Prescription medicine
Fluoxetine Brand names: Prozac; first approved as Sarafem
Fluoxetine (Prozac) is a prescription medicine with an FDA approval on record since 1987. FDA's NDC Directory lists it from 58 generic labelers, and pharmacies paid $0.0519 per fluoxetine HCl 40 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the fluoxetine FDA label on DailyMed (effective January 8, 2026, Dista Products Company); the NDA 18936 record on Drugs@FDA; every fluoxetine label on DailyMed.
Highlights of the record
FDA label of January 8, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 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 )]. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions ( 5.1 )]. PROZAC is not approved for use in children less than 7 years of age [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.4 )]. When using PROZAC and olanzapine in combination, also refer to Boxed Warning section of the package insert for Symbyax. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants ( 5.1 ). Monitor for worsening and emergence of suicidal thoughts and behaviors ( 5.1 ). […]
Used for
From the label: indications and usagePROZAC ® is indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies ( 14.1 )].
Forms and strengths
- 10 mg
- 20 mg
- 40 mg
- 60 mg
- 90 mg
- 20 mg/5ml
Capsule; film-coated tablet; tablet; coated tablet; solution.
On the market
- Earliest approval on file
- December 29, 1987 Sarafem, Eli Lilly And Co; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 69 first August 2, 2001; 34 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 59 of which 58 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0519 per capsule Fluoxetine HCl 40 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 9 since 2013 0 Class I among all firms' recalls; latest May 27, 2025; 1 more by firms not listed as its makers
- FAERS reports
- 131,827 through July 30, 2026
What is fluoxetine used for?
From the label: indications and usagePROZAC ® 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 )]. Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies ( 14.3 )]. Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies ( 14.4 )]. PROZAC and Olanzapine in Combination is indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder. […]
Conditions named in the indications of fluoxetine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Serotonin Reuptake Inhibitor.
Source: FDA drug label (Prozac), NDA018936 (Eli Lilly And Co), as published by Dista Products Company, effective January 8, 2026 (SPL set c88f33ed-6dfb-4c5e-bc01-d8e36dd97299), via openFDA; the full label on DailyMed
What does the patient leaflet for fluoxetine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about PROZAC?PROZAC and other antidepressant medicines may cause serious side effects, including: Suicidal thoughts or actions: PROZAC and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. Watch for these changes and call your healthcare provider right away if you notice: New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. Pay particular attention to such changes when PROZAC is started or when the dose is changed. Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you: attempts to commit suicide acting on dangerous impulses acting aggressive or violent thoughts about suicide or dying new or worse depression new or worse anxiety or panic attacks feeling agitated, restless, angry or irritable trouble sleeping an increase in activity or talking more than what is normal for you other unusual changes in behavior or mood Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. PROZAC may be associated with these serious side effects: Serotonin Syndrome. […]
From the patient leaflet: What should I avoid while taking PROZAC?PROZAC can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how PROZAC affects you. Do not drink alcohol while using PROZAC.
From the patient leaflet: How should I store PROZAC?Store PROZAC at room temperature between 59°F and 86°F (15°C to 30°C). Keep PROZAC away from light. Keep PROZAC bottle closed tightly. Keep PROZAC and all medicines out of the reach of children.
Source: FDA drug label (Prozac), NDA018936 (Eli Lilly And Co), as published by Dista Products Company, effective January 8, 2026 (SPL set c88f33ed-6dfb-4c5e-bc01-d8e36dd97299), via openFDA; the full label on DailyMed
Is there a generic for fluoxetine (Prozac)?
