Drug Safety Alerts

Benadryl Drug Safety Communication

9/24/2020

On September 24, 2020, the United States Food and Drug Administration (FDA) issued a drug safety communication warning that taking higher than recommended doses of the common over-the-counter (OTC) allergy medicine Benadryl (diphenhydramine) can lead to serious heart problems, seizures, coma, or even death. The FDA is aware of news reports of teenagers ending up in emergency rooms or dying after participating in the “Benadryl Challenge” encouraged in videos posted on the social media application TikTok.

The FDA is investigating these reports and conducting a review to determine if additional cases have been reported. The FDA will update the public once the review is complete or if there is more information to share. 

The FDA recommends that health care professionals should be aware that the “Benadryl Challenge” is occurring among teens and alert their caregivers about it. Encourage teens and caregivers to read and follow the Drug Facts label. In the event of an overdose, health care professionals should attempt to determine whether a patient with a suspected overdose took diphenhydramine.

Patients and health care professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program

CVS Caremark® Response:

For more information about this issue, health care providers may call the FDA consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.