CONTRAVE can cause serious side effects including:
Suicidal thoughts or actions: One of the ingredients in CONTRAVE is bupropion.
Bupropion has caused some people to have suicidal thoughts or actions or unusual changes in
behavior, whether or not they are taking medicines used to treat depression. Bupropion may
increase the risk of suicidal thoughts or actions in some children, teenagers, and young adults
within the first few months of treatment. If you already have depression or other mental
illnesses, taking bupropion may cause it to get worse, especially within the first few months of
treatment.
While taking CONTRAVE, you or your family members should pay close attention to
any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very
important when you start taking CONTRAVE or when your dose changes.
Stop taking CONTRAVE and call a healthcare provider right away if you or your family
members notice any of the following symptoms, especially if they are new, worse, or worry
you: thoughts about suicide or dying; attempts to commit suicide; depression;
anxiety; feeling agitated or restless; panic attacks; irritability; aggression, anger, or
violence; acting on dangerous impulses; an extreme increase in activity and talking; other
unusual changes in behavior or mood; trouble sleeping.
CONTRAVE is not approved for use in children under the age of 18.
Do not take CONTRAVE if you have uncontrolled high blood pressure; have or have
had seizures; use other medicines that contain bupropion such as WELLBUTRIN, WELLBUTRIN SR,
WELLBUTRIN XL, APLENZIN and ZYBAN; have or have had an eating disorder called anorexia or
bulimia; are dependent on opioid pain medicines or use medicines to help stop taking opioids, or
are in opiate withdrawal; drink a lot of alcohol and abruptly stop drinking, or use medicines
called sedatives (these make you sleepy), benzodiazepines, or anti‐seizure medicines and stop
using them all of a sudden; are taking or have taken medicines called monoamine oxidase
inhibitors (MAOIs) in the past 14 days; or are allergic to any of the ingredients in CONTRAVE.
Tell your healthcare provider about all of your medical conditions including if you
have: depression or other mental illnesses; attempted suicide; seizures; head
injury; tumor or infection of brain or spine; low blood sugar or low sodium; liver or kidney
problems; high blood pressure; heart attack, heart problems, or stroke; eating disorder;
drinking a lot of alcohol; prescription medicine or street drug abuse; are 65 or older;
diabetes; pregnant or planning to become pregnant; or breastfeeding.
Tell your healthcare provider about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of CONTRAVE include nausea, constipation, headache,
vomiting, dizziness, trouble sleeping, dry mouth, and diarrhea. These are not all of the
possible side effects of CONTRAVE.
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.
CONTRAVE is a prescription weight-loss medicine that may help some adults with a body mass index
(BMI) of 30 kg/m2 or greater (obese), or adults with a BMI of 27 kg/m2 or
greater (overweight) with at least one weight-related medical problem such as high blood
pressure, high cholesterol, or type 2 diabetes, lose weight and keep the weight off.
CONTRAVE should be used with a reduced-calorie diet and increased physical activity.
It is not known if CONTRAVE changes your risk of heart problems or stroke or of death due to
heart problems or stroke.
It is not known if CONTRAVE is safe and effective when taken with other prescription,
over-the-counter, or herbal weight-loss products.
CONTRAVE is not approved to treat depression or other mental illnesses, or to help people quit
smoking (smoking cessation).
Please see Full Prescribing Information,
including Medication Guide,
for CONTRAVE.
