fluoxetine
Brand names: Prozac, Sarafem
Fluoxetine is a medicine that can help treat depression and other mental health conditions. It belongs to a class of drugs called selective serotonin reuptake inhibitors (SSRIs).
Drug Pricing (NADAC)
Brand Price
$13.66/unit
Generic Price
$28.59/unit
Generic Available
Yes (33 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Fluoxetine can treat major depressive disorder in adults and children.
Common side effects
Abnormal dreams, Problems ejaculating, Loss of appetite
Key warnings
Antidepressants may increase the risk of suicidal thoughts and behaviors in children, teenagers, and young adults.
How It Works
Fluoxetine works by increasing the amount of serotonin in your brain. Serotonin is a chemical that helps regulate mood. By increasing serotonin, fluoxetine can help improve mood and reduce symptoms of depression, OCD, and other conditions.
How to Take It
Take fluoxetine exactly as your doctor tells you. For depression, the usual starting dose for adults is 20 mg each day, usually in the morning. Children may start with 10 to 20 mg per day. Your doctor may change your dose over time. You can take fluoxetine with or without food.
Pregnancy & Breastfeeding
Talk to your doctor if you are pregnant or plan to become pregnant. Fluoxetine should only be used during pregnancy if the benefit outweighs the risk to the baby. Breastfeeding is not recommended while taking fluoxetine.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
Storage
Store fluoxetine at room temperature, away from heat and moisture.
Side Effects (from patient reports)
Based on 29,645 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 64,119 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
64,119
Death-Related Reports
8,833
Hospitalization Reports
22,346
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG INEFFECTIVE | 3,638 |
| 2 | DRUG INTERACTION | 3,335 |
| 3 | TOXICITY TO VARIOUS AGENTS | 3,316 |
| 4 | NAUSEA | 3,233 |
| 5 | FATIGUE | 3,156 |
| 6 | COMPLETED SUICIDE | 2,904 |
| 7 | HEADACHE | 2,774 |
| 8 | OFF LABEL USE | 2,478 |
| 9 | ANXIETY | 2,444 |
| 10 | DIARRHOEA | 2,374 |
| 11 | DIZZINESS | 2,357 |
| 12 | DEPRESSION | 2,313 |
| 13 | VOMITING | 2,241 |
| 14 | DYSPNOEA | 2,177 |
| 15 | PAIN | 2,042 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Antidepressants may increase the risk of suicidal thoughts and behaviors in children, teenagers, and young adults. Watch closely for worsening depression or suicidal thoughts. Tell your doctor right away if you notice any changes in mood or behavior. Fluoxetine is not approved for use in children younger than 7 years old.
Known Drug Interactions
NSAIDs, Aspirin, Warfarin): May potentiate the risk of bleeding ( 7.4 ) Drugs Tightly Bound to Plasma Proteins: May cause a shift in plasma concentrations ( 7.6 , 7.7 ) Olanzapine: When used in combination with fluoxetine, also refer to the Drug Interactions section of the package insert for Symbyax ( 7.7 ) Drugs that Prolong the QT Interval: Do not use fluoxetine with thioridazine or pimozide. 7.4 Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, Warfarin) Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort...
Mechanism: Both drugs can interfere with how your blood cells clump together to stop bleeding, which increases your risk of bruising or bleeding.
What to do: Your doctor should monitor you closely for any signs of unusual bleeding or bruising while taking these together.
NSAIDs, Aspirin, Warfarin): May potentiate the risk of bleeding ( 7.4 ) Drugs Tightly Bound to Plasma Proteins: May cause a shift in plasma concentrations ( 7.6 , 7.7 ) Olanzapine: When used in combination with fluoxetine, also refer to the Drug Interactions section of the package insert for Symbyax ( 7.7 ) Drugs that Prolong the QT Interval: Do not use fluoxetine with thioridazine or pimozide. 7.4 Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, Warfarin) Serotonin release by platelets plays an important role in hemostasis. Altered anticoagulant effects, including increased ble...
Mechanism: Fluoxetine can change how your blood thinner works and affect how your blood clots, making it more likely for you to bleed.
What to do: Your doctor will need to monitor your blood clotting levels very closely and may need to adjust your warfarin dose.
NSAIDs, Aspirin, Warfarin): May potentiate the risk of bleeding ( 7.4 ) Drugs Tightly Bound to Plasma Proteins: May cause a shift in plasma concentrations ( 7.6 , 7.7 ) Olanzapine: When used in combination with fluoxetine, also refer to the Drug Interactions section of the package insert for Symbyax ( 7.7 ) Drugs that Prolong the QT Interval: Do not use fluoxetine with thioridazine or pimozide. Olanzapine — Fluoxetine (60 mg single dose or 60 mg daily dose for 8 days) causes a small (mean 16%) increase in the maximum concentration of olanzapine and a small (mean 16%) decrease in olanzapine ...
