Fluoxetine
Generic name: fluoxetine hydrochloride · Brand names: Prozac, Prozac Weekly, Rapiflux, Sarafem, Selfemra
Quick facts
Drug class
Value
selective serotonin reuptake inhibitor (SSRI)
Source
DailyMed label, Highlights: 'Fluoxetine capsules are a selective serotonin reuptake inhibitor indicated for:'; openFDA pharm_class_epc: Serotonin Reuptake Inhibitor [EPC]
Source url
https://api.fda.gov/drug/label.json?search=openfda.generic_name:fluoxetine&count=openfda.pharm_class_epc.exact
Rx or otc
Value
Rx only
Source
DailyMed label: 'Rx only'
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Forms and strengths
Text
Capsules: 10 mg, 20 mg, and 40 mg
Section
DOSAGE FORMS AND STRENGTHS
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Generic available
Value
Yes. Chosen label is an ANDA (ANDA204597) generic capsule label. MedlinePlus lists Prozac as a brand name.
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Common use one line
Treats depression, OCD, bulimia nervosa and panic disorder.
Scope note
Capsules are the primary form covered. Tablets, delayed-release capsules (weekly) and oral solution have separate labels and are NOT covered. Fluoxetine plus olanzapine combination content is referenced by the label to Symbyax and is not covered here.
What it is used for
Fluoxetine treats major depressive disorder, obsessive compulsive disorder (OCD), moderate to severe bulimia nervosa, and panic disorder. Taken together with olanzapine it treats depressive episodes in Bipolar I Disorder and treatment resistant depression. Fluoxetine alone is not indicated for those two uses.
Section
1 INDICATIONS AND USAGE
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
Fluoxetine is indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder. Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa. Acute treatment of Panic Disorder, with or without agoraphobia. Fluoxetine and Olanzapine in Combination is indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder. Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.
How it works
The exact way fluoxetine works is unknown. It is presumed to be linked to blocking the uptake of serotonin by nerve cells in the brain.
Section
12.1 Mechanism of Action
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
Although the exact mechanism of fluoxetine is unknown, it is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin.
Dosage: adults
For adult depression the label says to start at 20 mg/day in the morning, with a maximum of 80 mg/day. For OCD, start at 20 mg/day; 20 mg/day to 60 mg/day is recommended and the maximum is 80 mg/day. For bulimia nervosa the dose is 60 mg/day in the morning. For panic disorder, start at 10 mg/day and increase to 20 mg/day after one week. Full effect in depression may take 4 weeks or longer. Doses are set by the prescriber.
Section
2 DOSAGE AND ADMINISTRATION (2.1 MDD, 2.2 OCD, 2.3 Bulimia Nervosa, 2.4 Panic Disorder; Adult)
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
MDD 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). The maximum fluoxetine dose should not exceed 80 mg/day. OCD Adult: Initiate fluoxetine 20 mg/day, orally in the morning. A dose range of 20 mg/day to 60 mg/day is recommended; however, doses of up to 80 mg/day have been well tolerated in open studies of OCD. The maximum fluoxetine dose should not exceed 80 mg/day. 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. Panic Disorder: Initiate treatment with fluoxetine 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. All patients (MDD): As with other drugs effective in the treatment of Major Depressive Disorder, the full effect may be delayed until 4 weeks of treatment or longer.
Dosage: children
For children and teens with depression, start at 10 mg/day or 20 mg/day; lower-weight children may start and stay at 10 mg/day. For OCD, start at 10 mg/day and, in teens and higher-weight children, raise to 20 mg/day after 2 weeks. Safety and effectiveness are not established under age 8 for depression or under age 7 for OCD.
Section
2.1 Major Depressive Disorder; 2.2 Obsessive Compulsive Disorder; 8.4 Pediatric Use
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
MDD Pediatric (children and adolescents): Initiate Fluoxetine 10 mg/day or 20 mg/day. After 1 week at 10 mg/day, increase the dose 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. OCD Pediatric: In adolescents and higher weight children, initiate treatment with a dose of 10 mg/day. After 2 weeks, increase the dose to 20mg/day. A dose range of 20 mg/day to 60 mg/day is recommended. In lower weight children, initiate treatment with a dose of 10 mg/day. A dose range of 20 mg/day to 30 mg/day is recommended. The safety and effectiveness in pediatric patients < 8 years of age in Major Depressive Disorder and < 7 years of age in OCD have not been established.
Dosage adjustments
Drug interaction caps
Patients on many medicines may need dose changes. Drugs mainly broken down by CYP2D6 with a narrow therapeutic index should be started at the low end of the dose range if the patient takes fluoxetine or took it in the previous 5 weeks.
