Fluoxetine
Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) antidepressant used for major depressive disorder, obsessive compulsive disorder, bulimia nervosa and panic disorder, depending on the product.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 188 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Fluoxetine (Prozac) is an SSRI antidepressant that keeps nerve cells from reabsorbing serotonin, a brain chemical tied to mood, and treats depression, OCD, bulimia nervosa and panic disorder; one of the first SSRIs, on the market since about 1987 and available as a generic, it remains a common first choice. Most people tolerate it well, though nausea, headache, trouble sleeping and jitteriness are common early on. It carries a boxed warning for suicidal thoughts and behavior in children, teens and young adults up to 24, so watch closely for worsening mood in the first months and after any dose change. Do not stop it suddenly.
Clinical pearls
- Take it in the morning, with or without food, since it tends to be energizing and can interfere with sleep.
- Never combine it with MAOI antidepressants, pimozide or thioridazine, and allow five weeks after stopping fluoxetine before starting an MAOI.
- Tramadol, triptans for migraine, other antidepressants and St. John's Wort raise serotonin syndrome risk, so check with your pharmacist first.
- On warfarin, expect extra blood clotting checks when fluoxetine starts or stops, and report unusual bruising or black stools.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Antidepressants, including fluoxetine, can increase suicidal thoughts and behavior in children, teens and young adults (up to age 24). This was seen in short-term studies. Adults over 24 did not have a higher risk, and risk was lower in adults 65 and older.
Anyone starting an antidepressant should be watched closely for worsening mood or new suicidal thoughts, especially in the first few months and after dose changes. Families and caregivers should watch for agitation, irritability and unusual behavior changes and tell the prescriber right away. Fluoxetine is not approved for children under 7. When used with olanzapine, also see the Symbyax boxed warning.
Patient information guide A plain-language walkthrough of Fluoxetine, written from its FDA label.
What Fluoxetine is used for
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Fluoxetine is used for several conditions, depending on the product.
- Major depressive disorder (adults and children 8 to 18 for most products)
- Obsessive compulsive disorder (adults and children 7 to 17 for most products)
- Bulimia nervosa (binge-eating and vomiting behaviors) in adults
- Panic disorder, with or without agoraphobia, in adults
- Fluoxetine delayed-release capsules: labeled for major depressive disorder
- Prozac and fluoxetine capsules, with olanzapine: depressive episodes with Bipolar I Disorder and treatment resistant depression (fluoxetine alone is not approved for these)
How Fluoxetine works
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Fluoxetine is an SSRI. It blocks the reuptake (recycling) of serotonin by nerve cells in the brain. This is believed to be linked to its effects, though the exact mechanism is unknown.
Fluoxetine dosage
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Fluoxetine is taken by mouth as capsules, delayed-release capsules, tablets or oral solution. It is usually taken once daily in the morning, and higher doses may be split into morning and noon. It can be taken with or without food.
Doses are adjusted over several weeks. Follow your prescriber and your product label, and ask your pharmacist what to do if you miss a dose.
