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
- 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.
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.
One of the ingredients in CONTRAVE, bupropion, may increase the risk
of suicidal thinking in children, adolescents, and young adults. CONTRAVE
patients should be monitored for suicidal thoughts and behaviors.
In patients taking bupropion for smoking cessation, serious neuropsychiatric
adverse events have been reported. CONTRAVE is not approved for use in
children under the age of 18.
Stop taking CONTRAVE and call a healthcare provider right away if
you have 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;
trouble sleeping (insomnia); irritability; aggression, anger, or violence;
acting on dangerous impulses; an extreme increase in activity and talking
(mania); other unusual changes in behavior or mood.
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, APLENZIN or ZYBAN; have or have had an eating
disorder; are dependent on opioid pain medicines or use medicines to help
stop taking opioids such as methadone or buprenorphine, or are in opiate
withdrawal; drink a lot of alcohol and abruptly stop drinking; are allergic
to any of the ingredients in CONTRAVE; or are pregnant or planning to become
Before taking CONTRAVE, tell your healthcare provider about all the
medicines you take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. Do not take any other medicines
while you are taking CONTRAVE unless your healthcare provider says it is
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 breastfeeding.
CONTRAVE may cause serious side effects, including:
Seizures. There is a risk of having a seizure when you
take CONTRAVE. If you have a seizure, stop taking CONTRAVE, tell
your healthcare provider right away.
Risk of opioid overdose. Do not take
large amounts of opioids, including opioid-containing medicines, such as
heroin or prescription pain pills, to try to overcome the opioid-blocking
effects of naltrexone.
Sudden opioid withdrawal. Do not use any type of opioid
for at least 7 to 10 days before starting CONTRAVE.
Severe allergic reactions. Stop taking CONTRAVE and get
medical help immediately if you have any signs and symptoms of severe
allergic reactions: rash, itching, hives, fever, swollen lymph glands,
painful sores in your mouth or around your eyes, swelling of your lips or
tongue, chest pain, or trouble breathing.
Increases in blood pressure or heart rate.
Liver damage or hepatitis. Stop taking CONTRAVE if you
have any symptoms of liver problems: stomach area pain lasting more than a
few days, dark urine, yellowing of the whites of your eyes, or tiredness.
Visual problems (angle-closure glaucoma). Signs and
symptoms may include: eye pain, changes in vision, swelling or redness in
or around the eye.
Increased risk of low blood sugar (hypoglycemia) in people with
type 2 diabetes mellitus who also take medicines to treat their diabetes
(such as insulin or sulfonylureas).
The most common side effects of CONTRAVE include nausea,
constipation, headache, vomiting, dizziness, trouble sleeping, dry mouth,
These are not all the possible side effects of CONTRAVE. Tell your
healthcare provider about any side effect that bothers you or does not go