Prozac Weekly Side Effects

Generic Name: fluoxetine,fluoxetine hydrochloride

Please note - some side effects for Prozac Weekly may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Prozac Weekly - for the Consumer

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Prozac Weekly Delayed-Release Capsules:

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; trouble urinating; unusual bruising or bleeding; unusual or severe mental or mood changes; unusual swelling; unusual weakness; vision changes; worsening of depression.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Prozac Weekly Side Effects - for the Professional

Prozac Weekly

When using PROZAC and olanzapine in combination, also refer to the Adverse Reactions section of the package insert for Symbyax.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect or predict the rates observed in practice.

Multiple doses of PROZAC have been administered to 10,782 patients with various diagnoses in US clinical trials. In addition, there have been 425 patients administered PROZAC in panic clinical trials. Adverse reactions 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 reactions without first grouping similar types of reactions into a limited (i.e., reduced) number of standardized reaction categories.

In the tables and tabulations that follow, COSTART Dictionary terminology has been used to classify reported adverse reactions. The stated frequencies represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction 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 reactions 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 3 enumerates the most common treatment-emergent adverse reactions 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 5 enumerates treatment-emergent adverse reactions 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 4 provides combined data for the pool of studies that are provided separately by indication in Table 3.

Table 3: Most Common Treatment-Emergent Adverse Reactions: Incidence in Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Placebo-Controlled Clinical Trials1,2

1 Incidence less than 1%.
2 Includes US data for Major Depressive Disorder, OCD, Bulimia, and Panic Disorder clinical trials, plus non-US data for Panic Disorder clinical trials.
3 Denominator used was for males only (N=690 PROZAC Major Depressive Disorder; N=410 placebo Major Depressive Disorder; N=116 PROZAC OCD; N=43 placebo OCD; N=14 PROZAC bulimia; N=1 placebo bulimia; N=162 PROZAC panic; N=121 placebo panic).
	Percentage of Patients Reporting Event
	Major Depressive Disorder		OCD		Bulimia		Panic Disorder
Body System/ Adverse Reaction	PROZAC (N=1728)	Placebo (N=975)	PROZAC (N=266)	Placebo (N=89)	PROZAC (N=450)	Placebo (N=267)	PROZAC (N=425)	Placebo (N=342)
Body as a Whole
Asthenia	9	5	15	11	21	9	7	7
Flu syndrome	3	4	10	7	8	3	5	5
Cardiovascular System
Vasodilatation	3	2	5	--	2	1	1	--
Digestive System
Nausea	21	9	26	13	29	11	12	7
Diarrhea	12	8	18	13	8	6	9	4
Anorexia	11	2	17	10	8	4	4	1
Dry mouth	10	7	12	3	9	6	4	4
Dyspepsia	7	5	10	4	10	6	6	2
Nervous System
Insomnia	16	9	28	22	33	13	10	7
Anxiety	12	7	14	7	15	9	6	2
Nervousness	14	9	14	15	11	5	8	6
Somnolence	13	6	17	7	13	5	5	2
Tremor	10	3	9	1	13	1	3	1
Libido decreased	3	--	11	2	5	1	1	2
Abnormal dreams	1	1	5	2	5	3	1	1
Respiratory System
Pharyngitis	3	3	11	9	10	5	3	3
Sinusitis	1	4	5	2	6	4	2	3
Yawn	--	--	7	--	11	--	1	--
Skin and Appendages
Sweating	8	3	7	--	8	3	2	2
Rash	4	3	6	3	4	4	2	2
Urogenital System
Impotence3	2	--	--	--	7	--	1	--
Abnormal ejaculation3	--	--	7	--	7	--	2	1

Table 4: Treatment-Emergent Adverse Reactions: Incidence in Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Placebo-Controlled Clinical Trials1,2

1 Incidence less than 1%.
2 Includes US data for Major Depressive Disorder, OCD, bulimia, and Panic Disorder clinical trials, plus non-US data for Panic Disorder clinical trials.
	Percentage of Patients Reporting Event
	Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Combined
Body System/ Adverse Reaction	PROZAC (N=2869)	Placebo (N=1673)
Body as a Whole
Headache	21	19
Asthenia	11	6
Flu syndrome	5	4
Fever	2	1
Cardiovascular System
Vasodilatation	2	1
Digestive System
Nausea	22	9
Diarrhea	11	7
Anorexia	10	3
Dry mouth	9	6
Dyspepsia	8	4
Constipation	5	4
Flatulence	3	2
Vomiting	3	2
Metabolic and Nutritional Disorders
Weight loss	2	1
Nervous System
Insomnia	19	10
Nervousness	13	8
Anxiety	12	6
Somnolence	12	5
Dizziness	9	6
Tremor	9	2
Libido decreased	4	1
Thinking abnormal	2	1
Respiratory System
Yawn	3	--
Skin and Appendages
Sweating	7	3
Rash	4	3
Pruritus	3	2
Special Senses
Abnormal vision	2	1

Associated with discontinuation in Major Depressive Disorder, OCD, bulimia, and Panic Disorder placebo-controlled clinical trials (excluding data from extensions of trials) — Table 5 lists the adverse reactions 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 reaction associated with discontinuation) in Major Depressive Disorder, OCD, bulimia, and Panic Disorder clinical trials, plus non-US Panic Disorder clinical trials.

