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.

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; yawning.

Seek medical attention right away if any of these SEVERE side effects occur when using Fluvoxamine:

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 or unusually heavy 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.

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.

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; yawning.

Seek medical attention right away if any of these SEVERE side effects occur when using Fluvoxamine Extended-Release Capsules:

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 or unusually heavy 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.

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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Fluvoxamine Side Effects - for the Professional

Fluvoxamine

Adverse Reactions Leading to Treatment Discontinuation

Of the 1087 OCD and depressed patients treated with Fluvoxamine maleate in controlled clinical trials in North America, 22% discontinued due to an adverse reaction. Adverse reactions that led to discontinuation in at least 2% of Fluvoxamine maleate-treated patients in these trials were: nausea (9%), insomnia (4%), somnolence (4%), headache (3%), and asthenia, vomiting, nervousness, agitation, and dizziness (2% each).

Incidence in Controlled Trials

Commonly Observed Adverse Reactions in Controlled Clinical Trials: Fluvoxamine Maleate Tablets have been studied in 10-week short-term controlled trials of OCD (N=320) and depression (N=1350). In general, adverse reaction rates were similar in the two data sets as well as in the pediatric OCD study. The most commonly observed adverse reactions associated with the use of Fluvoxamine Maleate Tablets and likely to be drug-related (incidence of 5% or greater and at least twice that for placebo) derived from Table 2 were: nausea, somnolence, insomnia, asthenia, nervousness, dyspepsia, abnormal ejaculation, sweating, anorexia, tremor, and vomiting. In a pool of two studies involving only patients with OCD, the following additional reactions were identified using the above rule: anorgasmia, decreased libido, dry mouth, rhinitis, taste perversion, and urinary frequency. In a study of pediatric patients with OCD, the following additional reactions were identified using the above rule: agitation, depression, dysmenorrhea, flatulence, hyperkinesia, and rash.

Adverse Reactions Occurring at an Incidence of 1%: Table 2 enumerates adverse reactions that occurred in adults at a frequency of 1% or more, and were more frequent than in the placebo group, among patients treated with Fluvoxamine Maleate Tablets in two short-term placebo controlled OCD trials (10 week) and depression trials (6 week) in which patients were dosed in a range of generally 100 to 300 mg/day. This table shows the percentage of patients in each group who had at least one occurrence of a reaction at some time during their treatment. Reported adverse reactions were classified using a standard COSTART-based Dictionary terminology.

The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors may 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 non-drug factors to the side-effect incidence rate in the population studied.

TABLE 2 TREATMENT-EMERGENT ADVERSE REACTION INCIDENCE RATES BY BODY SYSTEM IN ADULT OCD AND DEPRESSION POPULATIONS COMBINED1

BODY SYSTEM/ ADVERSE REACTION	Percentage of Patients Reporting Reaction
	Fluvoxamine N = 892	PLACEBO N = 778
1Reactions for which Fluvoxamine maleate incidence was equal to or less than placebo are not listed in the table above. 2 Includes “toothache,” “tooth extraction and abscess,” and “caries.” 3 Mostly feeling warm, hot, or flushed. 4 Mostly “blurred vision.” 5 Mostly “delayed ejaculation.” 6 Incidence based on number of male patients.
BODY AS WHOLE
Headache	22	20
Asthenia	14	6
Flu Syndrome	3	2
Chills	2	1
CARDIOVASCULAR
Palpitations	3	2
DIGESTIVE SYSTEM
Nausea	40	14
Diarrhea	11	7
Constipation	10	8
Dyspepsia	10	5
Anorexia	6	2
Vomiting	5	2
Flatulence	4	3
Tooth Disorder2	3	1
Dysphagia	2	1
NERVOUS SYSTEM
Somnolence	22	8
Insomnia	21	10
Dry Mouth	14	10
Nervousness	12	5
Dizziness	11	6
Tremor	5	1
Anxiety	5	3
Vasodilatation3	3	1
Hypertonia	2	1
Agitation	2	1
Decreased Libido	2	1
Depression	2	1
CNS Stimulation	2	1
RESPIRATORY SYSTEM
Upper Respiratory Infection	9	5
Dyspnea	2	1
Yawn	2	0
SKIN
Sweating	7	3
SPECIAL SENSES
Taste Perversion	3	1
Amblyopia4	3	2
UROGENITAL
Abnormal Ejaculation5,6	8	1
Urinary Frequency	3	2
Impotence6	2	1
Anorgasmia	2	0
Urinary Retention	1	0

 

Adverse Reactions in OCD Placebo Controlled Studies Which are Markedly Different (defined as at least a two-fold difference) in Rate from the Pooled Reaction Rates in OCD and Depression Placebo Controlled Studies: The reactions in OCD studies with a two-fold decrease in rate compared to reaction rates in OCD and depression studies were dysphagia and amblyopia (mostly blurred vision). Additionally, there was an approximate 25% decrease in nausea.

The reactions in OCD studies with a two-fold increase in rate compared to reaction rates in OCD and depression studies were: asthenia, abnormal ejaculation (mostly delayed ejaculation), anxiety, rhinitis, anorgasmia (in males), depression, libido decreased, pharyngitis, agitation, impotence, myoclonus/twitch, thirst, weight loss, leg cramps, myalgia, and urinary retention. These reactions are listed in order of decreasing rates in the OCD trials.

