Fluoxetine: Drug Uses, Dosage & Side Effects

Generic Name: fluoxetine (floo OX e teen)
Brand Names: PROzac, PROzac Weekly, Sarafem, Rapiflux, Selfemra, PROzac Pulvules

What is fluoxetine?

Fluoxetine is a selective serotonin reuptake inhibitors (SSRI) antidepressant. Fluoxetine affects chemicals in the brain that may be unbalanced in people with depression, panic, anxiety, or obsessive-compulsive symptoms.

Fluoxetine is used to treat major depressive disorder, bulimia nervosa (an eating disorder), obsessive-compulsive disorder, panic disorder, and premenstrual dysphoric disorder (PMDD).

Fluoxetine is sometimes used together with another medication called olanzapine (Zyprexa) to treat manic depression caused by bipolar disorder. This combination is also used to treat depression after at least 2 other medications have been tried without successful treatment of symptoms.

If you also take olanzapine (Zyprexa), read the Zyprexa medication guide and all patient warnings and instructions provided with that medication.

Important information

You should not use fluoxetine if you also take pimozide or thioridazine, or if you are being treated with methylene blue injection.

Do not use fluoxetine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

You must wait at least 14 days after stopping an MAO inhibitor before you can take fluoxetine. You must wait 5 weeks after stopping fluoxetine before you can take thioridazine or an MAOI.

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Before taking this medicine

Do not use fluoxetine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine. You must wait at least 14 days after stopping an MAO inhibitor before you can take fluoxetine. You must wait 5 weeks after stopping fluoxetine before you can take thioridazine or an MAOI.

You should not use fluoxetine if you are allergic to it, if you also take pimozide or thioridazine, or if you are being treated with methylene blue injection.

Tell your doctor about all other antidepressants you take, especially Celexa, Cymbalta, Desyrel, Effexor, Lexapro, Luvox, Oleptro, Paxil, Pexeva, Symbyax, Viibryd, or Zoloft.

Some medicines can interact with fluoxetine and cause a serious condition called serotonin syndrome. Be sure your doctor knows about all other medicines you use. Ask your doctor before making any changes in how or when you take your medications.

To make sure fluoxetine is safe for you, tell your doctor if you have:

  • cirrhosis of the liver;
  • kidney disease;
  • diabetes;
  • narrow-angle glaucoma;
  • seizures or epilepsy;
  • bipolar disorder (manic depression);
  • a history of drug abuse or suicidal thoughts; or
  • if you are being treated with electroconvulsive therapy (ECT).

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Taking an SSRI antidepressant during pregnancy may cause serious lung problems or other complications in the baby. However, you may have a relapse of depression if you stop taking your antidepressant. Tell your doctor right away if you become pregnant. Do not start or stop taking fluoxetine during pregnancy without your doctor’s advice.

Fluoxetine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Fluoxetine is not approved for use by anyone younger than 18 years old.

How should I take fluoxetine?

Take fluoxetine exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Do not crush, chew, break, or open a delayed-release capsule. Swallow it whole.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

To treat premenstrual dysphoric disorder, the usual dose of fluoxetine is once daily while you are having your period, or 14 days before you expect your period to start. Follow your doctor’s instructions.

It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Do not stop using fluoxetine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using fluoxetine.

Store at room temperature away from moisture and heat.

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

If you miss a dose of Prozac Weekly, take the missed dose as soon as you remember and take the next dose 7 days later. However, if it is almost time for the next regularly scheduled weekly dose, skip the missed dose and take the next one as directed. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking fluoxetine?

Drinking alcohol can increase certain side effects of fluoxetine.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others. Using an NSAID with fluoxetine may cause you to bruise or bleed easily.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Fluoxetine side effects

Get emergency medical help if you have signs of an allergic reaction to fluoxetine: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • high levels of serotonin in the body–agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;
  • low levels of sodium in the body–headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
  • severe nervous system reaction–very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out; or
  • severe skin reaction–fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common fluoxetine side effects may include:

  • sleep problems (insomnia), strange dreams;
  • headache, dizziness, vision changes;
  • tremors or shaking, feeling anxious or nervous;
  • pain, weakness, yawning, tired feeling;
  • upset stomach, loss of appetite, nausea, vomiting, diarrhea;
  • dry mouth, sweating, hot flashes;
  • changes in weight or appetite;
  • stuffy nose, sinus pain, sore throat, flu symptoms; or
  • decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Fluoxetine dosing information

Usual Adult Dose of Fluoxetine for Bulimia:

Immediate-release oral formulations:
Recommended dose: 60 mg orally once a day

Comments:
-Some patients may need to be started at a lower dose and titrated up over several days to the recommended dose
-Daily doses greater than 60 mg have not been systematically studied for the treatment of Bulimia

Use: Acute and maintenance treatment of binge-eating and vomiting behaviors in moderate to severe Bulimia Nervosa.

