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What are the possible side effects of duloxetine (Cymbalta)?

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:

    * nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
    * painful or difficult urination;
    * easy bruising or bleeding, nosebleeds;
    * black, bloody, or tarry stools;
    * very stiff (rigid) muscles, high fever, vomiting, diarrhea, sweating, fast or uneven heartbeats, tremors, overactive reflexes;
    * headache, trouble concentrating, memory problems, confusion, hallucinations; or
    * weakness, feeling unsteady, loss of coordination, fainting, seizure, shallow breathing or breathing that stops.

Less serious side effects may include:

    * dry mouth, blurred vision;
    * drowsiness, dizziness, spinning sensation;
    * mild nausea, constipation, gas;
    * sleep problems (insomnia);
    * joint or muscle pain;
    * weight changes; or
    * decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about duloxetine (Cymbalta)?

Do not take duloxetine together with thioridazine (Mellaril), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate). You must wait at least 14 days after stopping an MAOI before you can take duloxetine. After you stop taking duloxetine, you must wait at least 5 days before you start taking an MAOI.

You may have thoughts about suicide when you first start taking an antidepressant, 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), more depressed, or have thoughts about suicide or hurting yourself.

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.

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