Side effects of contrave

Medication Guide

CONTRAVE® (CON-trayv)

(naltrexone HCl and bupropion HCl)

Extended-Release Tablets

Read this Medication Guide before you start taking CONTRAVE and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical problems or treatment.

What is the most important information I should know about CONTRAVE?

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 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 • 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
• panic attacks • other unusual changes in behavior or mood
• trouble sleeping (insomnia)

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. • 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.

CONTRAVE has not been studied in and is not approved for use in children under the age of 18.

What is CONTRAVE?

CONTRAVE 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.

• 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. • It is not known if CONTRAVE is safe and effective in children under 18 years of age. • CONTRAVE is not approved to treat depression or other mental illnesses, or to help people quit smoking (smoking cessation). One of the ingredients in CONTRAVE, bupropion, is the same ingredient in some other medicines used to treat depression and to help people quit smoking.

Who should not take CONTRAVE?

Do not take CONTRAVE if you:

• have uncontrolled hypertension • 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 (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 CONTRAVE until you have stopped taking your MAOI for at least 14 days. • are allergic to naltrexone or bupropion or any of the ingredients in CONTRAVE. See the end of this Medication Guide for a complete list of ingredients in CONTRAVE. • are pregnant or planning to become pregnant. Tell your healthcare provider right away if you become pregnant while taking CONTRAVE.

What should I tell my healthcare provider before taking CONTRAVE?

Before you take CONTRAVE, tell your healthcare provider if you:

• 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 • have any other medical conditions • are breastfeeding or plan to breastfeed. CONTRAVE can pass into your breast milk and may harm your baby. You and your healthcare provider should decide if you should take CONTRAVE or breastfeed. You should not do both. • Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements.

CONTRAVE may affect the way other medicines work and other medicines may affect the way CONTRAVE 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.

How should I take CONTRAVE?

How to take CONTRAVE

Morning Dose

Evening Dose

Starting: Week 1

1 tablet

None

Week 2

1 tablet

1 tablet

Week 3

2 tablets

1 tablet

Week 4 Onward

2 tablets

2 tablets

• Take CONTRAVE exactly as your healthcare provider tells you to. • Do not change your CONTRAVE dose without talking with your healthcare provider. • Your healthcare provider will change your dose if needed. • Your healthcare provider should tell you to stop taking CONTRAVE if you have not lost a certain amount of weight after 16 weeks of treatment. • Swallow CONTRAVE tablets whole. Do not cut, chew, or crush CONTRAVE tablets. Tell your healthcare provider if you cannot swallow CONTRAVE 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 CONTRAVE with high-fat meals. It may increase your risk of seizures. • If you miss a dose of CONTRAVE, wait until your next regular time to take it. Do not take more than 1 dose of CONTRAVE at a time. • If you take too much CONTRAVE, call your healthcare provider or go to the nearest emergency room right away.

What should I avoid while taking CONTRAVE?

• Do not drink a lot of alcohol while taking CONTRAVE. 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 CONTRAVE?

CONTRAVE may cause serious side effects, including:

• See “What is the most important information I should know about CONTRAVE?” • Seizures. There is a risk of having a seizure when you take CONTRAVE. The risk of seizure 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 to take them.

If you have a seizure while taking CONTRAVE, stop taking CONTRAVE and call your healthcare provider right away.

You should not take CONTRAVE again if you have a seizure.

• Risk of opioid overdose. One of the ingredients in CONTRAVE (naltrexone) can increase your chance of having an opioid overdose if you take opioid medicines while taking CONTRAVE.

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 CONTRAVE is due • if you miss a dose of CONTRAVE • after you stop CONTRAVE 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 CONTRAVE 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 CONTRAVE. Using opioids in the 7 to 10 days before you start taking CONTRAVE 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 CONTRAVE before a medical procedure or surgery. • Severe allergic reactions. Some people have had a severe allergic reaction to bupropion, one of the ingredients in CONTRAVE. Stop taking CONTRAVE 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
• hives • swelling of your lips or tongue
• fever • chest pain
• swollen lymph glands • trouble breathing

Your healthcare provider may need to stop treating you with CONTRAVE if you get signs or symptoms of a serious liver problem.

