Navigation Links
FDA: Serious Side Effects from Swallowing Topical Benadryl Product

SILVER SPRING, Md., May 12 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration is warning consumers about potentially serious side effects from mistakenly swallowing Benadryl Extra Strength Itch Stopping Gel, an over-the-counter (OTC) product that should only be used on the skin.

(Logo: )

The FDA has received reports of serious side effects in people who have mistakenly swallowed the product. Some OTC Benadryl products are intended to be swallowed. However, Benadryl Extra Strength Itch Stopping Gel is only safe and effective when used, as directed, on the skin.. People swallowing the gel can ingest a dangerous amount of the active ingredient, diphenhydramine. Large doses of diphenhydramine can result in serious side effects such as unconsciousness, hallucinations, and confusion.

"Consumer confusion and incorrect product use are serious public health issues," said Carol Holquist, R.Ph., director of FDA's Division of Medication Error Prevention and Analysis. "FDA is advising consumers and pharmacies to store products for the skin separately from products that should be swallowed."

Many pharmacies and grocery stores sell diphenhydramine topical gels that look very similar in packaging to Benadryl Extra Strength Itch Stopping Gel. It is important that consumers also avoid swallowing these products.

To help consumers recognize that Benadryl Extra Strength Itch Stopping Gel is meant for use on the skin, the manufacturer, Johnson and Johnson, has taken the following actions:

  • Changed the product label to add a new, prominent statement "For Skin Use Only."
  • Attached a sticker to the cap of the product that says "For Skin Use Only."  
  • Initiated consumer studies to better understand factors that may contribute to consumers mistakenly swallowing Benadryl Extra Strength Itch Stopping Gel.

The FDA encourages manufacturers of similar products to adopt similar changes to their labeling and packaging.  

The repackaged product is currently stocked in retail stores. The FDA reminds consumers and health care professionals to always read the "Drug Facts" box to identify active ingredients, directions for use, and warnings before using any OTC drug product.

Consumers and health care professionals are encouraged to report adverse side effects to the FDA's MedWatch Adverse Event Reporting program at or by calling 800-332-1088.

For more information

FDA 101: Medication Errors

Media Inquiries: Shelly Burgess, 301-796-4651,

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Medical Research Council Technologys Centre for Therapeutics Discovery Opens its First Call For Targets in an Effort to Develop Drugs in Areas of Serious Unmet Need
2. Dermatologists Caution That Severe Cases of Psoriasis Can Be Associated With Other Serious Medical Conditions
3. Genomas Clinical Study Finds Increased Prevalence of Drug Metabolism Deficiencies in Patients With Serious Psychotropic Side Effects
4. FDA Approves Promacta(R) (Eltrombopag), the First Oral Medication to Increase Platelet Production for People With Serious Blood Disorder
5. Video: New Survey Finds Mothers See Influenza as a Serious Health Threat, but Often Dont Get Their Families Vaccinated
6. VIA Pharmaceuticals Announces Positive Results of Phase 2 Studies of VIA-2291 in Patients With Serious Cardiovascular Disease
7. Omega-3 Fatty Acids Critical to Infants, Mothers and the Seriously Ill
8. The Largest Ever Study of Diabetes Shows Intensive Glucose Control Reduces Serious Complications
9. Vermillion and the Ohio State University Report That Novel Diagnostic Test May Help Predict Risk for Relapse of TTP, A Serious Blood Disorder
10. Infant Formula Manufacturers Again under Ethical Cloud: Marketing Gimmick Linked to Serious Illnesses
11. Simple Test Accurately Predicts Risk of Serious Jaundice in Newborns
Post Your Comments:
(Date:10/12/2017)... EXTON, Pa. , Oct. 12, 2017 ... global leader in innovative solutions for injectable drug administration, ... results before the market opens on Thursday, October 26, ... discuss the results and business expectations at 9:00 a.m. ... 877-930-8295 (U.S.) or 253-336-8738 (International). The conference ID is ...
(Date:10/11/2017)... FRISCO, Texas , Oct. 11, 2017 /PRNewswire/ ... healthcare services, has amplified its effort during National ... patients about hereditary cancer risks. ... Journal of Clinical Oncology calculated that more than ... to have inherited mutations in BRCA1 or BRCA2 and ...
(Date:10/10/2017)... EXTON, Pa. , Oct. 10, 2017   ... leader in innovative solutions for injectable drug administration, today ... of West,s ID Adapter for improving the intradermal administration ... the Fourth Skin Vaccination Summit in May 2017 by ... Team Lead, Polio Department, World Health Organization (WHO), and ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Many families have long-term ... long-term care insurance companies have a waiver for care if the client has a ... when the family pays for care, is often waived, so the benefits from their ...
(Date:10/13/2017)... ... 13, 2017 , ... Talented host, actor Rob Lowe, is ... a new episode of "Success Files," which is an award-winning educational program broadcasted ... each subject in-depth with passion and integrity. , Sciatica occurs when the sciatic ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and San Francisco dentists, ... cutting-edge Oventus O2Vent technology. As many as 18 million Americans are estimated to ... breathing. Oral appliances can offer significant relief to about 75 percent of people ...
(Date:10/12/2017)... ... October 12, 2017 , ... Asante, a nationally ... care, have expanded their existing home health joint venture through an agreement, effective ... operating a joint venture home health company with Asante, delivering clinically integrated care, ...
(Date:10/12/2017)... ... ... On Saturday, October 21, the Health & Wellness Center at Florida Hospital ... for the American Heart Association Heart Walk. Teams of up to 10 people can ... their treadmills moving for 5 hours. Treadmills will start at 7:00 p.m. on Saturday, ...
Breaking Medicine News(10 mins):