duloxetine

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

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

What is duloxetine?

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 nerve pain caused by diabetes (diabetic neuropathy), or chronic muscle or joint pain (such as low back pain and osteoarthritis pain).

Duloxetine is also used to treat fibromyalgia (a chronic pain disorder) in adults and children at least 13 years old.

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

What should I discuss with my healthcare provider before taking duloxetine?

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.

Tell your doctor if you have ever had:

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

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Taking an SNRI antidepressant during late pregnancy could increase your risk of excessive bleeding after you give birth, and may cause serious medical complications in the baby. However, stopping the medicine may not be safe if you have a relapse of depression. 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.

How should I take duloxetine?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Taking duloxetine in higher doses or more often than prescribed will not make it more effective, and may increase side effects.

Take with or without food.

Your blood pressure will need to be checked often.

Your symptoms may not improve for up to 4 weeks. You may have unpleasant symptoms if you stop using venlafaxine suddenly. Ask your doctor before stopping the medicine.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Overdose symptoms may include vomiting, dizziness or drowsiness, seizures, fast heartbeats, fainting, or coma.

What should I avoid while taking duloxetine?

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

What are the possible side effects of duloxetine?

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.

• 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;
• impotence, sexual problems;
• liver problems --right-sided upper stomach pain, itching, dark urine, jaundice (yellowing of the skin or eyes);
• low levels of sodium in the body --headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady; or
• manic episodes --racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative.

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.

What other drugs will affect duloxetine?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

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.

Many drugs can affect duloxetine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.

Where can I get more information?

Your pharmacist can provide more information about duloxetine.