Prescription medicine
Fluoxetine and olanzapine First approved as Symbyax
Fluoxetine and olanzapine (Symbyax) is a prescription medicine with an FDA approval on record since 2003. FDA's NDC Directory lists it from 3 generic labelers, and pharmacies paid $3.44 per unit (Olanzapine-fluoxetine 3-25 mg) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the fluoxetine and olanzapine FDA label on DailyMed (effective March 31, 2026, Teva Pharmaceuticals USA, Inc.); the NDA 21520 record on Drugs@FDA; every fluoxetine and olanzapine label on DailyMed.
Highlights of the record
FDA label of March 31, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SUICIDAL THOUGHTS AND.
BEHAVIORS and INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS 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. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening and emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the healthcare provider. Olanzapine and fluoxetine capsules are not approved for use in children less than 10 years of age [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 )]. Increased Mortality in Elderly Patients with Dementia-Related Psychosis – Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Olanzapine and fluoxetine capsules are not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.2 )]. […]
Used for
From the label: indications and usageOlanzapine and fluoxetine capsules are indicated for the treatment of: Acute depressive episodes in Bipolar I Disorder [see Clinical Studies ( 14.1 )].
Forms and strengths
- 3 mg / 25 mg
- 6 mg / 50 mg
- 6 mg / 25 mg
- 12 mg / 25 mg
- 12 mg / 50 mg
Capsule.
On the market
- Earliest approval on file
- December 24, 2003 Symbyax, Lilly; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first June 19, 2012; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 3 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $3.44 per unit Olanzapine-fluoxetine 3-25 mg
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 25 through July 30, 2026
What is fluoxetine and olanzapine used for?
From the label: indications and usageOlanzapine and fluoxetine capsules are indicated for the treatment of: Acute depressive episodes in Bipolar I Disorder [see Clinical Studies ( 14.1 )]. Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies ( 14.2 )]. Olanzapine and fluoxetine capsules combine olanzapine, an atypical antipsychotic and fluoxetine, a selective serotonin reuptake inhibitor, indicated for treatment of: Acute Depressive Episodes Associated with Bipolar I Disorder ( 1 ) Treatment Resistant Depression
Conditions named in the indications of fluoxetine and olanzapine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Atypical Antipsychotic and Serotonin Reuptake Inhibitor.
Source: FDA drug label (Olanzapine and Fluoxetine), Teva Pharmaceuticals USA, Inc., effective March 31, 2026 (SPL set 3c28cf18-01a3-468a-ab3e-8aa82f918251), via openFDA; the full label on DailyMed
What does the patient leaflet for fluoxetine and olanzapine 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 olanzapine and fluoxetine capsules?Olanzapine and fluoxetine capsules may cause serious side effects, including: 1. Suicidal thoughts or actions. 2. Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). 3. High blood sugar (hyperglycemia). 4. High fat levels in your blood (increased cholesterol and triglycerides), especially in children and adolescents age 10 to 17. 5. Weight gain, especially in children and adolescents age 10 to 17. These serious side effects are described below. 1. Suicidal thoughts or actions. Antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions: Talk to your, or your family member ’ s, healthcare provider about: all risks and benefits of treatment with antidepressant medicines. all treatment choices for depression or other serious mental illness. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. […]
From the patient leaflet: What should I avoid while taking olanzapine and fluoxetine capsules?Olanzapine and fluoxetine capsules can cause sleepiness and 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 olanzapine and fluoxetine capsules affect you. Avoid drinking alcohol while taking olanzapine and fluoxetine capsules. Drinking alcohol while you take olanzapine and fluoxetine capsules may make you sleepier than if you take olanzapine and fluoxetine capsules alone.
From the patient leaflet: How should I store olanzapine and fluoxetine capsules?Store olanzapine and fluoxetine capsules at room temperature, between (20°C to 25°C) 68°F to 77°F. Keep olanzapine and fluoxetine capsules away from light. Keep olanzapine and fluoxetine capsules dry and away from moisture. Keep the bottle closed tightly. Keep olanzapine and fluoxetine capsules and all medicines out of the reach of children.
Source: FDA drug label (Olanzapine and Fluoxetine), Teva Pharmaceuticals USA, Inc., effective March 31, 2026 (SPL set 3c28cf18-01a3-468a-ab3e-8aa82f918251), via openFDA; the full label on DailyMed
Is there a generic for fluoxetine and olanzapine (Symbyax)?
The FDA approved the first generic fluoxetine and olanzapine on June 19, 2012. 4 generic applications are approved; 4 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 and olanzapine from 3 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2003 earliest approval on file
- 2012 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for fluoxetine and olanzapine (Symbyax)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $3.44 per unit (Olanzapine-fluoxetine 3-25 mg), down 12% from $3.89 on October 8, 2025. 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.
- Olanzapine-fluoxetine 3-25 mg (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Olanzapine-fluoxetine 12-25 mg | Generic | $9.93 per unit | n/a | +50% |
| Olanzapine-fluoxetine 12-50 mg | Generic | $6.53 per unit | n/a | -17% |
| Olanzapine-fluoxetine 3-25 mg | Generic | $3.44 per unit | n/a | -12% |
| Olanzapine-fluoxetine 6-25 mg | Generic | $4.06 per unit | n/a | -18% |
| Olanzapine-fluoxetine 6-50 mg | Generic | $4.43 per unit | n/a | -17% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the fluoxetine and olanzapine label say about other medicines?
The fluoxetine and olanzapine label names 40 other medicines in its interaction, contraindication or warning sections. 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 | Coadministration of alprazolam and fluoxetine has resulted in increased alprazolam plasma concentrations and in further psychomotor performance decrement due to increased alprazolam levels. |
| 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 | May increase olanzapine levels; a lower dose of the olanzapine component of olanzapine and fluoxetine capsules should be considered ( 7.6 ) Drugs that Interfere with Hemostasis: (e.g., NSAIDs, Aspirin, Warfarin, etc.): |
| 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 olanzapine and fluoxetine capsules increases the risk of serotonin syndrome. |
| Carbamazepine | drug interactions | Elevated haloperidol levels have been observed ( 7.7 ) Carbamazepine: Potential for elevated carbamazepine levels and clinical anticonvulsant toxicity ( 7.7 ) Phenytoin: |
| 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 | May potentiate orthostatic hypotension and sedation ( 7.6 , 7.7 ) Clozapine: May elevate clozapine levels ( 7.7 ) Haloperidol: |
| Desipramine | drug interactions | In 2 fluoxetine studies, previously stable plasma levels of imipramine and desipramine have increased >2- to 10-fold when fluoxetine has been administered in combination. |
| Diazepam | drug interactions | Drugs to Affect Olanzapine and Fluoxetine Capsules Benzodiazepines – Co-administration of diazepam with olanzapine potentiated the orthostatic hypotension observed with olanzapine [see Drug Interactions ( 7.7 )]. |
| 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); |
| 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. |
| Fluvoxamine | drug interactions | May potentiate sedation and orthostatic hypotension ( 7.7 ) Serotonergic Drugs: ( 2.4 , 2.5 , 4.1 , 5.6 , 7.3 ) Fluvoxamine: |
| 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 and olanzapine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Haloperidol | drug interactions | May potentiate orthostatic hypotension and sedation ( 7.6 , 7.7 ) Clozapine: May elevate clozapine levels ( 7.7 ) Haloperidol: |
| 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 | In 2 fluoxetine studies, previously stable plasma levels of imipramine and desipramine have increased >2- to 10-fold when fluoxetine has been administered in combination. |
| Ketoconazole | drug interactions | In addition, in vitro studies have shown ketoconazole, a potent inhibitor of CYP3A activity, to be at least 100 times more potent than fluoxetine or norfluoxetine as an inhibitor of the metabolism of … |
