What the label lists and what reports show
Bupropion and naltrexone side effects
Bupropion and naltrexone's FDA label: “Most common adverse reactions (greater than or equal to 5%): nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth and diarrhea.” FAERS holds 8,477 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (1,984 reports).
- 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 FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: 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. […]
Source: FDA drug label, 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 label list?
From the label: adverse reactionsMost common adverse reactions (greater than or equal to 5%): nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth and diarrhea.
Table 3. Adverse Reactions Reported by Obese or Overweight Patients With an Incidence (%) of at Least 2% Among Patients Treated with CONTRAVE and More Common than with Placebo
| Adverse Reaction | CONTRAVE 32 mg/360 mg N=2545 % | Placebo N=1515 % |
|---|---|---|
| Nausea | 32.5 | 6.7 |
| Constipation | 19.2 | 7.2 |
| Headache | 17.6 | 10.4 |
| Vomiting | 10.7 | 2.9 |
| Dizziness | 9.9 | 3.4 |
| Insomnia | 9.2 | 5.9 |
| Dry mouth | 8.1 | 2.3 |
| Diarrhea | 7.1 | 5.2 |
| Anxiety | 4.2 | 2.8 |
| Hot flush | 4.2 | 1.2 |
| Fatigue | 4.0 | 3.4 |
| Tremor | 4.0 | 0.7 |
| Upper abdominal pain | 3.5 | 1.3 |
| Viral gastroenteritis | 3.5 | 2.6 |
| Influenza | 3.4 | 3.2 |
| Tinnitus | 3.3 | 0.6 |
| Urinary tract infection | 3.3 | 2.8 |
| Hypertension | 3.2 | 2.2 |
| Abdominal pain | 2.8 | 1.4 |
| Hyperhidrosis | 2.6 | 0.6 |
| Irritability | 2.6 | 1.8 |
| Blood pressure increased | 2.4 | 1.5 |
| Dysgeusia | 2.4 | 0.7 |
| Rash | 2.4 | 2.0 |
| Muscle strain | 2.2 | 1.7 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in other sections of the labeling: Suicidal Behavior and Ideation [see Boxed Warning, Warnings and Precautions (5.1) ] Neuropsychiatric Adverse Events [see Warnings and Precautions (5.2) ] Seizures [see Contraindications (4), Warnings and Precautions (5.3) ] Increase in Blood Pressure and Heart Rate [see Warnings and Precautions (5.5) ] Allergic Reactions [see Warnings and Precautions (5.6) ] Angle-Closure Glaucoma [see Warnings and Precautions (5.9) ] Most common adverse reactions (greater than or equal to 5%): nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Currax Pharmaceuticals LLC at 1-800-793-2145 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. CONTRAVE was evaluated for safety in five double-blind placebo-controlled trials in 4,754 overweight or obese patients (3,239 patients treated with CONTRAVE and 1,515 patients treated with placebo) for a treatment period up to 56 weeks. …
Source: FDA drug label, 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?
8,477 reports list bupropion and naltrexone among the medicines taken, 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. Of the 23 reactions below, 18 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Bupropion and naltrexone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions