Bupropion-Naltrexone® can cause serious side effects, including:
Suicidal thoughts or actions. One of the ingredients in Bupropion-Naltrexone® 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 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 Bupropion-Naltrexone® 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
new or worse irritability
attempts to commit suicide
acting aggressive, being angry, or violent
new or worse depression
acting on dangerous impulses
new or worse anxiety
an extreme increase in activity and talking (mania)
feeling very agitated or restless
other unusual changes in behavior or mood
panic attacks
trouble sleeping (insomnia)

Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when you start taking Bupropion-Naltrexone® or when your dose changes.
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 symptoms.
Bupropion-Naltrexone® has not been studied in and is not approved for use in children under the age of 18.

Bupropion-Naltrexone® is a prescription medicine which contains 2 medicines (naltrexone and bupropion) that may help some obese or overweight adults, who also have weight related medical problems, lose weight and keep the weight off.
Bupropion-Naltrexone® should be used with a reduced calorie diet and increased physical activity.
It is not known if Bupropion-Naltrexone® changes your risk of heart problems or stroke or of death due to heart problems or stroke.
It is not known if Bupropion-Naltrexone® is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products.
It is not known if Bupropion-Naltrexone® is safe and effective in children under 18 years of age.
Bupropion-Naltrexone® is not approved to treat depression or other mental illnesses, or to help people quit smoking (smoking cessation). One of the ingredients in Bupropion-Naltrexone®, bupropion, is the same ingredient in some other medicines used to treat depression and to help people quit smoking.

have uncontrolled hypertension.
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 (eating very little) or bulimia (eating too much and vomiting to avoid gaining weight).
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, or use medicines called sedatives (these make you sleepy), benzodiazepines, or anti-seizure medicines and you stop using them all of a sudden.
are taking medicines called monoamine oxidase inhibitors (MAOIs). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including linezolid. Do not start Bupropion-Naltrexone® until you have stopped taking your MAOI for at least 14 days.
are allergic to naltrexone or bupropion or any of the ingredients in Bupropion-Naltrexone®. See the end of this Medication Guide for a complete list of ingredients in Bupropion-Naltrexone®.

have or have had depression or other mental illnesses (such as bipolar disorder)
have attempted suicide in the past
have or have had seizures
have had a head injury
have had a tumor or infection of your brain or spine (central nervous system)
have had a problem with low blood sugar (hypoglycemia) or low levels of sodium in your blood (hyponatremia)
have or have had liver problems
have high blood pressure
have or have had a heart attack, heart problems, or have had a stroke
have kidney problems
are diabetic taking insulin or other medicines to control your blood sugar
have or have had an eating disorder
drink a lot of alcohol
abuse prescription medicines or street drugs
are over the age of 65
are pregnant or plan to become pregnant. Losing weight while pregnant may harm your unborn baby. Stop taking Bupropion-Naltrexone® if you become pregnant. Tell your healthcare provider if you become pregnant or you think you may be pregnant during treatment with Bupropion-Naltrexone®.
are breastfeeding or plan to breastfeed. Bupropion-Naltrexone® can pass into your breast milk and may harm your baby. You and your healthcare provider should decide if you should take Bupropion-Naltrexone® or breastfeed. You should not do both.

Bupropion-Naltrexone® may affect the way other medicines work and other medicines may affect the way Bupropion-Naltrexone® works causing side effects.
Ask your healthcare provider for a list of these medicines if you are not sure.
Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

Take Bupropion-Naltrexone® exactly as your healthcare provider tells you to.
If you have kidney or liver problems, your final dose may be lower (for example, one tablet in the morning and one tablet in the evening or one tablet in the morning).
Your healthcare provider will change your dose if needed.
Do not change your Bupropion-Naltrexone® dose without talking with your healthcare provider.
Your healthcare provider should tell you to stop taking Bupropion-Naltrexone® if you have not lost a certain amount of weight after 16 weeks of treatment.
Swallow Bupropion-Naltrexone® tablets whole. Do not cut, chew, or crush Bupropion-Naltrexone® tablets. Tell your healthcare provider if you cannot swallow Bupropion-Naltrexone® tablets whole.
Do not take more than 2 tablets in the morning and 2 tablets in the evening.
Do not take more than 2 tablets at the same time or more than 4 tablets in 1 day.
Do not take Bupropion-Naltrexone® with high-fat meals. It may increase your risk of seizures.
If you miss a dose of Bupropion-Naltrexone®, wait until your next regular time to take it. Do not take more than 1 dose of Bupropion-Naltrexone® at a time.
If you take too much Bupropion-Naltrexone®, call your healthcare provider or your poison control center at 1-800-222-1222 right away, or go to the nearest emergency room.