Usual Adult Dose of Fluoxetine for Depression:

Immediate-release oral formulations:
Initial dose: 20 mg orally once a day, increased after several weeks if insufficient clinical improvement is observed
Maintenance dose: 20 to 60 mg orally per day
Maximum dose: 80 mg orally per day

Delayed release oral capsules:
Initial dose: 90 mg orally once a week, commenced 7 days after the last daily dose of immediate-release fluoxetine 20 mg formulations.

Comments:
-Doses above 20 mg per day may be given in divided doses, in the morning and at noon
-The full effect may be delayed until after at least 4 weeks of treatment
-If a satisfactory response with the once weekly oral fluoxetine is not maintained, a change back to daily fluoxetine dosing using the immediate-release oral formulations should be considered.
-Acute episodes of Major Depressive Disorder require several months or longer of sustained pharmacologic therapy
-Whether the dose needed to induce remission is the same as the dose needed to maintain and/or sustain euthymia is unknown

Use: Acute and maintenance treatment of Major Depressive Disorder (MDD)

Usual Adult Dose for Obsessive Compulsive Disorder:

Immediate-release oral formulations:
Initial dose: 20 mg orally once a day, increased after several weeks if insufficient clinical improvement is observed.
Maintenance dose: 20 to 60 mg orally per day
Maximum dose: 80 mg orally per day

Comments:
-Doses above 20 mg per day may be given in divided doses, in the morning and at noon
-The full effect may be delayed until after at least 5 weeks of treatment

Use: Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD)

Usual Adult Dose of Fluoxetine for Panic Disorder:

Immediate-release oral formulations:
Initial dose: 10 mg orally once a day, increased after one week to 20 mg orally once a day
Maintenance dose: 20 to 60 mg orally per day
Maximum dose: 60 mg orally per day

Comments:
-Doses above 20 mg per day may be given in divided doses, in the morning and at noon
-A dose increase may be considered after several weeks if no clinical improvement is observed.
-Doses greater than 60 mg per day have not been systematically studied for the treatment of Panic Disorder

Use: Acute treatment of Panic Disorder

Usual Adult Dose for Premenstrual Dysphoric Disorder:

Immediate-release oral formulations:
Initial dose:
Continuous regimen: 20 mg orally once a day on every day of the menstrual cycle
Cyclic regimen: 20 mg orally once a day starting 14 days prior to the anticipated start of menstruation through to the first full day of menses, and repeated with each new cycle

Maintenance dose: 20 to 60 mg per day for either the continuous or intermittent regimens
Maximum dose: 80 mg orally per day

Duration: The 20 mg daily dosage has been shown to be effective for up to 6 months of treatment

Comments:
-A daily dose of 60 mg has not been shown to be significantly more effective than 20 mg daily
-Daily doses above 60 mg have not been systematically studied in patients with this condition

Usual Pediatric Dose of Fluoxetine for Depression:

Immediate-release oral formulations:
8 to 18 years:
Initial dose: 10 to 20 mg orally once a day; the 10 mg daily dose may be increased after one week to 20 mg orally once a day

Lower weight children:
Initial dose: 10 mg orally once a day, increased to 20 mg orally once a day after several weeks if insufficient clinical improvement is observed

Maintenance dose: 10 to 20 mg orally once a day

Comments:
-The full effect may be delayed until after at least 4 weeks of treatment
-The potential risks versus clinical need should be assessed prior to using this drug in children and adolescents

Use: Acute and maintenance treatment of Major Depressive Disorder (MDD)

Usual Pediatric Dose of Fluoxetine for Obsessive Compulsive Disorder:

7 to 18 years:
Immediate-release oral formulations:
Adolescents and higher weight children:
Initial dose: 10 mg orally once a day, increased to 20 mg orally once a day after 2 weeks
Maintenance dose: 20 to 60 mg orally per day
Maximum dose: 60 mg orally per day

Lower weight children:
Initial dose: 10 mg orally once a day, increased after several weeks if insufficient clinical improvement is observed
Maintenance dose: 20 to 30 mg orally once a day
Maximum dose: 60 mg orally per day

Comments:
-Additional dose increases may be considered after several more weeks if clinical improvement is insufficient
-Doses above 20 mg per day may be given in divided doses, in the morning and at noon
-In lower weight children, there is minimal experience with doses greater than 20 mg per day, and none with doses greater than 60 mg per day
-The full effect may be delayed until after at least 5 weeks of treatment
-The potential risks versus clinical need should be assessed prior to using this drug in children and adolescents

Use: Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder

What other drugs will affect fluoxetine?