Other Adverse Reactions in OCD Pediatric Population

In pediatric patients (N=57) treated with Fluvoxamine Maleate Tablets, the overall profile of adverse reactions was generally similar to that seen in adult studies, as shown in Table 2. However, the following adverse reactions, not appearing in Table 2, were reported in two or more of the pediatric patients and were more frequent with Fluvoxamine Maleate Tablets than with placebo: cough increase, dysmenorrhea, ecchymosis, emotional lability, epistaxis, hyperkinesia, manic reaction, rash, sinusitis, and weight decrease.

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 and with aging, they may also be a consequence of pharmacologic treatment. In particular, some evidence suggests that selective serotonin reuptake inhibitors (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.

Table 3 displays the incidence of sexual side effects reported by at least 2% of patients taking Fluvoxamine Maleate Tablets in placebo-controlled trials in depression and OCD.

TABLE 3 PERCENTAGE OF PATIENTS REPORTING SEXUAL ADVERSE REACTIONS IN ADULT PLACEBO-CONTROLLED TRIALS IN OCD AND DEPRESSION  

	Fluvoxamine Maleate     Tablets   N = 892	Placebo   N = 778
* Based on the number of male patients.
Abnormal Ejaculation*	8%	1%
Impotence*	2%	1%
Decreased Libido	2%	1%
Anorgasmia	2%	0%

There are no adequate and well-controlled studies examining sexual dysfunction with Fluvoxamine treatment.

Fluvoxamine treatment has been associated with several cases of priapism. In those cases with a known outcome, patients recovered without sequelae and upon discontinuation of Fluvoxamine.

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.

Vital Sign Changes

Comparisons of Fluvoxamine maleate and placebo groups in separate pools of short-term OCD and depression trials on (1) median change from baseline on various vital signs variables and on (2) incidence of patients meeting criteria for potentially important changes from baseline on various vital signs variables revealed no important differences between Fluvoxamine maleate and placebo.

Laboratory Changes

Comparisons of Fluvoxamine maleate and placebo groups in separate pools of short-term OCD and depression trials on (1) median change from baseline on various serum chemistry, hematology, and urinalysis variables and on (2) incidence of patients meeting criteria for potentially important changes from baseline on various serum chemistry, hematology, and urinalysis variables revealed no important differences between Fluvoxamine maleate and placebo.

ECG Changes

Comparisons of Fluvoxamine maleate and placebo groups in separate pools of short-term OCD and depression trials on (1) mean change from baseline on various ECG variables and on (2) incidence of patients meeting criteria for potentially important changes from baseline on various ECG variables revealed no important differences between Fluvoxamine maleate and placebo.

Other Reactions Observed During the Premarketing Evaluation of Fluvoxamine Maleate Tablets

During premarketing clinical trials conducted in North America and Europe, multiple doses of Fluvoxamine maleate were administered for a combined total of 2737 patient exposures in patients suffering OCD or Major Depressive Disorder. Untoward reactions associated with this exposure 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 untoward reactions into a limited (i.e., reduced) number of standard reaction categories.

In the tabulations which follow, a standard COSTART-based Dictionary terminology has been used to classify reported adverse reactions. If the COSTART term for a reaction was so general as to be uninformative, it was replaced with a more informative term. The frequencies presented, therefore, represent the proportion of the 2737 patient exposures to multiple doses of Fluvoxamine maleate who experienced a reaction of the type cited on at least one occasion while receiving Fluvoxamine maleate. All reported reactions are included in the list below, with the following exceptions: 1) those reactions already listed in Table 2, which tabulates incidence rates of common adverse experiences in placebo-controlled OCD and depression clinical trials, are excluded; 2) those reactions for which a drug cause was not considered likely are omitted; 3) reactions for which the COSTART term was too vague to be clinically meaningful and could not be replaced with a more informative term; and 4) reactions which were reported in only one patient and judged to not be potentially serious are not included. It is important to emphasize that, although the reactions reported did occur during treatment with Fluvoxamine maleate, a causal relationship to Fluvoxamine maleate has not been established.
 
Reactions are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse reactions are defined as those occurring on one or more occasions in at least 1/100 patients; infrequent adverse reactions are those occurring between 1/100 and 1/1000 patients; and rare adverse reactions are those occurring in less than 1/1000 patients.

Body as a Whole – Frequent: malaise; Infrequent: photosensitivity reaction and suicide attempt.
Cardiovascular System – Frequent: syncope.
Digestive System – Infrequent: gastrointestinal hemorrhage and melena; Rare: hematemesis.
Hemic and Lymphatic Systems – Infrequent: anemia and ecchymosis; Rare: purpura.
Metabolic and Nutritional Systems – Frequent: weight gain and weight loss.
Nervous System – Frequent: hyperkinesia, manic reaction, and myoclonus; Infrequent: abnormal dreams, akathisia, convulsion, dyskinesia, dystonia, euphoria, extrapyramidal syndrome, and twitching; Rare: withdrawal syndrome.
Respiratory System – Infrequent: epistaxis. Rare: hemoptysis and laryngismus.
Skin – Infrequent: urticaria.
Urogenital System* – Infrequent: hematuria, menorrhagia, and vaginal hemorrhage; Rare: hematospermia.

* Based on the number of males or females, as appropriate.

Postmarketing Reports

Voluntary reports of adverse reactions in patients taking Fluvoxamine Maleate Tablets that have been received since market introduction and are of unknown causal relationship to Fluvoxamine Maleate Tablets use include: acute renal failure, agranulocytosis, amenorrhea, anaphylactic reaction, angioedema, aplastic anemia, bullous eruption, Henoch-Schoenlein purpura, hepatitis, ileus, pancreatitis, porphyria, Stevens-Johnson syndrome, toxic epidermal necrolysis, vasculitis, and ventricular tachycardia (including torsades de pointes).

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Side Effects by Body System - for Healthcare Professionals

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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