Two medicines, side by side
Fluoxetine vs diazepam
Fluoxetine and diazepam are both labeled for anxiety. Drugs@FDA records approvals of fluoxetine since 1987 and of diazepam since 1963. Pharmacies paid $0.0519 per fluoxetine HCl 40 mg capsule and $0.0283 per diazepam 10 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, fluoxetine is a serotonin reuptake inhibitor and diazepam a benzodiazepine.
Check it at the source: the fluoxetine FDA label on DailyMed (effective January 8, 2026); the diazepam FDA label on DailyMed (effective August 11, 2026).
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
Highlights of the diazepam record
Diazepam (Valium) · label of August 11, 2026
RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required.
Used for
From the label: indicationsValium is indicated for the management of anxiety disorders or for the short- term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, Valium may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. […]
On the market
- Earliest approval on file
- November 15, 1963
- Generic labelers
- 45 labelers
- Pharmacy cost
- $0.0283 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 8
Source: FDA drug labels via openFDA (Fluoxetine label of January 8, 2026, Diazepam label of August 11, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do fluoxetine and diazepam differ on the record?
In FDA's classes, fluoxetine is a serotonin reuptake inhibitor and diazepam a benzodiazepine.
Half-life, in each label's words: Fluoxetine, “Its mean terminal half-life after a single dose was 8.6 days and after multiple dosing was 9.3 days.”; Diazepam, “The initial distribution phase has a half-life of approximately 1 hour, although it may range up to >3 hours.”
Both labels carry a boxed warning; the records quote them.
Generics: fluoxetine since 2001; diazepam since 1985 (Drugs@FDA).
DEA schedule: fluoxetine none; diazepam CIV.
| Fluoxetine | Diazepam | |
|---|---|---|
| Labeled for | Depression, Anxiety, Bipolar disorder | Anxiety, Muscle spasms and spasticity |
| Pharmacologic class | Serotonin Reuptake Inhibitor | Benzodiazepine |
| How it works (label) | Although the exact mechanism of PROZAC is unknown, it is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin. | n/a |
| Half-life (label) | Its mean terminal half-life after a single dose was 8.6 days and after multiple dosing was 9.3 days. | The initial distribution phase has a half-life of approximately 1 hour, although it may range up to >3 hours. |
| Earliest approval on file (Drugs@FDA) | December 29, 1987 | November 15, 1963 |
| First generic approved | August 2, 2001 | September 4, 1985 |
| Generic labelers (NDC) | 58 labelers | 45 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.0519 per capsule (Fluoxetine HCl 40 mg capsule) | $0.0283 per tablet (Diazepam 10 mg tablet) |
| 12-month price change | -20% | -5% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 9 | 8 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 131,827 | 121,010 |
| DEA schedule | none | CIV |
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?
Fluoxetine label, drug interactionsDiazepam – increased t½, alprazolam - further psychomotor performance decrement due to increased levels ( 7.7 ) Antipsychotics:
Diazepam label, drug interactionsAt present, this reaction is known to occur with cimetidine, ketoconazole, fluvoxamine, fluoxetine, and omeprazole.
Source: FDA drug labels via openFDA
What do the labels say about using others of their kind?
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.
Diazepam label, drug interactionsCentrally Acting Agents If Valium is to be combined with other centrally acting agents, careful consideration should be given to the pharmacology of the agents employed particularly with compounds that may potentiate or be potentiated by the action of Valium, such as phenothiazines, antipsychotics, anxiolytics/sedatives, hypnotics, anticonvulsants, narcotic analgesics, anesthetics, sedative antihistamines …
Source: FDA drug labels via openFDA
What next?
- Alternatives to fluoxetine
- every medicine labeled for the same conditions