Taking fluoxetine with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Many drugs can interact with fluoxetine. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

  • any other antidepressant;
  • St. John’s Wort;
  • tryptophan (sometimes called L-tryptophan);
  • a blood thinner – warfarin, Coumadin, Jantoven;
  • medicine to treat anxiety, mood disorders, thought disorders, or mental illness – amitriptyline, buspirone, desipramine, lithium, nortriptyline, and many others;
  • medicine to treat ADHD or narcolepsy – Adderall, Concerta, Ritalin, Vyvanse, Zenzedi, and others;
  • migraine headache medicine – rizatriptan, sumatriptan, zolmitriptan, and others; or
  • narcotic pain medicine – fentanyl, tramadol.

This list is not complete and many other drugs can interact with fluoxetine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Fluoxetine Side Effects

In Summary

Commonly reported side effects of fluoxetine include: anxiety, asthenia, diarrhea, drowsiness, dyspepsia, insomnia, nausea, nervousness, tremor, headache, anorexia, decreased libido, xerostomia, and decreased appetite. Other side effects include: dizziness, skin rash, and diaphoresis. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to fluoxetine: oral capsule, oral capsule delayed release, oral solution, oral syrup, oral tablet

In addition to its needed effects, some unwanted effects may be caused by fluoxetine. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking fluoxetine:

More common:

  • Hives, itching, or skin rash
  • inability to sit still
  • restlessness

Less common:

  • Chills or fever
  • joint or muscle pain

Rare

  • Anxiety
  • cold sweats
  • confusion
  • convulsions (seizures)
  • cool pale skin
  • diarrhea
  • difficulty with concentration
  • drowsiness
  • dryness of the mouth
  • excessive hunger
  • fast or irregular heartbeat
  • headache
  • increased sweating
  • increased thirst
  • lack of energy
  • mood or behavior changes
  • overactive reflexes
  • purple or red spots on the skin
  • racing heartbeat
  • shakiness or unsteady walk
  • shivering or shaking
  • talking, feeling, and acting with excitement and activity you cannot control
  • trouble with breathing
  • unusual or incomplete body or facial movements
  • unusual tiredness or weakness

Incidence not known:

  • Abdominal or stomach pain
  • agitation
  • back or leg pains
  • bleeding gums
  • blindness
  • blistering, peeling, or loosening of the skin
  • bloating
  • blood in the urine or stools
  • bloody, black or tarry stools
  • blue-yellow color blindness
  • blurred vision
  • chest pain or discomfort
  • clay-colored stools
  • constipation
  • continuing vomiting
  • cough or dry cough
  • dark urine
  • decreased urine output
  • decreased vision
  • depression
  • difficulty with breathing
  • difficulty with swallowing
  • dizziness or lightheadedness
  • eye pain
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • general body swelling
  • high fever
  • hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • hostility
  • indigestion
  • irregular or slow heart rate
  • irritability
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • loss of appetite
  • loss of bladder control
  • muscle twitching
  • nausea
  • nightmares
  • no blood pressure or pulse
  • noisy breathing
  • nosebleeds
  • pain in the ankles or knees
  • painful, red lumps under the skin, mostly on the legs
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pinpoint red spots on the skin
  • rapid weight gain
  • red or irritated eyes
  • red skin lesions, often with a purple center
  • redness, tenderness, itching, burning, or peeling of the skin
  • severe muscle stiffness
  • severe sleepiness
  • slurred speech
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stopping of heart
  • sudden shortness of breath or troubled breathing
  • sudden weakness in the arms or legs
  • sudden, severe chest pain
  • swelling of the face, ankles, or hands
  • swollen or painful glands
  • thoughts of killing oneself
  • tightness in the chest
  • tiredness
  • twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
  • unconsciousness
  • unpleasant breath odor
  • unusual bleeding or bruising
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  • unusually pale skin
  • use of extreme physical or emotional force
  • vomiting of blood
  • yellow eyes or skin

Minor Side Effects

Some of the side effects that can occur with fluoxetine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:

  • Decreased appetite

Less common or rare:

  • Abnormal dreams
  • breast enlargement or pain
  • change in sense of taste
  • changes in vision
  • feeling of warmth or heat
  • flushing or redness of the skin, especially on face and neck
  • frequent urination
  • hair loss
  • increased appetite
  • increased sensitivity of the skin to sunlight
  • menstrual pain
  • stomach cramps, gas, or pain
  • unusual secretion of milk, in females
  • weight loss
  • yawning

Incidence not known:

  • Cracks in the skin
  • loss of heat from the body
  • painful or prolonged erections of the penis
  • scaly skin
  • swelling of the breasts or breast soreness in both females and males
  • unusual milk production

For Healthcare Professionals

Applies to fluoxetine: compounding powder, oral capsule, oral delayed release capsule, oral solution, oral tablet

General

The most common side effects that have been associated with the discontinuation of placebo-controlled clinical trials were anxiety, nervousness, nausea, rash, pruritus, insomnia, asthenia, and headache.