Dosing details from the FDA-approved label
From the Fluoxetine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Major Depressive Disorder - Adult
- Initiate fluoxetine 20 mg/day orally in the morning
- Consider a dose increase after several weeks if insufficient clinical improvement is observed
- Administer doses above 20 mg/day once daily in the morning or twice daily (i.e., morning and noon)
- Maximum: 80 mg/day
- Use a lower or less frequent dosage in patients with hepatic impairment, the elderly, and those with concurrent disease or on multiple concomitant medications
- Major Depressive Disorder - Pediatric (children and adolescents)
- Initiate 10 mg/day or 20 mg/day
- After 1 week at 10 mg/day, increase the dose to 20 mg/day
- Consider a dose increase to 20 mg/day after several weeks if insufficient clinical improvement is observed
- Due to higher plasma levels in lower weight children, the starting and target dose may be 10 mg/day
- Obsessive Compulsive Disorder - Adult
- Initiate 20 mg/day orally in the morning
- Consider a dose increase after several weeks if insufficient clinical improvement is observed
- A dose range of 20 mg/day to 60 mg/day is recommended
- Doses above 20 mg/day may be given once daily in the morning or twice daily (morning and noon)
- Maximum: 80 mg/day
- Full therapeutic effect may be delayed until 5 weeks of treatment or longer
- Obsessive Compulsive Disorder - Pediatric, adolescents and higher weight children
- Initiate 10 mg/day
- After 2 weeks, increase the dose to 20 mg/day
- Consider additional dose increases after several more weeks if insufficient clinical improvement is observed
- A dose range of 20 mg/day to 60 mg/day is recommended
- No experience with doses greater than 60 mg
- Obsessive Compulsive Disorder - Pediatric, lower weight children
- Initiate 10 mg/day
- Consider additional dose increases after several more weeks if insufficient clinical improvement is observed
- A dose range of 20 mg/day to 30 mg/day is recommended
- Experience with daily doses greater than 20 mg is very minimal
- Bulimia Nervosa
- Administer fluoxetine 60 mg/day in the morning
- For some patients it may be advisable to titrate up to this target dose over several days
- Doses above 60 mg/day have not been systematically studied
- Panic Disorder
- Initiate treatment with 10 mg/day
- After one week, increase the dose to 20 mg/day
- Consider a dose increase after several weeks if no clinical improvement is observed
- Maximum: 60 mg/day (maximum dose studied)
- Depressive Episodes Associated with Bipolar I Disorder (with olanzapine) - Adult
- Administer fluoxetine in combination with oral olanzapine once daily in the evening, without regard to meals, generally beginning with 5 mg of oral olanzapine and 20 mg of fluoxetine
- Adjust within fluoxetine 20 mg to 50 mg and oral olanzapine 5 mg to 12.5 mg
- Safety of doses above 18 mg olanzapine with 75 mg fluoxetine has not been evaluated
- Depressive Episodes Associated with Bipolar I Disorder (with olanzapine) - Children and adolescents (10-17 years)
- Administer olanzapine and fluoxetine once daily in the evening, generally beginning with 2.5 mg of olanzapine and 20 mg of fluoxetine
- Adjust according to efficacy and tolerability
- Safety of doses above 12 mg olanzapine with 50 mg fluoxetine has not been evaluated in pediatric studies
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION This product is only available in a 60 mg dosage form. A 30 mg dose may be achieved with one-half of the scored tablet. Use of this product requires initial titration with another fluoxetine product according to the dosing guidelines indicated below. Use another fluoxetine product for initial doses of 10 to 20 mg/day or for doses other than 30 mg or 60 mg: Indication Adult Pediatric MDD (2.1) 20 mg/day in morning (initial dose) 20 mg/day (target dose) 80 mg/day (maximum dose studied) 10 to 20 mg/day (initial dose)* *This product has not been studied in doses greater than 20 mg/day in pediatric MDD. OCD (2.2) 20 mg/day in morning (initial dose) 20 to 60 mg/day (target dose) 10 mg/day (initial dose) 10 to 60 mg/day (target dose) Bulimia Nervosa (2.3) 60 mg/day in morning – Panic Disorder (2.4) 10 mg/day (initial dose) 20 mg/day (target dose) 60 mg/day (maximum dose studied) – No additional benefits seen at higher doses above 20 mg/day in MDD (2.1, 14.1) Use a lower or less frequent dosage in patients with hepatic impairment, the elderly, and for patients with concurrent disease or on multiple concomitant medications (2.5, 8.6) 2.1 Major Depressive Disorder Initial Treatment Adult —Initiate fluoxetine tablets 20 mg/day orally in the morning. Consider a dose increase after several weeks if insufficient clinical improvement is observed. Administer doses above 20 mg/day once daily in the morning or twice daily (i.e., morning and noon). The maximum fluoxetine tablets dose should not exceed 80 mg/day. In controlled trials used to support the efficacy of fluoxetine tablets, patients were administered morning doses ranging from 20 to 80 mg/day. Studies comparing fluoxetine tablets 20, 40, and 60 mg/day to placebo indicate that 20 mg/day is sufficient to obtain a satisfactory response in MDD in most cases [see Clinical Studies (14.1)]. Pediatric (children and adolescents) —Treatment should be initiated with a dose of 10 or 20 mg/day. After 1 week at 10 mg/day, the dose should be increased to 20 mg/day. However, due to higher plasma levels in lower weight children, the starting and target dose in this group may be 10 mg/day. A dose increase to 20 mg/day may be considered after several weeks if insufficient clinical improvement is observed.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Fluoxetine side effects
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Common side effects seen in studies include:
Common side effects
- Nausea
- Headache
- Trouble sleeping (insomnia)
- Nervousness or anxiety
- Diarrhea
- Dry mouth
- Sleepiness or weakness
- Decreased appetite, sweating or tremor (shakiness)
- Dry mouth, indigestion, decreased appetite
- Decreased sex drive and other sexual problems
When to get medical help
- Get help right away if you or someone you care for has new or worsening depression, suicidal thoughts, or unusual changes in behavior.
