OTC Eye Drops and Nasal Sprays
October 26, 2012
FDA issued a warning regarding over-the-counter nasal congestion sprays and eye drops used to relieve redness causing serious adverse effects when accidentally ingested by children. Serious adverse effects requiring hospitalization can occur after even a small amount (1-2 mL) is ingested by a child. Reported cases involved children 5 years old and younger. To date, 96 cases have been reported over a span of about 17 years. Reported serious events include sedation, decreased heart rate or breathing, or even coma. No deaths have been reported.
Tetrahydrozoline, oxymetazoline, or naphazoline is the active ingredient in the eye drops and nasal sprays involved. These products are not packaged with child-resistant closures and are sold under various store, generic, or brand names. Examples of these products are included in the FDA website at
FDA recommends keeping these products out of the reach of children. Contact the local poison control center immediately at 1-800-222-1222 if accidental ingestion occurs. Adverse events or side effects may be reported to FDA’s MedWatch Safety Information and Adverse Event Reporting Program online at
Additional information is available at the following links:
- FDA MedWatch:
- FDA Drug Safety Communication:
- FDA Consumer Update:
October 26, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.