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
(du LOX e teen)

Before taking duloxetine, tell your doctor if you are using any of the following medicines:

  • a blood thinner such as warfarin (Coumadin);

  • cimetidine (Tagamet);

  • fluvoxamine (Luvox);

  • linezolid (Zyvox);

  • lithium (Lithobid, Eskalith);

  • St. John's wort;

  • tramadol (Ultram);

  • tryptophan (sometimes called L-tryptophan);

  • an antibiotic such as ciprofloxacin (Cipro) or enoxacin (Penetrex);

  • almotriptan (Axert), frovatriptan (Frova), sumatriptan (Imitrex), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig);

  • aspirin or an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others;

  • any other antidepressant such as desipramine (Norpramin), fluoxetine (Prozac, Sarafem), paroxetine (Paxil), and others.

This list is not complete and there may be other drugs that can interact with duloxetine. 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.

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:

  • stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • restlessness, overactive reflexes, hallucinations, loss of coordination, fainting, coma;

  • nausea, vomiting, diarrhea, fever, and fast heartbeat;

  • easy bruising or bleeding, nosebleeds, or

  • black, bloody, or tarry stools.

Less serious side effects may include:

  • dry mouth;

  • drowsiness, dizziness, headache;

  • diarrhea, constipation;

  • sleep problems (insomnia);

  • weight changes;

  • feeling anxious or nervous, increased sweating; or

  • decreased sex drive, impotence, or difficulty having an orgasm.

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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