- Call your doctor if you notice agitation, panic attacks, severe restlessness, irritability, hostility or impulsive behavior.
- Seek urgent care for signs of serotonin syndrome: agitation, hallucinations, fast heartbeat, fever, heavy sweating, muscle stiffness or twitching, loss of coordination, seizures, nausea, vomiting or diarrhea.
- Stop the medicine and call your doctor if you develop a rash, hives or other possible allergic signs, such as swelling or trouble breathing.
- Report unusual bleeding or bruising, black stools, or vomiting blood.
- Call your doctor for signs of low sodium (hyponatremia), or for fainting, a racing or irregular heartbeat, or dizziness (possible QT prolongation).
- Report symptoms of mania or hypomania, seizures, or eye pain or vision changes (angle-closure glaucoma).
Fluoxetine warnings and precautions
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- Suicidal thoughts and behavior in children, teens and young adults (boxed warning).
- Serotonin syndrome, a potentially life-threatening reaction.
- Allergic reactions and rash.
- Mania or hypomania, especially in people at risk for bipolar disorder.
- Seizures, bleeding, low sodium and angle-closure glaucoma.
- QT prolongation and heart rhythm problems.
- Weight loss and sexual dysfunction.
- Long half-life: dose changes take weeks to be fully reflected.
Fluoxetine interactions
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Fluoxetine interacts with many medicines.
- MAOIs, linezolid and intravenous methylene blue: serotonin syndrome risk; contraindicated.
- Pimozide and thioridazine: QT risk; contraindicated.
- Other serotonergic drugs (SSRIs, SNRIs, triptans, tramadol, St. John's Wort): higher serotonin syndrome risk.
- NSAIDs, aspirin, warfarin: more bleeding.
- CYP2D6 drugs such as tricyclic antidepressants: higher levels of those drugs.
- Diazepam, alprazolam, haloperidol, clozapine, phenytoin, carbamazepine: levels may rise.
- Lithium: levels may change.
Interactions listed in the FDA-approved label
From the Fluoxetine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Pimozide: Fluoxetine can increase the level of pimozide through inhibition of CYP2D6, and both can prolong the QT interval. Concomitant use is contraindicated.
- Thioridazine: Risk of QT prolongation and elevated thioridazine levels because fluoxetine inhibits CYP2D6. Do not administer with fluoxetine or within a minimum of 5 weeks after fluoxetine has been discontinued.
- Other serotonergic drugs (other SSRIs, SNRIs, triptans, TCAs, opioids, lithium, buspirone, amphetamines, tryptophan, St. John's Wort): Concomitant use increases the risk of serotonin syndrome. Monitor for signs and symptoms of serotonin syndrome, particularly during initiation and dosage increases; if it occurs, consider discontinuing fluoxetine and/or the serotonergic drugs.
- Tricyclic antidepressants (TCAs): Plasma levels of imipramine and desipramine increased greater than 2- to 10-fold with fluoxetine, and this may persist for 3 weeks or longer after fluoxetine is discontinued. The TCA dose may need to be reduced and plasma TCA concentrations monitored temporarily when co-administered or recently discontinued.
