CONTRAVE (naltrexone HCI/bupropion HCl) is an FDA-approved weight loss medication. It is prescribed for use in conjunction with diet and exercise for adults who fit certain criteria to lose weight and keep it off.

It is prescribed for adults who are:

• Obese: (BMI greater than or equal to 30 kg/m2)
• Overweight (BMI greater than or equal to 27 kg/m2) with at least one weight-related medical condition, such as high blood pressure and Type 2 Diabetes

See Full Prescribing Information, including Medication Guide

Tell your healthcare provider about any side effect that bothers you or does not go away. A few of the possible serious side effects of Contrave include:

• 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.
• Increased 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.

The most common side effects of CONTRAVE include nausea, constipation, headache, vomiting, dizziness, trouble sleeping, dry mouth, and diarrhea.

LIMITATIONS OF USE

The effect of CONTRAVE on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of CONTRAVE in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.

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.

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