Section
2.7 Dosing in Specific Populations; 7.7
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
Concomitant Illness — Patients with concurrent disease or on multiple concomitant medications may require dosage adjustments. Therapy with medications that are predominantly metabolized by the CYP2D6 system and that have a relatively narrow therapeutic index (see list below) should be initiated at the low end of the dose range if a patient is receiving fluoxetine concurrently or has taken it in the previous 5 weeks.
Kidney
The label says a lower or less frequent dose is not routinely necessary in patients with kidney impairment.
Section
12.4 Specific Populations (Renal Disease)
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
use of a lower or less frequent dose is not routinely necessary in renally impaired patients.
Liver
Use a lower or less frequent dose in patients with liver impairment or cirrhosis.
Section
2.7 Dosing in Specific Populations; 8.6 Hepatic Impairment
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
Hepatic Impairment — As with many other medications, use a lower or less frequent dosage in patients with hepatic impairment. A lower or less frequent dose of fluoxetine should be used in patients with cirrhosis.
Elderly
Consider a lower or less frequent dose for older adults.
Section
2.7 Dosing in Specific Populations
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
Geriatric — Consider a lower or less frequent dosage for the elderly
Missed dose
Take a missed dose when you remember. If it is almost time for the next dose, skip it. Do not take two doses at the same time.
Section
Medication Guide: How should I take fluoxetine capsules?
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Medlineplus
Same advice as the Medication Guide.
Section
What should I do if I forget a dose?
Source
MedlinePlus Fluoxetine (Last Revised - 11/15/2025)
Source url
https://medlineplus.gov/druginfo/meds/a689006.html
Source text (exact source wording)
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Source text (exact source wording)
If you miss a dose of fluoxetine capsules, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of fluoxetine capsules at the same time.
Overdose
Overdose has caused seizures, altered mental status including coma, heart rhythm problems and cardiac arrest, and serotonin syndrome. Get emergency help. Poison control: 1-800-222-1222 (MedlinePlus).
Section
10 OVERDOSAGE
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Poison control
Source
MedlinePlus Fluoxetine (Last Revised - 11/15/2025)
Source url
https://medlineplus.gov/druginfo/meds/a689006.html
Source text (exact source wording)
In case of overdose, call the poison control helpline at 1-800-222-1222.
Source text (exact source wording)
The following have been reported with fluoxetine overdosage: Seizures, which may be delayed, and altered mental status including coma. Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation, wide complex tachyarrhythmias, torsade de pointes, and cardiac arrest. Hypertension most commonly seen, but rarely can see hypotension alone or with co-ingestants including alcohol. Serotonin syndrome (patients with a multiple drug overdosage with other pro-serotonergic drugs may have a higher risk). Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a fluoxetine overdose.
Storage
Store at 20° to 25°C (68° to 77°F); brief trips to 15° to 30°C (59° to 86°F) are allowed. The Medication Guide also says to keep the capsules away from light and the bottle closed tightly. This is the labeler's text.
Section
16.2 Storage and Handling (ScieGen label)
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Boxed warning
Antidepressants raised the risk of suicidal thoughts and behavior in children, teens and young adults in short-term studies. The studies did not show this increase in people over age 24, and risk went down in people aged 65 and older. Everyone starting an antidepressant should be watched closely for worsening and new suicidal thoughts, and families and caregivers should help watch. Fluoxetine is not approved for children less than 7 years of age.
Present
YES
Section
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
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)] . Fluoxetine 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 fluoxetine and olanzapine in combination, also refer to Boxed Warning section of the package insert for Symbyax.
Contraindications
Do not use fluoxetine with MAOIs meant for psychiatric conditions, within 5 weeks of stopping fluoxetine, or within 14 days of stopping an MAOI. Do not start fluoxetine in someone being treated with linezolid or intravenous methylene blue. The reason is a higher risk of serotonin syndrome.
Section
4.1 Monoamine Oxidase Inhibitors (MAOIs)
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
The use of MAOIs intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine is contraindicated because of an increased risk of serotonin syndrome. The use of fluoxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated. Starting fluoxetine 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.
Do not use fluoxetine with pimozide or thioridazine. Both affect the QT interval, and fluoxetine can raise their levels and can also prolong the QT interval.
Section
4.2 Other Contraindications
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
The use of fluoxetine is contraindicated with the following: Pimozide, Thioridazine. Pimozide and thioridazine prolong the QT interval. Fluoxetine can increase the levels of pimozide and thioridazine through inhibition of CYP2D6. Fluoxetine can also prolong the QT interval.
Warnings and precautions
Patients on antidepressants should be watched closely for worsening and unusual behavior changes, especially in the first few months and when doses change. Prescriptions should be for the smallest quantity consistent with good care.
Heading
Suicidal thoughts and behaviors in children, adolescents and young adults
Section
5.1
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. Prescriptions for fluoxetine should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose.
