Important Safety Information About Cymbalta

Antidepressants can increase suicidal thoughts and behaviors in children, teens, and young adults. Suicide is a known risk of depression and some other psychiatric disorders. Call your doctor right away if you have new or worsening depression symptoms, unusual changes in behavior, or thoughts of suicide. Be especially observant within the first few months of treatment or after a change in dose. Approved only for adults 18 and over.

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.

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 (increased eye pressure)
• You are taking Mellaril® (thioridazine)

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

Before starting Cymbalta, talk with your healthcare provider:

• about all of your medical conditions, including kidney or liver problems, glaucoma, diabetes, seizures, or if you have bipolar disorder. Cymbalta may worsen a type of glaucoma or the control of blood sugar in some patients with 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, talk with 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.
• about your blood pressure. Cymbalta can increase your blood pressure. Your healthcare provider should check your blood pressure prior to and while taking Cymbalta
• if you experience headache, weakness, confusion, problems concentrating, memory problems, or feel unsteady while taking Cymbalta which may be signs of low sodium levels
• if you develop problems with urine flow

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 depression, the most common side effect of Cymbalta was nausea. Other common side effects included dry mouth, constipation, decreased appetite, fatigue, sleepiness, and increased sweating. This is not a complete list of side effects.

Other safety information about Cymbalta:

Cymbalta may cause sleepiness and dizziness. Until you know how Cymbalta affects you, you should not drive a car or operate hazardous machinery.

See Prescribing Information for additional Important Safety Information, including Boxed Warning.