Two medicines, side by side
Fluoxetine vs hydroxyzine
Fluoxetine and hydroxyzine are both labeled for anxiety. Drugs@FDA records approvals of fluoxetine since 1987 and of hydroxyzine since 1956. Pharmacies paid $0.0519 per fluoxetine HCl 40 mg capsule and $0.0326 per hydroxyzine HCl 25 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 hydroxyzine an antihistamine.
Check it at the source: the fluoxetine FDA label on DailyMed (effective January 8, 2026); the hydroxyzine FDA label on DailyMed (effective March 3, 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 hydroxyzine record
Hydroxyzine (Atarax) · label of March 3, 2026
Used for
From the label: indicationsFor symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. […]
On the market
- Earliest approval on file
- April 12, 1956
- Generic labelers
- 61 labelers
- Pharmacy cost
- $0.0326 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 18
Source: FDA drug labels via openFDA (Fluoxetine label of January 8, 2026, Hydroxyzine label of March 3, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do fluoxetine and hydroxyzine differ on the record?
In FDA's classes, fluoxetine is a serotonin reuptake inhibitor and hydroxyzine an antihistamine.
Only the fluoxetine label carries a boxed warning.
Generics: fluoxetine since 2001; hydroxyzine since 1979 (Drugs@FDA).
| Fluoxetine | Hydroxyzine | |
|---|---|---|
| Labeled for | Depression, Anxiety, Bipolar disorder | Anxiety, Alcohol use disorder |
| Pharmacologic class | Serotonin Reuptake Inhibitor | Antihistamine |
| 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. | n/a |
| Earliest approval on file (Drugs@FDA) | December 29, 1987 | April 12, 1956 |
| First generic approved | August 2, 2001 | August 24, 1979 |
| Generic labelers (NDC) | 58 labelers | 61 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.0519 per capsule (Fluoxetine HCl 40 mg capsule) | $0.0326 per tablet (Hydroxyzine HCl 25 mg tablet) |
| 12-month price change | -20% | -12% |
| Boxed warning | Yes | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 9 | 18 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 131,827 | 50,844 |
| 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?
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 fluoxetine
- every medicine labeled for the same conditions