Fluoxetine can cause serotonin syndrome, which can be life-threatening. Signs include agitation, hallucinations, fast heartbeat, sweating, tremor, muscle rigidity, seizures, nausea, vomiting and diarrhea. If they occur, fluoxetine and other serotonergic drugs are stopped right away.
Heading
Serotonin syndrome
Section
5.2
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
Selective serotonin reuptake inhibitors (SSRIs), including Fluoxetine, can precipitate serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome signs and symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Discontinue treatment with fluoxetine and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment.
In US trials, 7% of 10,782 patients developed rashes or hives. Severe allergic reactions have been reported. If rash or other allergic signs appear with no other explanation, fluoxetine should be stopped.
Heading
Allergic reactions and rash
Section
5.3
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
In US fluoxetine clinical trials, 7% of 10,782 patients developed various types of rashes and/or urticaria. Anaphylactoid reactions, including bronchospasm, angioedema, laryngospasm, and urticaria alone and in combination, have been reported. Upon the appearance of rash or of other possibly allergic phenomena for which an alternative etiology cannot be identified, fluoxetine should be discontinued.
Before starting an antidepressant, patients are screened for risk of bipolar disorder, including family history. Fluoxetine alone is not indicated for depressive episodes in Bipolar I Disorder.
Heading
Screening for bipolar disorder; mania/hypomania
Section
5.4
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
A major depressive episode may be the initial presentation of Bipolar Disorder. prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for Bipolar Disorder; such screening should include a detailed psychiatric history, including a family history of suicide, Bipolar Disorder, and depression. Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.
Use with care in patients with a history of seizures.
Heading
Seizures
Section
5.5
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
Fluoxetine should be introduced with care in patients with a history of seizures.
Significant weight loss can occur, especially in underweight patients. In depression trials, 11% of fluoxetine patients and 2% of placebo patients reported decreased appetite.
Heading
Altered appetite and weight
Section
5.6
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
Significant weight loss, especially in underweight depressed or bulimic patients, may be an undesirable result of treatment with fluoxetine. In US placebo-controlled clinical trials for Major Depressive Disorder, 11% of patients treated with fluoxetine and 2% of patients treated with placebo reported anorexia (decreased appetite).
Fluoxetine may raise the risk of bleeding, from bruising and nosebleeds to life-threatening bleeding. Aspirin, NSAIDs, warfarin and other blood thinners may add to the risk.
Heading
Increased risk of bleeding
Section
5.7
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
SNRIs and SSRIs, including fluoxetine, may increase the risk of bleeding reactions. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, warfarin, and other anti-coagulants may add to this risk. Bleeding reactions related to SNRIs and SSRIs use have ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages.
Pupil widening from fluoxetine may trigger an angle-closure glaucoma attack in people with anatomically narrow eye angles.
Heading
Angle-closure glaucoma
Section
5.8
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
The pupillary dilation that occurs following use of many antidepressant drugs including fluoxetine may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
Low blood sodium has been reported; older adults and people on diuretics may be at greater risk. Signs include headache, trouble concentrating, memory problems, confusion, weakness and unsteadiness.
Heading
Hyponatremia
Section
5.9
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
Hyponatremia has been reported during treatment with SNRIs and SSRIs, including fluoxetine. Elderly patients may be at greater risk of developing hyponatremia with SNRIs and SSRIs. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls.
In depression trials, 12% to 16% of fluoxetine patients and 7% to 9% of placebo patients reported anxiety, nervousness or insomnia.
Heading
Anxiety and insomnia
Section
5.10
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
In US placebo-controlled clinical trials for Major Depressive Disorder, 12% to 16% of patients treated with fluoxetine and 7% to 9% of patients treated with placebo reported anxiety, nervousness, or insomnia.
QT prolongation and dangerous heart rhythms have been reported. Use caution with long QT syndrome or other risk factors.
Heading
QT prolongation
Section
5.11
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
Post-marketing cases of QT interval prolongation and ventricular arrhythmia including Torsades de Pointes have been reported in patients treated with fluoxetine. Fluoxetine should be used with caution in patients with congenital long QT syndrome; a previous history of QT prolongation; a family history of long QT syndrome or sudden cardiac death; and other conditions that predispose to QT prolongation and ventricular arrhythmia.
In people with diabetes, fluoxetine may change blood sugar control. Low blood sugar can occur on treatment and high blood sugar after stopping.
Heading
Concomitant illness and glycemic control
Section
5.12
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
Glycemic Control— In patients with diabetes, fluoxetine may alter glycemic control. Hypoglycemia has occurred during therapy with fluoxetine, and hyperglycemia has developed following discontinuation of the drug.
