Drug Notebook

FDA Alerts

    Suicidality
  • Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need. Fluvoxamine is not approved for use in pediatric patients except for patients with obsessive-compulsive disorder. (See Pediatric Use under Cautions.)
  • In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.
  • Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.
  • Appropriately monitor and closely observe all patients who are started on fluvoxamine therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process. (See Worsening of Depression and Suicidality Risk under Cautions.)

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fluvoxamine
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(floo VOX a meen)

What is the most important information I should know about fluvoxamine?

Do not take this medication if you are allergic to fluvoxamine, or if you are also taking alosetron (Lotronex), tizanidine (Zanaflex), thioridazine (Mellaril), pimozide (Orap), or an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam). Some of these medications can cause serious or life-threatening drug interactions when taken within 14 days before or after taking fluvoxamine.

You may have thoughts about suicide when you first start taking an this medication, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms 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), depressed, or have thoughts about suicide or hurting yourself. There are many other medicines that can cause serious medical problems if you take them together with fluvoxamine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

What is fluvoxamine?

Fluvoxamine is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Fluvoxamine affects chemicals in the brain that may become unbalanced and cause obsessive-compulsive symptoms.

Fluvoxamine is used to treat social anxiety disorder (social phobia), or obsessive-compulsive disorders involving recurring thoughts or actions.

Fluvoxamine may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking fluvoxamine?

You should not take this medication if you are allergic to fluvoxamine, or if you are also taking:
  • alosetron (Lotronex);

  • tizanidine (Zanaflex);

  • thioridazine (Mellaril);

  • pimozide (Orap); or

  • an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam).

Some of these medications can cause serious or life-threatening drug interactions when taken together with fluvoxamine. You must wait at least 14 days after stopping an MAO inhibitor before you can take fluvoxamine. After you stop taking fluvoxamine, you must wait at least 14 days before you can start taking an MAOI.

Before taking fluvoxamine, tell your doctor if you have:

If you have any of these conditions, you may need a dose adjustment or special tests to safely take fluvoxamine.

You may have thoughts about suicide when you first start taking fluvoxamine, especially if you are younger than 24 years old. Tell your doctor if you have symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

FDA pregnancy category C. This medication may cause serious or life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of symptoms if you stop taking fluvoxamine during pregnancy. If you are planning a pregnancy, or if you become pregnant while taking fluvoxamine, do not stop taking the medication without first talking to your doctor. Fluvoxamine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give fluvoxamine to anyone younger than 18 years old without the advice of a doctor.
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