• Manic episodes. One of the ingredients in CONTRAVE, 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 CONTRAVE, 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 CONTRAVE and while you take CONTRAVE.

The most common side effects of CONTRAVE include:

• nausea • dizziness
• constipation • trouble sleeping
• headache • dry mouth
• vomiting • diarrhea

Tell your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of CONTRAVE. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800-FDA-1088.

How should I store CONTRAVE?

Store CONTRAVE at room temperature between 59oF to 86oF (15oC to 30oC).

Keep CONTRAVE and all medicines out of the reach of children.

General information about the safe and effective use of CONTRAVE.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CONTRAVE for a condition for which it was not prescribed. Do not give CONTRAVE to other people, even if they have the same symptoms or condition that you have. It may harm them.

If you take a urine drug screening test, CONTRAVE may make the test result positive for amphetamines. If you tell the person giving you the drug screening test that you are taking CONTRAVE, they can do a more specific drug screening test that should not have this problem.

This Medication Guide summarizes the most important information about CONTRAVE. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about CONTRAVE that is written for health professionals.

For more information, go to www.contrave.com or call 1-877-825-3327.

What are the ingredients in CONTRAVE?

Active ingredients: naltrexone hydrochloride and bupropion hydrochloride

Inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, lactose anhydrous, L‑cysteine hydrochloride, crospovidone, magnesium stearate, hypromellose, edetate disodium, lactose monohydrate, colloidal silicon dioxide, Opadry II Blue and FD&C Blue #2 aluminum lake

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed by:

Takeda Pharmaceuticals America, Inc.

Deerfield, IL 60015

Manufactured for:

Orexigen Therapeutics, Inc.

La Jolla, CA 92037

CONTRAVE® is a trademark of Orexigen Therapeutics, Inc. registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

All other trademarks are the property of their respective owners.

©2014 Takeda Pharmaceuticals America, Inc.

Approved: 2014

Among the substances consumed by humans on a regular basis, alcohol is certainly the most popular and socially accepted option for altering one’s consciousness and behavior. Alcohol has been around for thousands of years, presented in a wide variety of drinks ranging in concentration from low (such as beer) to fairly high (spirits). People have been consuming alcohol in its different forms all around the world since the dawn of agriculture and it’s really hard to imagine any social event without some moderate alcoholic beverage consumption. So it’s natural for those, who start using Contrave weight loss drug, to wonder whether it’s OK for them to enjoy a glass or two of their favorite drink while going through the weight loss program.

The short answer to anyone wondering about the safety of Contrave and alcohol is negative. Doctors strongly recommend avoiding any alcohol consumption during the course of Contrave diet and there’s a whole set of reasons why it’s a good idea to follow this suggestion. Don’t be afraid, a sip of an alcoholic beverage while taking the drug won’t kill you or lead to hospitalization, the adverse reactions are not that severe. However, on a chemical level the active substances in Contrave are rather antagonistic towards alcohol, which may lead to unpleasant side effects when both drugs are mixed in significant concentrations.

The first active substance in Contrave is Bupropion, which on its own is prescribed as an antidepressant. Anyone who has ever had an experience with antidepressants knows that it’s a very bad idea to mix these medications with alcohol in any form. Since both the alcohol and the active substances in antidepressants affect the central nervous system, the combined effect can lead to serious health hazards. In case of Bupropion the side effects include seizures, hallucinations, paranoia, mood swings, suicidal tendencies, panic attacks and anxiety among many others. This is especially relevant for patients, who have a history or seizures or psychological disorders, as well as alcohol abuse. On the other hand, a sudden withdrawal from alcohol consumption, especially in cases of regular heavy drinking, may lead to similar side effects, which will only be amplified by the use of Contrave. Therefore, it is crucial to consult with your family doctor or a pharmacist regarding the safety of Contrave in case you have a history of any aforementioned conditions.

