Two medicines, side by side
Doxepin vs duloxetine
Doxepin and duloxetine are both labeled for depression and anxiety. Drugs@FDA records approvals of doxepin since 1969 and of duloxetine since 2004. Pharmacies paid $0.0779 per doxepin 10 mg capsule and $0.102 per duloxetine HCl DR 30 mg capsule (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 duloxetine a serotonin and norepinephrine reuptake inhibitor.
Check it at the source: the doxepin FDA label on DailyMed (effective December 30, 2025); the duloxetine FDA label on DailyMed (effective May 14, 2024).
Highlights of the doxepin record
Doxepin (Sinequan) · label of December 30, 2025
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: indicationsDoxepin 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 duloxetine record
Duloxetine (Cymbalta) · label of May 14, 2024
SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning.
Used for
From the label: indicationsDRIZALMA SPRINKLE is indicated for the treatment of: • Major Depressive Disorder in adults • Generalized Anxiety Disorder in adults and pediatric patients 7 years of age and older • Diabetic Peripheral Neuropathy in adults • Fibromyalgia in adults • Chronic Musculoskeletal Pain in adults Additional pediatric use information is approved for Eli Lilly and Company, Inc.’s CYMBALTA (duloxetine delayed-release capsules). […]
On the market
- Earliest approval on file
- August 3, 2004
- Generic labelers
- 45 labelers
- Pharmacy cost
- $0.102 per capsule
Supply and safety
- Shortage
- No current entry
- Recalls
- 56
Source: FDA drug labels via openFDA (Doxepin label of December 30, 2025, Duloxetine label of May 14, 2024); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do doxepin and duloxetine differ on the record?
In FDA's classes, doxepin is a tricyclic antidepressant and duloxetine a serotonin and norepinephrine reuptake inhibitor.
Both labels carry a boxed warning; the records quote them.
Generics: doxepin since 1986; duloxetine since 2013 (Drugs@FDA).
| Doxepin | Duloxetine | |
|---|---|---|
| Labeled for | Depression, Anxiety, Eczema (atopic dermatitis), Insomnia | Depression, Anxiety, Nerve pain and fibromyalgia, Pain |
| Pharmacologic class | Tricyclic Antidepressant | Serotonin and Norepinephrine Reuptake Inhibitor |
| How it works (label) | n/a | Although the exact mechanisms of the antidepressant, central pain inhibitory and anxiolytic actions of duloxetine in humans are unknown, these actions are believed to be related to its potentiation of serotonergic and noradrenergic … |
| Half-life (label) | n/a | Mean terminal half-life was 12.4 hours (range 7.8 to 22.2 hour) in subjects receiving a single dose DRIZALMA SPRINKLE. |
| Earliest approval on file (Drugs@FDA) | September 23, 1969 | August 3, 2004 |
| First generic approved | May 13, 1986 | December 11, 2013 |
| Generic labelers (NDC) | 49 labelers | 45 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.0779 per capsule (Doxepin 10 mg capsule) | $0.102 per capsule (Duloxetine HCl DR 30 mg capsule) |
| 12-month price change | -9% | +31% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 2 | 56 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 12,554 | 69,298 |
| DEA schedule | none | none |
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 do the labels say about using others of their kind?
Duloxetine label, drug interactionsExamples Selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, intravenous methylene blue Other Serotonergic Drugs Clinical Impact Concomitant use of duloxetine with other serotonergic drugs increases the risk of serotonin syndrome.
Source: FDA drug labels via openFDA
What next?
- Alternatives to doxepin
- every medicine labeled for the same conditions