- NSAIDs, aspirin, warfarin (drugs that interfere with hemostasis): Concurrent use may potentiate the risk of bleeding; altered anticoagulant effects including increased bleeding have been reported with warfarin. Carefully monitor patients receiving warfarin when fluoxetine is initiated or discontinued.
- Benzodiazepines (diazepam, alprazolam): Diazepam half-life may be prolonged; alprazolam plasma concentrations increase, causing further psychomotor performance decrement.
- Antipsychotics (haloperidol, clozapine): Elevation of blood levels of haloperidol and clozapine has been observed with concomitant fluoxetine.
- Anticonvulsants (phenytoin, carbamazepine): Elevated plasma anticonvulsant concentrations and clinical anticonvulsant toxicity developed after starting fluoxetine.
- Lithium: Both increased and decreased lithium levels have been reported, along with cases of lithium toxicity and increased serotonergic effects. Monitor lithium levels when administered concomitantly.
- Drugs metabolized by CYP2D6: Fluoxetine inhibits CYP2D6, making individuals with normal activity resemble poor metabolizers. Approach with caution; start narrow therapeutic index drugs at the low end of the dose range if the patient is taking fluoxetine or took it in the previous 5 weeks; consider a decreased dose of the original medication.
Read the label’s full interactions text
7 DRUG INTERACTIONS As with all drugs, the potential for interaction by a variety of mechanisms (e.g., pharmacodynamic, pharmacokinetic drug inhibition or enhancement, etc.) is a possibility. Drugs Metabolized by CYP2D6: Fluoxetine is a potent inhibitor of CYP2D6 enzyme pathway (7.6) Tricyclic Antidepressants (TCAs): Monitor TCA levels during co-administration with fluoxetine or when fluoxetine has been recently discontinued (5.2, 7.6) Benzodiazepines: Diazepam—increased t½, alprazolam—further psychomotor performance decrement due to increased levels (7.6) Antipsychotics: Potential for elevation of haloperidol and clozapine levels (7.6) Anticonvulsants: Potential for elevated phenytoin and carbamazepine levels and clinical anticonvulsant toxicity (7.6) Serotonergic Drugs: (2.6, 2.7, 4.1, 5.2) Drugs that Prolong the QT Interval: Do not use fluoxetine with thioridazine or pimozide. Use with caution in combination with other drugs that prolong the QT interval (4.2, 5.11, 7.6, 7.7) 7.1 Monoamine Oxidase Inhibitors (MAOIs) [See Dosage and Administration (2.6, 2.7), Contraindications (4.1), and Warnings and Precautions (5.2)]. 7.2 CNS Acting Drugs Caution is advised if the concomitant administration of fluoxetine and such drugs is required. In evaluating individual cases, consideration should be given to using lower initial doses of the concomitantly administered drugs, using conservative titration schedules, and monitoring of clinical status [see Clinical Pharmacology (12.3)]. 7.3 Other Serotonergic Drugs The concomitant use of serotonergic drugs (including other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. John's Wort) with fluoxetine increases the risk of serotonin syndrome. Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Fluoxetine
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- Tell your prescriber about bipolar disorder, seizures, liver disease, glaucoma or heart rhythm problems.
- Children: approved only for major depressive disorder and OCD; not for children under 7.
- Pregnancy: later use may affect the newborn, including breathing problems and persistent pulmonary hypertension.
- Older adults and people on many medicines may need lower or less frequent dosing.
- Do not take with MAOIs, pimozide or thioridazine.
Fluoxetine overdose
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Overdose can cause seizures (sometimes delayed), altered mental status including coma, serious heart rhythm problems and cardiac arrest, high blood pressure, and serotonin syndrome. Call Poison Control at 1-800-221-2222 or seek emergency care right away. Activated charcoal may be considered if treated early.
What Fluoxetine does in the body
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Fluoxetine blocks serotonin uptake into human platelets and is much more potent at blocking serotonin than norepinephrine uptake in animal studies. It binds much less strongly than older tricyclic antidepressants to receptors linked to sedation and anticholinergic effects.
How your body processes Fluoxetine
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Peak levels occur around 6 to 8 hours after a dose. Food may delay absorption slightly but does not meaningfully change how much is absorbed. Fluoxetine is broken down by the liver into an active metabolite called norfluoxetine and cleared by the kidneys.
