Luvox CR Side Effects

Generic Name: fluvoxamine,fluvoxamine maleate

Please note - some side effects for Luvox CR 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 Luvox CR - for the Consumer

Luvox CR 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 Luvox CR 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 Luvox CR 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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Luvox CR Side Effects - for the Professional

Luvox CR

Associated with Discontinuation of Treatment

Of the 279 patients with social anxiety disorder and 124 patients with OCD treated with Luvox CR Capsules in controlled clinical trials, 26% and 19% discontinued treatment due to an adverse event. The most common events (≥1%) associated with discontinuation and considered to be drug related (i.e., those events associated with dropout at a rate at least twice that of placebo) are provided in Table 4.

TABLE 4 ADVERSE EVENTS ASSOCIATED WITH DISCONTINUATION OF TREATMENT IN SOCIAL ANXIETY DISORDER AND OCD POPULATIONS

1Includes, but is not limited to, loss of appetite and decreased appetite.
BODY SYSTEM/ ADVERSE EVENT	PERCENTAGE OF PATIENTS
	SOCIAL ANXIETY DISORDER		OBSESSIVE COMPULSIVE DISORDER
	Luvox CR	PLACEBO	Luvox CR	PLACEBO
BODY AS A WHOLE
Asthenia	4	<1	2	0
Headache	3	<1	–	–
Abdominal Pain	1	0	–	–
Pain	–	–	2	0
DIGESTIVE
Nausea	8	<1	6	0
Diarrhea	3	0	2	0
Anorexia1	2	0	–	–
Dyspepsia	–	–	2	0
NERVOUS SYSTEM
Insomnia	5	<1	5	2
Somnolence	5	<1	4	0
Anxiety	4	<1	2	<1
Dizziness	4	0	3	0
Abnormal Thinking	2	<1	–	–
Nervousness	2	<1	–	–
Depression	1	0	–	–
Agitation	1	0	–	–
Paresthesia	1	0	–	–
Tremor	1	0	–	–
SKIN AND APPENDAGES
Sweating	1	0	–	–

Incidence in Controlled Trials

Commonly Observed Adverse Events:

Luvox CR Capsules have been studied in two controlled trials of social anxiety disorder (N = 279) and one trial of OCD (N = 124). In general, adverse event rates were similar in the two data sets as well as in a study of pediatric patients with OCD treated with immediate-release fluvoxamine maleate tablets. The most commonly observed adverse events associated with the use of Luvox CR Capsules and likely to be drug-related (incidence of 5% or greater and at least twice that for placebo) for patients in social anxiety disorder and in OCD derived from Table 5 were: abnormal ejaculation, anorexia, anorgasmia, asthenia, diarrhea, nausea, somnolence, sweating and tremor. In addition, the following events occurred in the social anxiety disorder population: dyspepsia, dizziness, insomnia, and yawning. In the OCD population, the following additional events occurred: accidental injury, anxiety, decreased libido, myalgia, pharyngitis, and vomiting. In a study evaluating immediate-release fluvoxamine maleate tablets in pediatric patients with OCD, the following additional events were identified using the above rule: agitation, depression, dysmenorrhea, flatulence, hyperkinesia, and rash.

Adverse Events Occurring at an Incidence of 2%:

Table 5 enumerates adverse events that occurred in adults at a frequency of 2% or more, and were more frequent than in the placebo group, among patients treated with Luvox CR Capsules in two short-term, placebo-controlled social anxiety disorder trials (12 week) and one short-term placebo-controlled OCD trial (12 week) and in which patients were dosed once-a-day in a range of 100 to 300 mg/day. This table shows the percentage of patients in each group who had at least one occurrence of an event at some time during their treatment. Reported adverse events were classified using a 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 health care provider 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 5 TREATMENT-EMERGENT ADVERSE EVENT INCIDENCE RATES BY BODY SYSTEM IN ADULT SOCIAL ANXIETY DISORDER AND OCD POPULATIONS1

