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Luvox CR Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Luvox CR (fluvoxamine maleate) is used to treat social anxiety disorder (social phobia), or obsessive-compulsive disorders involving recurring thoughts or actions. It is a selective serotonin reuptake inhibitor (SSRI) antidepressant. Common side effects include nausea, vomiting, loss of appetite, upset stomach, drowsiness, dizziness, diarrhea, trouble sleeping, and sweating. Tell your doctor if your depression worsens or if you have suicidal thoughts.
The recommended starting dose of Luvox CR is 100 mg at bedtime, with weekly increases of 50 mg as tolerated to maximum therapeutic benefit, not to exceed 300 mg per day. Luvox CR may interact with medicines for pain, arthritis, fever, or swelling, aspirin and NSAIDs (nonsteroidal anti-inflammatory drugs), carbamazepine, clopidogrel, clozapine, diuretics (water pills), linezolid, lithium, methadone, mexiletine, omeprazole, phenytoin, propranolol, quinidine, ramelteon, St. John's wort, tacrine, tramadol, tryptophan, theophylline, blood thinners, sedatives, almotriptan, frovatriptan, sumatriptan, naratriptan, rizatriptan, zolmitriptan, triptans, medicine to treat psychiatric disorders, or other antidepressants. Tell your doctor all medications and supplements you use. Use Luvox CR only when prescribed during pregnancy. It may harm a fetus. Babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop withdrawal symptoms such as feeding/breathing difficulties, seizures, muscle stiffness, or constant crying. If you notice symptoms in your newborn, tell the doctor. Since untreated depression can be a serious condition, do not stop taking this medication unless directed by your doctor. This drug passes into breast milk and could have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this drug.
Our Luvox CR (fluvoxamine maleate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Luvox CR in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: 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. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Luvox CR (Fluvoxamine Maleate Extended-Release Capsules) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Luvox CR Overview - Patient Information: Side Effects
Nausea, vomiting, drowsiness, dizziness, loss of appetite, trouble sleeping, weakness, and sweating may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, muscle pain, shaking (tremor), decrease in sexual interest/ability, fast/pounding heartbeat.
Get medical help right away if you have any very serious side effects, including: black stools, vomit that looks like coffee grounds, seizures.
This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.
Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Luvox CR (Fluvoxamine Maleate Extended-Release Capsules)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Luvox CR FDA Prescribing Information: Side Effects
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 the rates observed in clinical practice.
Clinical Trial Data Sources
LUVOX CR Capsules were studied in one 12-week controlled trial in patients with OCD (N = 124; mean exposure 66.6 days) and in two 12-week controlled trials for another condition (N = 279; mean exposure 59.2 days). Patients in these trials were initiated on 100 mg/day and were titrated in 50 mg increments over the first 6 weeks to within a range of 100 mg to 300 mg/day. The reactions listed in Table 2 show reactions from the two populations separately. Table 3 shows reactions from the three controlled studies combined.
Adverse Reactions Observed In Controlled Trials
Adverse Reactions Associated with Discontinuation of Treatment
Of the 124 patients with OCD and 279 patients in other studies treated with LUVOX CR Capsules in controlled clinical trials, 19% and 26% discontinued treatment due to an adverse reaction. The most common reactions ( ≥ 1%) associated with discontinuation and considered to be drug related (i.e., those reactions associated with dropout at a rate at least twice that of placebo) were anorexia (including, but not limited to, loss of appetite and decreased appetite) (1%), anxiety (3%), asthenia (3%), diarrhea (2%), dizziness (4%), headache (2%), insomnia (5%), nausea (7%), nervousness (1%), somnolence (5%), and thinking abnormal (1%).
