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. Duloxetine is not approved for use in pediatric patients. (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 duloxetine 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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duloxetine
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(du LOX e teen)

How should I take duloxetine?

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. Your doctor may occasionally change your dose to make sure you get the best results from the medication.

Try to take the medicine at the same time each day. Follow the directions on your prescription label.

Do not crush, chew, break, or open a delayed-release capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time. It may take 4 weeks or longer for your symptoms to improve. For best results, keep using the medication as directed. Do not stop using duloxetine without first talking to your doctor. You may have unpleasant side effects if you stop taking this medication suddenly. Store duloxetine 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 nausea, vomiting, diarrhea, agitation, confusion, hallucinations, fast heart rate, feeling light-headed, or fainting.

What should I avoid while taking duloxetine?

Avoid drinking alcohol while taking duloxetine. Alcohol may increase the risk of damage to your liver. Duloxetine 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.

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures or anxiety can add to sleepiness caused by duloxetine. Tell your doctor if you regularly use any of these other medicines.

What are the possible side effects of duloxetine?

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), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

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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