It is eliminated slowly. The half-life is 4 to 6 days for fluoxetine with ongoing use, and 4 to 16 days for norfluoxetine. The drug can stay in the body for weeks after stopping.
How to store Fluoxetine
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Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Fluoxetine
163 supplements and herbal products have documented interactions with Fluoxetine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 8
- Moderate · 127
- Minor · 28
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Fluoxetine has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Fluoxetine: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Fluoxetine — the kind of thing our pharmacy team would talk through with you at the counter.
What is fluoxetine for?
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How should I take it?
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What side effects should I expect?
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When should I call my doctor right away?
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What medicines should I avoid with it?
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Is it safe in pregnancy?
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Is Fluoxetine available over the counter?
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When was Fluoxetine first available?
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Who makes Fluoxetine?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Fluoxetine on HelloPharmacist
Fluoxetine forms and strengths (how it comes)
Fluoxetine is available in 4 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Capsule
How this form is used
- Prozac capsules are used for major depressive disorder, OCD, bulimia nervosa and panic disorder.
- Prozac and olanzapine together are used for depressive episodes with Bipolar I Disorder and treatment resistant depression.
- Prozac alone is not approved for bipolar depressive episodes or treatment resistant depression.
- Fluoxetine capsules are taken by mouth, usually once daily in the morning.
- Fluoxetine capsules used with olanzapine are adjusted by the individual components based on response and tolerability.
Tablet
How this form is used
- Fluoxetine tablets are used for major depressive disorder, OCD, bulimia nervosa and panic disorder.
- Fluoxetine tablets are taken by mouth, usually once daily in the morning.
- Some fluoxetine tablet products come only as a scored 60 mg tablet and need initial titration with another fluoxetine product.
Oral solution
How this form is used
- Fluoxetine oral solution is used for major depressive disorder, OCD, bulimia nervosa and panic disorder.
- Fluoxetine oral solution alone is not approved for bipolar depressive episodes or treatment resistant depression.
- Fluoxetine oral solution is taken by mouth, usually once daily in the morning.
Delayed-release capsule
How this form is used
- Fluoxetine delayed-release capsules are labeled for major depressive disorder.
- Fluoxetine delayed-release capsules (weekly capsules) are started 7 days after the last daily fluoxetine dose.
Fluoxetine on the U.S. market: products, makers and brands
How Fluoxetine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
55 companies list 227 Fluoxetine product records with the FDA, mostly as capsule, tablet, oral solution; the earliest marketing or approval year on record is 1987. Brand names on the directory include Prozac, Prozac Weekly, Rapiflux and 3 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (25) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Fluoxetine is used (Medicaid data)
A general measure of how commonly Fluoxetine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Fluoxetine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Fluoxetine prescribed? Of the 1,601 medications we measure, Fluoxetine ranks #25 by Medicaid prescriptions — more than 98% of them.
Utilization by Fluoxetine product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
fluoxetine 20 MG Oral Capsule Most dispensed
Summed across the 29 of 297 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310385
fluoxetine 40 MG Oral Capsule
Summed across the 34 of 201 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313989
fluoxetine 10 MG Oral Capsule
Summed across the 24 of 193 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310384
fluoxetine 20 MG Oral Tablet
Summed across the 14 of 42 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 248642
fluoxetine 10 MG Oral Tablet
Summed across the 16 of 53 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313990
fluoxetine 4 MG/ML Oral Solution
Summed across the 6 of 21 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310386
fluoxetine 60 MG Oral Tablet
Summed across the 9 of 24 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1190110
fluoxetine 90 MG Delayed Release Oral Capsule
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313995
PMDD fluoxetine 10 MG Oral Tablet
Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2532159
PMDD fluoxetine 20 MG Oral Tablet
Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2532163
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Fluoxetine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 137 of 844 listed Fluoxetine NDCs with Medicaid activity.