1Events for which fluvoxamine maleate incidence was equal to or less than placebo include the following for social anxiety disorder patients: abdominal pain, accidental injury, back pain, flu syndrome, infection, pain, flatulence, pharyngitis, rhinitis, rash, and dysmenorrhea. In OCD patients the following events were seen: abdominal pain, flu syndrome, infection, palpitation, flatulence, increased appetite, weight gain, abnormal dreams, amnesia, hypertonia, nervousness, paresthesia, increased cough, dyspnea, rhinitis, and ear pain. 2Term includes body aches/pains, dental pain, pain from surgery, unspecified pain, and general pain secondary to injuries (sprains, fractures). 3Includes, but is not limited to, loss of appetite and decreased appetite.
BODY SYSTEM/ ADVERSE EVENT	PERCENTAGE OF PATIENTS REPORTING EVENT
	SOCIAL ANXIETY DISORDER		OBSESSIVE COMPULSIVE DISORDER
	Luvox CR N = 279	PLACEBO N = 276	Luvox CR N = 124	PLACEBO N = 124
BODY AS A WHOLE
Headache	35	30	32	31
Asthenia	24	10	26	8
Pain2	–	–	10	8
Abdominal Pain	5	4	–	–
Accidental Injury	–	–	5	3
Chest Pain	3	1	–	–
Viral Infection	–	–	2	<1
CARDIOVASCULAR
Palpitation	3	1	–	–
Vasodilatation	2	<1	–	–
Hypertension	–	–	2	<1
DIGESTIVE SYSTEM
Nausea	39	11	34	13
Diarrhea	14	5	18	8
Anorexia3	14	1	13	5
Dyspepsia	10	4	8	5
Constipation	6	5	4	<1
Vomiting	–	–	6	2
Tooth Disorder	–	–	2	<1
Liver Function Test Abnormal	2	<1	–	–
Gingivitis	–	–	2	0
HEMIC AND LYMPHATIC
Ecchymosis	–	–	4	2
METABOLIC AND NUTRITIONAL DISORDERS
Weight Loss	–	–	2	<1
MUSCULOSKELETAL
Myalgia	–	–	5	2
NERVOUS SYSTEM
Insomnia	32	13	35	20
Somnolence	26	9	27	11
Dizziness	15	7	12	10
Dry Mouth	11	8	10	9
Nervousness	10	9	–	–
Libido Decreased	6	4	6	2
Male	8	6	10	5
Female	4	3	4	1
Anxiety	8	5	6	2
Tremor	8	<1	6	0
Abnormal Thinking	3	2	3	<1
Abnormal Dreams	3	2	–	–
Agitation	3	<1	2	<1
Hypertonia	2	1	–	–
Apathy	–	–	3	0
Paresthesia	3	2	–	–
Neurosis	–	–	2	<1
Twitching	–	–	2	0
RESPIRATORY SYSTEM
Pharyngitis	–	–	6	<1
Yawn	5	<1	2	0
Laryngitis	–	–	3	0
Bronchitis	2	1	–	–
Epistaxis	–	–	2	0
SKIN
Sweating	6	2	7	<1
Acne	–	–	2	0
SPECIAL SENSES
Taste Perversion	2	<1	2	<1
Amblyopia	–	–	2	<1
UROGENITAL
Abnormal Ejaculation	11	2	10	0
Anorgasmia	5	1	5	0
Male	4	2	4	0
Female	5	0	5	0
Menorrhagia	–	–	3	0
Sexual Function Abnormal	3	<1	2	<1
Male	2	1	4	3
Female	3	0	0	0
Urinary Tract Infection	2	<1	–	–
Polyuria	–	–	2	<1

Other Adverse Events in OCD Pediatric Population

In pediatric patients (N = 57) treated with immediate-release fluvoxamine maleate tablets, the overall profile of adverse events was generally similar to that seen in adult studies, as shown in Table 5. However, the following adverse events, not appearing in Table 5, were reported in two or more of the pediatric patients and were more frequent with immediate-release fluvoxamine maleate tablets than with placebo: cough increase, dysmenorrhea, emotional lability, fever, flatulence, flu syndrome, hyperkinesia, infection, manic reaction, rash, rhinitis, and sinusitis.

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 health care providers 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 6 displays the incidence of sexual side effects reported by at least 2% of patients taking Luvox CR Capsules in placebo-controlled trials of social anxiety disorder and OCD.

TABLE 6 PERCENTAGE OF PATIENTS REPORTING SEXUAL ADVERSE EVENTS IN PLACEBO-CONTROLLED TRIALS

	Luvox CR N = 403	Placebo N = 400
Abnormal Ejaculation	11	2
Anorgasmia
Male	4	1
Female	5	0
Impotence	2	3
Libido Decreased
Male	8	5
Female	4	2
Sexual Function Abnormal
Male	3	5
Female	2	0

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, health care providers should routinely inquire about such possible side effects.

Weight and Vital Sign Changes

No statistically significant differences in weight gain or loss were found between patients treated with Luvox CR Capsules or placebo. Comparisons of immediate-release fluvoxamine maleate tablets or Luvox CR Capsules versus placebo groups in separate short-term 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 measures of vital signs variables revealed no important differences between fluvoxamine maleate and placebo.

Laboratory Changes

Comparisons of immediate-release fluvoxamine maleate tablets or Luvox CR Capsules versus placebo groups in separate short-term 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 immediate-release fluvoxamine maleate tablets or Luvox CR Capsules 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 Events Observed During the Premarketing Evaluation of Fluvoxamine

During premarketing clinical trials conducted in North America and Europe, multiple doses of immediate-release fluvoxamine maleate tablets were administered for a combined total of 2737 patient exposures in patients suffering OCD or Major Depressive Disorder. Untoward events 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 events without first grouping similar types of untoward events into a limited (i.e., reduced) number of standard event categories.

