July 24, 2019

What Does it Mean If My Medication Has a ‘Black Box Warning’?

A drug information specialist explains

Medication with extra black box warning labels on container

You heard on the news that a medicine you’re taking now has a “black box warning.” That sounds alarming, but what does it actually mean?


Cleveland Clinic is a non-profit academic medical center. Advertising on our site helps support our mission. We do not endorse non-Cleveland Clinic products or services. Policy

Black box warnings, also called boxed warnings, are required by the U.S. Food and Drug Administration for certain medications that carry serious safety risks. Often these warnings communicate potential rare but dangerous side effects, or they may be used to communicate important instructions for safe use of the drug.

They appear printed in bold font surrounded by a black border on the insert that comes inside a medication’s packaging, and on the drug manufacturer’s website, if it has one.

Communicating risk

The warnings are intended to call attention to certain risks or instructions so that healthcare professionals will be aware of them and carefully consider them when prescribing medications to patients.

If a medication you’re taking carries risk that warrants a black box warning, that doesn’t necessarily mean that you shouldn’t take it. But the risks and benefits of a medication are something your healthcare provider should discuss with you.


“If the warnings involve a serious adverse reaction and are applicable to a particular patient, the provider should discuss them with that patient before prescribing the medication,” says registered pharmacist and drug information specialist Meghan Lehmann, Pharm.D., BCPS. “A pharmacist should reiterate applicable warnings and help address any additional questions.”

How does a medicine get this warning?

FDA often identifies safety concerns with medications through clinical trial data or through reports of so-called “adverse events” submitted to the agency by consumers and healthcare professionals.

It’s not always possible to know that those adverse events are directly caused by a medication, but if FDA identifies a serious concern, it can require a drug company to update its product’s labeling, restrict its use or, in rare cases, remove it from the market.

For example, several kinds of combination birth control pills carry a black box warning related to cardiovascular risks associated with them. The warning also strongly advises that women who use them not smoke, as cigarette smoking is known to increase the risk of those side effects.


Worried about a warning? Talk to your healthcare provider

All medications come with potential risks and benefits. If you have concerns about a medicine you’re taking, don’t delay bringing them up with a healthcare professional who can help to put them in context or discuss alternatives.

“If your prescriber or pharmacist hasn’t discussed them with you, contact either one of them for help answering any questions you might have,” Dr. Lehmann says.

Related Articles

Person handing a pharmacist a prescription.
March 30, 2023
Is Ozempic the Answer for Your Weight Loss?

This diabetes med can treat obesity, but it’s not for people who just want to drop a few pounds

woman taking medication
February 4, 2021
7 Myths About Medication and the Facts Behind Them

Here’s a healthy dose of truth about taking your meds

a couple listening to the doctor's instructions
September 24, 2019
Why We Forget What the Doctor Told Us (and What To Do About It)

Tips to help you get the most from your visit

Various medications with a warning symbol over them
February 4, 2019
Medication Recalled? What You Should Do Next May Surprise You

Major recalls are rare — but you’ll definitely hear about them

illustration of old medications floating away
January 2, 2019
How to Safely Throw Away Old Medications

Here's what to do when it's time to clean out your medicine cabinet

Female swimmer in the water at edge of a pool
December 1, 2023
Can Exercise Reduce Your Risk of Breast Cancer?

Physical activity and weight management can minimize your chances of getting the disease

Two people standing in the cold.
November 29, 2023
10 Colds Not To Catch This Winter

The flu, RSV, COVID-19, pneumonia and more typically circulate during cold weather months

Parent breastfeeding baby on bed, against the headboard.
November 27, 2023
Looking for Foods To Increase Your Milk Supply? Think Big Picture

No single food will increase your milk, but an overall healthy diet will help

Trending Topics

group of hands holding different beverages
November 14, 2023
10 Myths About Drinking Alcohol You Should Stop Repeating

Coffee won’t cure a hangover and you definitely shouldn’t mix your cocktail with an energy drink

Person applies moisturizer as part of their skin care routine after a shower.
November 10, 2023
Korean Skin Care Routines: What You Need To Know

Focus on the philosophy — replenishing and respecting your skin — not necessarily the steps

glass of cherry juice with cherries on table
November 8, 2023
Sleepy Girl Mocktail: What’s in It and Does It Really Make You Sleep Better?

This social media sleep hack with tart cherry juice and magnesium could be worth a try