Prescription medicine
Bupropion and naltrexone Brand names: Contrave
Bupropion and naltrexone (Contrave) is a prescription medicine with an FDA approval on record since 2014. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the bupropion and naltrexone FDA label on DailyMed (effective November 10, 2025, Nalpropion Pharmaceuticals LLC); the NDA 200063 record on Drugs@FDA; every bupropion and naltrexone label on DailyMed.
Highlights of the record
FDA label of November 10, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SUICIDAL THOUGHTS AND BEHAVIORS WARNING: SUICIDAL THOUGHTS AND BEHAVIORS.
See full prescribing information for complete boxed warning Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants for major depressive disorder and other psychiatric disorders. ( 5.1 ) Monitor for worsening and emergence of suicidal thoughts and behaviors. ( 5.1 ) CONTRAVE is not approved for use in pediatric patients. ( 5.1 ) 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). 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 CONTRAVE, 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. […]
Used for
From the label: indications and usageCONTRAVE is 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.
Forms and strengths
- 8 mg / 90 mg
Extended-release tablet.
On the market
- Earliest approval on file
- September 10, 2014 Contrave, Azurity; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- July 2, 2034 Contrave tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2018 0 Class I among all firms' recalls; latest October 5, 2018
- FAERS reports
- 8,477 through July 30, 2026
What is bupropion and naltrexone used for?
From the label: indications and usageCONTRAVE is 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. 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. […]
Conditions named in the indications of bupropion and naltrexone's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Aminoketone and Opioid Antagonist.
Source: FDA drug label (Contrave Extended-Release), NDA200063 (Azurity), as published by Nalpropion Pharmaceuticals LLC, effective November 10, 2025 (SPL set 485ff360-32c8-11df-928b-0002a5d5c51b), via openFDA; the full label on DailyMed
What does the patient leaflet for bupropion and naltrexone say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: 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 attempts to commit suicide new or worse depression new or worse anxiety feeling very agitated or restless panic attacks new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) 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.
From the patient leaflet: 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.
From the patient leaflet: How should I store CONTRAVE?Store CONTRAVE at room temperature between 68°F to 77°F (20°C to 25°C). Keep CONTRAVE and all medicines out of the reach of children.
Source: FDA drug label (Contrave Extended-Release), NDA200063 (Azurity), as published by Nalpropion Pharmaceuticals LLC, effective November 10, 2025 (SPL set 485ff360-32c8-11df-928b-0002a5d5c51b), via openFDA; the full label on DailyMed
Is there a generic for bupropion and naltrexone (Contrave)?
No generic bupropion and naltrexone is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 18 patents for Contrave tablets, the last expiring on July 2, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2014 earliest approval on file
- 2034 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has bupropion and naltrexone been recalled?
The FDA's Enforcement Report lists 2 recalls naming bupropion and naltrexone since 2018: 0 Class I (the most serious), 0 Class II, 2 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 5, 2018 | Class III | Orexigen Therapeutics, Inc. | Container packaging defect. |
| August 9, 2018 | Class III | Orexigen Therapeutics, Inc. | Defective Container: Customer complaints of punctures in the bottle. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the bupropion and naltrexone label say about other medicines?
The bupropion and naltrexone label names 26 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amantadine | drug interactions | Dose CONTRAVE with caution. ( 5.3 , 7.5 ) Dopaminergic Drugs (levodopa and amantadine): CNS toxicity can occur when used concomitantly with CONTRAVE. |
| Buprenorphine | contraindications | … Warnings and Precautions (5.3) ] Chronic opioid or opiate agonist (e.g., methadone) or partial agonists (e.g., buprenorphine) use, or acute opiate withdrawal [see Warnings and Precautions (5.4) and Drug Interactions (7.2) ] Patients undergoing an abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and … |
| Carbamazepine | drug interactions | Do not exceed one tablet twice daily when taken with CYP2B6 inhibitors. ( 2.5 , 7.4 ) CYP2B6 Inducers (e.g., ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital, and phenytoin) may reduce efficacy by reducing bupropion exposure, avoid concomitant use. ( 7.4 ) Drugs that Lower Seizure Threshold: |
| Clopidogrel | drug interactions | Monitor digoxin levels. ( 7.3 ) Concomitant Treatment with CYP2B6 Inhibitors (e.g., ticlopidine or clopidogrel) can increase bupropion exposure. |
| Cocaine | warnings and precautions | … hyponatremia, severe hepatic impairment, and hypoxia) excessive use of alcohol or sedatives, addiction to cocaine or stimulants, or withdrawal from sedatives patients with diabetes treated with insulin and/or oral diabetic medications (sulfonylureas and meglitinides) that may cause hypoglycemia concomitant … |
| Desipramine | drug interactions | Similar clinical drug interactions resulting in increased pharmacokinetic exposure of CYP2D6 substrates have also been observed with bupropion as a single agent with desipramine or venlafaxine. |
| Digoxin | drug interactions | Consider dose reduction when using with CONTRAVE. ( 7.3 ) Digoxin: May decrease plasma digoxin levels. |
