Fluvoxamine

Fluvoxamine is a prescription medication used to treat Obsessive-Compulsive Disorder and Social Anxiety Disorder (Social Phobia). 

• Fluvoxamine is available under the following different brand names: Luvox, Luvox CR (DSC).

Adult and pediatric dosage

Tablets

• 25mg
• 50mg
• 100mg

Obsessive-Compulsive Disorder

Adult dosage

Conventional tablets

• 50 mg every night at bedtime initially; may increase by 50 mg/day every 4-7 days up to 100-300 mg/day
• Doses greater than 100 mg/day should be divided every 12 hours

Pediatric dosage

• Children younger than 8 years of age: Safety and efficacy not established
• Ages 8-17 years (conventional tablets): 25 mg orally at bedtime initially; may titrate by 25 mg/day increments every 4-7 days to 50-200 mg/day
• Not to exceed 200 mg (for ages 8-11 years) or 300 mg for adolescents 
• Give doses greater than 50 mg/day divided every 12 hours

Dosage Considerations – Should be Given as Follows: 

• See "Dosages."

Common side effects of Fluvoxamine include:

• drowsiness, 
• dizziness, 
• shaking, 
• anxiety, 
• depressed mood, 
• sleep problems (insomnia), 
• upset stomach, 
• gas, 
• loss of appetite, 
• nausea, 
• vomiting, 
• diarrhea, 
• dry mouth, 
• yawning, 
• sore throat, 
• muscle pain, 
• sweating, 
• rash, 
• heavy menstrual periods; 
• decreased sex drive, 
• abnormal ejaculation, and
• trouble having an orgasm

Serious side effects of Fluvoxamine include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• skin rash, 
• blisters, 
• fever, 
• joint pain, 
• mood or behavior changes, 
• anxiety, 
• panic attacks, 
• impulsive behavior, 
• irritableness, 
• agitation, 
• hostility, 
• aggression, 
• restlessness, 
• hyperactivity (mentally or physically), 
• increased depression, 
• thoughts of self-harm, 
• racing thoughts, 
• risk-taking behavior, 
• sleep problems (insomnia), 
• feelings of extreme happiness or irritability, 
• blurred vision, 
• tunnel vision, 
• eye pain or swelling, 
• seeing halos around lights, 
• seizure, 
• changes in weight or appetite, 
• easy bruising, 
• unusual bleeding, 
• headache, 
• confusion, 
• memory problems, 
• severe weakness, 
• loss of coordination, 
• feeling unsteady, 
• very stiff (rigid) muscles, 
• high fever, 
• sweating, 
• fast or uneven heartbeats, 
• tremors, 
• lightheadedness, 
• hallucinations, 
• shivering, 
• fast heart rate, 
• twitching, 
• nausea, 
• vomiting, and 
• diarrhea 

Rare side effects of Fluvoxamine include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them.  Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Fluvoxamine has unknown severe interactions with the following drugs: 
  • alosetron
  • dihydroergotamine
  • isocarboxazid
  • lonafarnib
  • ramelteon
  • selegiline
• Fluvoxamine has serious interactions with at least 112 other drugs.
• Fluvoxamine has moderate interactions with at least 297 other drugs.
• Fluvoxamine has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drugs interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use.  Keep a list of all your medications with you, and share this information with your doctor and pharmacist.  Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

Hypersensitivity

• Coadministration with serotonergic drugs
  • Concomitant use or within 14 days of MAOIs increases risk of serotonin syndrome
  • Reactions to concomitant administration with MAOIs include tremor, myoclonus, diaphoresis, nausea, vomiting, flushing, dizziness, hyperthermia with features resembling neuroleptic malignant syndrome, seizures, rigidity, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes (including extreme agitation progressing to delirium and coma)
  • Starting fluvoxamine in a patient who is being treated with linezolid or IV methylene blue is contraindicated because of an increased risk of serotonin syndrome
  • If linezolid or IV methylene blue must be administered, discontinue SSRI immediately and monitor for CNS toxicity; may resume 24 hr after last linezolid or methylene blue dose, or after 2 weeks of monitoring (5 weeks for fluoxetine), whichever comes first

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Fluvoxamine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Fluvoxamine?”