Table 5: Most Common Adverse Reactions Associated with Discontinuation in Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Placebo-Controlled Clinical Trials1

1 Includes US Major Depressive Disorder, OCD, bulimia, and Panic Disorder clinical trials, plus non-US Panic Disorder clinical trials.
Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Combined (N=1533)	Major Depressive Disorder (N=392)	OCD (N=266)	Bulimia (N=450)	Panic Disorder (N=425)
Anxiety (1%)	--	Anxiety (2%)	--	Anxiety (2%)
--	--	--	Insomnia (2%)	--
--	Nervousness (1%)	--	--	Nervousness (1%)
--	--	Rash (1%)	--	--

Other adverse reactions in pediatric patients (children and adolescents) — Treatment-emergent adverse reactions were collected in 322 pediatric patients (180 fluoxetine-treated, 142 placebo-treated). The overall profile of adverse reactions was generally similar to that seen in adult studies, as shown in Tables 4 and 5. However, the following adverse reactions (excluding those which appear in the body or footnotes of Tables 4 and 5 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 reaction (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 reaction associated with discontinuation was collected.

Reactions observed in Prozac Weekly clinical trials — Treatment-emergent adverse reactions in clinical trials with Prozac Weekly were similar to the adverse reactions 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.

Symptoms of sexual dysfunction occasionally persist after discontinuation of 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 Reactions

Following is a list of treatment-emergent adverse reactions reported by patients treated with fluoxetine in clinical trials. This listing is not intended to include reactions (1) already listed in previous tables or elsewhere in labeling, (2) for which a drug cause was remote, (3) which were so general as to be uninformative, (4) which were not considered to have significant clinical implications, or (5) which occurred at a rate equal to or less than placebo.

Reactions are classified by body system using the following definitions: frequent adverse reactions are those occurring in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1000 patients; rare reactions are those occurring in fewer than 1/1000 patients.

Body as a Whole — Frequent: chills; Infrequent: suicide attempt; Rare: acute abdominal syndrome, photosensitivity reaction.

Cardiovascular System — Frequent: palpitation; Infrequent: arrhythmia, hypotension1.

Digestive System — Infrequent: dysphagia, gastritis, gastroenteritis, melena, stomach ulcer; Rare: bloody diarrhea, duodenal ulcer, esophageal ulcer, gastrointestinal hemorrhage, hematemesis, hepatitis, peptic ulcer, stomach ulcer hemorrhage.

Hemic and Lymphatic System — Infrequent: ecchymosis; Rare: petechia, purpura.

Nervous System — Frequent: emotional lability; Infrequent: akathisia, ataxia, balance disorder1, bruxism1, buccoglossal syndrome, depersonalization, euphoria, hypertonia, libido increased, myoclonus, paranoid reaction; Rare: delusions.

Respiratory System — Rare: larynx edema.

Skin and Appendages — Infrequent: alopecia; Rare: purpuric rash.

Special Senses — Frequent: taste perversion; Infrequent: mydriasis.

Urogenital System — Frequent: micturition disorder; Infrequent: dysuria, gynecological bleeding2.

1 MedDRA dictionary term from integrated database of placebo controlled trials of 15870 patients, of which 9673 patients received fluoxetine.

2 Group term that includes individual MedDRA terms: cervix hemorrhage uterine, dysfunctional uterine bleeding, genital hemorrhage, menometrorrhagia, menorrhagia, metrorrhagia, polymenorrhea, postmenopausal hemorrhage, uterine hemorrhage, vaginal hemorrhage. Adjusted for gender.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of PROZAC. Because these reactions are reported voluntarily from a population of uncertain size, it is difficult to reliably estimate their frequency or evaluate a causal relationship to drug exposure.

Voluntary reports of adverse reactions 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 fibrillation1, cataract, cerebrovascular accident1, cholestatic jaundice, 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 pneumonia1, epidermal necrolysis, erythema multiforme, erythema nodosum, exfoliative dermatitis, gynecomastia, heart arrest1, hepatic failure/necrosis, hyperprolactinemia, hypoglycemia, immune-related hemolytic anemia, kidney failure, memory impairment, movement disorders developing in patients with risk factors including drugs associated with such reactions and worsening of pre-existing movement disorders, optic neuritis, pancreatitis1, pancytopenia, pulmonary embolism, pulmonary hypertension, QT prolongation, Stevens-Johnson syndrome, thrombocytopenia1, thrombocytopenic purpura, ventricular tachycardia (including torsades de pointes–type arrhythmias), vaginal bleeding, and violent behaviors1.

1 These terms represent serious adverse events, but do not meet the definition for adverse drug reactions. They are included here because of their seriousness.

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Side Effects by Body System - for Healthcare Professionals

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. Balance disorder and bruxism have also been reported. Postmarketing experience has included memory impairment.

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 non depressed 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. Gynecological bleeding, dysuria and micturition disorder have also been reported. It has been reported that symptoms of sexual dysfunction occasionally persist after discontinuation of fluoxetine treatment.

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. Hypotension has also been reported.

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. Alopecia has also been reported.

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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