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Two medicines, side by side

Doxepin vs hydroxyzine

Doxepin and hydroxyzine are both labeled for anxiety. Drugs@FDA records approvals of doxepin since 1969 and of hydroxyzine since 1956. Pharmacies paid $0.0779 per doxepin 10 mg capsule and $0.0326 per hydroxyzine HCl 25 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, doxepin is a tricyclic antidepressant and hydroxyzine an antihistamine.

Check it at the source: the doxepin FDA label on DailyMed (effective December 30, 2025); the hydroxyzine FDA label on DailyMed (effective March 3, 2026).

Highlights of the doxepin record

Doxepin (Sinequan) · label of December 30, 2025

Boxed warning

Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of doxepin hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need.

Used for

From the label: indications

Doxepin Hydrochloride is recommended for the treatment of: Psychoneurotic patients with depression and/or anxiety. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). […]

On the market

Earliest approval on file
September 23, 1969
Generic labelers
49 labelers
Pharmacy cost
$0.0779 per capsule

Supply and safety

Shortage
No current entry
Recalls
2

Highlights of the hydroxyzine record

Hydroxyzine (Atarax) · label of March 3, 2026

Used for

From the label: indications

For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. […]

On the market

Earliest approval on file
April 12, 1956
Generic labelers
61 labelers
Pharmacy cost
$0.0326 per tablet

Supply and safety

Shortage
No current entry
Recalls
18

Source: FDA drug labels via openFDA (Doxepin label of December 30, 2025, Hydroxyzine label of March 3, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do doxepin and hydroxyzine differ on the record?

In FDA's classes, doxepin is a tricyclic antidepressant and hydroxyzine an antihistamine.

Only the doxepin label carries a boxed warning.

Generics: doxepin since 1986; hydroxyzine since 1979 (Drugs@FDA).

DoxepinHydroxyzine
Labeled forDepression, Anxiety, Eczema (atopic dermatitis), InsomniaAnxiety, Alcohol use disorder
Pharmacologic classTricyclic AntidepressantAntihistamine
How it works (label)n/an/a
Half-life (label)n/an/a
Earliest approval on file (Drugs@FDA)September 23, 1969April 12, 1956
First generic approvedMay 13, 1986August 24, 1979
Generic labelers (NDC)49 labelers61 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$0.0779 per capsule (Doxepin 10 mg capsule)$0.0326 per tablet (Hydroxyzine HCl 25 mg tablet)
12-month price change-9%-12%
Boxed warningYesNo
Shortage nowNo current entryNo current entry
Recalls recorded218
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)12,55450,844
DEA schedulenonenone

Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)

What next?

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