Compare Fluoxetine products
A representative set of FDA-listed product records for Fluoxetine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 10 mg | Oral | A-S Medication Solutions × 3 listings | ANDA | View NDC → |
| 20 mg | Oral | A-S Medication Solutions × 8 listings | ANDA | View NDC → |
| 40 mg | Oral | A-S Medication Solutions × 8 listings | ANDA | View NDC → |
| 20 mg | Oral | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | View NDC → |
| 10 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 20 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 40 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 10 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 20 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 40 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 40 mg | Oral | American Health Packaging × 2 listings | ANDA | View NDC → |
| 10 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC | ANDA | View NDC → |
| 20 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC × 2 listings | ANDA | View NDC → |
| 10 mg | Oral | Aurobindo Pharma Limited × 2 listings | ANDA | View NDC → |
| 20 mg | Oral | Aurobindo Pharma Limited × 2 listings | ANDA | View NDC → |
| 40 mg | Oral | Aurobindo Pharma Limited × 2 listings | ANDA | View NDC → |
| 10 mg | Oral | BluePoint Laboratories × 2 listings | ANDA | View NDC → |
| 20 mg | Oral | BluePoint Laboratories × 2 listings | ANDA | View NDC → |
| 40 mg | Oral | BluePoint Laboratories × 2 listings | ANDA | View NDC → |
| 10 mg | Oral | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | ANDA | View NDC → |
| 20 mg | Oral | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | ANDA | View NDC → |
| 10 mg | Oral | Bryant Ranch Prepack × 4 listings | ANDA | View NDC → |
| 20 mg | Oral | Bryant Ranch Prepack × 4 listings | ANDA | View NDC → |
| 40 mg | Oral | Bryant Ranch Prepack × 4 listings | ANDA | View NDC → |
| 10 mg | Oral | Cadila Pharmaceuticals Limited | ANDA | View NDC → |
| 20 mg | Oral | Cadila Pharmaceuticals Limited | ANDA | View NDC → |
| 40 mg | Oral | Cadila Pharmaceuticals Limited | ANDA | View NDC → |
| 10 mg | Oral | Calvin Scott & Co., Inc. | ANDA | View NDC → |
| 20 mg | Oral | Calvin Scott & Co., Inc. | ANDA | View NDC → |
| 20 mg | Oral | Cardinal Health 107, LLC | ANDA | View NDC → |
| 10 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 20 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 40 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 40 mg | Oral | CouplerLLC | ANDA | View NDC → |
| 40 mg | Oral | Direct Rx | ANDA | View NDC → |
| 20 mg | Oral | Direct_rx | ANDA | View NDC → |
| 40 mg | Oral | Direct_Rx | ANDA | View NDC → |
| 10 mg | Oral | Dista Products Company | NDA | View NDC → |
| 20 mg | Oral | Dista Products Company | NDA | View NDC → |
| 40 mg | Oral | Dista Products Company | NDA | View NDC → |
| 10 mg | Oral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | View NDC → |
| 20 mg | Oral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | View NDC → |
| 40 mg | Oral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | View NDC → |
| 10 mg | Oral | Legacy Pharmaceutical Packaging, LLC | ANDA | View NDC → |
| 20 mg | Oral | Legacy Pharmaceutical Packaging, LLC | ANDA | View NDC → |
| 10 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 20 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 10 mg | Oral | Marksans Pharma Limited | ANDA | View NDC → |
| 20 mg | Oral | Marksans Pharma Limited | ANDA | View NDC → |
| 40 mg | Oral | Marksans Pharma Limited | ANDA | View NDC → |
| 20 mg | Oral | Medsource Pharmaceuticals | ANDA | View NDC → |
| 10 mg | Oral | Modavar Pharmaceuticals LLC | ANDA | View NDC → |
| 20 mg | Oral | Modavar Pharmaceuticals LLC | ANDA | View NDC → |
| 40 mg | Oral | Modavar Pharmaceuticals LLC | ANDA | View NDC → |
| 10 mg | Oral | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | View NDC → |
| 20 mg | Oral | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | View NDC → |
| 40 mg | Oral | NCS HealthCare of KY, LLC dba Vangard Labs × 2 listings | ANDA | View NDC → |
| 10 mg | Oral | NorthStar Rx LLC × 2 listings | ANDA | View NDC → |
| 20 mg | Oral | NorthStar Rx LLC × 2 listings | ANDA | View NDC → |
| 40 mg | Oral | NorthStar Rx LLC × 2 listings | ANDA | View NDC → |
| 10 mg | Oral | Northwind Health Company, LLC × 3 listings | ANDA | View NDC → |
| 20 mg | Oral | Northwind Health Company, LLC × 3 listings | ANDA | View NDC → |
| 40 mg | Oral | Northwind Health Company, LLC × 2 listings | ANDA | View NDC → |
Showing 105 of 227 products — FDA National Drug Code Directory. See every product, package size and price: browse all 227 Fluoxetine NDCs →
Fluoxetine side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Fluoxetine — a signal of what to watch for, not proof the drug caused it.
