Duloxetine is a serotonin and norepinephrine reuptake inhibitor antidepressant (SNRI).

Duloxetine is used to treat major depressive disorder in adults. Duloxetine is also used to treat general anxiety disorder in adults and children at least 7 years old.

Duloxetine is also used in adults to treat diabetic nerve pain or chronic muscle or joint pain (such as low back pain and osteoarthritis pain).

Some brands of duloxetine are also used to treat fibromyalgia (a chronic pain disorder). Drizalma is for treating fibromyalgia only in adults. Cymbalta may be used to treat fibromyalgia in adults and children at least 13 years old.

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

You should not use duloxetine if you are allergic to it.

Do not take duloxetine within 5 days before or 14 days after you have used an MAO inhibitor, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine. A dangerous drug interaction could occur.

Tell your doctor if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with duloxetine could cause a serious condition called serotonin syndrome.

Not approved for use by anyone younger than 7 years old.

Tell your doctor if you have ever had:

• heart problems, high blood pressure;
• liver or kidney disease;
• slow digestion;
• a seizure;
• bleeding problems;
• sexual problems;
• narrow-angle glaucoma;
• bipolar disorder (manic depression);
• drug addiction or suicidal thoughts; or
• if you drink large amounts of alcohol.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

Taking this medicine during pregnancy could harm the baby, but stopping the medicine may not be safe for you. Do not start or stop duloxetine without asking your doctor.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of duloxetine on the baby.

If you are breastfeeding, tell your doctor if you notice drowsiness, feeding problems, and slow weight gain in the nursing baby.

Use Drizalma Sprinkle (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• pounding heartbeats or fluttering in your chest;
• a light-headed feeling, like you might pass out;
• easy bruising, unusual bleeding;
• vision changes;
• painful or difficult urination;
• liver problems--right-sided upper stomach pain, itching, dark urine, jaundice (yellowing of the skin or eyes);
• low blood sodium--headache, confusion, problems with thinking or memory, weakness, feeling unsteady; or
• manic episodes--racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common side effects may include:

• drowsiness;
• nausea, constipation, loss of appetite;
• dry mouth; or
• increased sweating.

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.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen, naproxen, Advil, Aleve, Motrin, and others. Using an NSAID with duloxetine may cause you to bruise or bleed easily.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Drinking alcohol may increase your risk of liver damage, especially if you take Drizalma.