Another active component in Contrave is Naltrexone, which is often prescribed for treating alcohol and opioid dependence. If that doesn’t sound self-explicatory, let’s go a bit in-depth to see what can go wrong. Naltrexone, its counterpart Bupropion, works by affecting certain receptors in the central nervous system. In case of Naltrexone, these are the receptors that are responsible for the feeling of satisfaction, triggered by the use of alcohol or opioid narcotics. By blocking the receptors, the drug eliminates the pleasant psychological effects associated with the use of these substances, leaving only the physical effects to the user. So, imagine feeling the full spectrum of the physical sensations while being drunk, but without the pleasant psychological relaxation. Doesn’t sound very exciting, right? Well, that’s exactly what will happen if you consume alcohol while taking Contrave. While you will certainly experience the effects on a physical level – dizziness, loss of coordination, drowsiness, lightheadedness – there won’t be anything to enjoy on a psychological level. And if your daily Contrave dosage is high, there’s also a significant risk of experiencing liver damage, which will manifest through symptoms, such as fever, chills, constant fatigue, vomiting, nausea, joint pain and swelling, abnormal bleeding, abdominal pain, dark urine and others. In case you consumer some alcohol while on Contrave and experience any of these effects, seek medical attention immediately and consult with your doctor once your condition is stabilized.

So, as you can see, ordering Contrave online and drinking alcohol, even in moderate amounts, isn’t such a good idea. Both active substances in this medication have serious side-effects when interacting with alcohol, so it’s a good idea to avoid doing that in general. However, if you still find yourself drinking some alcohol while on Contrave, at least try to follow general precautions: avoid driving or operating any heavy machinery, don’t perform any tasks that require full concentration, and preferably have a reliable person nearby, who would be able to help in case any serious side-effects manifest. There are many situations when you may find yourself being forced to consume alcohol, especially when there’s a social pressure for doing so at various events. In such cases, try following the aforementioned recommendations and seek medical help in case of any unusual sensations.

Apart from the direct pharmacological factors mentioned before, there’s also a significant psychological aspect of drinking alcohol while going through a weight loss phase. Besides the well-known physical and psychological effects any alcoholic beverage exhibits on the recipient’s organism, there’s also the aspect of appetite stimulation. You’ve certainly experienced this effect after drinking a glass of red wine or refreshing lager beer – the drink makes you want to eat something. In fact, this property has been established as the root cause behind the so-called “beer belly”, previously associated with the consumption of beer itself. Because the alcohol stimulates hunger, people tend to eat more calorie-rich food while being inebriated. And isn’t that what you would like to avoid while losing weight? Contrave is used specifically to suppress one’s appetite and make them eat less. So why consuming a substance, which is known to deliver the exactly opposite effect? This will effectively undermine your current efforts, while also putting your health in risk. Is a glass of wine really worth it or maybe it’s better to exercise some willpower and avoid alcohol in general?

Contrave Side Effects

Generic Name: bupropion / naltrexone

Medically reviewed by Drugs.com. Last updated on Nov 7, 2018.

  • Overview
  • Side Effects
  • Dosage
  • Professional
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Note: This document contains side effect information about bupropion / naltrexone. Some of the dosage forms listed on this page may not apply to the brand name Contrave.

