Rapid Message Testing with Consumer Panel - Additional Testing of Drug Safety Communications About Misuse and Abuse of Over-the-Counter Medications (CDER)

FDA warns about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl)
Teen misuse sparked by dangerous “Benadryl Challenge” promoted on social media
FDA Drug Safety Communication
The U.S. Food and Drug Administration (FDA) is warning that taking higher than recommended doses of the
common over-the-counter (OTC) allergy medicine diphenhydramine (Benadryl) can lead to serious heart
problems, seizures, coma, or even death. We are 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.
We are investigating these reports and conducting a review to determine if additional cases have been
reported. We will update the public once we have completed our review or have more information to share.
We also contacted TikTok and strongly urged them to remove the videos from their platform and to be vigilant
to remove additional videos that may be posted.
Consumers, parents, and caregivers should store diphenhydramine and all other OTC and prescription
medicines up and away and out of children’s reach and sight. FDA recommends you lock up medicines to
prevent accidental poisonings by children and misuse by teens, especially when they are home more often due
to the COVID-19 pandemic and may be more likely to experiment.
Always read the Drug Facts label included on all OTC medicines to find out if they contain
diphenhydramine, how much and how often you should take them, and important safety information. Do not
take more than the dose listed on the label, as doing so can cause serious problems. If someone takes too much
diphenhydramine and is hallucinating, can’t be awakened, has a seizure, has trouble breathing, or has
collapsed, immediately get medical attention or contact poison control at 1-800-222-1222 or online.
Diphenhydramine is an antihistamine used to temporarily relieve symptoms due to hay fever, upper respiratory
allergies, or the common cold, such as runny nose and sneezing. It works by blocking histamine in the body,
which is a substance that causes allergic symptoms. When used as recommended, it is a safe and effective
medicine. Diphenhydramine is marketed under the brand-name Benadryl, store brands, and generics. It is
also available in combination with pain relievers, fever reducers, and decongestants.
We urge health care professionals and consumers to report side effects involving diphenhydramine and other
medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of
the page.
Contact FDA
For More Info
855-543-DRUG (3784) and press 4
[email protected]
Report a Serious Problem to MedWatch
Complete and submit the report Online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address
on the pre-addressed form, or submit by fax to 1-800-FDA-0178.