Prozac Side Effects

Generic Name: fluoxetine

Please note - some side effects for Prozac may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Prozac - for the Consumer

Prozac

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Prozac:

Abnormal dreams; anxiety; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; flu-like symptoms (eg, fever, chills, muscle aches); flushing; increased sweating; loss of appetite; nausea; nervousness; runny nose; sore throat; stomach upset; trouble sleeping; weakness; yawning.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bizarre behavior; black or bloody stools; chest pain; confusion; decreased concentration; decreased coordination; exaggerated reflexes; excessive sweating; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; increased hunger, thirst, or urination; joint or wrist aches or pain; memory loss; new or worsening agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; persistent or severe ringing in the ears;persistent, painful erection; red, swollen, blistered, or peeling skin; seizures; severe or persistent anxiety, trouble sleeping, or weakness; severe or persistent nausea, vomiting, diarrhea, or headache; significant weight loss; stomach pain; suicidal thoughts or attempts; tremor; unusual bruising or bleeding; unusual or severe mental or mood changes; unusual swelling; unusual weakness; vision changes; worsening of depression.

Prozac Weekly Delayed-Release Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Prozac Weekly Delayed-Release Capsules:

Abnormal dreams; anxiety; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; flu-like symptoms (eg, fever, chills, muscle aches); flushing; increased sweating; loss of appetite; nausea; nervousness; runny nose; sore throat; stomach upset; trouble sleeping; weakness; yawning.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bizarre behavior; black or bloody stools; chest pain; confusion; decreased concentration; decreased coordination; exaggerated reflexes; excessive sweating; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; increased hunger, thirst, or urination; joint or wrist aches or pain; memory loss; new or worsening agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; persistent or severe ringing in the ears; persistent, painful erection; red, swollen, blistered, or peeling skin; seizures; severe or persistent anxiety, trouble sleeping, or weakness; severe or persistent nausea, vomiting, diarrhea, or headache; significant weight loss; stomach pain; suicidal thoughts or attempts; tremor; unusual bruising or bleeding; unusual or severe mental or mood changes; unusual swelling; unusual weakness; vision changes; worsening of depression.

Prozac Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Prozac Solution:

Abnormal dreams; anxiety; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; flu-like symptoms (eg, fever, chills, muscle aches); flushing; increased sweating; loss of appetite; nausea; nervousness; runny nose; sore throat; stomach upset; trouble sleeping; weakness; yawning.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bizarre behavior; black or bloody stools; chest pain; confusion; decreased concentration; decreased coordination; exaggerated reflexes; excessive sweating; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; increased hunger, thirst, or urination; joint or wrist aches or pain; memory loss; new or worsening agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; persistent or severe ringing in the ears;persistent, painful erection; red, swollen, blistered, or peeling skin; seizures; severe or persistent anxiety, trouble sleeping, or weakness; severe or persistent nausea, vomiting, diarrhea, or headache; significant weight loss; stomach pain; suicidal thoughts or attempts; tremor; unusual bruising or bleeding; unusual or severe mental or mood changes; unusual swelling; unusual weakness; vision changes; worsening of depression.

Prozac Side Effects - for the Professional

Prozac

Multiple doses of Prozac had been administered to 10,782 patients with various diagnoses in US clinical trials as of May 8, 1995. In addition, there have been 425 patients administered Prozac in panic clinical trials. Adverse events were recorded by clinical investigators using descriptive terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a limited (i.e., reduced) number of standardized event categories.

In the tables and tabulations that follow, COSTART Dictionary terminology has been used to classify reported adverse events. The stated frequencies represent the proportion of individuals who experienced, at least once, a treatment–emergent adverse event of the type listed. An event was considered treatment–emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. It is important to emphasize that events reported during therapy were not necessarily caused by it.

The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence rate in the population studied.

Incidence in major depressive disorder, OCD, bulimia, and panic disorder placebo–controlled clinical trials (excluding data from extensions of trials) — Table 2 enumerates the most common treatment–emergent adverse events associated with the use of Prozac (incidence of at least 5% for Prozac and at least twice that for placebo within at least 1 of the indications) for the treatment of major depressive disorder, OCD, and bulimia in US controlled clinical trials and panic disorder in US plus non–US controlled trials. Table 3 enumerates treatment–emergent adverse events that occurred in 2% or more patients treated with Prozac and with incidence greater than placebo who participated in US major depressive disorder, OCD, and bulimia controlled clinical trials and US plus non–US panic disorder controlled clinical trials. Table 3 provides combined data for the pool of studies that are provided separately by indication in Table 2.

