For the Consumer

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

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

• 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

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

• 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 commonly reported side effects included insomnia, asthenia, and headache.

Nervous system

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.

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.

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

Gastrointestinal

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.

Respiratory

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

Other

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

Metabolic

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

Genitourinary

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

Immunologic

Very Common (10% or more): Flu syndrome (up to 12%)

Common (1% to 10%): Infection

Rare (less than 0.1%): Herpes zoster

Cardiovascular

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

Dermatologic

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

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, hyperacusis, iritis, scleritis, strabismus, visual field defect

Frequency not reported: Increased intraocular pressure

Postmarketing reports: Cataract, oculogyric crises, optic neuritis

Musculoskeletal

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.

Hypersensitivity

Common (1% to 10%): Allergic reaction

Rare (less than 0.1%): Anaphylactic/anaphylactoid reaction, angioedema, serum sickness

Hepatic

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

Hematologic

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

Endocrine

Uncommon (0.1% to 1%): Hypothyroidism

Rare (less than 0.1%): Inappropriate secretion of antidiuretic hormone

Frequency not reported: Gynecomastia, hyperprolactinemia

Renal

Uncommon (0.1% to 1%): Albuminuria

Rare (less than 0.1%): Blood urea nitrogen (BUN) increased, kidney pain, oliguria

Postmarketing reports: Kidney failure