Important Safety Information

Cymbalta^® (duloxetine HCl) is approved for the treatment of depression and generalized anxiety disorder, and for the management of diabetic peripheral neuropathic pain and fibromyalgia.

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?

Before starting Cymbalta, tell your healthcare provider:

• ·about all of your medical conditions, including kidney problems, glaucoma, or diabetes
• ·about your alcohol use
• ·if you are taking nonprescription or prescription medicines, including those for migraine, to address a possible life threatening condition
• ·if you are taking NSAID pain relievers, aspirin, or blood thinners. Use with Cymbalta may increase bleeding risk
• ·if you are pregnant, plan to become pregnant during therapy, or are breastfeeding an infant

While taking Cymbalta, tell your healthcare provider:

• ·if you have itching, right upper belly pain, dark urine, yellow skin/eyes, or unexplained flu-like symptoms, which may be signs of liver problems. Severe liver problems, sometimes fatal, have been reported
• ·if you have high fever, confusion, and stiff muscles to address a possible life-threatening condition
• ·before stopping Cymbalta or changing your dose
• ·if you experience dizziness or fainting 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?

The most common side effect of Cymbalta was nausea. For most people who had it, the nausea was mild to moderate. Other common side effects included dry mouth, sleepiness, constipation, decreased appetite, and, increased sweating. This is not a complete list of side effects.