Commonly Observed Adverse Reactions
LUVOX CR Capsules have been studied in one controlled trial in patients with OCD (N = 124) and two controlled trials for another condition (N = 279). In general, adverse reaction 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 treatment-emergent adverse reactions 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) and derived from Table 2 were: abnormal ejaculation, anorexia, anorgasmia, asthenia, diarrhea, nausea, somnolence, sweating, and tremor. In the one controlled trial in patients with OCD, the following additional reactions occurred at an incidence of 5% or greater and at least twice that for placebo: anxiety, decreased libido, myalgia, pharyngitis, and vomiting. The following additional reactions occurred in another studied population: dyspepsia, dizziness, insomnia, and yawning. In a study evaluating immediate-release fluvoxamine maleate tablets in 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 ≥ 2%
Table 2 enumerates adverse reactions 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 trials (12 weeks) in another population and one short-term placebo-controlled OCD trial (12 weeks) 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 a reaction at some time during their treatment. Reported adverse reactions 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 2 : TREATMENT-EMERGENT ADVERSE REACTION
INCIDENCE RATES BY BODY SYSTEM IN ADULT OCD PATIENTS AND ANOTHER STUDIED
|BODY SYSTEM/ ADVERSE REACTION||PERCENTAGE OF PATIENTS REPORTING REACTION|
|OBSESSIVE COMPULSIVE DISORDER||OTHER STUDIED POPULATION|
N = 124
N = 124
N = 279
N = 276
|BODY AS A WHOLE|
|Viral Infection||2||< 1||-||-|
|Tooth Disorder||2||< 1||-||-|
|Liver Function Test Abnormal||-||-||2||< 1|
|HEMIC AND LYMPHATIC|
|METABOLIC AND NUTRITIONAL DISORDERS|
|Weight Loss||2||< 1|
|Abnormal Thinking||3||< 1||3||2|
|Agitation||2||< 1||3||< 1|
|Taste Perversion||2||< 1||2||< 1|
|Sexual Function Abnormal||2||< 1||3||< 1|
|Urinary Tract Infection||-||-||2||< 1|
|1Events for which fluvoxamine maleate
incidence was equal to or less than placebo include the following for OCD
patients: abdominal pain, flu syndrome, infection, palpitation, flatulence,
increased appetite, weight gain, abnormal dreams, amnesia, hypertonia,
nervousness, paresthesia, increased cough, dyspnea, rhinitis, and ear pain. In
the other studied population the following events were seen: abdominal pain,
accidental injury, back pain, flu syndrome, infection, pain, flatulence,
pharyngitis, rhinitis, rash, and dysmenorrhea.
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.
Other Adverse Reactions In OCD Pediatric Population
In pediatric patients (N=57) treated with immediate-release 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 immediate-release 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 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 3 displays the incidence of sexual side effects reported by at least 2% of patients taking LUVOX CR Capsules in placebo-controlled trials.
TABLE 3 : PERCENTAGE OF PATIENTS REPORTING SEXUAL
ADVERSE REACTIONS IN PLACEBO-CONTROLLED TRIALS
N = 403
N = 400
|Sexual Function Abnormal|
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.
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.
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 Reactions Observed During The Premarketing Evaluation Of Fluvoxamine
During premarketing clinical trials conducted in North America and Europe, multiple doses of LUVOX CR Capsules or immediate-release fluvoxamine maleate tablets were administered for a combined total of 3219 patient exposures in patients suffering OCD or other studied disorders. These exposures include 482 patient exposures with LUVOX CR Capsules and 2737 patient exposures with immediate-release fluvoxamine maleate tablets. 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 that follow, a 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 when possible. The frequencies presented, therefore, represent the proportion of the total 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. 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. 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.
For LUVOX CR, all reported events are included in the list below, with the following exclusions: 1) those events already listed in Table 2 or previous sections of this prescribing information; 2) those events for which there is no basis to suspect a causal relationship; and 3) events that were reported in only one patient and judged not to be potentially serious.
Cardiovascular System: Infrequent: syncope.
Digestive System: Infrequent: eructation, increased salivation.
Metabolic and Nutritional Disorders: Frequent: weight gain.