In Summary

Common side effects of Contrave include: constipation, dizziness, headache, insomnia, nausea, and vomiting. Other side effects include: anxiety, diarrhea, increased blood pressure, tremor, depression, hypertension, and xerostomia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to bupropion / naltrexone: oral tablet extended release

Warning

Oral route (Tablet, Extended Release)

Naltrexone hydrochloride/buPROPion hydrochloride is not approved for use in the treatment of major depressant disorder or other psychiatric disorders. Naltrexone hydrochloride/buPROPion hydrochloride contains buPROPion, the same active ingredient as some other antidepressant medications (including, but not limited to, WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, and APLENZIN). Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects over age 24; there was a reduction in risk with antidepressant use in subjects aged 65 and older. In patients of all ages who are started on naltrexone hydrochloride/buPROPion hydrochloride, monitor closely for worsening, and for the emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. Naltrexone hydrochloride/buPROPion hydrochloride is not approved for use in pediatric patients.

Along with its needed effects, bupropion / naltrexone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking bupropion / naltrexone:

More common

  • Blurred vision
  • discouragement
  • dizziness
  • fear or nervousness
  • feeling sad or empty
  • headache
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • pounding in the ears
  • slow or fast heartbeat
  • trouble concentrating
  • trouble sleeping
  • unusual tiredness or weakness

Less common

  • Bladder pain
  • bloody or cloudy urine
  • difficult, burning, or painful urination
  • fast, irregular, pounding, or racing heartbeat or pulse
  • frequent urge to urinate
  • lower back or side pain
  • shakiness in the legs, arms, hands, or feet
  • trembling or shaking of the hands or feet

Less common or rare

  • Chest pain or discomfort
  • nausea
  • pain or discomfort in the arms, jaw, back, or neck
  • sweating
  • vomiting

Rare

  • Changes in behavior
  • thoughts of killing oneself

Incidence not known

  • Aggressive or angry
  • anxiety
  • blistering, peeling, or loosening of the skin
  • chills
  • clay colored stools
  • cough
  • dark urine
  • delusions of persecution, mistrust, suspiciousness, or combativeness
  • diarrhea
  • difficulty with moving
  • difficulty with swallowing
  • dry mouth
  • false beliefs that cannot be changed by facts
  • feeling that others are watching you or controlling your behavior
  • feeling, seeing, or hearing things that are not there
  • fever
  • hives, itching, or rash
  • hyperventilation
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • muscle stiffness
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red, irritated eyes
  • restlessness
  • severe mood or mental changes
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • stomach pain or tenderness
  • swelling of the feet or lower legs
  • tightness in the chest
  • unusual behavior
  • yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking bupropion / naltrexone:

Symptoms of overdose

  • Blue lips, fingernails, or skin
  • change in or loss of consciousness
  • confusion
  • decreased awareness or responsiveness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • muscle cramps or spasms
  • severe sleepiness

Some side effects of bupropion / naltrexone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Difficulty having a bowel movement

Less common

  • Change or loss of taste
  • continuing ringing or buzzing or other unexplained noise in the ears
  • feeling of warmth
  • hearing loss
  • increased sweating
  • redness of the face, neck, arms, and occasionally, upper chest
  • stomach pain

Less common or rare

  • Feeling of constant movement of self or surroundings
  • indigestion
  • sensation of spinning
  • severe nausea or vomiting
  • thinning of the hair or hair loss

For Healthcare Professionals

Applies to bupropion / naltrexone: oral tablet extended release

General

The more commonly reported adverse reactions have included nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea.

Psychiatric

Very common (10% or more): Sleep disorders (up to 13.8%)

Common (1% to 10%): Depression, anxiety, irritability

Uncommon (0.1% to 1%): Insomnia, abnormal dreams, nervousness, dissociation (feeling spacey), tension, agitation, mood swings

Rare (less than 0.1%): Suicidal ideation

During clinical trials, suicidal ideation was reported by 0.03% (n=1/3239) of patients receiving this drug and 0.2% of placebo (n=3/1239) patients. No suicides or suicide attempts were reported in studies up to 56 weeks.

Nervous system

Very common (10% or more): Headache (up to 17.6%), dizziness (up to 10.4%)

Common (1% to 10%): Tremor, dysgeusia, attention disorders

Postmarketing reports: Loss of consciousness

The incidence of seizure in patients receiving this drug in clinical trials was approximately 0.1% vs 0% on placebo.

Cardiovascular

Common (1% to 10%): Hot flush, hypertension, increased blood pressure, palpitations

Uncommon (0.1% to 1%): Tachycardia, myocardial infarction

Frequency not reported: Increased heart rate

During clinical trials, patients receiving this drug had increases to mean systolic and diastolic blood pressure (BP) of approximately 1 mmHg from baseline at weeks 4 and 8, BP similar to baseline at week 12, and BP approximately 1 mmHg below baseline between weeks 24 and 56. In contrast, mean BP for placebo treated patients was approximately 2 to 3 mmHg below baseline throughout the study. Mean heart rate was 2.1 beats per minute higher in the drug-treated patients at weeks 4 and 8; at week 52, the difference between groups was 1.7 beats per minute.

Hypersensitivity

Bupropion:

Frequency not reported: Anaphylactoid/anaphylactic reactions, symptoms suggestive of delayed hypersensitivity such as arthralgia, myalgia, fever with rash

Postmarketing reports: Erythema multiforme, Stevens-Johnson syndrome, and anaphylactic shock

Hepatic

Uncommon (0.1% to 1%): Cholecystitis, increased hepatic enzymes

Renal

Serum creatinine increases that exceeded the upper limit of normal and were also 50% higher than baseline or greater occurred in 0.6% of patients receiving this drug (0.1% in placebo). The observed increase may be the result of OCT2 inhibition.

Uncommon (0.1% to 1%): Kidney infection, increased blood creatinine, increased serum creatinine, micturition urgency

Dermatologic

Common (1% to 10%): Hyperhidrosis, rash

Uncommon (0.1% to 1%): Alopecia

Gastrointestinal

Very common (10% or more): Nausea (up to 32.5%), constipation (up to 19.2%), vomiting (up to 10.7%)

Common (1% to 10%): Dry mouth, diarrhea, upper abdominal pain, viral gastroenteritis, abdominal pain

Uncommon (0.1% to 1%): Lower abdominal pain, eructation, lip swelling, hematochezia

Genitourinary

Common (1% to 10%): Urinary tract infection

Uncommon (0.1% to 1%): Vaginal hemorrhage, irregular menstruation, erectile dysfunction, vulvovaginal dryness

Hematologic

Uncommon (0.1% to 1%): Decreased hematocrit

Immunologic

Common (1% to 10%): Influenza

Metabolic

Uncommon (0.1% to 1%): Dehydration

Musculoskeletal

Common (1% to 10%): Muscle strain

Uncommon (0.1% to 1%): Intervertebral disc protrusion, jaw pain

Other

Common (1% to 10%): Fatigue, tinnitus

Uncommon (0.1% to 1%): Feeling jittery, feeling abnormal, asthenia, thirst, feeling hot, staphylococcal infection

Postmarketing reports: Malaise

Respiratory

Uncommon (0.1% to 1%): Pneumonia

1. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0

2. Cerner Multum, Inc. “Australian Product Information.” O 0

3. “Product Information. Contrave (buPROPion-naltrexone).” Orexigen Therapeutics Inc, La Jolla, CA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer

More about Contrave (bupropion / naltrexone)

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“I have limited enthusiasm for pharmacotherapy to manage weight, and these results certainly don’t change my view on the topic,” said Dr. David Katz, associate professor Public Health at Yale University and expert in obesity. “The results are promising, although certainly less than dazzling.”

Katz said he thought the Contrave results were “fairly consistent” with the success of other drugs for weight loss.

“Perhaps the single uniquely promising element here is that Contrave is a combination of two drugs long in use for other purposes, and thus likely to be at least relatively safe,” Katz wrote in an e-mail to ABC News.

Contrave is the first drug to combine a anti-depression and smoking cessation drug called bupropion and naltrexone, prescribed to fight alcohol and opiate addiction.

