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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:
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:
Less common or rare
Incidence not known
Applies to fluoxetine: compounding powder, oral capsule, oral delayed release capsule, oral solution, oral tablet
The most commonly reported side effects included insomnia, asthenia, and headache.
Very 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.
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.
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
Very 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.
Very 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
Very 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
Decreased 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
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.
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
Very Common (10% or more): Flu syndrome (up to 12%)
Common (1% to 10%): Infection
Rare (less than 0.1%): Herpes zoster
Patients 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
Alopecia 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
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, hyperacusis, iritis, scleritis, strabismus, visual field defect
Frequency not reported: Increased intraocular pressure
Postmarketing reports: Cataract, oculogyric crises, optic neuritis
Common (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.
Common (1% to 10%): Allergic reaction
Rare (less than 0.1%): Anaphylactic/anaphylactoid reaction, angioedema, serum sickness
Uncommon (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
Rare (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
Uncommon (0.1% to 1%): Hypothyroidism
Rare (less than 0.1%): Inappropriate secretion of antidiuretic hormone
Frequency not reported: Gynecomastia, hyperprolactinemia
Uncommon (0.1% to 1%): Albuminuria
Rare (less than 0.1%): Blood urea nitrogen (BUN) increased, kidney pain, oliguria
Postmarketing reports: Kidney failure
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