Yes. 73 FDA-approved labels for Morphine Sulfate carry a boxed warning, and its subject is addiction, abuse, and misuse; risk evaluation and mitigation strategy (rems); life-threatening respiratory depression. 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 Morphine Sulfate warning opens on one specific label, identified underneath it. Of the 25 Morphine Sulfate labels sampled, 16 carried materially different wordings and this was the most common, used by 7 of them.
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Addiction, Abuse, and Misuse Morphine sulfate exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing morphine sulfate extended-release tablets, and monitor all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1)] .
MORPHINE SULFATE, Bryant Ranch Prepack, label version effective 13 February 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 Morphine Sulfate labels sampled for this page, 16 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 16 versions. Only the sentences do, which is why a refill from a different manufacturer can carry warning text that reads differently without anything about Morphine Sulfate or its risks having changed.
Morphine Sulfate 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 Morphine Sulfate have a black box warning?
Yes. 73 FDA-approved labels for Morphine Sulfate carry a boxed warning, and its subject is addiction, abuse, and misuse; risk evaluation and mitigation strategy (rems); life-threatening respiratory depression. 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 Morphine Sulfate 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 13 February 2026, the warning concerns addiction, abuse, and misuse; risk evaluation and mitigation strategy (rems); life-threatening respiratory depression. The full text is linked so the exact version can be read rather than summarised.
Does the Morphine Sulfate boxed warning mean the drug is unsafe or being withdrawn?
No. It means the FDA requires the risk of addiction, abuse, and misuse; risk evaluation and mitigation strategy (rems); life-threatening respiratory depression to be communicated prominently so prescribers weigh it explicitly. Morphine Sulfate 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 Morphine Sulfate labels sampled here, 16 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 Morphine Sulfate because of this warning?
This page does not answer that and cannot. The warning about addiction, abuse, and misuse; risk evaluation and mitigation strategy (rems); life-threatening respiratory depression is written for a prescriber deciding whether Morphine Sulfate 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 Morphine Sulfate 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 16 distinct wordings among 25 sampled, were computed from the openFDA labelling API on 30 August 2026.
- MORPHINE SULFATE prescribing information, Bryant Ranch Prepack, effective 13 February 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.