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:
- 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).
- 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
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.
- attempts to commit suicide
- acting on dangerous impulses
- acting aggressive, being angry, or violent
- thoughts about suicide or dying
- new or worsening depression
- new or worsening anxiety
- panic attacks
- feeling very agitated or restless
- new or worsening irritability
- trouble sleeping
- an extreme increase in activity or talking (mania)
- other unusual changes in behavior or mood
What else do I need to know about antidepressant medicines?
- Never stop or change your dose of an antidepressant medicine without first talking
to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other
- Antidepressants are medicines used to treat depression and other illnesses. It is important
to discuss all the risks of treating depression and also the risks of not treating it. Patients
should discuss all treatment choices with your healthcare provider, not just the use of
- Antidepressant medicines have other side effects. Talk to your healthcare provider about the side
effects of the medicine prescribed for you or your family member.
- Antidepressant medicines can interact with other medicines. Know all of the medicines that you or
your family member takes. Keep a list of all medicines to show your healthcare provider. Do not start
new medicines without first checking with your healthcare provider.
Cymbalta is not for everyone. Do not take Cymbalta if you:
- take a monoamine oxidase inhibitor (MAOI), including the antibiotic linezolid and intravenous methylene
blue. Taking Cymbalta close in time to these medicines may have a serious or even life-threatening
problem called Serotonin Syndrome.
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:
- Itching, right upper-belly pain, dark urine, yellow skin/eyes, or unexplained flu-like
symptoms, which may be signs of life-threatening liver problems. Severe liver problems,
some fatal, have been reported.
- Decreased blood pressure upon standing, which can cause falls, dizziness or fainting,
mostly when first starting or increasing the dose. Elderly patients reported more
- High fever, confusion, stiff muscles, muscle twitching, or racing heart rate, which may
be signs of Serotonin Syndrome, a potentially life-threatening condition.
- Abnormal bleeding, especially if Cymbalta is taken with blood thinners, NSAID pain
relievers (like ibuprofen or naproxen), or aspirin.
- Serious, possibly life-threatening skin reactions, which may include skin blisters,
peeling rash, mouth sores, hives, or other allergic reactions.
- Abnormal mood (mania), which may include greatly increased energy, severe trouble
sleeping, racing thoughts, talking more or faster than usual, and reckless
- Visual problems, including eye pain, changes in vision, and swelling or redness in or
around the eye. Only some people are at risk for these problems, so you may want to
undergo an eye examination to see if you are at risk and receive preventative treatment
if you are.
- Seizures or convulsions
- Cymbalta can also increase blood pressure. Your healthcare provider should check your
blood pressure prior to and while taking Cymbalta.
- Headache, weakness or feeling unsteady, confusion, problems concentrating, or memory
problems, which may be signs of low sodium levels in the blood. Elderly people may
be at greater risk.
- Problems with urination, including decreased flow or inability to pass any urine.
Before taking Cymbalta, talk with your healthcare provider:
- About all your medical conditions, including:
- heart problems or high blood pressure
- diabetes (Cymbalta makes it harder for some people with diabetes to control blood sugar)
- kidney or liver problems
- bipolar disorder or mania
- if you have ever had or been told you have bleeding problems, low sodium levels in your blood,
or delayed stomach emptying
- About all prescription and over-the-counter medicines and supplements you take or
plan to take, including
- antibiotics or medicines for migraine, mood, or psychotic disorders, to avoid a
potentially life-threatening condition when taken with Cymbalta
- thioridazine (Mellaril) to avoid a serious heart rhythm problem or sudden
- aspirin, NSAID pain relievers, or blood thinners, because they may increase
risk for bleeding
- About your alcohol use (you should not take Cymbalta if you drink heavily)
- If you are pregnant or breastfeeding or plan to become pregnant or breastfeed during therapy
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:
- Cymbalta may cause sleepiness and dizziness. Until you know how Cymbalta affects
you, you shouldn’t drive a car or operate hazardous machinery
- People age 65 and older who took Cymbalta reported more falls, some resulting in
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.
including Boxed Warning about antidepressants and risk of suicide, and
DD CON ISI 04DEC2014