Two medicines, side by side
Duloxetine vs fluoxetine
Duloxetine and fluoxetine are both labeled for depression and anxiety. Drugs@FDA records approvals of duloxetine since 2004 and of fluoxetine since 1987. Pharmacies paid $0.102 per duloxetine HCl DR 30 mg capsule and $0.0519 per fluoxetine HCl 40 mg capsule (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, duloxetine is a serotonin and norepinephrine reuptake inhibitor and fluoxetine a serotonin reuptake inhibitor.
Check it at the source: the duloxetine FDA label on DailyMed (effective May 14, 2024); the fluoxetine FDA label on DailyMed (effective January 8, 2026).
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
Highlights of the fluoxetine record
Fluoxetine (Prozac) · label of January 8, 2026
SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions ( 5.1 )].
Used for
From the label: indicationsPROZAC ® is indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies ( 14.1 )]. Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies ( 14.2 )]. […]
On the market
- Earliest approval on file
- December 29, 1987
- Generic labelers
- 58 labelers
- Pharmacy cost
- $0.0519 per capsule
Supply and safety
- Shortage
- No current entry
- Recalls
- 9
Source: FDA drug labels via openFDA (Duloxetine label of May 14, 2024, Fluoxetine label of January 8, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do duloxetine and fluoxetine differ on the record?
In FDA's classes, duloxetine is a serotonin and norepinephrine reuptake inhibitor and fluoxetine a serotonin reuptake inhibitor.
How each works, in its label's words: Duloxetine, “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 …”; Fluoxetine, “Although the exact mechanism of PROZAC is unknown, it is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin.”
Half-life, in each label's words: Duloxetine, “Mean terminal half-life was 12.4 hours (range 7.8 to 22.2 hour) in subjects receiving a single dose DRIZALMA SPRINKLE.”; Fluoxetine, “Its mean terminal half-life after a single dose was 8.6 days and after multiple dosing was 9.3 days.”
Both labels carry a boxed warning; the records quote them.
Generics: duloxetine since 2013; fluoxetine since 2001 (Drugs@FDA).
| Duloxetine | Fluoxetine | |
|---|---|---|
| Labeled for | Depression, Anxiety, Nerve pain and fibromyalgia, Pain | Depression, Anxiety, Bipolar disorder |
| Pharmacologic class | Serotonin and Norepinephrine Reuptake Inhibitor | Serotonin Reuptake Inhibitor |
| How it works (label) | 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 … | Although the exact mechanism of PROZAC is unknown, it is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin. |
| Half-life (label) | Mean terminal half-life was 12.4 hours (range 7.8 to 22.2 hour) in subjects receiving a single dose DRIZALMA SPRINKLE. | Its mean terminal half-life after a single dose was 8.6 days and after multiple dosing was 9.3 days. |
| Earliest approval on file (Drugs@FDA) | August 3, 2004 | December 29, 1987 |
| First generic approved | December 11, 2013 | August 2, 2001 |
| Generic labelers (NDC) | 45 labelers | 58 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.102 per capsule (Duloxetine HCl DR 30 mg capsule) | $0.0519 per capsule (Fluoxetine HCl 40 mg capsule) |
| 12-month price change | +31% | -20% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 56 | 9 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 69,298 | 131,827 |
| 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)
Do their labels mention each other?
Duloxetine label, drug interactionsExamples; Paroxetine, fluoxetine, quinidine
Source: FDA drug labels via openFDA
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.
Fluoxetine label, warnings and precautionsSerotonin syndrome has been reported with SSRIs and SNRIs, including PROZAC, both when taken alone, but especially when co-administered with other serotonergic agents.
Source: FDA drug labels via openFDA
What next?
- Alternatives to duloxetine
- every medicine labeled for the same conditions