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 affects chemicals in the brain that may be unbalanced in people with depression.
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.
Some medicines can interact with duloxetine and cause a serious condition called serotonin syndrome. 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. Ask your doctor before making any changes in how or when you take your medications.
To make sure duloxetine is safe for you, tell your doctor if you have ever had:
- liver or kidney disease;
- seizures or epilepsy;
- a bleeding or blood clotting disorder;
- high blood pressure;
- 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 will need to check your progress at regular visits while you are using duloxetine. Your family or other caregivers should also be alert to changes in your mood or symptoms.
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 medicine.
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, but effects on the nursing baby are not known. Tell your doctor if you are breast-feeding.
Duloxetine is not approved for use by anyone younger than 18 years old.
How should I take duloxetine?
Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
You may take duloxetine with or without food.
Do not crush, chew, break, or open an extended-release capsule. Swallow it whole.
It may take 1 to 4 weeks 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 medicine suddenly.
Store at room temperature away from moisture and heat.
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.
What should I avoid while taking duloxetine?
Avoid drinking alcohol. It may increase your risk of liver damage.
Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) for pain, arthritis, fever, or swelling. This includes 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.
Duloxetine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.
Severe dizziness or fainting can cause falls, accidents, or severe injuries.
What are the possible side effects of duloxetine?
Get emergency medical help if you have 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:
- a light-headed feeling, like you might pass out;
- vision changes, eye pain or swelling, eye redness;
- easy bruising, unusual bleeding;
- painful or difficult urination;
- a seizure;
-
a manic episode --racing thoughts, increased energy, reckless behavior, feeling extremely happy or irritable, talking more than usual, severe problems with sleep;
-
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
-
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.
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.
Older adults may be more sensitive to the side effects of this medicine.
Common side effects may include:
- dry mouth;
- drowsiness, dizziness;
- tired feeling;
- nausea, constipation, loss of appetite, weight loss; 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?
Many drugs can interact with duloxetine. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:
- any other antidepressant;
- cimetidine;
- St. John's wort;
- theophylline;
- tryptophan (sometimes called L-tryptophan);
-
an amphetamine --Adderall, Focalin, Vyvanse, Ritalin, Concerta, Strattera, and others;
-
an antibiotic --ciprofloxacin, enoxacin;
-
a blood thinner --warfarin, Coumadin, Jantoven;
-
heart rhythm medication --flecainide, propafenone, quinidine, and others;
-
opioid medicine --fentanyl, tramadol;
-
medicine to treat mood disorders, thought disorders, or mental illness --buspirone, lithium, thioridazine, and many others; or
-
migraine headache medicine --sumatriptan, rizatriptan, zolmitriptan, and others.
This list is not complete and many other drugs can interact with duloxetine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.
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.
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