What is a Boxed Warning?

Medically reviewed by Carmen Pope, BPharm. Last updated on June 6, 2025.

What is a Boxed Warning?

A Boxed Warning is the strictest safety warning for a prescription medicine issued by the U.S. Food and Drug Administration (FDA). It was previously known as a Black Box Warning.

Boxed warnings help ensure a medicine is used appropriately and safely. The warning is enclosed within a black border on drug labeling and aims to alert healthcare providers and patients to serious or life-threatening risks or side effects associated with their medicine. Boxed Warnings were first implemented in 1979. 

While these warnings signal potential risks, many medications with boxed warnings are still widely prescribed because their benefits can outweigh the risks when used correctly.

Figure 1. An Example of a Boxed Warning

Why Do Medicines Receive a Boxed Warning?

A medicine is assigned a Boxed warning if it meets any of the following criteria:

• It has been associated with a serious side effect that could cause death or permanent disability
• The risk of severe side effects can be reduced if people and prescribers comply with specific administration or dosing guidelines, such as side effect monitoring, being alert for interacting medicines, and taking note of the recommended and maximum dosage.
• Mandatory prescribing restrictions apply, such as requiring special training for doctors or limiting the drug’s use to hospital settings.

Examples of Drugs with Boxed Warnings

Some commonly used medications that carry a Boxed Warning include:

• Accutane (isotretinoin): severe birth defects during pregnancy
• Methotrexate: liver toxicity and organ damage
• Ciprofloxacin: increased risk of tendon rupture
• Opioids (such as oxycodone, fentanyl): high risk of addiction and overdose
• Antidepressants (SSRIs, SNRIs): increased risk of suicidal thoughts in young adults
• Atypical antipsychotics (such as aripiprazole, olanzapine): increased risk of death and cerebrovascular events (such as a stroke) in dementia.

How to Check if a Drug Has a Boxed Warning

To find out if your medication has a Boxed warning, you can:

• Review the medication guide that comes with your prescription
• Visit the official FDA website for safety updates
• Search for the drug on Drugs.com and look under the “Warnings” section
• Consult your doctor or pharmacist for more information.

How Boxed Warnings Affect Drug Prescribing

Boxed warnings are primarily directed at healthcare professionals, who are responsible for:

• Informing patients about the risks before prescribing the medication
• Ensuring proper monitoring to minimize potential adverse effects
• Weighing the risks vs. benefits to decide if the drug is appropriate for a specific patient.

Some medications with boxed warnings also require an FDA Risk Evaluation and Mitigation Strategy (REMS), which may include restrictions like special certification for prescribers or dispensing only in certified healthcare facilities.

Boxed Warning vs. Drug Recall: What’s the Difference?

A Boxed Warning means the drug remains available but must be used with extreme caution. A drug recall, however, occurs when a medication is removed from the market due to safety concerns.

FAQs About Boxed Warnings

✅ Are all drugs with Boxed warnings dangerous?

• No, many are safe when used properly. The warning ensures careful monitoring and proper patient selection.

✅ Can I still take a drug if it has a Boxed warning?

• Yes, but only under a doctor’s supervision who will weigh the benefits vs. risks.

✅ Are Boxed warnings permanent?

• Not always. Some warnings are updated or removed if new research shows improved safety.

Bottom Line

Boxed warnings help patients and doctors make informed decisions about medication safety.

If you are prescribed a drug with this warning, have a conversation with your doctor about possible alternative treatments (if any), risk management strategies, and possible side effects. Do not be afraid to ask questions and take some time to think it through.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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