The side effect profile appears generally similar between adults, children, and adolescents. Treatment-emergent side effects reported in pediatric patients that were reported at an incidence of at least 2% or more for fluoxetine and greater than placebo included thirst, hyperkinesia, agitation, personality disorder, epistaxis, urinary frequency, and menorrhagia. The most common side effect associated with treatment discontinuation in children and adolescents was mania/hypomania.[Ref]

Psychiatric

Antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. An increased risk of suicidal thinking and behavior in children, adolescents, and young adults (aged 18 to 24 years) with major depressive disorder (MDD) and other psychiatric disorders has been reported with short-term use of antidepressant drugs.

Adult and pediatric patients receiving antidepressants for MDD, as well as for psychiatric and nonpsychiatric indications, have reported symptoms that may be precursors to emerging suicidality, including anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania. Causality has not been established.[Ref]

Very common (10% or more): Anxiety, insomnia, nervousness
Common (1% to 10%): Abnormal dreams, disturbance in attention, emotional lability, feeling abnormal, restlessness, sleep disorder, tension, thinking abnormal
Uncommon (0.1% to 1%): Akathisia, apathy, bruxism, depersonalization, elevated mood, euphoria, hostility, intentional overdose, manic reaction, neurosis, paranoid reaction, personality disorder, psychomotor hyperactivity, psychosis, suicide attempt
Rare (less than 0.1%): Agitation, antisocial reaction, delusions, hallucinations, hypomania, intentional injury, mania, panic attacks, stupor
Frequency not reported: Dysphemia, suicidal thoughts and behavior
Postmarketing reports: Confusion, violent behaviors[Ref]

Nervous system

Very common (10% or more): Dizziness, headache, somnolence, tremor
Common (1% to 10%): Amnesia, paresthesia, taste perversion
Uncommon (0.1% to 1%): Abnormal gait, acute brain syndrome, ataxia, balance disorder, CNS depression, CNS stimulation, dyskinesia, hyperkinesia, hypesthesia, hypertonia, incoordination, migraine, myoclonus, neuralgia, neuropathy, seizures, syncope, vascular headache
Rare (0.01% to 0.1%): Abnormal EEG, cerebral embolism, cerebral ischemia, circumoral paresthesia, convulsion, decreased reflexes, dysarthria, dystonia, extrapyramidal syndrome, foot drop, hyperesthesia, neuritis, paralysis, taste loss
Very rare (less than 0.01%): Serotonin syndrome (neuroleptic malignant syndrome-like effects)
Postmarketing reports: Cerebrovascular accident, memory impairment, movement disorders, oculogyric crisis, tardive dyskinesia[Ref]

One retrospective study of 23 outpatients with Parkinson’s disease treated with 40 mg of fluoxetine a day reported that three patients experienced worsening of parkinsonism, two patients experienced improvement of parkinsonism, and 18 patients experienced no change. Another small study reported a series of four patients who experienced worsening of parkinsonism during treatment with fluoxetine.

Potentially life-threatening serotonin syndrome has been reported with SSRIs and SNRIs as monotherapy, but particularly with concomitant use of other serotonergic drugs and drugs that impair the metabolism of serotonin.

A number of case reports have implicated fluoxetine in causing seizures. Twelve of 6000 patients experienced convulsions during pre-marketing testing.

A case of dose-dependent exacerbation of preexisting, mild restless legs syndrome (which ultimately required discontinuation of fluoxetine) has been reported.[Ref]

Cardiovascular

One placebo-controlled study has suggested that fluoxetine has no effects on intraventricular conduction. Other case reports have suggested that fluoxetine may rarely provoke dysrhythmias. Other conflicting case reports have suggested that fluoxetine may have a propensity to provoke and alleviate vasoconstriction. Several cases of unexpected death occurring shortly after initiation of fluoxetine therapy have been reported in elderly patients with multiple medical problems.

