Duloxetine (doo-LOX-e-teen)

Treats depression, anxiety, diabetic peripheral neuropathy, fibromyalgia, and chronic muscle or bone pain. This medicine is a SNRI.

Brand Name(s):

Cymbalta, Drizalma Sprinkle

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule, Delayed Release Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Delayed-release capsule: Swallow the capsule whole. Do not crush, chew, break, or open it. Do not open the Cymbalta® delayed-release capsule and sprinkle the contents on food or in liquids.
• If you have trouble swallowing the Drizalma Sprinkle™ delayed release capsule:
  • You may open the capsule and sprinkle the contents over one tablespoon (15 mL) of applesauce. Swallow the mixture right away and do not save any of the mixture to use later.
  • You may open the capsule and pour the contents to an all plastic catheter tip syringe and add 50 mL of water. Do not use other liquids. Gently shake it for 10 seconds, and then use it through a nasogastric tube. Rinse with additional water (about 15 mL) if needed.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not take duloxetine if you have used an MAO inhibitor (MAOI) within the past 14 days. Do not start taking an MAO inhibitor within 5 days of stopping duloxetine. Ask your doctor if you are not sure if you take an MAOI, including linezolid or methylene blue injection.
• Some medicines can affect how duloxetine works. Tell your doctor if you are using any of the following:
  • Buspirone, cimetidine, ciprofloxacin, enoxacin, fentanyl, fluvoxamine, lithium, meperidine, methadone, St John's wort, theophylline, tramadol, tryptophan, warfarin
  • Amphetamines
  • Blood pressure medicine
  • Diuretic (water pill)
  • Medicine for heart rhythm problems (including flecainide, propafenone, quinidine)
  • Medicine to treat migraine headaches (including triptans)
  • NSAID pain or arthritis medicine (including aspirin, celecoxib, diclofenac, ibuprofen, naproxen)
  • Other medicine to treat depression or mood disorders (including amitriptyline, desipramine, fluoxetine, imipramine, nortriptyline, paroxetine)
  • Phenothiazine medicine (including thioridazine)
  • Stomach medicine (including famotidine, antacids containing aluminum or magnesium, PPIs)
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, bleeding problems, diabetes, digestion problems, glaucoma, heart disease, high or low blood pressure, or problems with urination. Tell your doctor if you smoke or you have a history of seizures, mental health problems (including bipolar disorder, mania), or drug or alcohol addiction.
• This medicine may cause the following problems:
  • Serious liver problems
  • Serotonin syndrome, when used with certain medicines
  • Increased risk of bleeding problems
  • Serious skin reactions, including erythema multiforme, Stevens-Johnson syndrome
  • Low sodium levels in the blood
  • Sexual problems
• This medicine can increase thoughts of suicide. Tell your doctor right away if you start to feel depressed and have thoughts about hurting yourself.
• This medicine may cause blurred vision, dizziness, drowsiness, trouble with thinking, or trouble with controlling body movements, which may lead to falls, fractures, or other injuries. Do not drive or do anything that could be dangerous until you know how this medicine affects you. Stand up slowly to avoid falls.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fever, fast heartbeat, sweating, muscle spasms, diarrhea, seeing or hearing things that are not there
• Blistering, peeling, red skin rash
• Confusion, weakness, muscle twitching
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Decrease in how much or how often you urinate
• Decrease in sexual ability, desire, drive, or performance
• Eye pain, vision changes, seeing halos around lights
• Feeling more energetic than usual
• Lightheadedness, dizziness, fainting
• Unusual moods or behaviors, worsening depression, thoughts about hurting yourself, trouble sleeping
• Unusual bleeding or bruising

If you notice these less serious side effects, talk with your doctor:

• Decrease in appetite or weight
• Dry mouth, constipation, mild nausea
• Headache
• Unusual drowsiness, sleepiness, or tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

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