Safety Information: Benzocaine Topical Products: Sprays, Gels and Liquids - Risk of Methemoglobinemia
FDA continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect,
associated with benzocaine products both as a spray, used during medical procedures to numb the mucous
membranes of the mouth and throat, and benzocaine gels and liquids sold over-the-counter and used to
relieve pain from a variety of conditions, such as teething, canker sores, and irritation of the mouth and gums.
BACKGROUND: Methemoglobinemia is a rare, but serious condition in which the amount of oxygen
through the blood stream is greatly reduced. In the most severe cases, methemoglobinemia can result in
death. Patients who develop methemoglobinemia may experience signs and symptoms such as pale, gray or
blue colored skin, lips, and nail beds; headache; lightheadedness; shortness of breath; fatigue; and rapid
heart rate. Methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, and cases
occurred mainly in children aged two years or younger who were treated with benzocaine gel for teething. The
signs and symptoms usually appear within minutes to hours of applying benzocaine and may occur with the
first application of benzocaine or after additional use. The development of methemoglobinemia after treatment
with benzocaine sprays may not be related to the amount applied. In many cases, methemoglobinemia was
reported following the administration of a single benzocaine spray.
Recommendations for Consumers
• Benzocaine products should not be used on children less than two years of age, except under the
advice and supervision of a healthcare professional.
• Adult consumers who use benzocaine gels or liquids to relieve pain in the mouth should
follow the recommendations in the product label.
• Consumers should store benzocaine products out of reach of children.
• Talk to their healthcare professional about using benzocaine.
On the FDA web site (see above link) read the two Drug Safety Communications for other specific
recommendations for Healthcare Professionals, for Consumers and Caregivers and the Data Summary which
supports these recommendations. FDA is continuing to evaluate the safety of benzocaine products and the
Agency will update the public when it has additional information. FDA will take appropriate regulatory actions as
NCPIE encourages healthcare professionals and community groups to foster patient–professional communication about medicines. However, NCPIE does not supervise or endorse the activities of any group or professional. Discussion and action concerning medicines are solely the responsibility of the patient and their healthcare professionals, and not NCPIE.
Please consult a licensed health care professional with questions or concerns about your medication and/or condition.