In one case report, QTc prolongation and torsades de pointes developed in an elderly woman 6 months after starting therapy with fluoxetine 20 mg daily. The QTc interval returned to normal following discontinuation of fluoxetine. Four additional cases suggesting fluoxetine associated QTc prolongation or torsades de pointes have been reported.[Ref]

Common (1% to 10%): Chest pain, flushing, hypertension, palpitations, vasodilatation
Uncommon (0.1% to 1%): Angina pectoris, arrhythmia, congestive heart failure, generalized edema, hypotension, myocardial infarct, peripheral edema, postural hypotension
Rare (less than 0.1%): Bradycardia, extrasystoles, heart block, pallor, peripheral vascular disorder, phlebitis, shock, thrombophlebitis, thrombosis, vasculitis, vasospasm, ventricular extrasystoles, ventricular fibrillation
Postmarketing reports: Atrial fibrillation, heart arrest, QT-interval prolongation and ventricular arrhythmia including torsades de pointes[Ref]

Gastrointestinal

A study of 26,005 antidepressant users has reported 3.6 times more upper GI bleeding episodes with the use of SSRIs relative to the population who did not receive antidepressant medications. Upper gastrointestinal tract bleeding was observed in 3.9 times more frequently in patients receiving fluoxetine.[Ref]

Very common (10% or more): Diarrhea, dry mouth, nausea
Common (1% to 10%): Abdominal pain, constipation, dyspepsia, flatulence, increased appetite, vomiting
Uncommon (0.1% to 1%): Aphthous stomatitis, buccoglossal syndrome, cholelithiasis, colitis, dysphagia, eructation, esophagitis, gastritis, gastroenteritis, glossitis, gum hemorrhage, hyperchlorhydria, increased salivation, melena, mouth ulcerations, stomach ulcer, stomatitis, thirst
Rare (less than 0.1%): Acute abdominal syndrome, biliary pain, bloody diarrhea, cholecystitis, duodenal ulcer, enteritis, esophageal pain, esophageal ulcer, fecal incontinence, gastrointestinal hemorrhage, hematemesis, intestinal obstruction, pancreatitis, peptic ulcer, salivary gland enlargement, stomach ulcer hemorrhage, tongue edema
Postmarketing reports: Gastrointestinal bleeding[Ref]

Metabolic

Numerous cases of hyponatremia have been reported following treatment with an SSRI. Risk factors for the development of SSRI associated hyponatremia including advanced age, female gender, concomitant use of diuretics, low body weight, and lower baseline serum sodium levels have been identified. Hyponatremia tends to develop within the first few weeks of treatment (range 3 to 120 days) and typically resolves within 2 weeks (range 48 hours to 6 weeks) after therapy has been discontinued with some patients requiring treatment. The proposed mechanism for the development of hyponatremia involves the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) via release of antidiuretic hormone.

Decreased weight gain has been observed in association with the use of fluoxetine in children and adolescent patients.[Ref]

Very common (10% or more): Anorexia
Common (1% to 10%): Weight loss
Uncommon (0.1% to 1%): Decreased appetite, dehydration, gout, hypocholesteremia, hyperlipemia, hypokalemia
Rare (less than 0.1%): Alcohol intolerance, creatine phosphokinase increased, diabetes mellitus, hyperkalemia, hyperuricemia, hypocalcemia, hyponatremia
Postmarketing reports: Hypoglycemia[Ref]

Other

Very common (10% or more): Fatigue (including asthenia)
Common (1% to 10%): Accidental injury, chills, ear pain, feeling jittery, fever, infection, pain, tinnitus
Uncommon (0.1% to 1%): Face edema, feeling hot/cold, malaise, vertigo
Rare (less than 0.1%): Deafness, hyperacusis, hypothermia
Frequency not reported: Mucosal hemorrhage
Postmarketing reports: Malignant hyperthermia[Ref]

Genitourinary

Common (1% to 10%): Decreased libido, ejaculation disorder, erectile dysfunction, gynecological bleeding, impotence, urinary frequency
Uncommon (0.1% to 1%): Abortion, albuminuria, amenorrhea, anorgasmia, breast enlargement, breast pain, cystitis, dysuria, female lactation, fibrocystic breast, hematuria, impaired urination, Increased libido, leukorrhea, menorrhagia, metrorrhagia, nocturia, pelvic pain, polyuria, sexual dysfunction (occasionally persisting after treatment discontinuation), urinary incontinence, urinary retention, urinary urgency, vaginal hemorrhage
Rare (less than 0.1%): Breast engorgement, galactorrhea, glycosuria, hypomenorrhea, kidney pain, oliguria, priapism, uterine fibroids, uterine hemorrhage
Postmarketing reports: Enlarged clitoris, gynecomastia, vaginal bleeding[Ref]

Urinary retention and galactorrhea have been reported with other SSRIs.

The estimates of the incidence of untoward sexual experience and performance may underestimate their actual incidence, partly because patients and physicians may be reluctant to discuss this issue. In placebo-controlled clinical trials ejaculation disorder (primarily ejaculation delay) was reported as a treatment-emergent side effect at an incidence of 6% and at least twice the incidence in placebo-treated male patients.[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash, sweating, urticaria
Uncommon (0.1% to 1%): Acne, alopecia, cold sweat, contact dermatitis, ecchymosis, eczema, increased tendency to bruise, maculopapular rash, skin discoloration, skin ulcer
Rare (less than 0.1%): Angioedema, furunculosis, hirsutism, petechia, photosensitivity reaction, psoriasis, purpura, purpuric rash, seborrhea
Postmarketing reports: Epidermal necrolysis, erythema multiforme, erythema nodosum, exfoliative dermatitis, Stevens Johnson syndrome, thrombocytopenic purpura[Ref]

Approximately 3% of treated patients have been reported to develop a skin reaction.[Ref]

Endocrine

Uncommon (0.1% to 1%): Hypothyroidism
Rare (less than 0.1%): Diabetic acidosis, hyperprolactinemia
Postmarketing reports: Inappropriate secretion of antidiuretic hormone[Ref]

Hematologic

Uncommon (0.1% to 1%): Anemia
Rare (less than 0.1%): Blood dyscrasia, hypochromic anemia, leukopenia, lymphedema, lymphocytosis, thrombocythemia, iron deficiency anemia
Very rare (less than 0.01%): Thrombocytopenia
Postmarketing reports: Aplastic anemia, eosinophilia, immune-related hemolytic anemia, pancytopenia[Ref]

Hepatic

Uncommon (0.1% to 1%): Abnormal liver function tests
Rare (less than 0.1%): Alkaline phosphatase increased, hepatitis, liver fatty deposit, SGPT increased
Postmarketing reports: Aggravation of hepatic damage, cholestatic jaundice, hepatic failure/necrosis, idiosyncratic hepatitis[Ref]

Hypersensitivity

Common (1% to 10%): Allergic reaction
Rare (less than 0.1%): Anaphylactoid reaction, serum sickness[Ref]

Immunologic

Common (1% to 10%): Flu syndrome
Uncommon (0.1% to 1%): Herpes zoster[Ref]

Musculoskeletal

Epidemiological studies, primarily in patients aged 50 years or older, have shown an increased risk of bone fractures in patients receiving SSRIs or TCAs.[Ref]

Common (1% to 10%): Arthralgia, twitching
Uncommon (0.1% to 1%): Arthritis, bone pain, bursitis, leg cramps, tenosynovitis
Rare (less than 0.1%): Arthrosis, chondrodystrophy, myasthenia, myopathy, myositis, osteomyelitis, osteoporosis, rheumatoid arthritis
Frequency not reported: Myalgia[Ref]

Ocular

Common (1% to 10%): Abnormal vision, vision blurred
Uncommon (0.1% to 1%): Conjunctivitis, dry eyes, mydriasis, photophobia
Rare (less than 0.1%): Blepharitis, diplopia, exophthalmos, glaucoma, iritis, scleritis, strabismus, visual field defect
Frequency not reported: Angle-closure glaucoma, eye pain
Postmarketing reports: Cataract, optic neuritis[Ref]

Renal

Rare (less than 0.1%): BUN increased
Postmarketing reports: Kidney failure[Ref]

Respiratory

Very common (10% or more): Pharyngitis, rhinitis
Common (1% to 10%): Epistaxis, yawn
Uncommon (0.1% to 1%): Asthma, dyspnea, hiccup, hyperventilation
Rare (less than 0.1%): Apnea, atelectasis, decreased cough, emphysema, hemoptysis, hypoventilation, hypoxia, larynx edema, lung edema, parosmia, pneumothorax, stridor,
Frequency not reported: pulmonary events (inflammatory processes of varying histopathology and/or fibrosis)
Postmarketing reports: Eosinophilic pneumonia, pulmonary embolism, pulmonary hypertension[Ref]

References

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70. Kline MD “Fluoxetine and anorgasmia.” Am J Psychiatry 146 (1989): 804-5

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73. Meltzer HY, Young M, Metz J, Fang VS, Schyve PM, Arora RC “Extrapyramidal side effects and increased serum prolactin following fluoxetine, a new antidepressant.” J Neural Transm 45 (1979): 165-75

74. Musher JS “Anorgasmia with the use of fluoxetine.” Am J Psychiatry 147 (1990): 948

75. Balon R “Sexual obsessions associated with fluoxetine.” J Clin Psychiatry 55 (1994): 496

76. Modell JG “Repeated observations of yawning, clitoral engorgement, and orgasm associated with fluoxetine administration.” J Clin Psychopharmacol 9 (1989): 63-5

77. Benazzi F “Involuntary sperm emission with fluoxetine.” Can J Psychiatry 40 (1995): 431

78. King VL, Jr Horowitz IR “Vaginal anesthesia associated with fluoxetine use.” Am J Psychiatry 150 (1993): 984-5

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80. Mareth TR “Hair loss associated with fluoxetine use in 2 family members.” J Clin Psychiatry 55 (1994): 163