Weight Loss Pill That Targets the Brain’s Cravings

The point with Contrave, Kim said, isn’t to increase metabolism but to block the craving in the craving-reward system in the brain.

“It’s not so much the reaction to whatever you’re doing, it’s more the craving about those activities,” said Kim, who added that because the drug targets craving and not reward that patients are less likely to experience diminished enjoyment in exercise or sex.

Other weight-loss drugs on the market also target the brain or central nervous system rather than the metabolism. For example Meridia (or sibutramine) works as an appetite suppressant by boosting chemical messages that tell the brain you’re satisfied.

Based on the long-term outcomes of other weight-loss drugs that target the brain, Katz was cautious about the promise of Contrave.

“Weight is regulated by many pathways, and to date, efforts to turn off appetite along one pathway have resulted in compensation in others,” he said.

Only time will tell for Contrave. With the FDA bar for efficacy out of the way, the makers of Contrave say they are about to seek FDA approval for the drug in early 2010, which is not guaranteed.

Whether or not Contrave is approved, some doctors predict the approach behind the drug will become a trend in obesity treatment.

“There is no question that drugs like Contrave are the way of the future,” said Dr. Mitchell Roslin, of Lenox Hill Hospital in New York City. “For obesity drugs to be effective they will need to be this type of cocktail that hits multiple targets.”

Kim said the weight-loss results that came with that approach had some additional health advantages — patients feeling less grumpy, for example, lower LDL or “bad cholesterol” levels, lower triglycerides, less visceral fat between the organs and smaller waists. Diabetic patients on the drug also showed better control of their blood glucose levels.

What the FDA Asks of Weight-Loss Drug

The FDA requires at least a third of the patients on a weight-loss drug lose 5 percent of their body weight to call the drug effective. Of the people taking Contrave in two non-diabetic clinical trials, nearly half (48 -56 percent) lost more than 5 percent of their body weight in a year.

Contrave also exceeded the FDA expectation that twice as many people on the drug hit the 5 percent body weight goal as people on the placebo. In the two non-diabetic trials, three times more people hit the 5 percent reduction in body weight on the drug than on the placebo.

Keith Ayoob, director of the nutrition clinic at the Albert Einstein College of Medicine in Bronx, N.Y., wasn’t exactly blown over by the results.

“This drug seems to have an edge on the others out there. It appears to have met the FDA criteria and there is a reasonable amount of weight loss over a year’s time. However, let’s keep real about this,” said Ayoob. “Fifty six weeks is a long time to lose only 5 percent of weight. For a 200 pound person that amounts to 10 pounds in a year.”

“It’s good, no question, and better than placebos, but I wouldn’t want people thinking this is some sort of miracle,” he said.

Ayoob points out that the drug works by controlling cravings, but that people often overeat and become obese for other reasons.

Other doctors were concerned about what would happen if patients take the drug for a long period of time.

“Most significantly, what happens when the drug is stopped? Will the weight be regained? What will be the effects of years of use of these drugs?” said Katz. “Despite these issues, this is exciting data.”

Kim said the FDA usually asks for year-long studies in drugs that are intended for chronic use, and predicts Contrave will be prescribed for long-term use.

“There will be a small number of patients who will be able to get off these drugs,” said Kim. “But the vast majority of patients would probably need to take this medication chronically.”

Generic Name: bupropion and naltrexone (bue PRO pee on and nal TREX own)
Brand Names: Contrave

Medically reviewed by Sophia Entringer, PharmD Last updated on Jan 31, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

What is Contrave?

Contrave contains a combination of bupropion and naltrexone. Bupropion is an antidepressant medicine that can also decrease appetite. Naltrexone is usually given to block the effects of narcotics or alcohol in people with addiction problems. Naltrexone may also curb hunger and food cravings.

Contrave is an anorexiant and is used to help manage weight in obese or overweight adults with weight-related medical problems. This medicine is used together with diet and exercise.