The FDA approved the first generic fluoxetine on August 2, 2001. 69 generic applications are approved; 34 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists fluoxetine from 58 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1987 earliest approval on file
- 2001 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for fluoxetine (Prozac)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0519 per Fluoxetine HCl 40 mg capsule, down 20% from $0.0645 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Fluoxetine HCl 40 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Fluoxetine 20 mg/5 mL solution | Generic | $0.203 per mL | n/a | -2% |
| Fluoxetine DR 90 mg capsule | Generic | $30.68 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $920.45 | +2% |
| Fluoxetine HCl 10 mg capsule | Generic | $0.0353 per capsule | $1.06 | +8% |
| Fluoxetine HCl 10 mg tablet | Generic | $0.0698 per tablet | $2.09 | -36% |
| Fluoxetine HCl 20 mg capsule | Generic | $0.0293 per capsule | $0.880 | -0.9% |
| Fluoxetine HCl 20 mg tablet | Generic | $0.0838 per tablet | $2.51 | -23% |
| Fluoxetine HCl 40 mg capsule | Generic | $0.0519 per capsule | $1.56 | -20% |
| Fluoxetine HCl 60 mg tablet | Generic | $0.182 per tablet | $5.45 | -47% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has fluoxetine been recalled?
The FDA's Enforcement Report lists 10 recalls naming fluoxetine since 2013: 0 Class I (the most serious), 8 Class II, 2 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of fluoxetine and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 27, 2025 | Class II | Torrent Pharma Inc. | CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. |
| February 5, 2018 | Class III | Teva Pharmaceuticals USA | Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) … |
| April 13, 2015 | Class II | Teva Pharmaceuticals USA | Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern … |
| December 5, 2014 | Class III | Sandoz Incorporated | Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule. |
| February 14, 2014 | Class II | Legacy Pharmaceutical Packaging | Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor. |
| February 12, 2014 | Class II | Teva Pharmaceuticals USA | Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup; FLUoxetine HCl, Capsule, 10 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the fluoxetine label say about other medicines?
The fluoxetine label names 39 other medicines in its interaction, contraindication or warning sections. The labels of 48 other medicines name fluoxetine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Alprazolam | drug interactions | Diazepam – increased t½, alprazolam - further psychomotor performance decrement due to increased levels ( 7.7 ) Antipsychotics: |
| Amiodarone | drug interactions | Class III antiarrhythmics (e.g., amiodarone, sotalol); and others (e.g., pentamidine, levomethadyl acetate, methadone, halofantrine, mefloquine, dolasetron mesylate, probucol or tacrolimus). |
| Aspirin | drug interactions | Potential for elevation of haloperidol and clozapine levels ( 7.7 ) Anticonvulsants: Potential for elevated phenytoin and carbamazepine levels and clinical anticonvulsant toxicity ( 7.7 ) Serotonergic Drugs: ( 2.9 , 2.10 , 4.1 , 5.2 ) Drugs that Interfere with Hemostasis (e.g. NSAIDs, Aspirin, Warfarin): |
| Buspirone | drug interactions | The concomitant use of serotonergic drugs (including other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. John's Wort) with PROZAC increases the risk of serotonin syndrome. |
| Carbamazepine | drug interactions | Anticonvulsants – Patients on stable doses of phenytoin and carbamazepine have developed elevated plasma anticonvulsant concentrations and clinical anticonvulsant toxicity following initiation of concomitant fluoxetine treatment. |
| Chlorpromazine | drug interactions | These include: specific antipsychotics (e.g., ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol); specific antibiotics (e.g., erythromycin, gatifloxacin, moxifloxacin, sparfloxacin); |
| Clozapine | drug interactions | Elevation of blood levels of haloperidol and clozapine has been observed in patients receiving concomitant fluoxetine. |
| Desipramine | drug interactions | Tricyclic Antidepressants (TCAs) – In 2 studies, previously stable plasma levels of imipramine and desipramine have increased greater than 2- to 10-fold when fluoxetine has been administered in combination. |
| Diazepam | drug interactions | Diazepam – increased t½, alprazolam - further psychomotor performance decrement due to increased levels ( 7.7 ) Antipsychotics: |
| Droperidol | drug interactions | These include: specific antipsychotics (e.g., ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol); specific antibiotics (e.g., erythromycin, gatifloxacin, moxifloxacin, sparfloxacin); |
| Erythromycin | drug interactions | These include: specific antipsychotics (e.g., ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol); specific antibiotics (e.g., erythromycin, gatifloxacin, moxifloxacin, sparfloxacin); |
| Fentanyl | warnings and precautions | The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, meperidine, methadone, buspirone, amphetamines, and St. … |
| Flecainide | drug interactions | Coadministration of fluoxetine with other drugs that are metabolized by CYP2D6, including certain antidepressants (e.g., TCAs), antipsychotics (e.g., phenothiazines and most atypicals), and antiarrhythmics (e.g., propafenone, flecainide, and others) should be approached with caution. |
| Gatifloxacin | drug interactions | These include: specific antipsychotics (e.g., ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol); specific antibiotics (e.g., erythromycin, gatifloxacin, moxifloxacin, sparfloxacin); |
Every other medicine the fluoxetine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Haloperidol | drug interactions | Potential for elevation of haloperidol and clozapine levels ( 7.7 ) Anticonvulsants: Potential for elevated phenytoin and carbamazepine levels and clinical anticonvulsant toxicity ( 7.7 ) … |
| Iloperidone | drug interactions | These include: specific antipsychotics (e.g., ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol); specific antibiotics (e.g., erythromycin, gatifloxacin, moxifloxacin, sparfloxacin); |
| Imipramine | drug interactions | Tricyclic Antidepressants (TCAs) – In 2 studies, previously stable plasma levels of imipramine and desipramine have increased greater than 2- to 10-fold when fluoxetine has been administered in … |
| Ketoconazole | drug interactions | Additionally, in vitro studies have shown ketoconazole, a potent inhibitor of CYP3A4 activity, to be at least 100 times more potent than fluoxetine or norfluoxetine as an inhibitor of the metabolism … |
| Linezolid | contraindications | Starting PROZAC in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and … |
| Lithium | drug interactions | The concomitant use of serotonergic drugs (including other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. … |
| Mefloquine | drug interactions | Class III antiarrhythmics (e.g., amiodarone, sotalol); and others (e.g., pentamidine, levomethadyl acetate, methadone, halofantrine, mefloquine, dolasetron mesylate, probucol or tacrolimus). |
| Meperidine | warnings and precautions | … tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, meperidine, methadone, buspirone, amphetamines, and St. … |
| Methadone | drug interactions | Class III antiarrhythmics (e.g., amiodarone, sotalol); and others (e.g., pentamidine, levomethadyl acetate, methadone, halofantrine, mefloquine, dolasetron mesylate, probucol or tacrolimus). |
| Methylene blue | contraindications | Starting PROZAC in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and … |
| Midazolam | drug interactions | … several substrates for this enzyme, including astemizole, cisapride, and midazolam. |
| Moxifloxacin | drug interactions | These include: specific antipsychotics (e.g., ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol); specific antibiotics (e.g., erythromycin, gatifloxacin, moxifloxacin, sparfloxacin); |
| Olanzapine | boxed warning | When using PROZAC and olanzapine in combination, also refer to Boxed Warning section of the package insert for Symbyax. |
| Phenytoin | drug interactions | Potential for elevation of haloperidol and clozapine levels ( 7.7 ) Anticonvulsants: Potential for elevated phenytoin and carbamazepine levels and clinical anticonvulsant toxicity ( 7.7 ) … |
| Pimozide | contraindications | The use of PROZAC is contraindicated with the following: Pimozide [see Warnings and Precautions ( 5.11 ) and Drug Interactions ( 7.7 , 7.8 )] Thioridazine [see Warnings and Precautions ( 5.11 ) and … |
