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Registry Overview

Eli Lilly and Company, the manufacturer of Cymbalta, has established a voluntary Pregnancy Registry to learn more information about pregnant women who have taken Cymbalta during pregnancy, the outcome of the pregnancies, and their babies. The primary goal of this Pregnancy Registry is to estimate the risk of major birth defects and other adverse pregnancy outcomes among pregnancies exposed to Cymbalta. Information gathered in this registry may supplement other sources of data and assist clinicians and patients in weighing the risks and/or benefits of being treated with Cymbalta around the time of conception and during pregnancy.

This drug is not approved for use during pregnancy. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Cymbalta. Use of Cymbalta in the month before delivery may increase your risk of bleeding immediately after delivery.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Cymbalta passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby while taking Cymbalta.

Cymbalta is not provided by the Registry. Due to the observational nature of this registry, participation in the Registry will not influence or interfere with the treatment plan recommended by the patient's health care provider.

The success of the Registry depends on the continued participation of healthcare providers and pregnant women who have been treated with Cymbalta. Thank you for your time and participation.

Eligibility and Enrollment

You must be at least 18 years old, a U.S. resident, pregnant, and have been treated with Cymbalta during pregnancy. The patient or health care provider must contact the Registry to initiate enrollment (Contact Us). Enrollment is voluntary and patients must provide consent. We encourage patients to enroll as early as possible. Patients should click on the Patient link for details on their Registry participation. Healthcare Providers should click on the Healthcare Providers link for details on Registry participation.

Contact Information

This Registry is sponsored by Eli Lilly and Company and is managed by Syneos Health. Women who are interested in enrolling or would like additional information should click on the Contact Us link.

For general information about Cymbalta, please refer to following links located on each site page: Important Safety Information, including Boxed Warning on antidepressants and risk of suicide, Prescribing Information, and Medication Guide.

Indications and Important Safety Information

Indications

Important Safety Information for Cymbalta®

The most important information you should know 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 or seek emergency help if you have new or worsening depression symptoms; unusual changes in behavior, such as agitation, irritability, impulsivity, or restlessness; or thoughts of suicide. Be especially observant within the first few months of treatment or after a change in dose.

The most important information you should know about antidepressant medicines, depression, other serious mental illnesses, and suicidal thoughts or actions:

  1. Depression and other serious mental illnesses are the most important causes of suicidal thoughts or actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness).
  2. How can I watch for and try to prevent suicidal thoughts and actions?
    • Pay close attention to any changes in mood, behavior, actions, thoughts, or feelings, especially sudden changes. This is very important when an antidepressant medicine is started or when the dose is changed.
      • Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call your healthcare provider right away if you have any of the following symptoms or feelings, especially if they are new, worse, or worry you. In an emergency, call 911.

What else do I need to know about antidepressant medicines?

Cymbalta is not for everyone. Do not take Cymbalta if you:

Cymbalta may be associated with serious side effects. Call your healthcare provider right away or seek emergency help if you experience any of the following:

Before taking Cymbalta, talk with your healthcare provider:

Most common side effects of Cymbalta (this is not a complete list):

Nausea, dry mouth, sleepiness, fatigue, constipation, decreased appetite, increased sweating, and dizziness. Common side effects for children and adolescents who take Cymbalta include nausea, decreased weight, and dizziness. Side effects in adults may also occur in children and teens who take Cymbalta. Children and adolescents should have height and weight monitored during treatment.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Other safety information about Cymbalta:

How to take Cymbalta:

Take Cymbalta exactly as directed by your healthcare provider. Swallow Cymbalta whole; do not open, break, or chew capsule.
Cymbalta is available by prescription only.

See Prescribing Information, including Boxed Warning about antidepressants and risk of suicide, and Medication Guide.

DD CON ISI 09OCT2019