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. It is also used to treat pain caused by nerve damage in people with diabetes (diabetic neuropathy).

Studies of Cymbalta have shown it to be effective for women in significantly reducing FM pain and discomfort and improving their overall functioning and quality of life. Men, however, experienced no effect. Cymbalta is a dual-reuptake inhibitor of serotonin and norepinephrine, chemical messengers that are believed to play a role in pain perception and depression. Developed by Eli Lilly & Co., Cymbalta is FDA approved for treating depression and diabetic peripheral neuropathy.

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 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.

Do not use duloxetine together with:

• thioridazine (Mellaril®)
• isocarboxazid (Marplan®)
• tranylcypromine (Parnate®)
• phenelzine (Nardil®)
• rasagiline (Azilect®)
• 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 14 days before you start taking an MAOI. You must wait 5 days after stopping duloxetine before you can take 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:

• Liver or Kidney Disease
• Seizures or Epilepsy
• Bipolar Disorder (manic depression)
• History of Drug Abuse or Suicidal Thoughts

If you have any of these conditions, you may not be able to use duloxetine, or you may need a dosage adjustment or special tests during treatment.

You may have an increased risk of suicidal thoughts or behavior at the start of treatment with an antidepressant medication, especially if you are under 18 years old. Talk with your doctor about this risk. While you are taking duloxetine you will need to be monitored for worsening symptoms of depression and/ or suicidal thoughts during the first weeks of treatment, or whenever your dose is changed.

In addition to you watching for changes in your own symptoms, your family or other caregivers should 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.

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 this medication to anyone under 18 years old without the advice of a doctor.

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.

Seek emergency medical attention if you think you have taken too much of this medication. Symptoms of a duloxetine overdose may include:

• nausea
• vomiting
• diarrhea
• agitation
• confusion
• hallucinations
• fast heart rate
• feeling light-headed
• fainting

Avoid drinking alcohol while taking duloxetine. Alcohol may increase the risk of damage to your liver. Avoid using other medicines that make you sleepy such as:

• Cold Medicine
• Pain Medication
• Muscle Relaxers
• Medicine for Seizures
• Medication for Depression or Anxiety

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.

Side Effects

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

Contact your doctor promptly if you have any of the following side effects, especially if they are new symptoms or if they get worse:

• Mood Changes
• Anxiety
• Panic Attacks
• Trouble Sleeping
• Irritability
• Agitation
• Aggressiveness
• Severe Restlessness
• Mania (mental and/ or physical hyperactivity)
• Thoughts of Suicide or Hurting Yourself

Call your doctor at once if you have any of these SERIOUS side effects:

• Nausea
• Stomach Pain
• Low fever
• Loss of Appetite
• Dark Urine, Clay-Colored Stools
• Jaundice (yellowing of the skin or eyes)
• Restlessness
• Overactive reflexes
• Hallucinations
• Loss of Coordination
• Fainting
• Coma
• Nausea
• Vomiting
• Diarrhea
• Fever
• Fast Heartbeat

Other less serious side effects are more likely to occur, such as:

• Constipation
• Drowsiness, Dizziness
• Headache
• Sleep Problems (insomnia)
• Weight Changes
• Feeling Anxious or Nervous
• Increased Sweating
• Sore Throat
• Decreased Sex Drive, Impotence, or Difficulty Having An Orgasm

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

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:

• cimetidine (Tagamet®)
• linezolid (Zyvox®)
• lithium (Lithobid®, Eskalith®)
• St. John's wort
• tramadol (Ultram®)
• tryptophan (sometimes called L-tryptophan®)
• warfarin (Coumadin®)
• almotriptan (Axert®)
• frovatriptan (Frova®)
• sumatriptan (Imitrex®)
• naratriptan (Amerge®)
• rizatriptan (Maxalt®)
• zolmitriptan (Zomig®)
• amitriptyline (Elavil®)
• amoxapine (Ascendin®)
• clomipramine (Anafranil®)
• desipramine (Norpramin®)
• escitalopram (Lexapro®)
• fluoxetine (Prozac®, Sarafem®)
• fluvoxamine (Luvox®)
• imipramine (Janimine®, Tofranil®)
• nortriptyline (Pamelor®)
• paroxetine (Paxil®)
• protriptyline (Vivactil®)
• sertraline (Zoloft®)
• trimipramine (Surmontil®)
• venlafaxine (Effexor®)

If you are using any of these drugs, you may not be able to use duloxetine, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect 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.