Duloxetine is an antidepressant in a group of drugs called selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). Duloxetine affects chemicals in the brain that may become unbalanced and cause depression.

Duloxetine is used to treat major depressive disorder and general anxiety disorder.

Duloxetine is also used to treat fibromyalgia (a chronic pain disorder), or chronic muscle or joint pain (such as low back pain and osteoarthritis pain).

Duloxetine is also used to treat pain caused by nerve damage in people with diabetes (diabetic neuropathy).

Duloxetine may also be used for purposes not listed in this medication guide.

Do not use duloxetine together with thioridazine (Mellaril), or an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). A dangerous drug interaction could occur, leading to serious side effects.

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.

Report any new or worsening symptoms to your doctor, 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. It may increase your risk of liver damage.

Duloxetine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Do not use duloxetine together with thioridazine (Mellaril), or an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). A dangerous drug interaction could occur, leading to serious side effects. You must wait at least 14 days after stopping an MAO inhibitor before you can take duloxetine. After you stop taking duloxetine, you must wait at least 5 days before you start taking an MAOI.

Do not use this medication if you are allergic to duloxetine, or if you have untreated or uncontrolled glaucoma.

To make sure you can safely take duloxetine, tell your doctor if you have any of these other conditions:

• liver or kidney disease;

• seizures or epilepsy;

• a bleeding or blood clotting disorder;

• glaucoma;

• bipolar disorder (manic depression); or

• a history of drug abuse or suicidal thoughts.

You may have thoughts about suicide while taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

FDA pregnancy category C. It is not known whether duloxetine will harm an unborn baby. However, duloxetine may cause problems in a newborn if you take the medicine during the third trimester of pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of duloxetine on the baby.

Duloxetine can pass into breast milk and may harm a nursing baby. You should not breast-feed while taking this medication.

Older adults may be more sensitive to the side effects of this medication.

Do not give duloxetine to anyone younger than 18 years old without the advice of a doctor.