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. It is also
used to treat a chronic pain disorder called fibromyalgia, and to treat pain caused by nerve damage in
people with diabetes (diabetic neuropathy).
Duloxetine may also be used for other purposes not listed in this medication guide.
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
isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or
selegiline (Eldepryl, Emsam). Serious and sometimes fatal reactions can occur when these medicines
are taken with duloxetine. 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.
Before taking duloxetine, tell your doctor if you are allergic to any drugs, or if you have:
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liver or kidney disease;
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seizures or epilepsy;
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a bleeding or blood clotting disorder;
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glaucoma;
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bipolar disorder (manic depression); or
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a history of drug abuse or suicidal thoughts.
If you have any of these conditions, you may need a dose adjustment or
special tests to safely take duloxetine.
You may have thoughts about suicide when you first start taking an antidepressant, especially if
you are younger than 24 years old. Tell your doctor if you have worsening symptoms of 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. Duloxetine may be harmful to an unborn baby, and may
cause problems in a newborn baby if the mother takes the medication late in pregnancy (during the third
trimester). Tell your doctor if you are pregnant or plan to become pregnant during treatment.
Duloxetine can pass into breast milk and may harm a nursing baby. Do not use this
medication without telling your doctor if you are breast-feeding a baby.
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 this medication exactly as it was prescribed for you. Do not take the medication in larger
amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally
change your dose to make sure you get the best results from the medication.
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 the pill whole. It is
specially made to release medicine slowly in the body. Breaking or opening the pill would cause too
much of the drug to be released at one time.
It may take 4 weeks or longer for your symptoms to improve. For best results, 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 duloxetine at room temperature away from moisture and heat.
What happens if I miss a dose of duloxetine?
Take the missed dose as soon as you remember. However, if it is almost time for the next
regularly scheduled dose, skip the missed dose and take the next one as directed.
Do not
take extra medicine to make up the missed dose.
Where can I get more information about duloxetine?
Your pharmacist has information about duloxetine written for health professionals that you may read.
What are the possible side effects of duloxetine?
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.
Call your doctor at once if you have any new or worsening symptoms 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:
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nausea, stomach pain, low fever, loss of appetite, dark urine,
clay-colored stools, jaundice (yellowing of the skin or eyes);
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painful or difficult urination;
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easy bruising or bleeding, nosebleeds;
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black, bloody, or tarry stools;
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very stiff (rigid) muscles, high fever, vomiting, diarrhea,
sweating, fast or uneven heartbeats, tremors, overactive reflexes;
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headache, trouble concentrating, memory problems,
confusion, hallucinations; or
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weakness, feeling unsteady, loss of coordination, fainting,
seizure, shallow breathing or breathing that stops.
Less serious side effects may include:
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dry mouth, blurred vision;
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drowsiness, dizziness, spinning sensation;
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mild nausea, constipation, gas;
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sleep problems (insomnia);
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joint or muscle pain;
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weight changes; or
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decreased sex drive, impotence, or difficulty having an
orgasm.
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. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about duloxetine?
Do not take duloxetine together with thioridazine (Mellaril), or a monoamine oxidase
inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline
(Eldepryl, Emsam), or tranylcypromine (Parnate). You must wait at least 14 days after stopping an
MAOI before you can take duloxetine. After you stop taking duloxetine, you must wait at least 5 days
before you start taking an MAOI.
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.
Call your doctor at once if you have any new or worsening symptoms 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 while taking duloxetine. Alcohol may increase the risk of damage to
your liver.
Duloxetine can cause side effects that may impair your thinking or reactions. Be careful if
you drive or do anything that requires you to be awake and alert.
What should I avoid while taking duloxetine?
Avoid drinking alcohol while taking duloxetine. Alcohol may increase the risk of damage to
your liver.
Duloxetine can cause side effects that may impair your thinking or reactions. Be careful if
you drive or do anything that requires you to be awake and alert.
Tell your doctor if you regularly use other medicines that make you sleepy (such as cold or
allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures or
anxiety). They can add to sleepiness caused by duloxetine.
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.
Before taking duloxetine, tell your doctor if you are using any of the following medicines:
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a blood thinner such as warfarin (Coumadin);
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cimetidine (Tagamet);
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a diuretic (water pill);
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fluvoxamine (Luvox);
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linezolid (Zyvox);
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lithium (Lithobid, Eskalith);
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St. John's wort;
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tramadol (Ultram);
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tryptophan (sometimes called L-tryptophan);
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an antibiotic such as ciprofloxacin (Cipro) or enoxacin
(Penetrex);
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almotriptan (Axert), frovatriptan (Frova), sumatriptan
(Imitrex), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig); or
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any other antidepressant such as desipramine (Norpramin),
fluoxetine (Prozac, Sarafem), paroxetine (Paxil), and others.
This list is not complete and there may be other drugs that can interact with
duloxetine. Tell your doctor about all the prescription and over-the-counter medications you use. This
includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using
a new medication without telling your doctor.
What happens if I have an overdose of duloxetine?