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Fluoxetine is a selective serotonin reuptake inhibitor (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.
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, rasagiline, selegiline, phenelzine, or transcypromine). Do not use fluoxetine with thioridazine, linezolid, pimozide, or methylene blue injection.
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.
Fluoxetine could impair judgment, thinking, or motor skills. Use caution when operating machinery.
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.
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. Tell your doctor if you are breast-feeding a baby.
Fluoxetine is not approved for use by anyone younger than 18 years old.
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.
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.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
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.
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;
signs of high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;
signs of low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
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.
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;
over-the-counter pain medications including ibuprofen, acetaminophen, aspirin, or similar medications;
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.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use fluoxetine only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Fluoxetine Hcl (www.drugs.com/fluoxetine.html).
Applies to fluoxetine: oral capsule, oral capsule delayed release, oral solution, oral syrup, oral tablet
Oral route (Capsule; Capsule, Delayed Release)
Antidepressants can increase the risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder. Closely monitor patients of all ages for clinical worsening and emergence of suicidal thoughts and behaviors. When using fluoxetine hydrochloride and olanzapine in combination, also refer to the Boxed Warning section of the package insert for fluoxetine hydrochloride/olanzapine.
Oral route (Solution)
Antidepressants can increase the risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder (MDD). Closely monitor patients of all ages for clinical worsening and emergence of suicidal thoughts and behaviors. Fluoxetine oral solution is approved for use in pediatric patients with MDD and obsessive compulsive disorder.
Oral route (Tablet)
Antidepressants can increase the risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder. Closely monitor patients of all ages for clinical worsening and emergence of suicidal thoughts and behaviors. Fluoxetine hydrochloride oral tablets are not approved for use in pediatric patients.
Along with its needed effects, fluoxetine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking fluoxetine:
More common
Less common
Rare
Incidence not known
Some side effects of fluoxetine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common or rare
Incidence not known
For Healthcare Professionals
Applies to fluoxetine: compounding powder, oral capsule, oral delayed release capsule, oral solution, oral tablet
GeneralThe most commonly reported side effects included insomnia, asthenia, and headache.
Nervous systemVery common (10% or more): Headache (up to 21%), somnolence (up to 17%), tremor (up to 13%), dizziness (up to 11%)
Common (1% to 10%): Amnesia, hyperkinesia, paresthesia/sensory disturbances, taste perversion/dysgeusia
Uncommon (0.1% to 1%): Abnormal gait, acute brain syndrome, ataxia, balance disorder, central nervous system (CNS) depression, CNS stimulation, dyskinesia, hyperkinesia, hypertonia, hyperesthesia, incoordination, memory impairment, migraine, myoclonus, neuralgia, neuropathy, syncope, vascular headache, vertigo
Rare (0.01% to 0.1%): Abnormal electroencephalogram, cerebral embolism, cerebral ischemia, circumoral paresthesia, convulsion/seizures, delusions, dysarthria, dystonia, extrapyramidal syndrome, foot drop, hyperesthesia, neuritis, paralysis, parosmia, reflexed decreased, serotonin syndrome (neuroleptic malignant syndrome-like effects), stupor, taste loss
Very rare (less than 0.01%): Mild intensity headache
Frequency not reported: Autonomic instability, coma, hyperreflexia, hypersomnia, neuromuscular aberrations, sedation
Postmarketing reports: Cerebrovascular accident, movement disorders, tardive dyskinesia, worsening of preexisting movement disorders
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.
PsychiatricAntidepressants 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.
