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Two medicines, side by side

Vilazodone vs fluoxetine

Vilazodone and fluoxetine are both labeled for depression. Drugs@FDA records approvals of vilazodone since 2011 and of fluoxetine since 1987. Pharmacies paid $0.732 per vilazodone HCl 10 mg tablet 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.

Check it at the source: the vilazodone FDA label on DailyMed (effective May 22, 2024); the fluoxetine FDA label on DailyMed (effective January 8, 2026).

Highlights of the vilazodone record

Vilazodone (Viibryd) · label of May 22, 2024

Boxed warning

SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors 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 )]. Vilazodone hydrochloride tablets are not approved for use in pediatric patients [see Use in Specific Populations ( 8.4) ].

Used for

From the label: indications

Vilazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14 )]. Vilazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.

On the market

Earliest approval on file
January 21, 2011
Generic labelers
12 labelers
Pharmacy cost
$0.732 per tablet

Supply and safety

Shortage
No current entry
Recalls
0

Highlights of the fluoxetine record

Fluoxetine (Prozac) · label of January 8, 2026

Boxed warning

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: indications

PROZAC ® 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 (Vilazodone label of May 22, 2024, Fluoxetine label of January 8, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do vilazodone and fluoxetine differ on the record?

How each works, in its label's words: Vilazodone, “The mechanism of action of vilazodone in the treatment of major depressive disorder is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS …”; 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: Vilazodone, “Elimination of vilazodone is primarily by hepatic metabolism with a terminal half-life of approximately 25 hours.”; 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: vilazodone since 2019; fluoxetine since 2001 (Drugs@FDA).

VilazodoneFluoxetine
Labeled forDepressionDepression, Anxiety, Bipolar disorder
Pharmacologic classn/aSerotonin Reuptake Inhibitor
How it works (label)The mechanism of action of vilazodone in the treatment of major depressive disorder is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS through selective inhibition of serotonin …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)Elimination of vilazodone is primarily by hepatic metabolism with a terminal half-life of approximately 25 hours.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)January 21, 2011December 29, 1987
First generic approvedSeptember 30, 2019August 2, 2001
Generic labelers (NDC)12 labelers58 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$0.732 per tablet (Vilazodone HCl 10 mg tablet)$0.0519 per capsule (Fluoxetine HCl 40 mg capsule)
12-month price change-29%-20%
Boxed warningYesYes
Shortage nowNo current entryNo current entry
Recalls recorded09
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)9,170131,827
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 do the labels say about using others of their kind?

Vilazodone label, drug interactions

Other Serotonergic Drugs Concomitant use of vilazodone hydrochloride with other serotonergic drugs (including other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. John’s Wort) increases the risk of serotonin syndrome.

Fluoxetine label, warnings and precautions

Serotonin 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?

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