Associated with discontinuation in major depressive disorder, OCD, bulimia, and panic disorder placebo–controlled clinical trials (excluding data from extensions of trials) — Table 4 lists the adverse events associated with discontinuation of Prozac treatment (incidence at least twice that for placebo and at least 1% for Prozac in clinical trials collecting only a primary event associated with discontinuation) in major depressive disorder, OCD, bulimia, and panic disorder clinical trials, plus non–US panic disorder clinical trials.

Other adverse events in pediatric patients (children and adolescents) — Treatment–emergent adverse events were collected in 322 pediatric patients (180 fluoxetine–treated, 142 placebo–treated). The overall profile of adverse events was generally similar to that seen in adult studies, as shown in Tables 2 and 3. However, the following adverse events (excluding those which appear in the body or footnotes of Tables 2 and 3 and those for which the COSTART terms were uninformative or misleading) were reported at an incidence of at least 2% for fluoxetine and greater than placebo: thirst, hyperkinesia, agitation, personality disorder, epistaxis, urinary frequency, and menorrhagia.

The most common adverse event (incidence at least 1% for fluoxetine and greater than placebo) associated with discontinuation in 3 pediatric placebo–controlled trials (N=418 randomized; 228 fluoxetine–treated; 190 placebo–treated) was mania/hypomania (1.8% for fluoxetine–treated, 0% for placebo–treated). In these clinical trials, only a primary event associated with discontinuation was collected.

Events observed in Prozac Weekly clinical trials — Treatment–emergent adverse events in clinical trials with Prozac Weekly were similar to the adverse events reported by patients in clinical trials with Prozac daily. In a placebo–controlled clinical trial, more patients taking Prozac Weekly reported diarrhea than patients taking placebo (10% versus 3%, respectively) or taking Prozac 20 mg daily (10% versus 5%, respectively).

Male and female sexual dysfunction with SSRIs — Although changes in sexual desire, sexual performance, and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of pharmacologic treatment. In particular, some evidence suggests that SSRIs can cause such untoward sexual experiences. Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, however, in part because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance, cited in product labeling, are likely to underestimate their actual incidence. In patients enrolled in US major depressive disorder, OCD, and bulimia placebo–controlled clinical trials, decreased libido was the only sexual side effect reported by at least 2% of patients taking fluoxetine (4% fluoxetine,<1% placebo). There have been spontaneous reports in women taking fluoxetine of orgasmic dysfunction, including anorgasmia.

There are no adequate and well–controlled studies examining sexual dysfunction with fluoxetine treatment.

Priapism has been reported with all SSRIs.

While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, physicians should routinely inquire about such possible side effects.

Other Events Observed in Clinical Trials

Following is a list of all treatment–emergent adverse events reported at anytime by individuals taking fluoxetine in US clinical trials as of May 8, 1995 (10,782 patients) except (1) those listed in the body or footnotes of Tables 2 or 3 above or elsewhere in labeling; (2) those for which the COSTART terms were uninformative or misleading; (3) those events for which a causal relationship to Prozac use was considered remote; and (4) events occurring in only 1 patient treated with Prozac and which did not have a substantial probability of being acutely life–threatening.

Events are classified within body system categories using the following definitions: frequent adverse events are defined as those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in less than 1/1000 patients.

Body as a Whole — Frequent: chest pain, chills; Infrequent: chills and fever, face edema, intentional overdose, malaise, pelvic pain, suicide attempt; Rare: acute abdominal syndrome, hypothermia, intentional injury, neuroleptic malignant syndrome1, photosensitivity reaction.

Cardiovascular System — Frequent: hemorrhage, hypertension, palpitation; Infrequent: angina pectoris, arrhythmia, congestive heart failure, hypotension, migraine, myocardial infarct, postural hypotension, syncope, tachycardia, vascular headache; Rare: atrial fibrillation, bradycardia, cerebral embolism, cerebral ischemia, cerebrovascular accident, extrasystoles, heart arrest, heart block, pallor, peripheral vascular disorder, phlebitis, shock, thrombophlebitis, thrombosis, vasospasm, ventricular arrhythmia, ventricular extrasystoles, ventricular fibrillation.

Digestive System — Frequent: increased appetite, nausea and vomiting; Infrequent: aphthous stomatitis, cholelithiasis, colitis, dysphagia, eructation, esophagitis, gastritis, gastroenteritis, glossitis, gum hemorrhage, hyperchlorhydria, increased salivation, liver function tests abnormal, melena, mouth ulceration, nausea/vomiting/diarrhea, stomach ulcer, stomatitis, thirst; Rare: biliary pain, bloody diarrhea, cholecystitis, duodenal ulcer, enteritis, esophageal ulcer, fecal incontinence, gastrointestinal hemorrhage, hematemesis, hemorrhage of colon, hepatitis, intestinal obstruction, liver fatty deposit, pancreatitis, peptic ulcer, rectal hemorrhage, salivary gland enlargement, stomach ulcer hemorrhage, tongue edema.

