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Luvox Side Effects Center
Medical Editor: Melissa Conrad Stöppler, MD
Luvox (fluvoxamine) is a selective serotonin reuptake inhibitor (SSRI) antidepressant used to treat social anxiety disorder (social phobia) or obsessive-compulsive disorders. Luvox is taken orally in tablet form. Side effects of Luvox include loss of appetite, nausea, diarrhea, gas, dry mouth, sore throat, dizziness, drowsiness, weakness, yawning, anxiety, sleep problems (insomnia or unusual dreams), sweating, skin rash, heavy menstrual periods, muscle pain, decreased sex drive, abnormal ejaculation, or trouble having an orgasm. Other side effects can also occur.
Fluvoxamine can pose a risk of problems to an unborn baby and should be taken by pregnant women only when the potential benefits of the drug outweigh the risks to the fetus. Fluvoxamine is secreted in human breast milk. The decision of whether to discontinue nursing or to discontinue the drug should take into account the potential for serious adverse effects from exposure to fluvoxamine in the nursing infant.
Our Luvox 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 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 (Fluvoxamine Maleate Tablets)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Luvox 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, shaking (tremor), decrease in sexual interest/ability.
Get medical help right away if you have any very serious side effects, including: black stools, vomit that looks like coffee grounds, seizures, eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night, blurred vision).
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 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 (Fluvoxamine Maleate Tablets)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Luvox FDA Prescribing Information: Side Effects
Adverse Reactions Leading to Treatment Discontinuation
Of the 1087 OCD and depressed patients treated with fluvoxamine maleate (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 (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 (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|
|BODY AS WHOLE|
|Upper Respiratory Infection||9||5|
| 1 Reactions for which fluvoxamine maleate (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.
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 (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 (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 (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
| Muvoxaminc Maleate Tablets
|* Based on the number of male patients.|
There are no adequate and well-controlled studies examining sexual dysfunction with fluvoxamine treatment.
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 (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 (fluvoxamine maleate) and placebo.
Comparisons of fluvoxamine maleate (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 (fluvoxamine maleate) and placebo.
Comparisons of fluvoxamine maleate (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 (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 (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 COST ART 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 (fluvoxamine maleate) who experienced a reaction of the type cited on at least one occasion while receiving fluvoxamine maleate (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 COST ART 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 (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.
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.
Voluntary reports of adverse reactions in patients taking Fluvoxamine Maleate (fluvoxamine maleate) Tablets that have been received since market introduction and are of unknown causal relationship to Fluvoxamine Maleate (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).
* Based on the number of males or females, as appropriate.
Read the entire FDA prescribing information for Luvox (Fluvoxamine Maleate Tablets)
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