| Efavirenz | drug interactions | Do not exceed one tablet twice daily when taken with CYP2B6 inhibitors. ( 2.5 , 7.4 ) CYP2B6 Inducers (e.g., ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital, and phenytoin) may reduce efficacy by reducing bupropion exposure, avoid concomitant use. ( 7.4 ) Drugs that Lower Seizure Threshold: |
| Flecainide | drug interactions | 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). |
| Haloperidol | drug interactions | 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). |
| Levodopa | drug interactions | Dose CONTRAVE with caution. ( 5.3 , 7.5 ) Dopaminergic Drugs (levodopa and amantadine): CNS toxicity can occur when used concomitantly with CONTRAVE. |
| Linezolid | contraindications | Starting CONTRAVE in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated [see Dosage and Administration (2.4), Drug Interactions (7.1) ] Known allergy to bupropion, naltrexone or any other component of CONTRAVE. |
| Methadone | contraindications | … increase the risk for seizure [see Warnings and Precautions (5.3) ] Chronic opioid or opiate agonist (e.g., methadone) or partial agonists (e.g., buprenorphine) use, or acute opiate withdrawal [see Warnings and Precautions (5.4) and Drug Interactions (7.2) ] Patients undergoing an abrupt discontinuation of alcohol … |
| Methylene blue | contraindications | Starting CONTRAVE in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated [see Dosage and Administration (2.4), Drug Interactions (7.1) ] Known allergy to bupropion, naltrexone or any other component of CONTRAVE. |
Every other medicine the bupropion and naltrexone label names
| Medicine named | Section | What the label says |
|---|---|---|
| Metoprolol | drug interactions | … (e.g., haloperidol, risperidone and thioridazine), beta-blockers (e.g., metoprolol) and Type 1C antiarrhythmics (e.g., propafenone and flecainide). |
| Nicotine | warnings and precautions | Some patients who stopped smoking may have been experiencing symptoms of nicotine withdrawal, including depressed mood. |
| Phenelzine | drug interactions | Studies in animals demonstrate that the acute toxicity of bupropion is enhanced by the MAOI phenelzine. |
| Phenobarbital | drug interactions | … CYP2B6 Inducers (e.g., ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital, and phenytoin) may reduce efficacy by reducing bupropion exposure, avoid concomitant use. … |
| Phenytoin | drug interactions | … ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital, and phenytoin) may reduce efficacy by reducing bupropion exposure, avoid concomitant use. ( 7.4 ) Drugs that Lower Seizure Threshold: |
| Propafenone | drug interactions | … beta-blockers (e.g., metoprolol) and Type 1C antiarrhythmics (e.g., propafenone and flecainide). |
| Risperidone | drug interactions | … 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). |
| Ritonavir | drug interactions | Do not exceed one tablet twice daily when taken with CYP2B6 inhibitors. ( 2.5 , 7.4 ) CYP2B6 Inducers (e.g., ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital, and phenytoin) may reduce … |
| Theophylline | drug interactions | Use extreme caution when coadministering CONTRAVE with other drugs that lower seizure threshold (e.g., antipsychotics, antidepressants, theophylline, or systemic corticosteroids). … |
| Thioridazine | drug interactions | … many tricyclics), antipsychotics (e.g., haloperidol, risperidone and thioridazine), beta-blockers (e.g., metoprolol) and Type 1C antiarrhythmics (e.g., propafenone and flecainide). |
| Tramadol | warnings and precautions | … being treated for alcohol dependence, should be opioid-free (including tramadol) before starting CONTRAVE treatment. |
| Venlafaxine | drug interactions | Similar clinical drug interactions resulting in increased pharmacokinetic exposure of CYP2D6 substrates have also been observed with bupropion as a single agent with desipramine or venlafaxine. |
Source: FDA drug label (Contrave Extended-Release), NDA200063 (Azurity), as published by Nalpropion Pharmaceuticals LLC, effective November 10, 2025 (SPL set 485ff360-32c8-11df-928b-0002a5d5c51b), via openFDA; the full label on DailyMed
What do FAERS reports show for bupropion and naltrexone?
The FDA Adverse Event Reporting System holds 8,477 reports that list bupropion and naltrexone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 29 are coded as a death and 558 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (2,412, against a median of 355 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as bupropion and naltrexone?
7 other medicines are given the same way (oral) and in the same FDA class as bupropion and naltrexone or labeled mainly for the same use (weight management), the same class first. Weight management lists all 12 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Phentermine | Weight management | 27 labelers | $0.0727 per tablet 37.5 mg tablet | No current entry |
| Diethylpropion | Weight management | 13 labelers | $0.238 per tablet 25 mg tablet | No current entry |
| Phendimetrazine | Weight management | 11 labelers | $0.132 per tablet 35 mg tablet | No current entry |
| Phentermine and topiramate | Weight management | 2 labelers | $3.06 per capsule 7.5-46 mg capsule | No current entry |
| Benzphetamine | Weight management | 6 labelers | n/a | No current entry |
| Orforglipron | Weight management | none listed | $20.89 per tablet 0.8 mg tablet | No current entry |
| Orlistat | Weight management | none listed | $7.00 per capsule 120 mg capsule | No current entry |
Every medicine labeled for the same conditions as bupropion and naltrexone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to bupropion and naltrexone
- 7 medicines for the same use
- Other aminoketones
- the pharmacologic class, with prices and generics
- Bupropion and naltrexone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other