Fluoxetine may impair judgment, thinking or motor skills. Be careful with driving and machinery until you know how it affects you.
Heading
Cognitive and motor impairment
Section
5.13
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
As with any CNS-active drug, fluoxetine has the potential to impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that the drug treatment does not affect them adversely.
Dose changes take several weeks to be fully reflected in the body.
Heading
Long elimination half-life
Section
5.14
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
Because of the long elimination half-lives of the parent drug and its major active metabolite, changes in dose will not be fully reflected in plasma for several weeks, affecting both strategies for titration to final dose and withdrawal from treatment.
Stopping suddenly can cause symptoms such as low mood, irritability, agitation, dizziness, electric-shock sensations, anxiety, confusion, headache, tiredness and trouble sleeping. A gradual dose reduction is recommended whenever possible.
Heading
Discontinuation adverse reactions
Section
5.15
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
there have been spontaneous reports of adverse reactions occurring upon discontinuation of these drugs, particularly when abrupt, including the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, and hypomania. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible.
Fluoxetine may cause sexual problems in men and women, including decreased sex drive, ejaculation problems, erectile dysfunction and delayed or absent orgasm.
Heading
Sexual dysfunction
Section
5.17
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
Use of SSRIs, including fluoxetine, may cause symptoms of sexual dysfunction. In male patients, SSRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, SSRI use may result in decreased libido and delayed or absent orgasm.
Pregnancy and breastfeeding
Pregnancy
Use late in pregnancy has been linked to newborn complications, including breathing and feeding problems and persistent pulmonary hypertension of the newborn (PPHN), and to a slightly higher risk of bleeding after delivery. Studies have not established an increased risk of major birth defects or miscarriage. The label says to consider the risk of untreated depression. A pregnancy registry exists (1-844-405-6185).
Section
8.1 Pregnancy
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage. Available data from published epidemiologic studies and postmarketing reports over several decades have not established an increased risk of major birth defects or miscarriage. Neonates exposed to fluoxetine and other SSRI or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Exposure to SSRIs, particularly later in pregnancy, may have an increased risk for PPHN. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185.
Breastfeeding
Fluoxetine passes into breast milk. Infants have had agitation, irritability, poor feeding and poor weight gain, so exposed infants should be monitored.
Section
8.2 Lactation
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
Data from published literature report the presence of fluoxetine and norfluoxetine in human milk. There are reports of agitation, irritability, poor feeding, and poor weight gain in infants exposed to fluoxetine through breast milk. Infants exposed to fluoxetine should be monitored for agitation, irritability, poor feeding, and poor weight gain.
Medlineplus
Tell your doctor if you are pregnant (especially in the last few months), plan to be, or are breastfeeding.
Section
What special precautions should I follow?
Source
MedlinePlus Fluoxetine (Last Revised - 11/15/2025)
Source url
https://medlineplus.gov/druginfo/meds/a689006.html
Source text (exact source wording)
tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breastfeeding. If you become pregnant while taking fluoxetine, call your doctor.
Side effects
Common
The label's most common reactions (at least 5% and at least twice placebo in at least one of the conditions studied) are abnormal dreams, abnormal ejaculation, anorexia (decreased appetite), anxiety, asthenia (weakness), diarrhea, dry mouth, dyspepsia (indigestion), flu syndrome, impotence, insomnia, decreased libido, nausea, nervousness, pharyngitis (sore throat), rash, sinusitis, somnolence (sleepiness), sweating, tremor, vasodilatation and yawn. In the combined trials nausea was reported by 22% of fluoxetine patients and 9% of placebo patients.