Endocrine System — Infrequent: hypothyroidism; Rare: diabetic acidosis, diabetes mellitus.

Hemic and Lymphatic System — Infrequent: anemia, ecchymosis; Rare: blood dyscrasia, hypochromic anemia, leukopenia, lymphedema, lymphocytosis, petechia, purpura, thrombocythemia, thrombocytopenia.

Metabolic and Nutritional — Frequent: weight gain; Infrequent: dehydration, generalized edema, gout, hypercholesteremia, hyperlipemia, hypokalemia, peripheral edema; Rare: alcohol intolerance, alkaline phosphatase increased, BUN increased, creatine phosphokinase increased, hyperkalemia, hyperuricemia, hypocalcemia, iron deficiency anemia, SGPT increased.

Musculoskeletal System — Infrequent: arthritis, bone pain, bursitis, leg cramps, tenosynovitis; Rare: arthrosis, chondrodystrophy, myasthenia, myopathy, myositis, osteomyelitis, osteoporosis, rheumatoid arthritis.

Nervous System — Frequent: agitation, amnesia, confusion, emotional lability, sleep disorder; Infrequent: abnormal gait, acute brain syndrome, akathisia, apathy, ataxia, buccoglossal syndrome, CNS depression, CNS stimulation, depersonalization, euphoria, hallucinations, hostility, hyperkinesia, hypertonia, hypesthesia, incoordination, libido increased, myoclonus, neuralgia, neuropathy, neurosis, paranoid reaction, personality disorder2, psychosis, vertigo; Rare: abnormal electroencephalogram, antisocial reaction, circumoral paresthesia, coma, delusions, dysarthria, dystonia, extrapyramidal syndrome, foot drop, hyperesthesia, neuritis, paralysis, reflexes decreased, reflexes increased, stupor.

Respiratory System — Infrequent: asthma, epistaxis, hiccup, hyperventilation; Rare: apnea, atelectasis, cough decreased, emphysema, hemoptysis, hypoventilation, hypoxia, larynx edema, lung edema, pneumothorax, stridor.

Skin and Appendages — Infrequent: acne, alopecia, contact dermatitis, eczema, maculopapular rash, skin discoloration, skin ulcer, vesiculobullous rash; Rare: furunculosis, herpes zoster, hirsutism, petechial rash, psoriasis, purpuric rash, pustular rash, seborrhea.

Special Senses — Frequent: ear pain, taste perversion, tinnitus; Infrequent: conjunctivitis, dry eyes, mydriasis, photophobia; Rare: blepharitis, deafness, diplopia, exophthalmos, eye hemorrhage, glaucoma, hyperacusis, iritis, parosmia, scleritis, strabismus, taste loss, visual field defect.

Urogenital System — Frequent: urinary frequency; Infrequent: abortion3, albuminuria, amenorrhea3, anorgasmia, breast enlargement, breast pain, cystitis, dysuria, female lactation3, fibrocystic breast3, hematuria, leukorrhea3, menorrhagia3, metrorrhagia3, nocturia, polyuria, urinary incontinence, urinary retention, urinary urgency, vaginal hemorrhage3; Rare: breast engorgement, glycosuria, hypomenorrhea3, kidney pain, oliguria, priapism3, uterine hemorrhage3, uterine fibroids enlarged3.

Postintroduction Reports

Voluntary reports of adverse events temporally associated with Prozac that have been received since market introduction and that may have no causal relationship with the drug include the following: aplastic anemia, atrial fibrillation, cataract, cerebral vascular accident, cholestatic jaundice, confusion, dyskinesia (including, for example, a case of buccal–lingual–masticatory syndrome with involuntary tongue protrusion reported to develop in a 77–year–old female after 5 weeks of fluoxetine therapy and which completely resolved over the next few months following drug discontinuation), eosinophilic pneumonia, epidermal necrolysis, erythema multiforme, erythema nodosum, exfoliative dermatitis, gynecomastia, heart arrest, hepatic failure/necrosis, hyperprolactinemia, hypoglycemia, immune–related hemolytic anemia, kidney failure, misuse/abuse, movement disorders developing in patients with risk factors including drugs associated with such events and worsening of preexisting movement disorders, neuroleptic malignant syndrome–like events, optic neuritis, pancreatitis, pancytopenia, priapism, pulmonary embolism, pulmonary hypertension, QT prolongation, serotonin syndrome (a range of signs and symptoms that can rarely, in its most severe form, resemble neuroleptic malignant syndrome), Stevens–Johnson syndrome, sudden unexpected death, suicidal ideation, thrombocytopenia, thrombocytopenic purpura, vaginal bleeding after drug withdrawal, ventricular tachycardia (including torsades de pointes–type arrhythmias), and violent behaviors.

