title: Allergic contact dermatitis from topical doxepin: Food and Drug Administration's postmarketing surveillance experience.
abstract: A total of 26 postmarketing cases of allergic contact dermatitis to doxepin 5% cream were reported to the Food and Drug Administration. Our findings suggest that allergic contact dermatitis was more common when treatment duration exceeded the recommended 8 days. Allergic contact dermatitis to doxepin cream should be considered in patients whose condition fails to improve or worsens with doxepin use.
authors.affiliation: Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Room 15B-23, HFD-430, Rockville, MD 20857, USA.
authors.forename: Renan A
authors.initials: RA
authors.lastname: Bonnel
authors.forename: Lois
authors.initials: L
authors.lastname: La Grenade
authors.forename: Claudia B
authors.initials: CB
authors.lastname: Karwoski
authors.forename: Julie G
authors.initials: JG
authors.lastname: Beitz
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000982:Antipruritics / Q000008:administration & dosage / Q000009:adverse effects*; D017449:Dermatitis, Allergic Contact / Q000209:etiology*; D004316:Doxepin / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing
chemical_list: D000982:Antipruritics; D004316:Doxepin