Section
Highlights (ADVERSE REACTIONS) and 6.1 Clinical Trials Experience; Table 3
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Threshold
incidence of at least 5% for fluoxetine and at least twice that for placebo within at least 1 of the indications
Source text (exact source wording)
Most common adverse reactions (≥5% and at least twice that for placebo) associated with: Major Depressive Disorder, Obsessive Compulsive Disorder, Bulimia, and Panic Disorder: abnormal dreams, abnormal ejaculation, anorexia, anxiety, asthenia, diarrhea, dry mouth, dyspepsia, flu syndrome, impotence, insomnia, libido decreased, nausea, nervousness, pharyngitis, rash, sinusitis, somnolence, sweating, tremor, vasodilatation, and yawn. Table 3 (Most Common Treatment-Emergent Adverse Reactions; incidence in MDD / OCD / Bulimia / Panic Disorder placebo-controlled trials; fluoxetine vs placebo, % of patients): Body as a Whole: Asthenia 9 vs 5, 15 vs 11, 21 vs 9, 7 vs 7; Flu syndrome 3 vs 4, 10 vs 7, 8 vs 3, 5 vs 5. Cardiovascular System: Vasodilatation 3 vs 2, 5 vs --, 2 vs 1, 1 vs --. Digestive System: Nausea 21 vs 9, 26 vs 13, 29 vs 11, 12 vs 7; Diarrhea 12 vs 8, 18 vs 13, 8 vs 6, 9 vs 4; Anorexia 11 vs 2, 17 vs 10, 8 vs 4, 4 vs 1; Dry mouth 10 vs 7, 12 vs 3, 9 vs 6, 4 vs 4; Dyspepsia 7 vs 5, 10 vs 4, 10 vs 6, 6 vs 2. Nervous System: Insomnia 16 vs 9, 28 vs 22, 33 vs 13, 10 vs 7; Anxiety 12 vs 7, 14 vs 7, 15 vs 9, 6 vs 2; Nervousness 14 vs 9, 14 vs 15, 11 vs 5, 8 vs 6; Somnolence 13 vs 6, 17 vs 7, 13 vs 5, 5 vs 2; Tremor 10 vs 3, 9 vs 1, 13 vs 1, 3 vs 1; Libido decreased 3 vs --, 11 vs 2, 5 vs 1, 1 vs 2; Abnormal dreams 1 vs 1, 5 vs 2, 5 vs 3, 1 vs 1. Respiratory System: Pharyngitis 3 vs 3, 11 vs 9, 10 vs 5, 3 vs 3; Sinusitis 1 vs 4, 5 vs 2, 6 vs 4, 2 vs 3; Yawn -- vs --, 7 vs --, 11 vs --, 1 vs --. Skin and Appendages: Sweating 8 vs 3, 7 vs --, 8 vs 3, 2 vs 2; Rash 4 vs 3, 6 vs 3, 4 vs 4, 2 vs 2. (Impotence and abnormal ejaculation rows are in the label table with male-only denominators.) Column order: Major Depressive Disorder (fluoxetine N=1,728; placebo N=975), OCD (N=266; N=89), Bulimia (N=450; N=267), Panic Disorder (N=425; N=342).
Less common
Other reactions in the combined trials (not meeting the common threshold) include headache (21% vs 19% placebo), constipation (5% vs 4%), flatulence (3% vs 2%), vomiting (3% vs 2%), dizziness (9% vs 6%), pruritus (3% vs 2%) and abnormal vision (2% vs 1%). The label also lists chills, palpitation, emotional lability, taste perversion and micturition disorder as frequent (at least 1/100 patients).
Section
6.1 Clinical Trials Experience; Table 4 and Other Reactions
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
Table 4 (combined MDD, OCD, Bulimia, Panic Disorder; fluoxetine N=2,869 vs placebo N=1,673; % of patients): Headache 21 vs 19; Asthenia 11 vs 6; Flu syndrome 5 vs 4; Fever 2 vs 1; Vasodilatation 2 vs 1; Nausea 22 vs 9; Diarrhea 11 vs 7; Anorexia 10 vs 3; Dry mouth 9 vs 6; Dyspepsia 8 vs 4; Constipation 5 vs 4; Flatulence 3 vs 2; Vomiting 3 vs 2; Weight loss 2 vs 1; Insomnia 19 vs 10; Nervousness 13 vs 8; Anxiety 12 vs 6; Somnolence 12 vs 5; Dizziness 9 vs 6; Tremor 9 vs 2; Libido decreased 4 vs 1; Thinking abnormal 2 vs 1; Yawn 3 vs --; Sweating 7 vs 3; Rash 4 vs 3; Pruritus 3 vs 2; Abnormal vision 2 vs 1. Other Reactions (label definitions): frequent adverse reactions are those occurring in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1,000 patients; rare reactions are those occurring in fewer than 1/1,000 patients. Frequent: chills; palpitation; QT interval prolongation (QTcF ≥450 msec); emotional lability; taste perversion; micturition disorder.
Serious
Label
Serious reactions in the label include suicidal thoughts and behavior, serotonin syndrome, severe allergic reactions, bleeding, angle-closure glaucoma, seizures, mania, low sodium, and dangerous heart rhythms. Postmarketing reports include serious skin reactions, liver failure, kidney failure and blood disorders.
Section
5 WARNINGS AND PRECAUTIONS; 6.2 Postmarketing Experience
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
Suicidal thoughts and behavior; serotonin syndrome; severe allergic reactions including anaphylactoid reactions; abnormal bleeding; angle-closure glaucoma; seizures; mania/hypomania; hyponatremia; QT interval prolongation and ventricular arrhythmia including Torsades de Pointes. Postmarketing: anosmia, aplastic anemia, atrial fibrillation 1, cataract, cerebrovascular accident 1, cholestatic jaundice, drug reaction with eosinophilia and systemic symptoms (DRESS), eosinophilic pneumonia 1, epidermal necrolysis, erythema multiforme, exfoliative dermatitis, heart arrest 1, hepatic failure/necrosis, kidney failure, pancreatitis 1, pancytopenia, pulmonary embolism, pulmonary hypertension, Stevens-Johnson syndrome, thrombocytopenia 1, ventricular tachycardia (including Torsades de Pointes–type arrhythmias), and violent behaviors 1.