Do not drink a lot of alcohol while taking Bupropion-Naltrexone®. If you drink a lot of alcohol, talk with your healthcare provider before suddenly stopping. If you suddenly stop drinking alcohol, you may increase your chance of having a seizure.
What are the possible side effects of Bupropion-Naltrexone®?
Bupropion-Naltrexone® may cause serious side effects, including:
Seizures. There is a risk of having a seizure when you take Bupropion-Naltrexone®. The risk of seizure is higher in people who:
take higher doses of Bupropion-Naltrexone®
have certain medical conditions
take Bupropion-Naltrexone® with certain other medicines
Do not take any other medicines while you are taking Bupropion-Naltrexone® unless your healthcare provider has said it is okay to take them.
If you have a seizure while taking Bupropion-Naltrexone®, stop taking Bupropion-Naltrexone® and call your healthcare provider right away.
You should not take Bupropion-Naltrexone® again if you have a seizure.
Risk of opioid overdose. One of the ingredients in Bupropion-Naltrexone® (naltrexone) can increase your chance of having an opioid overdose if you take opioid medicines while taking Bupropion-Naltrexone®.
You can accidentally overdose in 2 ways:
Naltrexone blocks the effects of opioids, such as heroin, methadone or opioid pain medicines. 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.
After you take naltrexone, its blocking effect slowly decreases and completely goes away over time. If you have used opioid street drugs or opioid-containing medicines in the past, using opioids in amounts that you used before treatment with naltrexone can lead to overdose and death. You may also be more sensitive to the effects of lower amounts of opioids:

after you have gone through detoxification
when your next dose of Bupropion-Naltrexone® is due
if you miss a dose of Bupropion-Naltrexone®
after you stop Bupropion-Naltrexone® treatment
It is important that you tell your family and the people closest to you of this increased sensitivity to opioids and the risk of overdose.
You or someone close to you should get emergency medical help right away if you:
have trouble breathing
become very drowsy with slowed breathing
have slow, shallow breathing (little chest movement with breathing)
feel faint, very dizzy, confused, or have unusual symptoms
Sudden opioid withdrawal. People who take Bupropion-Naltrexone® must 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 Bupropion-Naltrexone®. Using opioids in the 7 to 10 days before you start taking Bupropion-Naltrexone® may cause you to suddenly have symptoms of opioid withdrawal when you take it. Sudden opioid withdrawal can be severe, and you may need to go to the hospital. Tell your healthcare provider you are taking Bupropion-Naltrexone® before a medical procedure or surgery.
Severe allergic reactions. Some people have had a severe allergic reaction to bupropion, one of the ingredients in Bupropion-Naltrexone®. Stop taking Bupropion-Naltrexone® and call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of an allergic reaction:
rash painful sores in your mouth or around your eyes
itching swelling of your lips or tongue
hives chest pain
fever trouble breathing
swollen lymph glands
Increases in blood pressure or heart rate. Some people may get high blood pressure or have a higher heart rate when taking Bupropion-Naltrexone®. Your healthcare provider should check your blood pressure and heart rate before you start taking, and while you take Bupropion-Naltrexone®.
Liver damage or hepatitis. One of the ingredients in Bupropion-Naltrexone®, naltrexone can cause liver damage or hepatitis. Stop taking Bupropion-Naltrexone® and tell your healthcare provider if you have any of the following symptoms of liver problems:
stomach area pain lasting more than a few days
dark urine
yellowing of the whites of your eyes
tiredness
Your healthcare provider may need to stop treating you with Bupropion-Naltrexone® if you get signs or symptoms of a serious liver problem.
Manic episodes. One of the ingredients in Bupropion-Naltrexone®, bupropion can cause some people who were manic or depressed in the past to become manic or depressed again.
Visual problems (angle-closure glaucoma). One of the ingredients in Bupropion-Naltrexone®, bupropion, can cause some people to have visual problems (angle-closure glaucoma). Signs and symptoms of angle-closure glaucoma may include:
eye pain
changes in vision
swelling or redness in or around the eye
Talk with your healthcare provider to find out if you are at risk for angle-closure glaucoma and to get treatment to prevent it 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. Weight loss can cause low blood sugar in people with type 2 diabetes mellitus who also take medicines used to treat type 2 diabetes mellitus (such as insulin or sulfonylureas). You should check your blood sugar before you start taking Bupropion-Naltrexone® and while you take Bupropion-Naltrexone®.

nausea
dizziness
constipation
trouble sleeping
headache
dry mouth
vomiting
diarrhea

These are not all of the possible side effects of Bupropion-Naltrexone®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Store Bupropion-Naltrexone® at room temperature between 68°F to 77°F (20°C to 25°C).
Keep Bupropion-Naltrexone® and all medicines out of the reach of children.