Generic Name: duloxetine (du LOX e teen)
Brand Names: Cymbalta
What is duloxetine?
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.
What is the most important information I should know about duloxetine?
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.
Treatments for depression are getting better everyday and there are things you can start doing right away.
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.
What should I discuss with my healthcare provider before taking duloxetine?
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.
How should I take duloxetine?
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.
Try to take the medicine at the same time each day. Follow the directions on your prescription label.
Do not crush, chew, break, or open a delayed-release capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time. It may take 4 weeks or longer before your symptoms improve. Keep using the medication as directed. Do not stop using duloxetine without first talking to your doctor. You may have unpleasant side effects if you stop taking this medication suddenly. Store at room temperature away from moisture and heat.
See also: Duloxetine dosage (in more detail)
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include agitation, hallucinations, fever, overactive reflexes, loss of coordination, extreme drowsiness, vomiting, diarrhea, seizure (convulsions), fast heart rate, feeling light-headed, or fainting.
What should I avoid while taking duloxetine?
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.
Duloxetine side effects
Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat. 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.
Call your doctor at once if you have any of these serious side effects:
nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
feeling like you might pass out;
agitation, hallucinations, fever, fast heart rate, overactive reflexes;
very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors;
easy bruising, unusual bleeding;
painful or difficult urination;
headache, trouble concentrating, memory problems, weakness, feeling unsteady, loss of coordination, fainting, seizure, shallow breathing or breathing that stops; or
severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Less serious side effects may include:
dry mouth;
drowsiness;
tired feeling;
mild nausea or loss of appetite; or
constipation.
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.
Duloxetine Dosing Information
Usual Adult Dose for Pain:
For use in the management of neuropathic pain associated with diabetic peripheral neuropathy and for the management of chronic musculoskeletal pain in patients with chronic low back pain and chronic pain due to osteoarthritis:
Usual Dose: 60 mg once a day without regard to meals.
For patients in whom tolerability is a concern, a lower starting dose may be considered.
Although a 120 mg per day dose was shown to be safe and effective, there is no evidence that doses higher than 60 mg have any additional benefit. Furthermore, the higher dose has been clearly less well tolerated.
Efficacy beyond 12 weeks has not been systematically studied in placebo-controlled studies, but a one year open label safety study has been conducted.
Usual Adult Dose for Depression:
Initial Dose: 40 mg per day (administered as 20 mg twice daily) to 60 mg per day (given either once a day or as 30 mg twice daily) without regard to meals.
Usual Adult Dose for Anxiety:
Initial dose: 60 mg orally once a day If necessary, dosage may be increased in increments of no more than 30 mg per day Maximum dose: 120 mg per day For patients in whom tolerability is a concern, a lower an initial dose of 30 mg orally once a day may be considered. Following one week of therapy, the dose may be increased to 60 mg orally once a day in this patient population. Although a 120 mg per day dose was shown to be safe and effective, there is no evidence that doses higher than 60 mg have any additional benefit.
It is generally agreed that episodes of generalized anxiety disorder require several months or longer of sustained pharmacological therapy. Maintenance of efficacy in generalized anxiety disorder has been demonstrated with duloxetine as monotherapy. Duloxetine should be administered in a dose range of 60 to 120 mg once daily. Patients should be periodically reassessed to determine the continued need for maintenance treatment and the appropriate dose for such treatment.
Usual Adult Dose for Fibromyalgia:
Initial Dose: 30 mg once a day without regard to meals for one week.
Usual Dose: 60 mg once a day without regard to meals.
Treatment should begin at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. Some patients may respond to the starting dose. There is no evidence that doses greater than 60 mg/day confer additional benefit, even in patients who do not respond to a 60 mg dose, and higher doses are associated with a higher rate of adverse reactions.
Fibromyalgia is recognized as a chronic condition. The efficacy of duloxetine in the management of fibromyalgia has been demonstrated in placebo-controlled studies up to three months. The efficacy of duloxetine was not demonstrated in longer studies; however, continued treatment should be based on individual patient response.
What other drugs will affect duloxetine?
Talk to your doctor before taking any medicine for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others. Taking any of these drugs with duloxetine may cause you to bruise or bleed easily.
Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, or anxiety can add to sleepiness caused by duloxetine. Tell your doctor if you regularly use any of these medicines, or any other antidepressant.
Tell your doctor about all other medicines you use, especially:
a blood thinner such as warfarin (Coumadin);
cimetidine (Tagamet);
a diuretic (water pill);
fluvoxamine (Luvox);
linezolid (Zyvox);
lithium (Lithobid, Eskalith);
St. John's wort;
tramadol (Ultram);
tryptophan (sometimes called L-tryptophan);
an antibiotic such as ciprofloxacin (Cipro);
almotriptan (Axert), frovatriptan (Frova), sumatriptan (Imitrex), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig); or
any other antidepressant such as desipramine (Norpramin), fluoxetine (Prozac, Sarafem), paroxetine (Paxil), and others.
This list is not complete and other drugs may interact with duloxetine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
More duloxetine resources
- Duloxetine Side Effects (in more detail)
- Duloxetine Dosage
- Duloxetine Use in Pregnancy & Breastfeeding
- Duloxetine Drug Interactions
- Duloxetine Support Group
- 479 Reviews for Duloxetine - Add your own review/rating
- duloxetine Advanced Consumer (Micromedex) - Includes Dosage Information
- Cymbalta Prescribing Information (FDA)
- Cymbalta Consumer Overview
- Duloxetine Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)
- Duloxetine Monograph (AHFS DI)
Compare duloxetine with other medications
- Anxiety
- Back Pain
- Bipolar Disorder
- Chronic Fatigue Syndrome
- Depression
- Diabetic Nerve Damage
- Dysthymia
- Fibromyalgia
- Generalized Anxiety Disorder
- Hot Flashes
- Osteoarthritis
- Pain
- Peripheral Neuropathy
- Urinary Incontinence
Where can I get more information?
- Your pharmacist can provide more information about duloxetine.
See also: duloxetine side effects (in more detail)
