Prescription medication · Selective Serotonin Reuptake Inhibitor (SSRI)
fluoxetine
Also sold as Prozac, Sarafem. Fluoxetine can treat major depressive disorder in adults and children.
Data updated 2026-05-15
- 64,119
- FDA reportsOften reported
- 68
- InteractionsMany interactions
- 1
- Recall record
What the data shows
fluoxetine (Prozac) is a prescription Selective Serotonin Reuptake Inhibitor (SSRI), more reported than most tracked drugs (64,119 FDA reports), with 68 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
fluoxetine (Prozac) is a prescription Selective Serotonin Reuptake Inhibitor (SSRI). Fluoxetine can treat major depressive disorder in adults and children.
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).
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from fluoxetine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
This is a plain-language summary of fluoxetine's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
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.
This is a plain-language summary of fluoxetine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
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.
This is a plain-language summary of fluoxetine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store fluoxetine at room temperature, away from heat and moisture.
Side Effects (from patient reports)
Based on 64,119 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for fluoxetine, by number of reports
- The medicine is interacting with another medicine
The medicine is interacting with another medicine
3,336 reports
- Harmful effect from different substances
Harmful effect from different substances
3,316 reports
- Feeling sick to your stomach
Feeling sick to your stomach
3,233 reports
- Feeling tired
Feeling tired
3,155 reports
- Death by suicide
Death by suicide
2,904 reports
- Pain in the head
Pain in the head
2,771 reports
- Feeling worried or nervous
Feeling worried or nervous
2,441 reports
- Loose or watery stools
Loose or watery stools
2,373 reports
- Feeling lightheaded
Feeling lightheaded
2,355 reports
- Feeling sad or hopeless
Feeling sad or hopeless
2,314 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for fluoxetine each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where fluoxetine sits
fluoxetine has more FDA adverse-event reports than 78% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is fluoxetine; the line is the median (50th percentile).
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
Reports Mentioning Death
8,833
13.8% of reports — not proof of cause
Hospitalization Reports
22,346
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 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 |
| 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 |
| 16 | FALL | 1,991 |
| 17 | INTENTIONAL OVERDOSE | 1,986 |
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...
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...
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...
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.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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)
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acamprosate
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alprazolam
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amitriptyline
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amphetamine/dextroamphetamine
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aripiprazole
Abilify
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Medication Guides
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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
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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 64,119 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.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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