| Levodopa | drug interactions | Enhanced antihypertensive effect ( 7.7 ) Levodopa and Dopamine Agonists: May antagonize levodopa/dopamine agonists ( 7.7 ) Benzodiazepines: |
| Linezolid | contraindications | Starting olanzapine and fluoxetine capsules 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 … |
| 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). |
| 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 olanzapine and fluoxetine capsules 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 … |
| 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); |
| Omeprazole | drug interactions | Agents that induce CYP1A2 or glucuronyl transferase enzymes, such as omeprazole and rifampin, may cause an increase in olanzapine clearance. |
| Phenytoin | drug interactions | Elevated haloperidol levels have been observed ( 7.7 ) Carbamazepine: Potential for elevated carbamazepine levels and clinical anticonvulsant toxicity ( 7.7 ) Phenytoin: |
| Pimozide | contraindications | Other Contraindications Pimozide [see Warnings and Precautions ( 5.20 ) and Drug Interactions ( 7.7 , 7.8 )] Thioridazine [see Warnings and Precautions ( 5.20 ) and Drug Interactions ( 7.7 , 7.8 )] … |
| 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); |
| Rifampin | drug interactions | Agents that induce CYP1A2 or glucuronyl transferase enzymes, such as omeprazole and rifampin, may cause an increase in olanzapine clearance. |
| 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). |
| Theophylline | drug interactions | Theophylline – Multiple doses of olanzapine did not affect the pharmacokinetics of theophylline or its metabolites. |
| Thioridazine | contraindications | Risk of QT interval prolongation ( 4.2 , 5.20 , 7.7 , 7.8 ) Thioridazine: Risk of QT interval prolongation. |
| Vinblastine | drug interactions | Drugs with a narrow therapeutic index represent the greatest concern (including but not limited to, flecainide, propafenone, vinblastine, and TCAs). |
| Warfarin | drug interactions | … 7.6 ) Drugs that Interfere with Hemostasis: (e.g., NSAIDs, Aspirin, Warfarin, etc.): |
| Ziprasidone | drug interactions | These include: specific antipsychotics (e.g., ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol); specific antibiotics (e.g., erythromycin, gatifloxacin, moxifloxacin, sparfloxacin); |
Source: FDA drug label (Olanzapine and Fluoxetine), Teva Pharmaceuticals USA, Inc., effective March 31, 2026 (SPL set 3c28cf18-01a3-468a-ab3e-8aa82f918251), via openFDA; the full label on DailyMed
What do FAERS reports show for fluoxetine and olanzapine?
The FDA Adverse Event Reporting System holds 25 reports that list fluoxetine and olanzapine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 9 are coded as a death and 5 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.
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 and olanzapine?
36 other medicines are given the same way (oral) and in the same FDA class as fluoxetine and olanzapine 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 |
|---|---|---|---|---|
| Quetiapine | Depression, Bipolar disorder | 50 labelers | $0.127 per tablet 300 mg tablet | No current entry |
| Aripiprazole | Depression, Bipolar disorder | 47 labelers | $0.110 per tablet 5 mg tablet | No current entry |
| Sertraline | Depression | 48 labelers | $0.0507 per tablet 100 mg tablet | No current entry |
| Risperidone | Bipolar disorder | 35 labelers | $0.0368 per tablet 0.25 mg tablet | No current entry |
| Paroxetine | Depression | 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 | 44 labelers | $0.0632 per tablet 20 mg tablet | No current entry |
| Lurasidone | Depression, Bipolar disorder | 29 labelers | $0.142 per tablet 20 mg tablet | No current entry |
Every medicine labeled for the same conditions as fluoxetine and olanzapine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to fluoxetine and olanzapine
- 36 medicines for the same use
- Other atypical antipsychotics
- the pharmacologic class, with prices and generics
- Fluoxetine and olanzapine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other