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. Sertraline 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 antidepressants 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 sertraline 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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sertraline
(SER tra leen)

Talk to your doctor before taking any medicine for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others. Taking any of these drugs with sertraline may cause you to bruise or bleed easily.

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

  • tramadol (Ultram, Ultram ER, Ultracet);

  • digitoxin (Crystodigin);

  • phenytoin (Dilantin), valproate (Depacon, Depakene);

  • lithium (Lithobid, Eskalith);

  • a blood thinner such as warfarin (Coumadin);

  • any other antidepressants such as amitriptyline (Elavil), citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), or paroxetine (Paxil);

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

  • heart rhythm medication such as flecainide (Tambocor), propafenone (Rhythmol), and others.

If you are using any of these drugs, you may not be able to use sertraline, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect sertraline. 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:

  • seizure (convulsions);

  • tremors, shivering, muscle stiffness or twitching;

  • problems with balance or coordination; or

  • agitation, confusion, sweating, fast heartbeat.

Other less serious side effects are more likely to occur, such as:

  • drowsiness, dizziness, weakness;

  • nausea, diarrhea, dry mouth, or changes in appetite or weight; or

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

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

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