIAC TOXICITY Amiodarone hydrochloride is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity [see Indications and Usage (1) ]. Amiodarone hydrochloride can cause pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis) that has resulted in clinically manifest disease at rates as high as 17% in some series of patients. Pulmonary toxicity has been fatal about 10% of the time. Obtain a baseline chest X-ray and pulmonary-function tests, including diffusion capacity, when amiodarone hydrochloride therapy is initiated.
AMIODARONE HYDROCHLORIDE, Cardinal Health 107, LLC, label version effective 20 April 2026. 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 Amiodarone labels sampled for this page, 7 carried materially different wordings of the same warning, and the version quoted above was used by 6 of them.
The hazard does not change between those 7 versions. Only the sentences do, which is why a refill from a different manufacturer can carry warning text that reads differently without anything about Amiodarone or its risks having changed.
Amiodarone is dispensed under 28 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 Amiodarone have a black box warning?
Yes. 28 FDA-approved labels for Amiodarone carry a boxed warning, and its subject is pulmonary, hepatic and cardiac toxicity. 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 Amiodarone 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 20 April 2026, the warning concerns pulmonary, hepatic and cardiac toxicity. The full text is linked so the exact version can be read rather than summarised.
Does the Amiodarone boxed warning mean the drug is unsafe or being withdrawn?
No. It means the FDA requires the risk of pulmonary, hepatic and cardiac toxicity to be communicated prominently so prescribers weigh it explicitly. Amiodarone remains FDA-approved and is dispensed under 28 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 Amiodarone labels sampled here, 7 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 Amiodarone because of this warning?
This page does not answer that and cannot. The warning about pulmonary, hepatic and cardiac toxicity is written for a prescriber deciding whether Amiodarone 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 Amiodarone label, linked below by its DailyMed set identifier so the exact version can be opened rather than taken on trust. The figure of 28 labels, and the count of 7 distinct wordings among 25 sampled, were computed from the openFDA labelling API on 30 August 2026.
- AMIODARONE HYDROCHLORIDE prescribing information, Cardinal Health 107, LLC, effective 20 April 2026.
- 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.