Cautions

• Conflicting evidence regarding use of SSRIs during pregnancy and increased risk of persistent pulmonary hypertension of the newborn (see Pregnancy)
• In neonates exposed to SNRIs/SSRIs late in third trimester: Risk of complications such as feeding difficulties, irritability, and respiratory problems
• Risk of mydriasis; may trigger angle closure attack in patients with angle closure glaucoma with anatomically narrow angles without a patent iridectomy
• May need to modify dose for hepatic impairment; titrate at smaller increments and longer intervals
• Clinical worsening and suicide ideation may occur despite medication in adolescents and young adults (18-24 years); prescriptions should be written for the smallest quantity consistent with good patient care
• May worsen mania symptoms or precipitate mania in patients with bipolar disorder
• May impair platelet aggregation; increases risk of bleeding in patients taking anticoagulants/antiplatelets concomitantly
• Do not use concurrently with alosetron, astemizole, cisapride, pimozide, terfenadine, or tizanidine due to QT prolongation risk
• Potentially life-threatening serotonin syndrome has been reported with drugs that impair serotonin metabolism (in particular, MAOIs, including nonpsychiatric MAOIs, such as linezolid and IV methylene blue); it has also been reported with reported with SNRIs and SSRIs, including fluvoxamine, alone but particularly with concomitant use of serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John's Wort (see Contraindications)
• May impair ability to operate heavy machinery and other tasks requiring mental alertness
• Bone fractures have been associated with antidepressant treatment; consider possibility of fragility fracture if patient presents with pain, joint tenderness, or swelling
• Impaired glucose control (hyperglycemia or hypoglycemia) reported; monitor for signs/symptoms of loss of glucose control, especially in patients with diabetes
• Syndrome of inappropriate antidiuretic hormone and hyponatremia reported with SSRI and SNRI use; volume depletion and/or concurrent use of diuretics may increase risk; consider discontinuing therapy if symptomatic hyponatremia occurs
• Use caution in patients with cardiovascular disease or history of seizure disorder
• Sexual dysfunction
  • Use of may cause symptoms of sexual dysfunction in both male and female patients; inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider
  • Use of SSRIs, may cause symptoms of sexual dysfunction; in male patients, SSRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction
  • In female patients, SSRI/SNRI use may result in decreased libido and delayed or absent orgasm
  • Important for prescribers to inquire about sexual function prior to initiation of therapy and to inquire specifically about changes in sexual function during treatment, because sexual function may not be spontaneously reported
  • When evaluating changes in sexual function, obtaining a detailed history (including timing of symptom onset) is important because sexual symptoms may have other causes, including underlying psychiatric disorder
  • Discuss potential management strategies to support patients in making informed decisions about treatment

Pregnancy and Lactation

• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy; healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants
• Prolonged experience with fluvoxamine in pregnant women over decades, based on published observational studies, have not identified a clear drug-associated risk of major birth defects or miscarriage; there are risks associated with untreated depression in pregnancy and risks of persistent pulmonary hypertension of newborn (PPHN) and poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (SSRIs), including fluvoxamine, during pregnancy
• Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants; consider risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum
• Neonates exposed to therapy and other SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding; such complications can arise immediately upon delivery; reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying; these features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome; it should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome
• Animal findings suggest fertility may be impaired while taking fluvoxamine  
• Data from published literature report presence of drug in human milk; no adverse effects on breastfed infant have been reported in most cases of maternal use of fluvoxamine during breastfeeding; however, there are reports of diarrhea, vomiting, decreased sleep, and agitation; there are no data on effect of fluvoxamine on milk production
• Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for fluvoxamine and any potential adverse effects on breastfed child from drug or from the underlying maternal condition
• Monitor infants exposed to fluvoxamine through breast milk for diarrhea, vomiting, decreased sleep, and agitation