[{"@context":"https:\/\/schema.org\/","@type":"Article","@id":"https:\/\/share-dev.upmc.com\/2025\/05\/medication-boxed-warning\/#Article","mainEntityOfPage":"https:\/\/share-dev.upmc.com\/2025\/05\/medication-boxed-warning\/","headline":"What Are Boxed Warnings on Medications?","name":"What Are Boxed Warnings on Medications?","description":"

All medicines come with warnings, but boxed warnings or black-box warnings are the most serious. Here's what to know before taking a medicine with one. <\/p>","datePublished":"2025-05-26","dateModified":"2025-05-23","author":{"@type":"Organization","@id":"https:\/\/www.upmc.com\/","name":"UPMC","url":"https:\/\/www.upmc.com\/","sameAs":"https:\/\/share-dev.upmc.com\/upmc\/","parentOrganization":"UPMC"},"publisher":{"@type":"Organization","name":"UPMC HealthBeat","logo":{"@type":"ImageObject","@id":"https:\/\/share-dev.upmc.com\/wp-content\/uploads\/2019\/04\/UPMC-HealthBeat-Logo.png","url":"https:\/\/share-dev.upmc.com\/wp-content\/uploads\/2019\/04\/UPMC-HealthBeat-Logo.png","width":600,"height":60}},"image":{"@type":"ImageObject","@id":"https:\/\/share-dev.upmc.com\/wp-content\/uploads\/2025\/05\/GettyImages-1262623637-e1748014772651.jpg","url":"https:\/\/share-dev.upmc.com\/wp-content\/uploads\/2025\/05\/GettyImages-1262623637-e1748014772651.jpg","height":887,"width":2048},"url":"https:\/\/share-dev.upmc.com\/2025\/05\/medication-boxed-warning\/","about":["Family Health","Health Topics A-Z"],"wordCount":1094,"articleBody":"All medications have warnings about possible side effects, but not all warnings are the same. The most serious is a boxed warning or black-box warning, which gets its name from the bold black border that often surrounds it on the drug label.The pharmaceutical industry uses this warning when taking a medicine comes with risks that may cause serious or life-threatening harm.Here are some common questions and answers to help you understand boxed warnings and weigh the risks before taking a medicine that has one.What Do Boxed Warnings on Medications Mean?Boxed or black-box warnings call attention to the most serious risks associated with a medicine. They’re on the medication bottle or box and highlighted in drug information pamphlets. They provide essential information about possible side effects and how to take medication safely.The U.S. Food and Drug Administration (FDA) requires these warnings on certain medications to:Alert you about possible serious or life-threatening side effects. These can include an increased risk of heart attack, stroke, addiction, and suicidal thoughts.Caution you about activities to avoid while taking the medicine. Standard warnings include driving or using large machinery while taking certain medications.Provide guidelines for taking medicines. Guidelines include when to take them, foods or drinks to avoid, and side effects to monitor.How Serious Is a Boxed Warning?Always take a boxed warning seriously. It means there’s reasonable evidence of a significant safety risk when taking the medicine.These risks may include severe health problems, such as a heart attack or mental health issues like suicidal thoughts or depression. They also warn about dangerous outcomes if you drive while taking the medicine or mix it with other drugs.What Types of Medications Have Boxed Warnings?The FDA can put boxed warnings on any approved medicine, including over-the-counter (OTC) drugs like ibuprofen.Often, all medications within a drug class have boxed warnings. This means every medication with similar ingredients will carry the warning.\u00a0Today, more than 400 drugs have this kind of warning.Where Can I Find a Boxed Warning?Drug manufacturers typically print warnings on the medication bottle or box beside the label. They often have colorful tags and bold or all-caps text. The guidelines and warnings are also in the informational booklet about the medicine.How Does a Medicine Get a Boxed Warning?A medicine can get a boxed warning from the beginning if tests show serious safety problems during clinical trials.But researchers or health care providers sometimes don\u2019t discover serious problems with a medicine until more people take it. The FDA monitors these problems, also called adverse effects, through its MedWatch program. Doctors and hospitals can report issues or serious side effects to MedWatch, as well as people who take the medication.The FDA tracks and evaluates these concerns, looking for trends, common problems, and serious risks to life. Based on its findings, the FDA can add a boxed warning to a medication label.The FDA may require a boxed warning if:Medicines aren’t safe for people with certain conditions. For example, some medicines aren’t safe for women who are pregnant or people with heart conditions.Side effects are serious and can cause death. This allows doctors and people who are considering taking the medication to weigh the benefits and risks beforehand.You can avoid issues or side effects. They can provide guidelines to lessen the problem and prevent it from happening.Does Tylenol Have a Boxed Warning?Yes, the FDA requires boxed warnings for acetaminophen, the primary ingredient in Tylenol. The FDA cautions that it may cause:Accidental overdose, particularly if taken with other medications that also contain acetaminophen.Liver damage.Rare and severe allergic skin reactions.Can Supplements Have Black Box Warnings?Dietary supplements don’t go through the same approval process as medications. One key difference is that they don’t have to undergo clinical trials.However, the FDA can put boxed warnings on any approved medicine. So, supplements and other medications with serious risks can also receive boxed warnings.Will My Doctor Tell Me if a Medicine Has a Boxed Warning?When discussing or prescribing a medicine, your doctor may discuss some of its biggest risks or guidelines. They may also tell you about any possible signs or symptoms.However, they may not review all warnings and risks with you. That\u2019s why it’s important to read all of the warnings on the label and in the information packet.Always tell your doctor about:Any issues you’ve had with medicines in the past.Any medications, supplements, or vitamins you take.Health problems you have.Your family\u2019s medical history.This information helps your doctor decide on your medical care and which medicines are safe.What Should I Do if My Medicine Has a Boxed Warning?Always check the medicine label before taking it and follow all directions. If you have any questions or concerns, talk to your doctor or pharmacist.Should I Take a Medicine if It Has a Warning?Before starting any new medicine, talk with your doctor to make sure you understand the risks and benefits. You can also ask about possible side effects and their likelihood. With this information, you can make the right decision.What Should I Do if I Experience a Side Effect Listed in the Boxed Warning?If the side effect is severe or life-threatening, call 911 or go to the nearest emergency department. If it’s not an emergency, contact your doctor or pharmacist right away. They can help you figure out what to do next and how to treat the problem.Stop taking the medicine until you talk to your doctor. You can also ask if you should report the side effects to the FDA\u2019s MedWatch program.If you have a bad reaction to a medicine, tell all of your doctors so they can record it in your medical records.Are Boxed Warnings Updated or Changed?The FDA continually monitors serious problems and side effects of medications. Based on new information, it can change or add new box warnings. It can also remove a warning, although this is rare.SourcesHarvard Health Publishing. The trouble with new drugs: Why unexpected safety problems are common. LinkGoodRx. What Does an FDA Black Box Warning Mean? LinkOncoLink. Box Warnings. LinkCureus. A Longitudinal Analysis of Black Box Warnings: Trends and Implications for Drug Safety. Link.StatPearls. Box Warning. LinkU.S. Food and Drug Administration. MedWatch Online Voluntary Reporting Form. LinkGoodRx. Acetaminophen. LinkU.S. Food and Drug Administration. Questions and Answers on Dietary Supplements. 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