Medlineplus
MedlinePlus says to call your doctor right away for these symptoms.
Section
What side effects can this medication cause?
Source
MedlinePlus Fluoxetine (Last Revised - 11/15/2025)
Source url
https://medlineplus.gov/druginfo/meds/a689006.html
Source text (exact source wording)
Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS section, call your doctor immediately: rash, hives, blisters, itching; difficulty breathing or swallowing; swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs; agitation, fever, sweating, confusion, fast or irregular heartbeat, shivering, severe muscle stiffness or twitching, hallucinations, loss of coordination, nausea, vomiting, or diarrhea; chest pain, shortness of breath, dizziness, fainting; seizures; abnormal bleeding or bruising; coma (loss of consciousness); headache; unsteadiness; problems with thinking, concentration, or memory
Led to discontinuation
The reactions most often linked to stopping the drug in trials were anxiety (1% combined; 2% in OCD and panic disorder), nervousness (1%), insomnia (2% in bulimia) and rash (1% in OCD). In children, mania/hypomania led to stopping in 1.8% of fluoxetine patients and 0% of placebo patients.
Section
6.1 Clinical Trials Experience (Table 5)
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
Table 5 lists the adverse reactions associated with discontinuation of fluoxetine treatment (incidence at least twice that for placebo and at least 1% for fluoxetine). Combined MDD, OCD, Bulimia, and Panic Disorder (N=1,533): Anxiety (1%). Major Depressive Disorder (N=392): Nervousness (1%). OCD (N=266): Anxiety (2%); Rash (1%). Bulimia (N=450): Insomnia (2%). Panic Disorder (N=425): Anxiety (2%); Nervousness (1%). Pediatric: The most common adverse reaction (incidence at least 1% for fluoxetine and greater than placebo) associated with discontinuation in 3 pediatric placebo-controlled trials was mania/hypomania (1.8% for fluoxetine-treated, 0% for placebo-treated).
Reporting
To report SUSPECTED ADVERSE REACTIONS contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Interactions
Drugs
Contraindicated: risk of serotonin syndrome.
Name
MAOIs, linezolid, intravenous methylene blue
Section
4.1; 7.1
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
The use of MAOIs intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine is contraindicated because of an increased risk of serotonin syndrome.
Do not use together.
Name
Pimozide
Section
7.7
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
Concomitant use in patients taking pimozide is contraindicated.
Do not use together or within 5 weeks after stopping fluoxetine.
Name
Thioridazine
Section
7.7
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
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.
These raise the risk of serotonin syndrome.
Name
Other serotonergic drugs
Section
7.3
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
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.
Bleeding risk may rise. Warfarin patients need careful monitoring when fluoxetine is started or stopped.
Name
NSAIDs, aspirin, warfarin
Section
7.4
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
Altered anticoagulant effects, including increased bleeding, have been reported when SNRIs or SSRIs are coadministered with warfarin. Patients receiving warfarin therapy should be carefully monitored when fluoxetine is initiated or discontinued.
Fluoxetine blocks CYP2D6, so these medicines should be approached with caution.
Name
Drugs metabolized by CYP2D6 (TCAs, antipsychotics, antiarrhythmics)
Section
7.7
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
Fluoxetine inhibits the activity of CYP2D6, and may make individuals with normal CYP2D6 metabolic activity resemble a poor metabolizer. 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.
TCA levels can rise a lot (greater than 2- to 10-fold) and the effect may last 3 weeks or longer after stopping fluoxetine.
Name
Tricyclic antidepressants
Section
7.7
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
previously stable plasma levels of imipramine and desipramine have increased greater than 2- to 10-fold when fluoxetine has been administered in combination. This influence may persist for 3 weeks or longer after fluoxetine is discontinued.
Diazepam may last longer and alprazolam levels may rise.
Name
Benzodiazepines (diazepam, alprazolam)
Section
7.7
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
The half-life of concurrently administered diazepam may be prolonged in some patients. Coadministration of alprazolam and fluoxetine has resulted in increased alprazolam plasma concentrations and in further psychomotor performance decrement due to increased alprazolam levels.
Blood levels of haloperidol and clozapine may rise.
Name
Haloperidol and clozapine
Section
7.7
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
Elevation of blood levels of haloperidol and clozapine has been observed in patients receiving concomitant fluoxetine.
Levels of these anticonvulsants may rise to toxic levels.