| Procainamide | drug interactions | Class 1A antiarrhythmic medications (e.g., quinidine, procainamide); |
| Propafenone | drug interactions | … (e.g., phenothiazines and most atypicals), and antiarrhythmics (e.g., propafenone, flecainide, and others) should be approached with caution. |
| Quinidine | drug interactions | Class 1A antiarrhythmic medications (e.g., quinidine, procainamide); |
| Sotalol | drug interactions | Class III antiarrhythmics (e.g., amiodarone, sotalol); and others (e.g., pentamidine, levomethadyl acetate, methadone, halofantrine, mefloquine, dolasetron mesylate, probucol or tacrolimus). |
| Tacrolimus | drug interactions | Class III antiarrhythmics (e.g., amiodarone, sotalol); and others (e.g., pentamidine, levomethadyl acetate, methadone, halofantrine, mefloquine, dolasetron mesylate, probucol or tacrolimus). |
| Thioridazine | contraindications | Risk of QT prolongation and drug interaction ( 4.2 , 5.11 , 7.7 , 7.8 ) Thioridazine: Risk of QT interval prolongation and elevated thioridazine plasma levels. |
| Tramadol | warnings and precautions | The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, meperidine, methadone, buspirone … |
| Vinblastine | drug interactions | Drugs with a narrow therapeutic index represent the greatest concern (e.g., flecainide, propafenone, vinblastine, and TCAs). |
| Warfarin | drug interactions | … 5.2 ) Drugs that Interfere with Hemostasis (e.g. NSAIDs, Aspirin, Warfarin): |
| Ziprasidone | drug interactions | These include: specific antipsychotics (e.g., ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol); specific antibiotics (e.g., erythromycin, gatifloxacin, moxifloxacin, sparfloxacin); |
Other labels that name fluoxetine
- Almotriptan
- Amitriptyline
- Aripiprazole
- Aripiprazole lauroxil
- Atomoxetine
- Bupropion
- Carvedilol
- Clomipramine
- Clonazepam
- Codeine
- Darifenacin
- Desloratadine
- Deutetrabenazine
- Dihydroergotamine
- Doxepin
- Gilteritinib
- Glimepiride
- Glipizide
- Glyburide
- Insulin aspart
- Insulin degludec
- Insulin detemir
- Insulin glargine
- Insulin glulisine
- Insulin human
- Insulin lispro
- Isocarboxazid
- Ketorolac
- Metoclopramide
- Nebivolol
- Nifedipine
- Nortriptyline
- Oliceridine
- Paroxetine
- Phenelzine
- Pramlintide
- Propranolol
- Rasagiline
- Repaglinide
- Risperidone
- Ritonavir
- Selegiline
- Tetrabenazine
- Tolterodine
- Trimipramine
- Vortioxetine
- Zolpidem
Source: FDA drug label (Prozac), NDA018936 (Eli Lilly And Co), as published by Dista Products Company, effective January 8, 2026 (SPL set c88f33ed-6dfb-4c5e-bc01-d8e36dd97299), via openFDA; the full label on DailyMed
What do FAERS reports show for fluoxetine?
The FDA Adverse Event Reporting System holds 131,827 reports that list fluoxetine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 13,381 are coded as a death and 40,996 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as fluoxetine?
29 other medicines are given the same way (oral) and in the same FDA class as fluoxetine or labeled mainly for the same use (depression), the same class first. Depression lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Sertraline | Depression, Anxiety | 48 labelers | $0.0507 per tablet 100 mg tablet | No current entry |
| Paroxetine | Depression, Anxiety | 45 labelers | $0.0611 per tablet 20 mg tablet | No current entry |
| Trazodone | Depression | 38 labelers | $0.0307 per tablet 50 mg tablet | No current entry |
| Escitalopram | Depression, Anxiety | 44 labelers | $0.0632 per tablet 20 mg tablet | No current entry |
| Citalopram | Depression | 35 labelers | $0.026 per tablet 10 mg tablet | No current entry |
| Nefazodone | Depression | 2 labelers | $1.17 per tablet 100 mg tablet | No current entry |
| Bupropion | Depression | 73 labelers | $0.0785 per tablet 150 mg tablet | No current entry |
| Venlafaxine | Depression, Anxiety | 62 labelers | $0.0799 per capsule 75 mg capsule | No current entry |
Every medicine labeled for the same conditions as fluoxetine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does fluoxetine compare with medicines for the same use?
23 side-by-side pages set fluoxetine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to fluoxetine
- 29 medicines for the same use
- Other serotonin reuptake inhibitors
- the pharmacologic class, with prices and generics
- Fluoxetine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other