Duloxetine

Duloxetine is a prescription medicine used to treat major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain.

Duloxetine is in a group of medications called SNRIs (serotonin norepinephrine reuptake inhibitors). It works by increasing the amount of serotonin and norepinephrine in the brain to promote mental balance and stop the movement of pain signals to the brain.

This medication comes in capsule form and is taken once or twice daily, with or without food.

Common side effects include nausea, dry mouth, and sleepiness. Do not drive or operate heavy machinery until you know how duloxetine affects you.

Duloxetine is a prescription medicine used to treat major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain.

Duloxetine may be found in some form under the following brand names:

• Cymbalta

​Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:  

• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling very agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mouth

The most common side effects of duloxetine are:

• nausea
• dry mouth
• sleepiness
• dizziness
• fatigue
• constipation
• decreased appetite
• increased sweating

This is not a complete list of duloxetine side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you are taking or are planning to take including prescription and non-prescription medicines, vitamins and herbal supplements. Especially tell your doctor if you take:

• aspirin, nonsteroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen (Advil, Motrin) and naproxen (Aleve), warfarin (Coumadin)
• MAO inhibitors
• thioridazine
• fluoxetine (Prozac), paroxetine (Paxil)
• lithium
• tramadol
• migraine medications
• cimetidine
• fluvoxamine
• ciprofloxacin
• linezolid
• St. John's Wort
• nortriptyline, amitriptyline, imipramine

This is not a complete list of duloxetine drug interactions. Ask your doctor or pharmacist for more information.

1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
   • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
   • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
   • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling very agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood

More important information about antidepressants:

• Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
• Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
• Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
• Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
• Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child's healthcare provider for more information.

Duloxetine can cause sleepiness. Do not drive or operate heavy machinery until you know how duloxetine affects you.

These are not all the possible side effects. Call your doctor for medical advice about side effects. 

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of duloxetine there are no specific foods that you must exclude from your diet when receiving duloxetine.

Before taking duloxetine, tell your doctor about all of your medical conditions. Especially tell your doctor if you have:

• kidney disease
• liver disease
• glaucoma
• diabetes
• seizures
• high blood pressure
• bipolar disorder

Tell your doctor about all of the medicines you take, or are planning to take, including prescription and non-prescription medicines, vitamins and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. There are no well-controlled studies that have been done in pregnant women. Duloxetine should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. Duloxetine may be excreted in human breast milk. It is not known how duloxetine will affect your baby.

Duloxetine comes as a delayed-release (long-acting) capsule to take by mouth. It is usually taken once a day with or without food. Swallow the capsules whole; do not crush or chew them. Take duloxetine at around the same time(s) every day. Take duloxetine exactly as directed. Do not take more or less of it, take it more often, or take it for a longer time than prescribed by your doctor.

Duloxetine may help control your symptoms but will not cure your condition. It may take 1 to 4 weeks or longer before you feel the full benefit of duloxetine. Continue to take duloxetine even if you feel well. Do not stop taking duloxetine without talking to your doctor. Your doctor will probably decrease your dose gradually.

Take duloxetine exactly as your doctor prescribes it. Follow the directions on your prescription label. Your doctor may start you on a low dose of medication and increase your dose after one week. Your doctor will determine the best dose for you.

When duloxetine is used to treat depression, it is usually taken once or twice a day. When duloxetine is used to treat generalized anxiety disorder, the pain of diabetic neuropathy, fibromyalgia, or ongoing bone or muscle pain, it is usually taken once a day.

If you take too much of this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store duloxetine in a closed container at room temperature, away from heat, moisture, and direct light.
• Do not freeze.
• Keep this and all medicines out of the reach of children.

WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of duloxetine or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Duloxetine is not approved for use in pediatric patients.