What is the most important information I should know about 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, rasagiline, selegiline, or tranylcypromine.
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.
What is duloxetine?
Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor antidepressant (SSNRI).
Duloxetine is used to treat major depressive disorder in adults. Duloxetine 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 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 adults with diabetes (diabetic neuropathy).
Duloxetine may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking duloxetine?
You should not use duloxetine if you are allergic to it.
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.
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:
- liver or kidney disease;
- slow digestion;
- a seizure;
- bleeding problems;
- narrow-angle glaucoma;
- bipolar disorder (manic depression); or
- drug addiction or suicidal thoughts.
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 duloxetine during pregnancy may cause breathing problems, feeding problems, seizures, or other complications in the newborn baby. However, you may have a relapse of depression if you stop taking this medicine. Tell your doctor right away if you become pregnant. Do not start or stop taking this medicine without your doctor's advice.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of duloxetine on the baby.
It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.
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.
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 duloxetine suddenly, or you could have unpleasant symptoms (such as dizziness, nausea, diarrhea, irritability, or anxiety). 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 severe drowsiness, seizures, fast heartbeats, fainting, or coma.
What should I avoid while taking duloxetine?
Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or fainting can cause falls, accidents, or severe injuries.
Avoid drinking alcohol. It may increase your risk of liver damage.
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.
What are the possible side effects of duloxetine?
Get emergency medical help if you have signs of an allergic reaction (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.
Call your doctor at once if you have:
- 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
-
a manic episode --racing thoughts, increased energy, reckless behavior, feeling extremely happy or irritable, talking more than usual, severe problems with sleep.
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 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.
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.
Where can I get more information?
Your pharmacist can provide more information about duloxetine.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2020 Cerner Multum, Inc. Version: 12.01. Revision date: 12/27/2018.
