Fluvoxamine Side Effects

Some side effects of fluvoxamine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to fluvoxamine: oral capsule extended release, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking fluvoxamine: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have;

• seizure (convulsions);

• changes in weight or appetite;

• easy bruising or unusual bleeding;

• racing thoughts, risk-taking behavior, feelings of extreme happiness or irritability;

• agitation, hallucinations, overactive reflexes, vomiting, diarrhea, loss of coordination, fainting;

• very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out; or

• headache, slurred speech, severe weakness, muscle cramps, feeling unsteady, shallow breathing (breathing may stop).

Common side effects may include:

• nausea, diarrhea, gas, loss of appetite;

• increased sweating, mild skin rash;

• dizziness, drowsiness, weakness, yawning;

• anxiety, sleep problems (insomnia);

• dry mouth, sore throat;

• heavy menstrual periods;

• muscle pain; or

• decreased sex drive, abnormal ejaculation, trouble having an orgasm;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to fluvoxamine: oral capsule extended release, oral tablet

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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