The effects most often named in FDA reports that mention Fluoxetine are nausea, fatigue, headache; about 71% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Fluoxetine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Fluoxetine FDA approval history
How Fluoxetine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Fluoxetine was first approved by the FDA in 1987 (Brand: SARAFEM · Eli Lilly And Co); the first generic version was approved in 2001. It remains available in U.S. pharmacies today.
Source: Drugs@FDA.
Fluoxetine recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list one Fluoxetine recall since July 2021, covering 2 product listings. It is no longer listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. ND… Lots: Lot# BDX6K001; Exp. Date: 06/30/2025 FDA record D-0456-2025 →
- Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 1366… Lots: Lot# BDX6K001; Exp. Date 06/30/2025 FDA record D-0455-2025 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 4493 5 dose forms · 15 strengths
-
Dose form (SCDF) Chewable Tablet RxCUI 826097No current FDA listingClinical drug / strength (SCD) hydrochloride 16 MGRxCUI 902714hydrochloride 32 MGRxCUI 902718hydrochloride 64 MGRxCUI 826103hydrochloride 8 MGRxCUI 826098 -
Dose form (SCDF) Delayed Release Oral Capsule RxCUI 378618In current FDA listingsClinical drug / strength (SCD) 90 MGRxCUI 313995 -
Dose form (SCDF) Oral Capsule RxCUI 372231In current FDA listings -
Dose form (SCDF) Oral Solution RxCUI 372232In current FDA listingsClinical drug / strength (SCD) 4 MG/MLRxCUI 310386 -
Dose form (SCDF) Oral Tablet RxCUI 372233In current FDA listingsClinical drug / strength (SCD) PMDD fluoxetine 10 MGRxCUI 2532159PMDD fluoxetine 20 MGRxCUI 253216310 MGRxCUI 31399020 MGRxCUI 24864260 MGRxCUI 1190110
Look up RxCUI 4493 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Fluoxetine supply and shortage status
Whether Fluoxetine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Fluoxetine costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Capsule · Oral | 40 mg | $0.052 per capsule | NDC details & price history |
| Tablet, Film Coated · Oral | 10 mg | $0.070 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 20 mg | $0.084 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 60 mg | $0.182 per tablet | NDC details & price history |
| Tablet, Coated · Oral | 10 mg | $0.070 per tablet | NDC details & price history |
| Tablet, Coated · Oral | 20 mg | $0.084 per tablet | NDC details & price history |
| Tablet · Oral | 60 mg | $0.182 per tablet | NDC details & price history |
| Tablet · Oral | 20 mg | $0.084–$0.143 per tablet | NDC details & price history |
| Tablet · Oral | 10 mg | $0.070–$0.180 per tablet | NDC details & price history |
| Solution · Oral | 20 mg/5 mL | $0.214 per mL | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Fluoxetine brand names
Fluoxetine is sold under 6 brand names in the FDA directory — Prozac, Prozac Weekly, Rapiflux, Sarafem and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Fluoxetine: manufacturers and labelers
55 companies list Fluoxetine products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, A-S Medication Solutions, Aurobindo Pharma Limited. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 31 more on the FDA NDC directory.
Fluoxetine drug class (RxNorm)
Fluoxetine belongs to the Serotonin Reuptake Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Fluoxetine page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Par Pharmaceutical, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →