Duloxetine

Generic name: duloxetine (du LOX e teen)
Brand name: Cymbalta
Drug class: Serotonin-norepinephrine reuptake inhibitors

Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor antidepressant (SSNRI). Duloxetine affects chemicals in the brain that may be unbalanced in people with depression.

Duloxetine is used to treat major depressive disorder in adults. It is also used to treat general anxiety disorder in adults and children who are 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.

Warnings

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, rasagiline, selegiline, or tranylcypromine. A dangerous drug interaction could occur.

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.

Do not stop using duloxetine without first talking to your doctor.

Before taking this medicine

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

Be sure your doctor knows 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. These medicines may interact with duloxetine and cause a serious condition called serotonin syndrome.

Duloxetine is 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;
  • 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.

Ask your doctor about taking duloxetine if you are pregnant. Taking this medicine during late pregnancy may cause excessive bleeding during childbirth, or serious medical complications in the baby. However, if not treated during pregnancy, conditions such as depression or fibromyalgia may cause complications in the baby or the mother.

Tell your doctor right away if you become pregnant while taking duloxetine. Do not start or stop taking this medicine without your doctor's advice. 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?

Take duloxetine exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

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

Swallow the capsule whole and do not crush, chew, break, or open it.

You may take duloxetine with or without food.

It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Your blood pressure will need to be checked often.

Do not stop using this medicine suddenly, or you could have unpleasant symptoms (such as dizziness, vomiting, agitation, sweating, confusion, numbness, tingling, or electric shock feelings). Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture and heat.

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?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

What to avoid

Avoid driving or hazardous activity until you know how duloxetine will affect you. Your reactions could be impaired. Dizziness or fainting can cause falls, accidents, or severe injuries.

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

Avoid drinking alcohol. It may increase your risk of liver damage.

Duloxetine side effects

Get emergency medical help if you have signs of an allergic reaction to duloxetine (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).

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.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

  • 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.

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 duloxetine 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 (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, 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 your current medicines and any medicine you start or stop using.