Nervous System: Infrequent: confusion, incoordination, sleep disorder, suicidal tendency.
Special Senses: Infrequent: dry eyes, photophobia, taste loss.
Urogenital System: Infrequent: vaginal hemorrhage1.
1Based on the number of females.
For immediate-release fluvoxamine tablets, all reported events are included in the list below, with the following exclusions: 1) those events already listed in Table 2, in previous sections of this prescribing information, or in the LUVOX CR list of Other Reactions Observed During Premarketing Evaluation; 2) those events for which there is no basis to suspect a causal relationship; and 3) events that were reported in only one patient and judged not to be potentially serious.
Body as a Whole: Infrequent: allergic reaction, neck pain, neck rigidity, overdose; Rare: sudden death.
Cardiovascular System: Frequent: hypotension; Infrequent: angina pectoris, bradycardia, cardiomyopathy, cardiovascular disease, cold extremities, conduction delay, myocardial infarction, pallor, pulse irregular, ST segment changes; Rare: AV block, cerebrovascular accident, embolus, pericarditis, phlebitis, pulmonary infarction, supraventricular extrasystoles.
Digestive System: Frequent: elevated liver transaminases; Infrequent: colitis, esophagitis, gastritis, gastroenteritis, gastrointestinal hemorrhage, gastrointestinal ulcer, glossitis, hemorrhoids, melena, rectal hemorrhage, stomatitis; Rare: biliary pain, cholecystitis, cholelithiasis, fecal incontinence, hematemesis, intestinal obstruction, jaundice.
Metabolic and Nutritional Systems: Frequent: edema; Infrequent: dehydration, hypercholesterolemia; Rare: diabetes mellitus, hyperglycemia, hyperlipidemia, hypoglycemia, hypokalemia, lactate dehydrogenase increased.
Nervous System: Frequent: amnesia, apathy, hyperkinesia, hypokinesia, manic reaction, myoclonus, psychotic reaction; Infrequent: agoraphobia, akathisia, ataxia, CNS depression, convulsion, delirium, delusion, depersonalization, dyskinesia, dystonia, emotional lability, euphoria, extrapyramidal syndrome, gait unsteady, hallucinations, hemiplegia, hostility, hypersomnia, hypochondriasis, hypotonia, hysteria, increased libido, paralysis, paranoid reaction, phobia, psychosis, 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.
Urogenital System: Infrequent: anuria, cystitis, delayed menstruation1, dysuria, female lactation1, hematuria, menopause1, metrorrhagia1, nocturia, premenstrual syndrome1, urination impaired, vaginitis1; Rare: kidney calculus, hematospermia2, oliguria.
1Based on the number of females.
2Based on the number of males.
The following adverse reactions have been identified during post-approval use of immediate-release fluvoxamine maleate tablets or LUVOX CR Capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. (Reactions that are discussed in other sections of this prescribing information are not repeated here.) These reactions include: activation syndrome, aggression, agranulocytosis, anaphylactic reaction, anger, blood glucose increased, bruxism, cardio-respiratory arrest, crying, dysarthria, dysphagia, electrocardiogram QT prolonged, fall, fatigue, feeling drunk, feeling jittery, gait disturbance, gastroesophageal reflux disease, glossodynia, hepatitis, homicidal ideation, impulsive behavior, ileus, inappropriate antidiuretic hormone secretion, interstitial lung disease, irritability, loss of consciousness, lethargy, muscular weakness, Parkinsonism, pancreatitis, pyrexia, renal impairment, rhabdomyolysis, self injurious behavior, shock, somnolence neonatal, Stevens-Johnson syndrome, tachycardia, urinary retention, ventricular arrythmia, ventricular tachycardia (including torsades de pointes known to cause cardiac arrest, sometimes fatal), vision blurred, white blood cell count decreased.
Read the entire FDA prescribing information for Luvox CR (Fluvoxamine Maleate Extended-Release Capsules) »
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