Key takeaways
- Black box warnings, or boxed warnings, are serious warnings that come from the FDA. They are meant to alert people about drug effects that may be dangerous.
- Specific drugs may carry a boxed warning, but most of the time it applies to a whole drug class. For example, ACE inhibtors carry a risk of harm if used during pregnancy as a boxed warning.
A boxed warning, previously known as a black box warning, is the most serious warning from the Food and Drug Administration (FDA). The
According to 2022 research, over 400 medications currently have boxed warnings.
Read on to learn more about boxed warnings and examples of drugs that carry these warnings.
Boxed warnings apply to certain medications that carry serious risks for the person taking them. The FDA decides which medications require boxed warnings.
These warnings are listed in the drug’s prescribing information. You will notice them at the top with a black box around them. Talk with your doctor or pharmacist if you have questions when looking at the prescribing information.
How does the FDA decide which medication get a boxed warning?
Before the
But there are also cases where new and serious side effects are discovered after the drug has been on the market. An FDA program called Medwatch allows for anyone to report side effects of drugs on the market. The FDA tracks these side effects and looks at patterns, severity, and frequency to help them determine if a new boxed warning needs to be added for a drug.
The FDA typically
- A risk is so serious, including life-threatening, that it needs to be considered when prescribing the medication.
- Serious side effects or risks could be lessened or prevented by appropriate use of the medication.
- Certain restrictions need to be applied to the medication to ensure safe use.
What do I do if my medication has a boxed warning?
You may feel worried if the medication you are taking has a boxed warning. Your doctor will review the risks and benefits of a medication with a boxed warning. They will decide whether a medication is safe for you based on certain factors, such as other health conditions you have or medications you take.
It’s important to remember that these medications are safe when they are used appropriately. If you have concerns, talk with your doctor or pharmacist.
Specific drugs may receive a boxed warning, but it’s
| Drug class | Examples | Boxed warning |
| glucagon-like peptide-1 receptor (GLP-1) agonists | • semaglutide (Wegovy, Ozempic) • tirzepatide (Mounjaro, Zepbound) | risk of thyroid cancer |
| Nonsteroidal anti-inflammatory drugs (NSAIDs) | • diclofenac • naproxen (Anaprox DS, Naprosyn) | • risk of serious heart and blood vessel problems • risk of serious digestive problems |
| antidepressants | • SSRIs, such as citalopram (Celexa) and escitalopram (Lexapro) • SNRIs, such as duloxetine (Cymbalta) and desvenlafaxine (Pristiq) • TCAs, such as amitriptyline and nortriptyline (Pamelor) | risk of suicidal thoughts and behaviors |
| angiotensin-converting enzymes (ACE) inhibitors | • lisinopril (Zestril) • enalapril (Vasotec) • benazepril (Lotensin) | risk of harm if used during pregnancy |
| combination birth control pills | • norethindrone acetate/ethinyl estradiol/ferrous fumarate (Lo Loestrin Fe) • drospirenone/ethinyl estradiol (Yaz) | risk of serious heart and blood vessel problems in people who smoke |
It is important to note that this is not a complete list of drugs with boxed warnings. If you are interested in more information about drugs and boxed warnings, talk with your doctor or pharmacist.
Note: SSRIs stands for selective serotonin reuptake inhibitors, SNRIs stands for serotonin norepinephrine reuptake inhibitors, and TCAs stands for tricyclic antidepressants.
A boxed warning is a serious warning from the FDA. If a drug has a boxed warning it means it carries risks of severe harm or death.
Drugs that have boxed warnings can be effective treatment options. Your doctor will review the risks and benefits of a medication with a boxed warning before prescribing it.
If you have questions about boxed warnings, talk with your doctor or pharmacist.
Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.