Weight lossActive ingredient
Naltrexone hydrochloride and bupropion hydrochloride
Combination opioid antagonist and aminoketone antidepressant1 FDA label read
Contrave combines naltrexone, used in opioid and alcohol dependence, with bupropion, an antidepressant also sold for smoking cessation. It is approved for long-term weight management and carries a boxed warning about suicidal thoughts and behaviours that comes from the bupropion component.
Highlights of the labels
- Contrave
- Long-term weight managementcovers weight loss
- Supply
- Prescription only
- Generic
- None approved
- Boxed warning
- WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
FDA boxed warning
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
In the Contrave label
- Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants for major depressive disorder and other psychiatric disorders. Monitor for worsening and emergence of suicidal thoughts and behaviors. CONTRAVE is not approved for use in pediatric patients. SUICIDALITY AND ANTIDEPRESSANT DRUGS CONTRAVE ® is not approved for use in the treatment of major depressive disorder or other psychiatric disorders. CONTRAVE contains bupropion, the same active ingredient as some antidepressant medications (including, but not limited to, WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, and APLENZIN).
A boxed warning is the most serious warning the FDA requires. This text is reproduced from the label.
Brands and what each one is approved for
One active ingredient can hold several separate FDA approvals. They are different documents with different approved uses, and mixing them up is the most common mistake made about these medications.
| Brand | What its label approves | Supply | Label version |
|---|---|---|---|
| ContraveNalpropion Pharmaceuticals LLC | What its label approvesLong-term weight managementCovers weight loss | SupplyPrescription | Label version10 November 2025 |
How it works
The two ingredients in Contrave are established medicines in their own right, an opioid antagonist and an antidepressant, brought together in one tablet. Neither was built for weight loss, and the label does not claim to know why the pair produces it. What it offers instead is where each component is thought to act, quoted below in the label's own words.
Mechanism of action, Contrave label
CONTRAVE has two components: naltrexone, an opioid antagonist, and bupropion, a relatively weak inhibitor of the neuronal reuptake of dopamine and norepinephrine. Nonclinical studies suggest that naltrexone and bupropion have effects on two separate areas of the brain involved in the regulation of food intake: the hypothalamus (appetite regulatory center) and the mesolimbic dopamine circuit (reward system). The exact neurochemical effects of CONTRAVE leading to weight loss are not fully understood.
What the FDA approved it for
The approved uses, as worded in the label.
- CONTRAVE is a combination of naltrexone, an opioid antagonist, and bupropion, an aminoketone antidepressant, indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight in the presence of at least one weight-related comorbid condition.
- Limitations of Use: The effect of CONTRAVE on cardiovascular morbidity and mortality has not been established.
- Coadministration with other naltrexone-containing products is not recommended.
Forms and strengths
The presentations and strengths listed in the label.
- CONTRAVE extended-release tablets: 8 mg/90 mg are blue, round, bi-convex, film-coated, and debossed with "NB-890" on one side.
- Extended-Release Tablets: 8 mg naltrexone hydrochloride (HCl) /90 mg bupropion HCl
How the label says it is taken
What the label states about administration. It is not a dosing instruction for any individual.
CONTRAVE dose escalation schedule: Morning Dose Evening Dose Week 1 1 tablet None Week 2 1 tablet 1 tablet Week 3 2 tablets 1 tablet Week 4 - Onward 2 tablets 2 tablets
Most common adverse reactions
The adverse reactions the label reports as most common.
Most common adverse reactions (greater than or equal to 5%): nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth and diarrhea.
Warnings and precautions
The warnings and precautions section of the label.
- Suicidal Behavior and Ideation: Monitor for depression or suicidal thoughts. Discontinue CONTRAVE if symptoms develop.
- Neuropsychiatric Adverse Events During Smoking Cessation: Postmarketing reports of serious or clinically significant neuropsychiatric adverse events have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed...
- Risk of seizure may be minimized by adhering to the recommended dosing schedule and avoiding coadministration with high-fat meal.