Name
Phenytoin and carbamazepine
Section
7.7
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
Patients on stable doses of phenytoin and carbamazepine have developed elevated plasma anticonvulsant concentrations and clinical anticonvulsant toxicity following initiation of concomitant fluoxetine treatment.
Lithium levels can go up or down and should be monitored.
Name
Lithium
Section
7.7
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
There have been reports of both increased and decreased lithium levels when lithium was used concomitantly with fluoxetine. Lithium levels should be monitored when these drugs are administered concomitantly.
Other highly protein-bound drugs may shift in level.
Name
Drugs tightly bound to plasma proteins
Section
7.6; 7.7
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
the administration of fluoxetine to a patient taking another drug that is tightly bound to protein (e.g., Coumadin, digitoxin) may cause a shift in plasma concentrations potentially resulting in an adverse effect
Use caution with other QT-prolonging drugs.
Name
Drugs that prolong the QT interval
Section
7.8
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
Do not use fluoxetine in combination with thioridazine or pimozide. Use fluoxetine with caution in combination with other drugs that cause QT prolongation.
Rare reports of prolonged seizures with ECT.
Name
Electroconvulsive therapy (ECT)
Section
7.5
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
There have been rare reports of prolonged seizures in patients on fluoxetine receiving ECT treatment.
Use caution with other CNS-acting drugs.
Name
CNS acting drugs
Section
7.2
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
Caution is advised if the concomitant administration of fluoxetine and such drugs is required.
Food and alcohol
The Medication Guide says not to drink alcohol while using fluoxetine. MedlinePlus says to talk to your doctor about alcohol and that alcohol can make side effects worse.
Name
Alcohol
Section
Medication Guide: What should I avoid while taking fluoxetine capsules?; MedlinePlus
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784 and MedlinePlus Fluoxetine (Last Revised - 11/15/2025)
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Conflict note
Wording differs (Medication Guide: do not drink; MedlinePlus: talk to your doctor about safe use). Both kept; not treated as a hard conflict.
Source text (exact source wording)
Do not drink alcohol while using fluoxetine capsules. (Medication Guide) talk to your doctor about the safe use of alcoholic beverages during your treatment with fluoxetine. Alcohol can make the side effects of fluoxetine worse. (MedlinePlus)
Fluoxetine can be taken with or without food.
Name
Food
Section
12.3 Pharmacokinetics
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
Food does not appear to affect the systemic bioavailability of fluoxetine, although it may delay its absorption by 1 to 2 hours, which is probably not clinically significant. Thus, fluoxetine may be administered with or without food.
Name
Grapefruit
Other
St. John's wort, tryptophan, aspirin and NSAIDs such as ibuprofen and naproxen may interact with fluoxetine.
Name
Herbal and OTC products
Section
What special precautions should I follow?
Source
MedlinePlus Fluoxetine (Last Revised - 11/15/2025)
Source url
https://medlineplus.gov/druginfo/meds/a689006.html
Source text (exact source wording)
the following nonprescription or herbal products may interact with fluoxetine: St. John's wort; tryptophan; aspirin, nonsteroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen and naproxen.
Do not take other fluoxetine-containing medicines such as Symbyax or Sarafem with it.
Name
Symbyax and Sarafem
Section
Medication Guide
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
If you take fluoxetine capsules, you should not take any other medicines that contain fluoxetine hydrochloride including: Symbyax, Sarafem
Patient tips
Label medication guide
Take it with or without food. Do not drive or use machinery until you know how it affects you, and do not drink alcohol. Do not stop suddenly. Call your healthcare provider right away, or 911 in an emergency, for new or worse depression, suicidal thoughts, aggression, agitation, trouble sleeping or other unusual mood or behavior changes.
Section
Medication Guide
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=23899405-007b-48d9-82a9-a530b8e90784&type=display
Source text (exact source wording)
Fluoxetine capsules may be taken with or without food. Fluoxetine capsules 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 fluoxetine capsules affects you. Do not drink alcohol while using fluoxetine capsules. Do not stop fluoxetine capsules without first talking to your healthcare provider. Stopping fluoxetine capsules too quickly may cause serious symptoms including: anxiety, irritability, high or low mood, feeling restless or changes in sleep habits; headache, sweating, nausea, dizziness; electric shock-like sensations, shaking, confusion. 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.
Medlineplus
It may take 4 to 5 weeks or longer to feel the full benefit. Keep taking it even if you feel well, and do not stop without talking to your doctor, who will probably lower the dose gradually.
Section
How should this medicine be used?