81. Olfson M, Wilner MT “A family case history of fluoxetine-induced skin reactions.” J Nerv Ment Dis 179 (1991): 504-5

82. Ogilvie AD “Hair loss during fluoxetine treatment.” Lancet 342 (1993): 1423

83. Hemlock C, Rosenthal JS, Winston A “Fluoxetine-induced psoriasis.” Ann Pharmacother 26 (1992): 211-2

84. Gupta S, Major LF “Hair loss associated with fluoxetine.” Br J Psychiatry 159 (1991): 737-8

85. Strain SL “Fluoxetine-initiated ovulatory cycles in 2 clomiphene-resistant women.” Am J Psychiatry 151 (1994): 620

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87. Kazal LA, Jr Hall DL, Miller LG, Noel ML “Fluoxetine-induced SIADH: a geriatric occurrence?” J Fam Pract 36 (1993): 341-3

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Not all side effects for fluoxetine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Fluoxetine Dosage

Applies to the following strength(s): 90 mg ; 10 mg ; 20 mg ; 40 mg ; 20 mg/5 mL ; 15 mg ; 60 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for Bulimia

Immediate-release oral formulations:
Recommended dose: 60 mg orally once a day

Comments:
-Some patients may need to be started at a lower dose and titrated up over several days to the recommended dose
-Daily doses greater than 60 mg have not been systematically studied for the treatment of Bulimia

Use: Acute and maintenance treatment of binge-eating and vomiting behaviors in moderate to severe Bulimia Nervosa.

Usual Adult Dose for Depression

Immediate-release oral formulations:
Initial dose: 20 mg orally once a day, increased after several weeks if insufficient clinical improvement is observed
Maintenance dose: 20 to 60 mg orally per day
Maximum dose: 80 mg orally per day

Delayed release oral capsules:
Initial dose: 90 mg orally once a week, commenced 7 days after the last daily dose of immediate-release fluoxetine 20 mg formulations.

Comments:
-Doses above 20 mg per day may be given in divided doses, in the morning and at noon
-The full effect may be delayed until after at least 4 weeks of treatment
-If a satisfactory response with the once weekly oral fluoxetine is not maintained, a change back to daily fluoxetine dosing using the immediate-release oral formulations should be considered.
-Acute episodes of Major Depressive Disorder require several months or longer of sustained pharmacologic therapy
-Whether the dose needed to induce remission is the same as the dose needed to maintain and/or sustain euthymia is unknown

Use: Acute and maintenance treatment of Major Depressive Disorder (MDD)

Usual Adult Dose for Obsessive Compulsive Disorder

Immediate-release oral formulations:
Initial dose: 20 mg orally once a day, increased after several weeks if insufficient clinical improvement is observed.
Maintenance dose: 20 to 60 mg orally per day
Maximum dose: 80 mg orally per day

Comments:
-Doses above 20 mg per day may be given in divided doses, in the morning and at noon
-The full effect may be delayed until after at least 5 weeks of treatment

Use: Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD)

Usual Adult Dose for Panic Disorder

Immediate-release oral formulations:
Initial dose: 10 mg orally once a day, increased after one week to 20 mg orally once a day
Maintenance dose: 20 to 60 mg orally per day
Maximum dose: 60 mg orally per day

Comments:
-Doses above 20 mg per day may be given in divided doses, in the morning and at noon
-A dose increase may be considered after several weeks if no clinical improvement is observed.
-Doses greater than 60 mg per day have not been systematically studied for the treatment of Panic Disorder

Use: Acute treatment of Panic Disorder

Usual Adult Dose for Premenstrual Dysphoric Disorder

Immediate-release oral formulations:
Initial dose:
Continuous regimen: 20 mg orally once a day on every day of the menstrual cycle
Cyclic regimen: 20 mg orally once a day starting 14 days prior to the anticipated start of menstruation through to the first full day of menses, and repeated with each new cycle

Maintenance dose: 20 to 60 mg per day for either the continuous or intermittent regimens
Maximum dose: 80 mg orally per day

Duration: The 20 mg daily dosage has been shown to be effective for up to 6 months of treatment

Comments:
-A daily dose of 60 mg has not been shown to be significantly more effective than 20 mg daily
-Daily doses above 60 mg have not been systematically studied in patients with this condition

Usual Pediatric Dose for Depression

Immediate-release oral formulations:
8 to 18 years:
Initial dose: 10 to 20 mg orally once a day; the 10 mg daily dose may be increased after one week to 20 mg orally once a day

Lower weight children:
Initial dose: 10 mg orally once a day, increased to 20 mg orally once a day after several weeks if insufficient clinical improvement is observed

Maintenance dose: 10 to 20 mg orally once a day

Comments:
-The full effect may be delayed until after at least 4 weeks of treatment
-The potential risks versus clinical need should be assessed prior to using this drug in children and adolescents