In the tabulations which follow, a COSTART-based Dictionary terminology has been used to classify reported adverse events. If the COSTART term for an event 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 an event of the type cited on at least one occasion while receiving fluvoxamine maleate. All reported events are included in the list below, with the following exceptions: 1) those events 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 events for which a drug cause was considered remote (i.e., neoplasia, gastrointestinal carcinoma, herpes simplex, herpes zoster, application site reaction, and unintended pregnancy) are omitted; and 3) events 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 events reported did occur during treatment with fluvoxamine maleate, a causal relationship to fluvoxamine maleate has not been established.

Events are further classified within body system categories and enumerated in order of decreasing frequency 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 between 1/100 and 1/1000 patients; and rare adverse events are those occurring in less than 1/1000 patients.

Body as a Whole: Frequent: malaise; Infrequent: allergic reaction, neck pain, neck rigidity, overdose, photosensitivity reaction, suicide attempt; Rare: cyst, pelvic pain, sudden death.

Cardiovascular System: Frequent: hypertension, hypotension, syncope; Infrequent: angina pectoris, bradycardia, cardiomyopathy, cardiovascular disease, cold extremities, conduction delay, heart failure, myocardial infarction, pallor, pulse irregular, ST segment changes; Rare: AV block, cerebrovascular accident, coronary artery disease, embolus, pericarditis, phlebitis, pulmonary infarction, supraventricular extrasystoles.

Digestive System: Frequent: elevated liver transaminases; Infrequent: colitis, eructation, esophagitis, gastritis, gastroenteritis, gastrointestinal hemorrhage, gastrointestinal ulcer, glossitis, hemorrhoids, melena, rectal hemorrhage, stomatitis; Rare: biliary pain, cholecystitis, cholelithiasis, fecal incontinence, hematemesis, intestinal obstruction, jaundice.

Endocrine System: Infrequent: hypothyroidism; Rare: goiter.

Hemic and Lymphatic Systems: Infrequent: anemia, leukocytosis, lymphadenopathy, thrombocytopenia; Rare: leukopenia, purpura.

Metabolic and Nutritional Systems: Frequent: edema, weight gain; Infrequent: dehydration, hypercholesterolemia; Rare: diabetes mellitus, hyperglycemia, hyperlipidemia, hypoglycemia, hypokalemia, lactate dehydrogenase increased.

Musculoskeletal System: Infrequent: arthralgia, arthritis, bursitis, generalized muscle spasm, myasthenia, tendinous contracture, tenosynovitis; Rare: arthrosis, myopathy, pathological fracture.

Nervous System: Frequent: amnesia, apathy, hyperkinesia, hypokinesia, manic reaction, myoclonus, psychotic reaction; Infrequent: agoraphobia, akathisia, ataxia, CNS depression, convulsion, delirium, delusion, depersonalization, drug dependence, dyskinesia, dystonia, emotional lability, euphoria, extrapyramidal syndrome, gait unsteady, hallucinations, hemiplegia, hostility, hypersomnia, hypochondriasis, hypotonia, hysteria, incoordination, increased salivation, increased libido, neuralgia, paralysis, paranoid reaction, phobia, psychosis, sleep disorder, stupor, twitching, vertigo; Rare: akinesia, coma, fibrillations, mutism, obsessions, reflexes decreased, slurred speech, tardive dyskinesia, torticollis, trismus, withdrawal syndrome.

Respiratory System: Frequent: cough increased, sinusitis; Infrequent: asthma, bronchitis, hoarseness, hyperventilation; Rare: apnea, congestion of upper airway, hemoptysis, hiccups, laryngismus, obstructive pulmonary disease, pneumonia.

Skin: Infrequent: alopecia, dry skin, eczema, exfoliative dermatitis, furunculosis, seborrhea, skin discoloration, urticaria.

Special Senses: Infrequent: accommodation abnormal, conjunctivitis, deafness, diplopia, dry eyes, ear pain, eye pain, mydriasis, otitis media, parosmia, photophobia, taste loss, visual field defect; Rare: corneal ulcer, retinal detachment.

Urogenital System: Infrequent: anuria, breast pain, cystitis, delayed menstruation1, dysuria, female lactation1, hematuria, menopause1, metrorrhagia1, nocturia, premenstrual syndrome1, urinary incontinence, urinary urgency, urination impaired, vaginal hemorrhage1, vaginitis1; Rare: kidney calculus, hematospermia2, oliguria.

1Based on the number of females.

2Based on the number of males.

Postmarketing Reports

Voluntary reports of adverse events in patients taking fluvoxamine maleate immediate-release tablets that have been received since market introduction and are of unknown causal relationship to fluvoxamine use include: acute renal failure, agranulocytosis, amenorrhea, anaphylactic reaction, angioedema, aplastic anemia, bullous eruption, Henoch-Schoenlein purpura, hepatitis, hyponatremia, ileus, laryngismus, neuropathy, pancreatitis, porphyria, priapism, serotonin syndrome, severe akinesia with fever when fluvoxamine was co-administered with antipsychotic medication, 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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