Mechanism: Fluoxetine can cause a small change in the amount of olanzapine that stays in your blood. This happens because fluoxetine interferes with how your body breaks down the other medication.
What to do: Your doctor may need to adjust your doses or monitor you more closely when these drugs are used together.
NSAIDs, Aspirin, Warfarin): May potentiate the risk of bleeding ( 7.4 ) Drugs Tightly Bound to Plasma Proteins: May cause a shift in plasma concentrations ( 7.6 , 7.7 ) Olanzapine: When used in combination with fluoxetine, also refer to the Drug Interactions section of the package insert for Symbyax ( 7.7 ) Drugs that Prolong the QT Interval: Do not use fluoxetine with thioridazine or pimozide. 7.7 Potential for Fluoxetine to affect Other Drugs Pimozide — Concomitant use in patients taking pimozide is contraindicated. Pimozide can prolong the QT interval.
Mechanism: Taking these two drugs together can cause dangerous changes to the electrical rhythm of your heart. This is known as QT prolongation and can be very serious.
What to do: Do not take these two medications together because the risk to your heart is too high.
NSAIDs, Aspirin, Warfarin): May potentiate the risk of bleeding ( 7.4 ) Drugs Tightly Bound to Plasma Proteins: May cause a shift in plasma concentrations ( 7.6 , 7.7 ) Olanzapine: When used in combination with fluoxetine, also refer to the Drug Interactions section of the package insert for Symbyax ( 7.7 ) Drugs that Prolong the QT Interval: Do not use fluoxetine with thioridazine or pimozide. Thioridazine — Thioridazine should not be administered with fluoxetine or within a minimum of 5 weeks after fluoxetine has been discontinued, because of the risk of QT Prolongation [see Contraindicat...
Mechanism: These drugs can cause serious heart rhythm problems when used at the same time. Because fluoxetine stays in your system for a long time, the danger remains even after you stop taking it.
What to do: Do not take these drugs together, and wait at least five weeks after stopping fluoxetine before starting thioridazine.
Common Questions
Can I stop taking fluoxetine suddenly?
How long does it take for fluoxetine to work?
Can I drink alcohol while taking fluoxetine?
Does fluoxetine cause weight gain?
Can fluoxetine affect my sleep?
Can I take other medicines with fluoxetine?
What should I do if I have side effects?
Can fluoxetine cause anxiety?
Is it safe to drive while taking fluoxetine?
What if fluoxetine doesn't seem to be working?
What are the common side effects of fluoxetine?
Does fluoxetine interact with other medications?
What drug class is fluoxetine?
Is fluoxetine safe during pregnancy?
Has fluoxetine been recalled?
Active Recalls
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Torrent Pharma Inc.
Related Medications in Selective Serotonin Reuptake Inhibitor (SSRI)
Other drugs grouped near fluoxetine — same-class peers and common alternatives.
acamprosate
Campral
Acamprosate is a medicine that can help you stay away from alcohol if you are alcohol-dependent and have already stopped drinking.
Compare with fluoxetine →
alprazolam
Xanax
Alprazolam (Xanax) is a medication that can help you with anxiety and panic disorders.
Compare with fluoxetine →
amitriptyline
Elavil
Amitriptyline is a medicine used to treat depression.
Compare with fluoxetine →
amphetamine/dextroamphetamine
Adderall, Adderall XR
Adderall XR is a stimulant medicine.
Compare with fluoxetine →
aripiprazole
Abilify
Aripiprazole (Abilify) is a medicine used to treat certain mental disorders and mood problems.
Compare with fluoxetine →
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Related Health & Safety Data
🩺 Find a Doctor
Search prescribers for Selective Serotonin Reuptake Inhibitor (SSRI)
🏨 Hospital Quality
CMS hospital ratings, safety scores & patient outcomes
💊 Supplement Data
NIH DSLD — check supplement ingredients & label claims
🍽️ Food Safety Alerts
FDA recalls, inspections & outbreak investigations
⚠️ Product Recalls
FDA, CPSC & NHTSA recall search
💉 Procedure Costs
Medicare procedure pricing for 9,297 procedures
Save on fluoxetine
Compare prices and find discounts at pharmacies near you. Free coupons can save up to 80% on prescriptions.
Disclosure: This link may earn us a commission at no extra cost to you. See our terms.
What the FDA Data Shows for fluoxetine
The FDA label for fluoxetine (sold under brand names such as Prozac, Sarafem) classifies it as a prescription-only medication in the Selective Serotonin Reuptake Inhibitor (SSRI) class. Fluoxetine can treat major depressive disorder in adults and children. Official labeling lists 22 commonly reported side effects, including Abnormal dreams, Problems ejaculating, Loss of appetite.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 29,645 voluntary reports. The database also lists 68 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $28.59 versus $13.66 for the brand.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: February 1, 2019
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages