Important Safety Information

Cymbalta (duloxetine HCl) is approved to manage diabetic nerve pain. It is also approved as an antidepressant.

What should I talk about with my healthcare provider?

Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, unusual changes in behavior, thoughts of suicide, anxiety, agitation, panic attacks, difficulty sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness, or extreme hyperactivity. Call your healthcare provider right away if you have thoughts of suicide or if any of these symptoms are severe or occur suddenly. Be especially observant within the first few months of antidepressant treatment or whenever there is a change in dose.

You should also know that:

• Suicide is a known risk of depression and some other psychiatric disorders.
• Antidepressants may increase suicidal thoughts or behaviors in some children, adolescents, and young adults especially within the first few months of treatment or when changing the dose. No increased risk has been shown for adults over age 24, and risk decreased for those over age 65.
• All patients starting therapy should be monitored appropriately and observed closely for new or worsening depression symptoms, suicidal thoughts or behavior, or unusual changes in behavior.
• Cymbalta is not approved for use in patients under age 18.

Who should NOT take Cymbalta?

You should not take Cymbalta if:

• You have recently taken a type of antidepressant called a monoamine oxidase inhibitor (MAOI)
• You have uncontrolled narrow-angle glaucoma (an eye disease)
• You are taking Mellaril^® (thioridazine)

What other important information should I discuss with my healthcare provider?

Talk to your healthcare provider about any medical conditions you may have, including liver or kidney problems, glaucoma or diabetes. Tell your healthcare provider about all nonprescription and prescription medicines you are taking, especially those for migraine, to avoid a potentially life-threatening condition and about your alcohol consumption. Taking NSAID pain relievers, aspirin or blood thinners with Cymbalta may increase bleeding risk. Consult with your healthcare provider before stopping Cymbalta or changing the dose and if you are pregnant or nursing.

Dizziness or fainting may occur upon standing, especially when first starting Cymbalta or when increasing the dose. Your healthcare provider may periodically check your blood pressure while you are taking Cymbalta.

If you have any questions, talk to your healthcare provider before taking Cymbalta.

What are the possible side effects of Cymbalta?

In clinical studies of diabetic nerve pain, the most common side effect of Cymbalta was nausea. For most people who had it, the nausea was mild to moderate and usually improved within 1 to 2 weeks. Other common side effects included sleepiness, dizziness, constipation, increased sweating, dry mouth, and decreased appetite. This is not a complete list of side effects.

To learn more about Cymbalta, read the full Prescribing Information.