National Alliance on Mental Illness
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Generic name: duloxetine (doo LOX e teen)
Medication class: Serotoninorepinephrine reuptake inhibitor (SNRI) antidepressant
All FDA black box warnings are at the end of this fact sheet. Please review before taking this medication.
What is Cymbalta® and what does it treat?
Duloxetine is an antidepressant medication that works in the brain. It is approved for the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), diabetic peripheral neuropathic pain (DPNP), fibromyalgia, and chronic musculoskeletal pain.
Symptoms of depression include:
Generalized Anxiety Disorder (GAD) occurs when a person experiences excessive anxiety or worry for at least six months. Other symptoms include
What is the most important information I should know about Cymbalta®?
Do not stop taking duloxetine, even when you feel better. Only your healthcare provider can determine the length of treatment that is right for you.
Missing doses of duloxetine may increase your risk for relapse in your symptoms.
Stopping duloxetine abruptly may result in one or more of the following withdrawal symptoms: irritability, nausea, feeling dizzy, vomiting, nightmares, headache, and/or paresthesias (prickling, tingling sensation on the skin).
Depression is also a part of bipolar illness. People with bipolar disorder who take antidepressants may be at risk for "switching" from depression into mania. Symptoms of mania include "high" or irritable mood, very high self esteem, decreased need for sleep, pressure to keep talking, racing thoughts, being easily distracted, frequently involved in activities with a large risk for bad consequences (for example, excessive buying sprees).
Medical attention should be sought if serotonin syndrome is suspected. Please refer to serious side effects for signs/symptoms.
Are there specific concerns about Cymbalta® and pregnancy?
If you are planning on becoming pregnant, notify your healthcare provider to best manage your medications. People living with MDD who wish to become pregnant face important decisions. Untreated MDD has risks to the fetus, as well as the mother. It is important to discuss the risks and benefits of treatment with your doctor and caregivers. For women who take antidepressant medications during weeks 13 through the end of their pregnancy (second and third trimesters), there is a risk that the baby can be born before it is fully developed (before 37 weeks).
Caution is advised with breastfeeding since duloxetine does pass into breast milk.
What should I discuss with my healthcare provider before taking Cymbalta®?
How should I take Cymbalta®?
Duloxetine is usually taken 1 or 2 times per day with or without food
Typically patients begin at a low dose of medicine and the dose is increased slowly over several weeks.
The dose usually ranges from 20 mg to 120 mg. Only your healthcare provider can determine the correct dose for you.
The capsule should be swallowed whole. It should not be chewed, crushed, or broken.
Consider using a calendar, pillbox, alarm clock, or cell phone alert to help you remember to take your medication. You may also ask a family member or friend to remind you or check in with you to be sure you are taking your medication.
What happens if I miss a dose of Cymbalta®?
If you miss a dose of duloxetine take it as soon as you remember, unless it is closer to the time of your next dose. Discuss this with your healthcare provider. Do not double your next dose or take more than what is prescribed.
What should I avoid while taking Cymbalta®?
Avoid drinking alcohol or using illegal drugs while you are taking antidepressant medications. They may decrease the benefits (e.g., worsen your condition) and increase adverse effects (e.g., sedation) of the medication. Alcohol increases the risk of liver problems with duloxetine.
What happens if I overdose with Cymbalta®?
If an overdose occurs, call your doctor or 911. You may need urgent medical care. You may also contact the poison control center at 1-800-222-1222.
A specific treatment to reverse the effects of duloxetine does not exist.
What are the possible side effects of Cymbalta®?
Common Side Effects
These will often improve over the first week or two as you continue to take the medication.
These often do not improve over time.
Rare Side Effects
Increased heart rate, low blood pressure, increased salivation, irregular menstrual cycle, increased frequency of urination, changes in taste, increased liver enzymes, increased bleeding (e.g., gums may bleed more easily), low sodium (symptoms of low sodium levels may include headache, weakness, difficulty concentrating and remembering), teeth grinding, difficulty urinating
Serious Side Effects
Serotonin syndrome (symptoms may include shivering, diarrhea, confusion, severe muscle tightness, fever, seizures, and death), hypertensive crisis (severely elevated blood pressure), myocardial infarction (heart attack), Stevensohnson syndrome (rash), and gastrointestinal hemorrhage (bleeding from the gastrointestinal tract)
Are there any risks of taking Cymbalta® for long periods of time?
To date, there are no known problems associated with long term use of duloxetine. It is a safe and effective medication when used as directed.
What other medications may interact with Cymbalta®?
Duloxetine should not be taken with or within 2 weeks of taking monoamine oxidase inhibitors (MAOIs). These include phenelzine (Nardil®), tranylcypromine (Parnate®), isocarboxazid (Marplan®), rasagiline (Azalect®) and selegeline (Emsam®).
Although rare, there is an increased risk of serotonin syndrome when duloxetine is used with other medications that increase serotonin, such as other antidepressants, migraine medications called “triptans” (e.g., Imitrex®), some pain medications (e.g., tramadol (Ultram®), and the antibiotic linezolid (Zyvox®).
Duloxetine may increase the effects of other medications that can cause bleeding (e.g., ibuprofen (Advil®, Motrin®), warfarin (Coumadin®) and aspirin).
The following medications may increase the levels and effects of duloxetine: cimetidine (Tagamet®), ciprofloxacin (Cipro®), fluoxetine (Prozac®), fluvoxamine (Luvox®), paroxetine (Paxil®)
How long does it take for Cymbalta® to work?
Sleep, energy, or appetite may show some improvement within the first 1-2 weeks. Improvement in these physical symptoms can be an important early signal that the medication is working. Depressed mood and lack of interest in activities may need up to 6-8 weeks to fully improve.
Provided by the College of Psychiatric and Neurologic Pharmacists
Summary of Black Box Warnings
Suicidal Thoughts or Actions in Children and Adults