1

Neuroleptic malignant syndrome is the COSTART term which best captures serotonin syndrome.

2

Personality disorder is the COSTART term for designating nonaggressive objectionable behavior.

3

Adjusted for gender.

Side Effects by Body System

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. (Although these studies focused on upper gastrointestinal bleeding, there is reason to believe that bleeding at other sites may also be potentiated.)

Gastrointestinal side effects have frequently included nausea (15% to 21%) and diarrhea (12%). Dry mouth, constipation, dyspepsia, stomatitis, and upper gastrointestinal bleeding have also been reported.

Nervous system

Nervous system side effects including headache, anxiety, nervousness, insomnia, drowsiness, sedation, tremor, dizziness, jitteriness, and fatigue have all been reported. The reported incidence of each of these effects ranges between 4% and 20% of treated patients. Cases of akathisia, neuromuscular twitching, tics, myoclonus, migraines, sleep abnormalities, dyskinesia, acute dystonic reactions, worsening of Parkinson's disease, seizures, stuttering, paresthesias, and cognitive dysfunction have also been reported.

Cases of the neuroleptic malignant syndrome occurring in patients started on fluoxetine have been reported.

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.

A number of case reports have implicated fluoxetine in causing seizures. The manufacturer reports that, during premarketing testing, 12 out of 6000 patients experienced convulsions.

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

Nearly all selective serotonin reuptake inhibitors, mixed serotonin/norepinephrine reuptake inhibitors, and tricyclic antidepressants cause sleep abnormalities to some extent. These antidepressants have marked dose-dependent effects on rapid eye movement (REM) sleep, causing reductions in the overall amount of REM sleep over the night and delays the first entry into REM sleep (increased REM sleep onset latency (ROL)), both in healthy subjects and depressed patients. The antidepressants that increase serotonin function appear to have the greatest effect on REM sleep. The reduction in REM sleep is greatest early in treatment, but gradually returns towards baseline during long-term therapy; however, ROL remains long. Following discontinuation of therapy the amount of REM sleep tends to rebound. Some of these drugs (i.e., bupropion, mirtazapine, nefazodone, trazodone, trimipramine) appear to have a modest or minimal effect on REM sleep.

Psychiatric

The reported association between fluoxetine therapy and the development of suicidal ideation is controversial. The 1991 meta-analysis of controlled trials (which was sponsored by the manufacturer of fluoxetine) reported six suicidal acts occurring in a total of 1763 patients treated with fluoxetine. The frequency of suicidal acts was 0.3% and was similar to the frequency reported for placebo (0.2%) and tricyclic antidepressant therapy (0.4%).

Several cases of fluoxetine abuse have been reported in patients with a history of stimulant abuse.

Additionally, several cases of panic attacks and severe nightmares have been associated with fluoxetine therapy.

Psychiatric side effects including hypomania, mania, transient psychosis, development of obsessive-compulsive symptoms, paranoid reaction, delusions, agitation, and a depersonalization syndrome have been reported. A number of reports have suggested that fluoxetine may be associated with the development of suicidal ideation. However, a meta-analysis of controlled studies has suggested that such an association may not exist. A retrospective study of suicidal ideation in 294 patients treated with fluoxetine for depression compared to other patients treated with a variety of therapeutic agents for depression has also suggested that an association between fluoxetine and increased risk of suicidal ideation may not exist.

Other

Nearly all selective serotonin reuptake inhibitors, mixed serotonin/norepinephrine reuptake inhibitors, and tricyclic antidepressants cause sleep abnormalities to some extent. These antidepressants have marked dose-dependent effects on rapid eye movement (REM) sleep, causing reductions in the overall amount of REM sleep over the night and delays the first entry into REM sleep (increased REM sleep onset latency (ROL)), both in healthy subjects and depressed patients. The antidepressants that increase serotonin function appear to have the greatest effect on REM sleep. The reduction in REM sleep is greatest early in treatment, but gradually returns towards baseline during long-term therapy; however, ROL remains long. Following discontinuation of therapy the amount of REM sleep tends to rebound. Some of these drugs (i.e., bupropion, mirtazapine, nefazodone, trazodone, trimipramine) appear to have a modest or minimal effect on REM sleep.

