Duloxetine is used to treat depression and anxiety. It is also used for pain caused by nerve damage associated with diabetes (diabetic peripheral neuropathy).

Duloxetine is also used to treat fibromyalgia (muscle pain and stiffness) and chronic (long-lasting) pain that is related to muscles and bones.

Duloxetine belongs to a group of medicines known as selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). These medicines are thought to work by increasing the activity of chemicals called serotonin and norepinephrine in the brain.

This medicine is available only with your doctor's prescription.

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the delayed-release capsule whole with or without food. Do not chew, crush, or break the capsule. Do not open the capsule and sprinkle the contents on food or in liquids.

You will need to use this medicine for several weeks before you begin to feel better. Keep using the medicine even if you feel you are not getting better, and talk to your doctor if you have any questions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

Abdominal or stomach pain

area rash

blindness

blistering, peeling, or loosening of the skin

blurred vision

change in consciousness

chills

clay-colored stools

cold sweats

confusion

convulsions

dark urine

decreased urine output

decreased vision

difficulty swallowing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

eye pain

fainting

fast or irregular heartbeat

general tiredness or weakness

hives or welts, itching, or skin rash

hives, itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue

increased thirst

joint or muscle pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

light-colored stools

loss of consciousness

red skin lesions, often with a purple center

red, irritated eyes

redness of the skin

sores, ulcers, or white spots in the mouth or on the lips

swelling of the face, ankles, or hands

tearing

tightness in the chest

unpleasant breath odor

upper right stomach pain

vomiting of blood

yellow eyes and skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Agitation

diarrhea

fever

loss of bladder control

muscle spasm or jerking of all extremities

overactive reflexes

poor coordination

restlessness

shivering

sleepiness or unusual drowsiness

sudden loss of consciousness

sweating

talking or acting with excitement you cannot control

trembling or shaking

twitching

unusual tiredness or weakness

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Body aches or pain

cough

difficulty having a bowel movement (stool)

dry mouth

ear congestion

frequent urination

headache

lack or loss of strength

loss of appetite

loss of voice

muscle aches

nausea

sleepiness or unusual drowsiness

sneezing

sore throat

stuffy or runny nose

sweating increased

trouble sleeping

weight loss

Less common

Abnormal orgasm

acid or sour stomach

belching

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

change in taste

change or problem with discharge of semen

decreased interest in sexual intercourse

difficulty with moving

feeling of warmth or redness of the face, neck, arms, and occasionally, upper chest

heartburn

inability to have or keep an erection

indigestion

joint pain

longer than usual time to ejaculation of semen

loose stools

loss in sexual ability, desire, drive, or performance

loss of taste

muscle aching or cramping

muscle pains or stiffness

shakiness in the legs, arms, hands, or feet

stomach discomfort or upset

sudden sweating

swollen joints

trembling or shaking of the hands or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

It is important that your doctor check your progress at regular visits to allow for changes in your dose and to help prevent any unwanted effects.

Do not take duloxetine if you have taken an monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], methylene blue injection, phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]) in the past 2 weeks. Do not start taking an MAO inhibitor within 5 days of stopping duloxetine. If you do, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, or severe convulsions.

Duloxetine may cause some teenagers and young adults to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you or your caregiver notice any of these unwanted effects, tell your doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

This medicine can cause serious liver problems. If you experience symptoms such as dark urine, general tiredness and weakness, light-colored stools, nausea and vomiting, upper right stomach pain, or yellow eyes and skin, contact your doctor right away.

Make sure your doctor knows about all the other medicines you are using. Duloxetine may cause serious conditions called serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions if taken with certain medicines such as buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), tryptophan, St. John's wort, amphetamines, or some pain medicines (eg, tramadol [Ultram®], sumatriptan [Imitrex®], zolmitriptan [Zomig®], or rizatriptan [Maxalt®]). Check with your doctor first before taking any other medicines.

This medicine may increase your risk for bleeding problems. Make sure your doctor knows if you are also taking other medicines that thin the blood, such as aspirin, NSAID pain medicines (eg, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, or Motrin®) or warfarin (Coumadin®).

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

Do not suddenly stop taking this medicine without checking first with your doctor. If you have been instructed to stop taking duloxetine, ask your doctor how to slowly decrease the dose. This will decrease your chance of having withdrawal symptoms such as dizziness, nausea, headaches, vomiting, increased sweating, irritability, nightmares, or prickling or tingling feelings.

This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

Duloxetine may cause some people to become dizzy or have blurred vision. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see clearly. You may also feel lightheaded or you may fall or faint when getting up suddenly from a lying or sitting position, so get up slowly. If these symptoms are bothering you or keeping you from doing your daily activities, tell your doctor right away.

You will need to measure your blood pressure before starting this medicine and while you are using it. If you notice any change to your recommended blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

Hyponatremia (low sodium in the blood) may occur with this medicine. Check with your doctor right away if you have confusion, difficulty concentrating, headaches, memory problems, weakness, and unsteadiness.

Avoid smoking while you are using this medicine. If you have any questions about this, check with your doctor.