- Increase in Blood Pressure and Heart Rate: Monitor blood pressure and heart rate in all patients, especially those with cardiac or cerebrovascular disease.
- Hepatotoxicity: Cases of hepatitis and clinically significant liver dysfunction observed with naltrexone exposure.
- Angle-closure glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants.
- Use of Antidiabetic Medications: Weight loss may cause hypoglycemia. Monitor blood glucose.
Contraindications
Situations in which the label states the medication must not be used.
- CONTRAVE is contraindicated in Uncontrolled hypertension Seizure disorder or a history of seizures Use of other bupropion-containing products (including, but not limited to, WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, APLENZIN and ZYBAN) Bulimia or anorexia nervosa, which increase the risk for seizure Chronic opioid or opiate agonist (e.g., methadone) or partial agonists (e.g., buprenorphine) use,...
- At least 14 days should elapse between discontinuation of MAOI and initiation of treatment with CONTRAVE.
- There is an increased risk of hypertensive reactions when CONTRAVE is used concomitantly with MAOIs.
- Starting CONTRAVE in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated Known allergy to bupropion, naltrexone or any other component of CONTRAVE.
Drug interactions
Interactions the label singles out.
- MAOIs: Increased risk of hypertensive reactions can occur when used concomitantly.
- Drugs Metabolized by CYP2D6: Bupropion inhibits CYP2D6 and can increase concentrations of antidepressants, (e.g., selective serotonin reuptake inhibitors and many tricyclics), antipsychotics (e.g., haloperidol, risperidone and thioridazine), beta-blockers (e.g., metoprolol) and Type 1C antiarrhythmics (e.g., propafenone and flecainide). Consider dose reduction when using with CONTRAVE.
- Digoxin: May decrease plasma digoxin levels. Monitor digoxin levels.
- Concomitant Treatment with CYP2B6 Inhibitors (e.g., ticlopidine or clopidogrel) can increase bupropion exposure. Do not exceed one tablet twice daily when taken with CYP2B6 inhibitors.
- CYP2B6 Inducers (e.g., ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital, and phenytoin) may reduce efficacy by reducing bupropion exposure, avoid concomitant use.
- Drugs that Lower Seizure Threshold: Dose CONTRAVE with caution.
Pregnancy and breastfeeding
The opening of the pregnancy section of the label. The full section is longer and is in the source document.
Weight loss offers no benefit to a pregnant patient and may cause fetal harm. When a pregnancy is recognized, advise the pregnant patient of the risk to the fetus, and discontinue CONTRAVE (see Clinical Considerations). Available pharmacovigilance data and data from clinical trials with the individual components of CONTRAVE use in pregnant patients have not demonstrated a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
Generic or brand
The naltrexone and bupropion extended-release combination has no widely available generic in the United States, although both ingredients are available separately as generics for their own approved uses.
The FDA label database lists no approved generic application for this ingredient.
What affects the cost
Contrave is a brand product. It is taken as tablets rather than injected, which is the practical difference most often cited against the GLP-1 medications. This site sells nothing and links to no sellers.
Compared with other medications
What the labels do not do is compare one medication against another. These pages put two of them side by side.
Common questions
- Why does Contrave have a boxed warning?
- Because it contains bupropion, an antidepressant. Antidepressants carry a class boxed warning about suicidal thoughts and behaviours. The full text of the warning is quoted on this page.
- Can Contrave be taken with opioid painkillers?
- The label contraindicates chronic opioid or opiate agonist use, partial agonist use, and acute opiate withdrawal. This is because of the naltrexone component.
Other medications under weight loss
Whether each one carries an FDA approval for this use is marked on its page and in this list.
Sources
Every fact above comes from one of these documents. The date is the effective date of the label version this page was built from.
FDA prescribing information for Contrave
Nalpropion Pharmaceuticals LLC. Label version 27, effective 10 November 2025.
Each stripe is one section of the label, each division in a stripe one entry in that section. The red bar marks a boxed warning.
Page last updated 18 August 2026
Compiled by the HealthyStudy editorial team from FDA source documents. No medical reviewer is credited on this page, because none reviewed it.