Side effects on sleep have been reported and, in addition to insomnia, include vivid dreaming and an increase in the number of eye movements during non-REM sleep.

General

Very rarely, the anorexic effects of fluoxetine have resulted in dramatic and dangerous reductions in body weight. One study of 20 nondepressed obese women receiving 60 mg of fluoxetine a day indicated that the drug increased resting energy expenditure and basal body temperature. The author also notes the theory that a higher basal temperature preceding a meal could limit food consumption.

One study has reported that while the initial four weeks of fluoxetine therapy was associated with modest weight loss, weight gain for patients taking fluoxetine for longer periods was not different from the weight gain of control subjects (and was believed to be related to recovery from depression).

General side effects including anorexia (9%) have been reported.

Genitourinary

Genitourinary side effects including sexual dysfunction have been reported. The manufacturer has reported sexual dysfunction side effects at rate of 2%. However, some studies have reported sexual dysfunction in 7.8% to 34% of patients. Specific problems reported include male and female anorgasmia, decreased libido, penile anesthesia, vaginal anesthesia, ejaculatory dysfunction, and impotence.

Clitoral enlargement and prolonged penile erection have been reported.

Cases of improved male sexual function in patients with erectile dysfunction have been reported. Sexual obsessions have also been reported.

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.

Cardiovascular side effects including bradycardia have been reported to occur in controlled studies of patients treated with fluoxetine. Several cases of bradycardia- induced syncope have also been reported. Several cases of QTc prolongation or torsades de pointes have been reported in association with fluoxetine treatment.

Hematologic

Hematologic side effects include case reports which have suggested that fluoxetine may interfere with platelet function. Petechiae, increased bleeding times, epistaxis, and gastrointestinal hemorrhage have been reported rarely in association with fluoxetine therapy.

Endocrine

Endocrine side effects include case reports which have suggested that fluoxetine may rarely result in the development of the syndrome of inappropriate secretion of antidiuretic hormone (particularly in elderly patients).

Cases of increased serum prolactin and resumption of menses and ovulation have been reported in patients taking fluoxetine.

Dermatologic

Dermatologic side effect including severe hair loss, psoriasis, excessive sweating, and cutaneous hypersensitivity reactions have been reported to occur in association with fluoxetine therapy. Erythema multiforme and toxic epidermal necrolysis have been reported rarely.

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

Ocular

Ocular side effects have included a case report which suggested that fluoxetine may provoke reversible narrow-angle glaucoma. In one study of 20 patients, all patients showed a significant increase in intraocular pressure 2 hours after oral administration of fluoxetine.

Respiratory

Respiratory side effects include a case report that suggested fluoxetine may provoke interstitial pulmonary damage. Another case report described a patient, receiving fluoxetine who developed progressive dyspnea, lung infiltrates, and restrictive lung disease. Pathologic findings were consistent with hypersensitivity pneumonitis. Associated pulmonary phospholipidosis was also noted.

Hypersensitivity

Hypersensitivity side effects involving rash, fever, lymphadenopathy, and arthralgias have been reported in association with fluoxetine use.

Hypersensitivity reactions generally require discontinuation of fluoxetine. Eli Lilly has disclosed 96 reports of serum sickness-like reactions occurring out of 15 million patients treated with fluoxetine.

Immunologic

Immunologic side effects including cases of reactivation of herpes simplex virus infection have been reported in patients treated with fluoxetine.

Hepatic

Hepatic side effects including five cases of hepatotoxicity have been reported in association with fluoxetine therapy. Asymptomatic increases in liver enzyme values have been reported in 0.5% of patients receiving long term fluoxetine therapy.

Musculoskeletal

In one study using the healthcare data from the providence of Ontario, Canada reviewing 8,239 patients treated for hip fractures, the adjusted odds ratio for hip fracture was 2.4 for exposure to selective serotonin reuptake inhibitors (including fluoxetine, fluvoxamine, paroxetine, and sertraline), compared to participants who had no exposure to antidepressants.

Musculoskeletal side effects may include an increased risk for hip fractures.

Other

Other side effects include a withdrawal-type reaction. In one retrospective chart review of 352 patients who were supervised during tapering and discontinuation from serotonin reuptake inhibitor therapy, dizziness, lethargy, paresthesia, nausea, vivid dreams, irritability, and lowered mood were the most common symptoms reported. Patients with at least on qualitatively new symptom were defined in the fluoxetine group at a rate of 1.5%.

Metabolic

Numerous cases of hyponatremia have been reported following treatment with a selective serotonin reuptake inhibitor (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.

Metabolic sides effects including hyponatremia have been reported in patients receiving fluoxetine.

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