Fluvoxamine Side Effects

Brand Names: Luvox CR

Please note - some side effects for Fluvoxamine 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 Fluvoxamine - for the Consumer

Fluvoxamine

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 Fluvoxamine:

Constipation; decreased sexual ability; diarrhea; dizziness; drowsiness; dry mouth; gas; headache; increased sweating; loss of appetite; nausea; nervousness; stomach upset; stuffy nose; taste changes; trouble sleeping; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre behavior; black or bloody stools; chest pain; confusion; decreased concentration; decreased coordination; exaggerated reflexes; fainting; fast or irregular heartbeat; fever; hallucinations; memory loss; new or worsening agitation, anxiety, depression, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; painful menstrual periods; persistent, painful erection; red, swollen, blistered, or peeling skin; seizures; severe or persistent headache or trouble sleeping; stiff muscles; stomach pain; suicidal thoughts or attempts; tremor; unusual bruising or bleeding; unusual or severe mental or mood changes; unusual swelling; unusual weakness; vision changes.

Fluvoxamine Extended-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 Fluvoxamine Extended-Release Capsules:

Constipation; decreased sexual ability; diarrhea; dizziness; drowsiness; dry mouth; gas; headache; increased sweating; loss of appetite; nausea; nervousness; sore throat; stomach upset; trouble sleeping; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre behavior; black or bloody stools; chest pain; confusion; decreased concentration; decreased coordination; exaggerated reflexes; fainting; fast or irregular heartbeat; fever; hallucinations; memory loss; new or worsening agitation, anxiety, depression, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; painful menstrual periods; persistent, painful erection; red, swollen, blistered, or peeling skin; seizures; severe or persistent headache or trouble sleeping; stiff muscles; stomach pain; suicidal thoughts or attempts; tremor; unusual bruising or bleeding; unusual or severe mental or mood changes; unusual swelling; unusual weakness; vision changes.

Fluvoxamine Side Effects - for the Professional

Fluvoxamine

• Most common reactions in controlled trials with adult OCD and depression patients (incidence ≥5% and at least twice that for placebo) were nausea, somnolence, insomnia, asthenia, nervousness, dyspepsia, abnormal ejaculation, sweating, anorexia, tremor, and vomiting (6.2). Using the above rule, the following events were also identified: anorgasmia, decreased libido, dry mouth, rhinitis, taste perversion, and urinary frequency in patients with OCD; and agitation, depression, dysmenorrhea, flatulence, hyperkinesia, and rash in pediatric patients with OCD.

Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects have included nausea, which may be the most common adverse effect of fluvoxamine and occurs in as many as 40% of treated patients. Other reported gastrointestinal side effects have included vomiting, diarrhea, constipation, dyspepsia, dry mouth, taste perversion, dysphagia, flatulence, and abdominal pain.

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 4.7 times more frequently in patients receiving fluvoxamine.

Nervous system

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.

Central nervous system side effects including headache, somnolence, and insomnia have been reported in up to 22% of treated patients. Other reported nervous system side effects include fatigue, dizziness, sleep abnormalities, tremor, nervousness, anxiety, agitation, malaise, amnesia, and vertigo. Cases of serotonin syndrome, akathisia, dyskinesia, dystonia, tics, confusion, aggression, and seizures have also been reported.

A few case reports have implicated fluvoxamine in causing seizures. The manufacturer reports that, during premarketing testing, 0.2% of patients experienced convulsions.

One case report suggested fluvoxamine may have been associated with the development of the symptoms of Tourette's Syndrome in a patient treated for obsessive compulsive disorder.

Psychiatric

The reported association between antidepressant drug therapy in patients with various diagnoses and the development of suicidal ideation is controversial.

Psychiatric side effects including cases of hypomania and mania, apathy, indifference, disinhibition (without concurrent hypomania), hallucinations, paranoid, suicidal or antisocial ideation, abnormal thinking, and panic attacks have been reported.

Other

Other side effects including insomnia, and abnormal dreaming have been reported.

One study, and several case reports, have suggested that fluvoxamine treated patients may be subject to a serotonergic withdrawal syndrome characterized by headaches, dizziness, confusion, irritability, hypomania followed by aggression, nausea, poor appetite, chest tightness, low energy, and weakness.

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 fluvoxamine group at a rate of 17.2%.

General

General side effects including anorexia have been reported in approximately 2% to 6% of treated patients.

A case report has suggested that fluvoxamine may promote weight loss as a result of increased resting metabolic rate.

Cardiovascular

Cardiovascular side effects including palpitations, faintness, and tachycardia have been reported in patients treated with fluvoxamine. One case report found no effect on blood pressure, heart rate, or ECG in elderly patients.

Dermatologic

Dermatologic side effects including excessive sweating has been reported to occur with fluvoxamine therapy. Six cases of alopecia (0.02%) have been reported. A single case report has suggested that fluvoxamine may provoke toxic epidermal necrolysis. In another case report, a 69- year- old woman developed tingling tender erythema and bilateral symmetric bullae on the back of her feet, fingers, intergluteal fold, and gluteal areas after taking fluvoxamine (50 mg daily) for 3 months. Following discontinuation of fluvoxamine and administration of steroids and antibiotics the lesions abated a week later.

Genitourinary

Genitourinary side effects including abnormal ejaculation, impotence, anorgasmia, and decreased libido have been reported to occur in treated patients. Urinary frequency and urinary retention have also been reported.

One study has reported the incidence of sexual dysfunction at 35% (which is higher than previously reported).

One case report has suggested that cyproheptadine may be an effective treatment for fluvoxamine induced male anorgasmia.

Respiratory

Respiratory side effects including rhinitis have been reported to occur in treated patients.

Endocrine

Endocrine side effects have included one case report suggesting that fluvoxamine may have been associated with the development of the syndrome of inappropriate secretion of antidiuretic hormone in an elderly patient.

Musculoskeletal

Musculoskeletal side effects including hip fracture have been reported. 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.

Hematologic

Hematologic side effects have included one case of fluvoxamine- induced bleeding. A case of epistaxis and ecchymoses has also been reported.

Metabolic

Metabolic side effects including hyponatremia have been reported.

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.

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