Very common (10% or more): Insomnia (up to 33%), anxiety (up to 15%), nervousness (up to 14%)
Common (1% to 10%): Abnormal dreams, agitation, disturbance in attention, emotional lability, hostility, hypomania, mania, personality disorder, restlessness, sleep disorder, tension, thinking abnormal
Uncommon (0.1% to 1%): Akathisia, apathy, bruxism, depersonalization, elevated mood, euphoria, intentional overdose, manic reaction, neurosis, paranoid reaction, psychomotor hyperactivity, psychosis, suicidal thoughts and behavior, suicide attempt
Rare (less than 0.1%): Aggression, antisocial reaction, delusions, dysphemia, hallucinations, panic attacks
Frequency not reported: Activation syndrome, anger, complete suicide, depression, depression suicidal, early morning awakening, initial insomnia, intense dreams, intentional self-injury, mental status changes, middle insomnia, morbid thoughts, nightmares, self-injurious ideation and behavior, sleep disturbances, suicidal ideation
Postmarketing reports: Confusion, discontinuation/withdrawal symptoms, irritability, violent behaviors
GastrointestinalVery common (10% or more): Nausea (up to 29%), diarrhea (up to 18%), dry mouth (up to 12%)
Common (1% to 10%): Abdominal pain, constipation, dyspepsia, flatulence, gastrointestinal disorder, vomiting
Uncommon (0.1% to 1%): Aphthous stomatitis, buccoglossal syndrome, colitis, dysphagia, eructation, esophagitis, gastritis, gastroenteritis, gastrointestinal (GI) hemorrhage, glossitis, gum hemorrhage, hyperchlorhydria, increased salivation, melena, mouth ulceration, stomach ulcer, stomatitis
Rare (less than 0.1%): Acute abdominal syndrome, bloody diarrhea, duodenal ulcer, enteritis, esophageal pain, esophageal ulcer, fecal incontinence, hematemesis, intestinal obstruction, pancreatitis, peptic ulcer, salivary gland enlargement, stomach ulcer hemorrhage, tongue edema
Frequency not reported: Anal/esophageal/gastric/upper and lower GI/hemorrhoidal/peritoneal/rectal hemorrhage, bleeding esophageal varices, enterocolitis, esophageal/duodenal/gastric ulcer hemorrhage, GI bleeding, gingival/mouth bleeding, hematochezia, hemorrhagic diarrhea/diverticulitis/gastritis, intraabdominal hemorrhage
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 this drug.
RespiratoryVery common (10% or more): Rhinitis (up to 23%), pharyngitis (up to 11%), yawn/yawning (up to 11%)
Common (1% to 10%): Epistaxis, sinusitis
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, pneumothorax, pulmonary events (inflammatory processes of varying histopathology and/or fibrosis), stridor
Frequency not reported: Increased cough, interstitial lung disease, pneumonitis
Postmarketing reports: Eosinophilic pneumonia, pulmonary embolism, pulmonary hypertension
OtherVery common (10% or more): Asthenia/fatigue (up to 21%),
Common (1% to 10%): Accidental injury, chills, ear pain, feeling jittery, fever, lethargy, thirst, tinnitus
Uncommon (0.1% to 1%): Abortion, face edema, feeling abnormal, feeling hot/cold, malaise
Rare (less than 0.1%): Deafness, hypothermia, mucosal hemorrhage
Frequency not reported: Growth delay, hyperthermia, pain
Postmarketing reports: Malignant hyperthermia
MetabolicDecreased weight gain has been observed in association with use in children and adolescents.
Very common (10% or more): Anorexia (up to 17%)
Common (1% to 10%): Decreased appetite, increased appetite, weight loss
Uncommon (0.1% to 1%): Dehydration, gout, hypercholesterolemia, hyperlipemia, hypokalemia
Rare (less than 0.1%): Alcohol intolerance, alkaline phosphatase increased, blood sugar level changes, diabetic acidosis, diabetes mellitus, hyperkalemia, hyperuricemia, hypocalcemia, hyponatremia
Frequency not reported: Decreased alkaline phosphatase levels
Postmarketing reports: Hypoglycemia
GenitourinaryUrinary 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.
