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)

How should I take fluvoxamine?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Do not crush, chew, or open an extended-release capsule. Swallow the pill whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

You may take fluvoxamine with or without food.

Do not stop using fluvoxamine without first talking to your doctor. You may have unpleasant side effects if you stop taking this medication suddenly. Store fluvoxamine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have taken too much of this medication. Overdose symptoms may include blurred vision, lack of coordination, extreme drowsiness, nausea and vomiting, fast heart rate, trouble breathing, fainting, and coma.

What should I avoid while taking fluvoxamine?

Avoid drinking alcohol, which can increase some of the side effects of fluvoxamine. Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, anxiety or depression can add to sleepiness caused by fluvoxamine. Tell your doctor if you regularly use any of these medicines.

Fluvoxamine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What are the possible side effects of fluvoxamine?

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.

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.

Call your doctor at once if you have a serious side effect such as:

  • seizure (convulsions);

  • unusual thoughts or behavior;

  • anxiety, restlessness, memory problems, trouble concentrating, hallucinations, feeling like you might pass out;

  • high fever, chills or goose bumps, loss of coordination, overactive reflexes, stiff muscles; or

  • confusion, sweating, fast or uneven heartbeats, and rapid breathing.

Less serious side effects may include:

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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