Two medicines, side by side
Venlafaxine vs fluoxetine
Venlafaxine and fluoxetine are both labeled for depression and anxiety. Drugs@FDA records approvals of venlafaxine since 1993 and of fluoxetine since 1987. Pharmacies paid $0.0799 per venlafaxine HCl ER 75 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, venlafaxine is a serotonin and norepinephrine reuptake inhibitor and fluoxetine a serotonin reuptake inhibitor.
Check it at the source: the venlafaxine FDA label on DailyMed (effective August 15, 2023); the fluoxetine FDA label on DailyMed (effective January 8, 2026).
Highlights of the venlafaxine record
Venlafaxine (Effexor) · label of August 15, 2023
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 emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1) ]. Effexor XR is not approved for use in pediatric patients [see Use in Specific Populations (8.4) ].
Used for
From the label: indicationsEffexor XR is indicated in adults for the treatment of: • Major Depressive Disorder (MDD) [see Clinical Studies (14.1) ] • Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2) ] • Social Anxiety Disorder (SAD) [see Clinical Studies (14.3) ] • Panic Disorder (PD) [see Clinical Studies (14.4) ] Effexor XR is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with: • Major Depressive Disorder (MDD) ( 1 ) • Generalized Anxiety Disorder (GAD) ( 1 ) • Social Anxiety Disorder (SAD) ( 1 ) • Panic Disorder (PD) […]
On the market
- Earliest approval on file
- December 28, 1993
- Generic labelers
- 61 labelers
- Pharmacy cost
- $0.0799 per capsule
Supply and safety
- Shortage
- No current entry
- Recalls
- 21
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 (Venlafaxine label of August 15, 2023, Fluoxetine label of January 8, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do venlafaxine and fluoxetine differ on the record?
In FDA's classes, venlafaxine is a serotonin and norepinephrine reuptake inhibitor and fluoxetine a serotonin reuptake inhibitor.
How each works, in its label's words: Venlafaxine, “The mechanism of action of venlafaxine in the treatment of MDD, GAD, SAD, and PD is unclear, but is thought to be related to the potentiation of serotonin and norepinephrine in the central nervous …”; 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: Venlafaxine, “The apparent elimination half-life is 5 ± 2 hours for venlafaxine and 11 ± 2 hours for ODV.”; 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: venlafaxine since 2006; fluoxetine since 2001 (Drugs@FDA).
| Venlafaxine | Fluoxetine | |
|---|---|---|
| Labeled for | Depression, Anxiety | Depression, Anxiety, Bipolar disorder |
| Pharmacologic class | Serotonin and Norepinephrine Reuptake Inhibitor | Serotonin Reuptake Inhibitor |
| How it works (label) | The mechanism of action of venlafaxine in the treatment of MDD, GAD, SAD, and PD is unclear, but is thought to be related to the potentiation of serotonin and norepinephrine in the central nervous system, through inhibition of their … | 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) | The apparent elimination half-life is 5 ± 2 hours for venlafaxine and 11 ± 2 hours for ODV. | 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) | December 28, 1993 | December 29, 1987 |
| First generic approved | August 3, 2006 | August 2, 2001 |
| Generic labelers (NDC) | 61 labelers | 58 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.0799 per capsule (Venlafaxine HCl ER 75 mg capsule) | $0.0519 per capsule (Fluoxetine HCl 40 mg capsule) |
| 12-month price change | -13% | -20% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 21 | 9 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 131,560 | 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?
Venlafaxine label, drug interactionsThese findings have been confirmed in a clinical drug interaction study comparing the effect of venlafaxine with that of fluoxetine on the CYP2D6-mediated metabolism of dextromethorphan to dextrorphan.
Source: FDA drug labels via openFDA
What do the labels say about using others of their kind?
Venlafaxine label, drug interactionsOther Serotonergic Drugs Clinical Impact Concomitant use of Effexor XR with other serotonergic drugs (including other SNRIs, SSRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. John's Wort) 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 venlafaxine
- every medicine labeled for the same conditions