Two medicines, side by side
Buspirone vs fluoxetine
Buspirone and fluoxetine are both labeled for anxiety. Drugs@FDA records approvals of buspirone since 1986 and of fluoxetine since 1987. Pharmacies paid $0.043 per buspirone HCl 15 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. Only the fluoxetine label carries a boxed warning.
Check it at the source: the buspirone FDA label on DailyMed (effective December 22, 2023); the fluoxetine FDA label on DailyMed (effective January 8, 2026).
Highlights of the buspirone record
Buspirone (Buspar) · label of December 22, 2023
Used for
From the label: indicationsBuspirone hydrochloride tablets, USP are indicated for the management of anxiety disorders or 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. […]
On the market
- Earliest approval on file
- September 29, 1986
- Generic labelers
- 47 labelers
- Pharmacy cost
- $0.043 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 10
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 (Buspirone label of December 22, 2023, Fluoxetine label of January 8, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do buspirone and fluoxetine differ on the record?
Only the fluoxetine label carries a boxed warning.
Half-life, in each label's words: Buspirone, “The average elimination half-life of unchanged buspirone after single doses of 10 mg to 40 mg is about 2 to 3 hours.”; Fluoxetine, “Its mean terminal half-life after a single dose was 8.6 days and after multiple dosing was 9.3 days.”
Generics: buspirone since 2001; fluoxetine since 2001 (Drugs@FDA).
| Buspirone | Fluoxetine | |
|---|---|---|
| Labeled for | Anxiety | Depression, Anxiety, Bipolar disorder |
| Pharmacologic class | n/a | Serotonin Reuptake Inhibitor |
| How it works (label) | n/a | 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 average elimination half-life of unchanged buspirone after single doses of 10 mg to 40 mg is about 2 to 3 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) | September 29, 1986 | December 29, 1987 |
| First generic approved | March 28, 2001 | August 2, 2001 |
| Generic labelers (NDC) | 47 labelers | 58 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.043 per tablet (Buspirone HCl 15 mg tablet) | $0.0519 per capsule (Fluoxetine HCl 40 mg capsule) |
| 12-month price change | -9% | -20% |
| Boxed warning | No | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 10 | 9 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 10,970 | 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)
What do the labels say about using others of their kind?
Buspirone label, warningsSerotonin Syndrome The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs, SSRIs, and other serotonergic drugs, including buspirone, alone but particularly with concomitant use of other serotonergic drugs (including triptans), with drugs that impair metabolism of serotonin (in particular, MAOIs, including reversible MAOIs such as linezolid and intravenous methylene blue) …
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 buspirone
- every medicine labeled for the same conditions