Contrave will not treat any weight-related medical condition, such as high blood pressure, diabetes, or high cholesterol.

Contrave is not approved to treat depression or other psychiatric conditions, or to help you quit smoking.

Important information

You should not use Contrave if you have uncontrolled high blood pressure, seizures, an eating disorder, opioid addiction, if you take narcotic medicine or other forms of bupropion, have bulimia or anorexia nervosa, are taking a MAOI, or if you have suddenly stopped using alcohol, seizure medication, or a sedative.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact with bupropion and naltrexone, and some drugs should not be used together.

Do not use Contrave if you are pregnant.

Some young people have thoughts about suicide when first taking bupropion. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Do not take Contrave if you also take narcotic medicine or other forms of bupropion (such as Wellbutrin or Zyban), or if you are going through withdrawal from alcohol or drug addiction.

Before taking this medicine

Do not use Contrave if you are pregnant. Weight loss during pregnancy can harm an unborn baby, even if you are overweight. Tell your doctor right away if you become pregnant during treatment.

You should not use Contrave if you are allergic to bupropion or naltrexone, or if you have:

  • untreated or uncontrolled high blood pressure;

  • an eating disorder (anorexia or bulimia);

  • a history of seizures;

  • opioid addiction or withdrawal (or if you take methadone or buprenorphine);

  • if you take other forms of bupropion (Wellbutrin, Aplenzin, Budeprion, Forfivo, Zyban, and others); or

  • if you have suddenly stopped using alcohol, seizure medication, or a sedative such as Xanax, Valium, Fiorinal, Klonopin, and others.

Do not use an MAO inhibitor within 14 days before or 14 days after you take Contrave. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

To make sure Contrave is safe for you, tell your doctor if you have ever had:

  • depression, bipolar disorder, or mental illness;

  • suicidal thoughts or actions;

  • a head injury;

  • a tumor or infection in your brain or spinal cord;

  • diabetes or low blood sugar;

  • low sodium levels;

  • liver or kidney disease;

  • heart disease, high blood pressure, heart attack, or stroke; or

  • drug addiction, or if you normally drink a lot of alcohol.

Some young people have thoughts about suicide when first taking bupropion. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Bupropion and naltrexone can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Contrave is not approved for use by anyone younger than 18 years old.

How should I take Contrave?

Take Contrave exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Do not crush, chew, or break the tablet. Swallow the tablet whole. Do not take more than 2 tablets at once.

Do not take Contrave with a high-fat meal, or you may be more likely to have a seizure.

If you need to use narcotic medicine for any reason (such as pain, surgery, or treatment for drug addiction) you may need to stop taking Contrave for a short time. Follow your doctor’s dosing instructions very carefully.

Store Contrave at room temperature away from moisture and heat.

If you have not lost at least 5% of your starting weight after 12 weeks of treatment, Contrave may not be right for you.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Do not take more than 4 tablets in 1 day.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of this medicine can be fatal, especially if you also take a narcotic (opioid medicine).

What should I avoid while taking Contrave?

Drinking alcohol with bupropion may increase your risk of seizures. If you drink alcohol regularly, talk with your doctor before changing the amount you drink. Bupropion can also cause seizures in a regular drinker who suddenly stops drinking.

Follow your doctor’s instructions about any restrictions on food, beverages, or activity. Do not take other weight-loss products or diet pills unless your doctor has told you to.

Do not use narcotic medication, methadone, heroin, or other street drugs while you are taking Contrave. Doing so could result in dangerous effects, including coma and death.

Contrave side effects

Get emergency medical help if you have signs of an allergic reaction to Contrave: fever, swollen glands, mouth sores, muscle or joint pain; hives, rash or itching; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.

A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, severe drowsiness, or if you are hard to wake up.