Use: Acute and maintenance treatment of Major Depressive Disorder (MDD)

Usual Pediatric Dose for Obsessive Compulsive Disorder

7 to 18 years:
Immediate-release oral formulations:
Adolescents and higher weight children:
Initial dose: 10 mg orally once a day, increased to 20 mg orally once a day after 2 weeks
Maintenance dose: 20 to 60 mg orally per day
Maximum dose: 60 mg orally per day

Lower weight children:
Initial dose: 10 mg orally once a day, increased after several weeks if insufficient clinical improvement is observed
Maintenance dose: 20 to 30 mg orally once a day
Maximum dose: 60 mg orally per day

Comments:
-Additional dose increases may be considered after several more weeks if clinical improvement is insufficient
-Doses above 20 mg per day may be given in divided doses, in the morning and at noon
-In lower weight children, there is minimal experience with doses greater than 20 mg per day, and none with doses greater than 60 mg per day
-The full effect may be delayed until after at least 5 weeks of treatment
-The potential risks versus clinical need should be assessed prior to using this drug in children and adolescents

Use: Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Immediate-release oral formulations:
Adults:
Cirrhosis: Lower or less frequent dosing may be appropriate in these patients

Children: Dose adjustment may be required; however, no specific guidelines have been suggested. Caution is recommended.

Delayed-release oral capsules: Data not available

Dose Adjustments

A lower or less frequent dose should be considered in elderly patients.

Patients with concurrent disease or those on multiple concomitant medicines may require dose adjustment.

Switching from
MAOI therapy to fluoxetine therapy: At least 14 days should elapse
Fluoxetine therapy to MAOI therapy: At least 5 weeks should elapse
Fluoxetine therapy to TCA therapy: The dose of the TCA may need to be reduced and plasma levels temporarily monitored

Treatment withdrawal:
-A gradual dose reduction is recommended instead of abrupt cessation where possible
-If intolerable symptoms occur, it is recommended to consider resuming the previously prescribed dose and to decrease the dose at a more gradual rate.

Precautions

US BOXED WARNING:
-Antidepressants increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older.
-In patients of all ages who are started on antidepressant therapy, monitor closely for worsening and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber.
-Fluoxetine is not approved for use in children less than 7 years of age.

Safety and efficacy have not been established in pediatric patients younger than 8 years of age in Major Depressive Disorder and younger than 7 years of age in Obsessive Compulsive Disorder.

Consult WARNINGS section for additional precautions.

Dialysis

No adjustment recommended

Other Comments

Administration advice:
-A once a day dose should be taken in the morning; doses greater than 20 mg per day may be divided into morning and noon doses.
-Because fluoxetine may cause insomnia, night-time dosing should be limited to those patients experiencing sedation.

General:
-Fluoxetine oral capsules (Pulvules (R)), tablets, oral solution, and delayed release oral capsules (given weekly) are bioequivalent
-Changes in dose will not be fully reflected in plasma for several weeks due to the long elimination half-lives of fluoxetine and its major active metabolite.
-The need for ongoing treatment should be regularly reviewed
-Patients should be maintained on the lowest effective dose
-Avoid use as monotherapy in treatment-resistant depression i.e., patients who do not respond to two antidepressants of adequate dose and duration in the current episode

Monitoring:
-Cardiovascular: ECG monitoring (in patients with risk factors for QT-interval prolongation)
-Hepatic: Liver function
-Metabolic: Hyponatremia
-Nervous system: Serotonin syndrome
-Psychiatric: Emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Patient advice:
-Tell your healthcare provider about all of the medicines that you take, including prescription and non-prescription medicines.
-This medicine may increase the risk of suicidal thoughts and behavior. Be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Report any behavior of concern to your healthcare provider as soon as possible.
-This medicine may cause impaired judgment, thinking, or motor skills; do not drive a car or operate dangerous machinery until you know how this drug affects you.
-Concomitant ingestion of alcohol is not advised.

Fluoxetine Drug Interactions

A total of 1063 drugs (6131 brand and generic names) are known to interact with fluoxetine.

  • 262 major drug interactions (1811 brand and generic names)
  • 757 moderate drug interactions (4080 brand and generic names)
  • 44 minor drug interactions (240 brand and generic names)

Show all medications in the database that may interact with fluoxetine.

Check for interactions with fluoxetine

Type in a drug name and select a drug from the list.

Common medications checked in combination with fluoxetine

fluoxetine alcohol/food Interactions

There is 1 alcohol/food interaction with fluoxetine

fluoxetine disease Interactions

There are 12 disease interactions with fluoxetine which include:

Originally published on:https://www.drugs.com/fluoxetine.html

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