July 23, 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?

Advertisement

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.

Advertisement

“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.

Advertisement

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

Variety of medication pills and tablets and liquids
February 22, 2024
Is It OK To Take Expired Medicine?

Some types of expired meds may not be harmful, but they probably aren’t worth the risk

Person handing a pharmacist a prescription.
March 29, 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 3, 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 23, 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 3, 2019
Medication Recalled? What You Should Do Next May Surprise You

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

Applying aloe vera to irritated skin
February 27, 2024
Do Home Remedies for Ringworm Actually Work?

Some natural home remedies may offer relief, but they lack scientific evidence and won’t typically cure the condition

Shoe storage shelf home, including purses and bike helmets
February 14, 2024
Wearing Shoes in the House: ‘OK’ or ‘No Way’?

Leaving footwear on invites germs, bacteria, toxins and other unwanted guests into your home

Male consults with pharmacist about herbal supplement
February 13, 2024
Herbal Supplements: Why To Check With a Healthcare Provider First

Besides questionable effectiveness, herbal supplements aren’t safe for everyone

Trending Topics

White bowls full of pumpkin seeds, dark chocolate and various kinds of nuts
25 Magnesium-Rich Foods You Should Be Eating

A healthy diet can easily meet your body’s important demands for magnesium

Woman feeling for heart rate in neck on run outside, smartwatch and earbuds
Heart Rate Zones Explained

A super high heart rate means you’re burning more than fat

Spoonful of farro salad with tomato
What To Eat If You’ve Been Diagnosed With Prediabetes

Type 2 diabetes isn’t inevitable with these dietary changes

Ad