Stop taking this medicine and call your doctor right away if you have:

  • a seizure (convulsions);

  • blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;

  • changes in mood or behavior – anxiety, depression, panic attacks, trouble sleeping, agitation, thoughts about suicide or hurting yourself;

  • a manic episode – racing thoughts, increased energy, unusual risk-taking behavior, extreme happiness, being irritable or talkative;

  • liver problems – upper stomach pain, tiredness, dark urine, jaundice (yellowing of the skin or eyes);

  • increased blood pressure – severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed; or

  • severe skin reaction – fever, mouth or throat pain, burning eyes, skin pain, red or purple rash that spreads and causes blisters and peeling.

Older adults may be more likely to have certain side effects.

Common Contrave side effects may include:

  • nausea, vomiting, diarrhea, constipation;

  • headache, dizziness;

  • dry mouth; or

  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Contrave?

When you start or stop taking Contrave, your doctor may need to adjust the doses of other medicines you take on a regular basis.

Tell your doctor about all your current medicines and any you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Contrave only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2020 Cerner Multum, Inc. Version: 3.01.

Medical Disclaimer

bupropion and naltrexone (Contrave)

Brand Names: Contrave

Generic Name: bupropion and naltrexone

  • What is bupropion and naltrexone (Contrave)?
  • What are the possible side effects of bupropion and naltrexone (Contrave)?
  • What is the most important information I should know about bupropion and naltrexone (Contrave)?
  • What should I discuss with my healthcare provider before taking bupropion and naltrexone (Contrave)?
  • How should I take bupropion and naltrexone (Contrave)?
  • What happens if I miss a dose (Contrave)?
  • What happens if I overdose (Contrave)?
  • What should I avoid while taking bupropion and naltrexone (Contrave)?
  • What other drugs will affect bupropion and naltrexone (Contrave)?
  • Where can I get more information (Contrave)?

What is bupropion and naltrexone (Contrave)?

Bupropion is an antidepressant medicine that can also decrease appetite. Naltrexone is usually given to block the effects of narcotics or alcohol in people with addiction problems. Naltrexone may also curb hunger and food cravings.

Bupropion and naltrexone is a combination medicine used to help manage weight in obese or overweight adults with weight-related medical problems. This medicine is used together with diet and exercise.

Bupropion and naltrexone will not treat any weight-related medical condition, such as high blood pressure, diabetes, or high cholesterol.

Contrave is not approved to treat depression or other psychiatric conditions, or to help you quit smoking.

Bupropion and naltrexone may also be used for purposes not listed in this medication guide.

What are the possible side effects of bupropion and naltrexone (Contrave)?

Get emergency medical help if you have signs of an allergic reaction: fever, swollen glands, mouth sores, muscle or joint pain; hives, rash or itching; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.

A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, severe drowsiness, or if you are hard to wake up.

Stop taking this medicine and call your doctor right away if you have:

  • a seizure (convulsions);
  • blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • changes in mood or behavior–anxiety, depression, panic attacks, trouble sleeping, agitation, thoughts about suicide or hurting yourself;
  • a manic episode–racing thoughts, increased energy, unusual risk-taking behavior, extreme happiness, being irritable or talkative;
  • liver problems–upper stomach pain, tiredness, dark urine, jaundice (yellowing of the skin or eyes);
  • increased blood pressure–severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed; or
  • severe skin reaction–fever, mouth or throat pain, burning eyes, skin pain, red or purple rash that spreads and causes blisters and peeling.

Older adults may be more likely to have certain side effects.

Common side effects may include:

  • nausea, vomiting, diarrhea, constipation;
  • headache, dizziness;
  • dry mouth; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about bupropion and naltrexone (Contrave)?

You should not use this medicine if you have uncontrolled high blood pressure, seizures, an eating disorder, opioid addiction, if you are pregnant, if you take narcotic medicine or other forms of bupropion, or if you have suddenly stopped using alcohol, seizure medication, or a sedative.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact with bupropion and naltrexone, and some drugs should not be used together.

Some young people have thoughts about suicide when first taking bupropion. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

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