Very Common (10% or more): Decreased libido/loss of libido (up to 11%)
Common (1% to 10%): Abnormal ejaculation/ejaculation disorder, dysmenorrhea, erectile dysfunction, gynecological bleeding, impotence, micturition disorder, urinary frequency
Uncommon (0.1% to 1%): Albuminuria, amenorrhea, anorgasmia, breast enlargement, breast pain, 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, vaginal hemorrhage
Rare (less than 0.1%): Breast engorgement, glycosuria, hypomenorrhea, uterine hemorrhage, uterine fibroids enlarged
Frequency not reported: Delayed ejaculation, delayed sexual maturation, dysfunctional uterine bleeding, ejaculation dysfunction/failure, galactorrhea, genital hemorrhage, menometrorrhagia, orgasmic dysfunction, polymenorrhea, postmenopausal hemorrhage, premature ejaculation, retrograde ejaculation, uterine cervix hemorrhage, vaginal bleeding after drug withdrawal
Postmarketing reports: Enlarged clitoris, pollakiuria
ImmunologicVery Common (10% or more): Flu syndrome (up to 12%)
Common (1% to 10%): Infection
Rare (less than 0.1%): Herpes zoster
CardiovascularPatients have developed QT prolongation of at least 450 msec.
Common (1% to 10%): Chest pain, flushing/hot flush, hypertension, palpitation, QT-interval prolongation, 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 arrhythmia, ventricular extrasystoles, ventricular fibrillation
Frequency not reported: Labile blood pressure, tachycardia
Postmarketing reports: Atrial fibrillation, heart arrest, torsades de pointes/torsades de pointes-type arrhythmias
DermatologicAlopecia was usually reversible.
Common (1% to 10%): Pruritus, rash, sweating/hyperhidrosis, 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%): Epidermal necrolysis/toxic epidermal necrolysis, erythema multiforme, furunculosis, hirsutism, petechia, photosensitivity reaction, psoriasis, purpura, purpuric rash, seborrhea, Stevens Johnson syndrome/Lyell syndrome
Frequency not reported: Erythema, exfoliative rash, heat rash, erythematous rash, follicular rash, generalized rash, macular rash, morbilliform rash, papular rash, pruritic rash, vesicular rash, umbilical erythema rash
Postmarketing reports: Erythema nodosum, exfoliative dermatitis, thrombocytopenic purpura
OcularCommon (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, hyperacusis, iritis, scleritis, strabismus, visual field defect
Frequency not reported: Increased intraocular pressure
Postmarketing reports: Cataract, oculogyric crises, optic neuritis
MusculoskeletalCommon (1% to 10%): Arthralgia, muscle twitching/twitching
Uncommon (0.1% to 1%): Arthritis, bone pain, bursitis, leg cramps, tenosynovitis
Rare (less than 0.1%): Arthrosis, chondrodystrophy, creatine phosphokinase increased, myalgia, myasthenia, myopathy, osteomyelitis, osteoporosis, rheumatoid arthritis
Frequency not reported: Back pain, bone fractures
Epidemiological studies, primarily in patients aged 50 years or older, have shown an increased risk of bone fractures in patients receiving SSRIs or TCAs.
HypersensitivityCommon (1% to 10%): Allergic reaction
Rare (less than 0.1%): Anaphylactic/anaphylactoid reaction, angioedema, serum sickness
HepaticUncommon (0.1% to 1%): Abnormal liver function tests, cholelithiasis
Rare (less than 0.1%): Biliary pain, cholecystitis, hepatitis, idiosyncratic hepatitis, liver fatty deposits, transaminases increased, gamma glutamyltransferase increased
Frequency not reported: Abnormal hepatic function, aggravation of hepatic damage, cholestatic jaundice, hepatic failure/necrosis
HematologicRare (less than 0.1%): Blood dyscrasias, hypochromic anemia, iron deficiency anemia, leukopenia, lymphedema, lymphocytosis, neutropenia, thrombocytopenia
Postmarketing reports: Aplastic anemia, eosinophilia, immune-related hemolytic anemia, pancytopenia
EndocrineUncommon (0.1% to 1%): Hypothyroidism
Rare (less than 0.1%): Inappropriate secretion of antidiuretic hormone
Frequency not reported: Gynecomastia, hyperprolactinemia
RenalUncommon (0.1% to 1%): Albuminuria
Rare (less than 0.1%): Blood urea nitrogen (BUN) increased, kidney pain, oliguria
Postmarketing reports: Kidney failure
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Fluoxetine Hcl (www.drugs.com/fluoxetine.html).
November 24, 2020
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November 15, 2020
December 2, 2020
December 1, 2020
October 19, 2020