Important Safety Information (Scroll Text Down)
CONTRAVE can cause serious side effects of suicidal thoughts or actions. CONTRAVE contains bupropion HCl which 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 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.
Stop taking CONTRAVE and call a healthcare provider right away if you, or your family member, 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.
While taking CONTRAVE, you and your family members should pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings, and tell your healthcare provider. CONTRAVE has not been studied in and 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, and APLENZIN; 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 such as methadone or buprenorphine, or are in opiate withdrawal; drink a lot of alcohol and abruptly stop drinking; use medicines called sedatives (these make you sleepy), benzodiazepines, or anti-seizure medicines and you stop using them suddenly, as these may increase your chance of having a seizure; have taken medicines called monoamine oxidase inhibitors (MAOIs), including linezolid, within the last 14 days; are allergic to any of the ingredients in CONTRAVE; are pregnant or planning to become pregnant. Tell your healthcare provider right away if you become pregnant.
Tell your healthcare provider about all of your medical conditions, especially: 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; breastfeeding.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Swallow CONTRAVE tablets whole. Do not cut, chew, or crush CONTRAVE tablets. Do not take CONTRAVE with high-fat meals. It may increase your risk of seizures. Take CONTRAVE exactly as prescribed.
CONTRAVE may cause serious side effects, including: Seizures. There is a risk of having a seizure when you take CONTRAVE. The risk is higher in people who: take higher doses of CONTRAVE; have certain medical conditions; take CONTRAVE with certain other medicines. Do not take any other medicines while you are taking CONTRAVE unless your healthcare provider has said it is okay. If you have a seizure, stop taking CONTRAVE, tell your healthcare provider right away, and do not take CONTRAVE again.
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. This can lead to serious injury, coma, or death. Get emergency medical help right away if you have trouble breathing; become drowsy with slowed breathing; have slow, shallow breathing; or feel faint, dizzy, or confused.
Sudden opioid withdrawal. Do not use any type of opioid (must be opioid-free) including street drugs, prescription pain medicines (including tramadol), cough, cold, or diarrhea medicines that contain opioids, or opioid-dependence treatments, buprenorphine, or methadone, for at least 7 to 10 days before starting CONTRAVE. This may cause you to have sudden symptoms of opioid withdrawal, which can be severe and may require hospitalization. Tell your healthcare provider you are taking CONTRAVE before a medical procedure or surgery.
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. Your healthcare provider should check your blood pressure and heart rate before and during CONTRAVE treatment.
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. Your healthcare provider may need to stop treatment if you get signs or symptoms of a serious liver problem.
Manic episodes. CONTRAVE can cause some people who were manic or depressed in the past to become manic or depressed again.
Visual problems (angle-closure glaucoma). Signs and symptoms may include: eye pain, changes in vision, swelling or redness in or around the eye. Talk with your doctor to find out if you are at risk.
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). Check your blood sugar before and during CONTRAVE treatment.
The most common side effects of CONTRAVE include nausea, constipation, headache, vomiting, dizziness, trouble sleeping, dry mouth, and diarrhea.
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 away.
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.
Use of CONTRAVE
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 Talk to your doctor or healthcare professional. Please see Full Prescribing Information, including Medication Guide, for CONTRAVE.