Source
MedlinePlus Fluoxetine (Last Revised - 11/15/2025)
Source url
https://medlineplus.gov/druginfo/meds/a689006.html
Source text (exact source wording)
Take fluoxetine with or without food. It may take 4 to 5 weeks or longer before you feel the full benefit of fluoxetine. Continue to take fluoxetine even if you feel well. Do not stop taking fluoxetine without talking to your doctor. If you suddenly stop taking fluoxetine, you may experience withdrawal symptoms such as mood changes, irritability, agitation, dizziness, numbness or tingling in the hands or feet, anxiety, sweating, confusion, headache, tiredness, and difficulty falling asleep or staying asleep. Your doctor will probably decrease your dose gradually.
Alternatives
Class
selective serotonin reuptake inhibitor (SSRI) / Serotonin Reuptake Inhibitor [EPC]
Class source
DailyMed label Highlights; openFDA label API pharm_class_epc
Class source url
https://api.fda.gov/drug/label.json?search=openfda.pharm_class_epc.exact:"Serotonin Reuptake Inhibitor [EPC]"&count=openfda.generic_name.exact&limit=15
Candidates
- citalopram (appears in the same openFDA class query)
Note
No recommendation.
Frequently asked questions
Question
What is fluoxetine used for?
Answer
Fluoxetine treats major depressive disorder, obsessive compulsive disorder (OCD), moderate to severe bulimia nervosa and panic disorder. Taken with olanzapine it treats depressive episodes in Bipolar I Disorder and treatment resistant depression.
Source section
1 INDICATIONS AND USAGE
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Question
How long until fluoxetine works?
Answer
The label says the full effect in depression may be delayed until 4 weeks of treatment or longer. MedlinePlus says it may take 4 to 5 weeks or longer to feel the full benefit.
Source section
2.1; MedlinePlus How should this medicine be used?
Source
DailyMed label and MedlinePlus
Question
Can I take fluoxetine with food?
Answer
Yes. Fluoxetine may be administered with or without food.
Source section
12.3 Pharmacokinetics
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Question
What if I miss a dose?
Answer
Take it as soon as you remember. If it is almost time for the next dose, skip the missed dose. Do not take two doses at the same time.
Source section
Medication Guide
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Question
Can I drink alcohol with fluoxetine?
Answer
The Medication Guide says not to drink alcohol while using fluoxetine. MedlinePlus says to talk to your doctor about alcohol and that it can make side effects worse.
Source section
Medication Guide; MedlinePlus
Source
DailyMed label and MedlinePlus
Question
What are the most common side effects?
Answer
The label's most common reactions (at least 5% and at least twice placebo) include nausea, insomnia, anxiety, nervousness, somnolence, tremor, diarrhea, dry mouth, sweating, asthenia, decreased libido, abnormal dreams, rash and yawning, among others listed in the label.
Source section
ADVERSE REACTIONS
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Question
Is fluoxetine safe in pregnancy or breastfeeding?
Answer
Use late in pregnancy has been associated with newborn complications, including persistent pulmonary hypertension of the newborn. Fluoxetine passes into breast milk, and infants should be monitored for agitation, irritability, poor feeding and poor weight gain. Talk to your doctor about your own situation.
Source section
8.1 Pregnancy; 8.2 Lactation
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Question
What should I not combine with fluoxetine?
Answer
The label contraindicates MAOIs (including linezolid and intravenous methylene blue), pimozide and thioridazine. It also warns about other serotonergic drugs, NSAIDs, aspirin and warfarin.
Source section
4 CONTRAINDICATIONS; 7 DRUG INTERACTIONS
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Question
Should I stop fluoxetine when I feel better?
Answer
No. The Medication Guide says not to stop without first talking to your healthcare provider, because stopping too quickly may cause serious symptoms.
Source section
Medication Guide
Source
DailyMed label, ScieGen Pharmaceuticals, Inc. fluoxetine capsules, set ID 23899405-007b-48d9-82a9-a530b8e90784
Sources
- DailyMed fluoxetine capsules, ScieGen Pharmaceuticals, Inc. (chosen label)
Set id: 23899405-007b-48d9-82a9-a530b8e90784 · Label effective or revised date: Revised: 8/2026 (Medication Guide: Revised: 10/2025) · Dailymed version date: Aug 21, 2026 (DailyMed list publish date) · Fetched at: 2026-11-02 · Sections used: Highlights, Boxed Warning, 1-8, 10, 12.1, 12.3, 12.4, 16, 17, Medication Guide - MedlinePlus Fluoxetine
Label effective or revised date: Last Revised - 11/15/2025 · Fetched at: 2026-11-02 · Sections used: all patient sections - openFDA drug label API (class)
Label effective or revised date: API last_updated 2026-10-30 · Fetched at: 2026-11-02 · Sections used: pharm_class_epc - Drugs@FDA
Label effective or revised date: NOT FOUND (not searched) · Fetched at: 2026-11-02 · Sections used: none
Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug