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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

BUPROPION\NALTREXONE: 7,763 Adverse Event Reports & Safety Profile

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7,763
Total FAERS Reports
30 (0.4%)
Deaths Reported
628
Hospitalizations
7,763
As Primary/Secondary Suspect
76
Life-Threatening
102
Disabilities

Active Ingredient: BUPROPION HYDROCHLORIDE\NALTREXONE HYDROCHLORIDE ·

First Report: 19230410 · Latest Report: 20250908

What Are the Most Common BUPROPION\NALTREXONE Side Effects?

#1 Most Reported
Nausea
1,857 reports (23.9%)
#2 Most Reported
Headache
1,054 reports (13.6%)
#3 Most Reported
Dizziness
986 reports (12.7%)

All BUPROPION\NALTREXONE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Nausea 1,857 23.9% 0 113
Headache 1,054 13.6% 0 69
Dizziness 986 12.7% 0 61
Vomiting 646 8.3% 0 64
Constipation 602 7.8% 0 30
Feeling abnormal 550 7.1% 0 35
Fatigue 474 6.1% 1 30
Anxiety 378 4.9% 0 28
Insomnia 367 4.7% 0 34
Diarrhoea 350 4.5% 0 28
Patient dissatisfaction with treatment 340 4.4% 0 9
Drug titration error 338 4.4% 0 44
Blood pressure increased 322 4.2% 0 36
Drug ineffective 313 4.0% 0 6
Tremor 306 3.9% 0 21
Illness 290 3.7% 0 13
Dry mouth 279 3.6% 0 22
Malaise 268 3.5% 0 18
Weight increased 255 3.3% 0 21
Abdominal pain upper 252 3.3% 0 30

Who Reports BUPROPION\NALTREXONE Side Effects? Age & Gender Data

Gender: 87.6% female, 12.4% male. Average age: 50.0 years. Most reports from: US. View detailed demographics →

Is BUPROPION\NALTREXONE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 0
2002 1 0 0
2003 1 0 0
2011 1 0 0
2012 1 0 1
2013 5 1 2
2014 58 1 7
2015 755 2 44
2016 356 3 32
2017 169 0 40
2018 165 2 31
2019 264 1 24
2020 328 1 29
2021 356 3 34
2022 560 0 59
2023 894 0 52
2024 432 1 44
2025 64 0 16

View full timeline →

What Is BUPROPION\NALTREXONE Used For?

IndicationReports
Weight control 2,842
Product used for unknown indication 2,801
Overweight 803
Obesity 726
Weight decreased 426
Decreased appetite 35
Depression 24
Weight increased 17
Food craving 13
Anxiety 9

BUPROPION\NALTREXONE vs Alternatives: Which Is Safer?

BUPROPION\NALTREXONE vs BUROSUMAB BUPROPION\NALTREXONE vs BUROSUMAB-TWZA BUPROPION\NALTREXONE vs BUSPIRONE BUPROPION\NALTREXONE vs BUSULFAN BUPROPION\NALTREXONE vs BUSULFEX BUPROPION\NALTREXONE vs BUTALBITAL BUPROPION\NALTREXONE vs BUTENAFINE BUPROPION\NALTREXONE vs BUTORPHANOL BUPROPION\NALTREXONE vs BUTRANS BUPROPION\NALTREXONE vs BUTYLSCOPOLAMINE

Official FDA Label for BUPROPION\NALTREXONE

Official prescribing information from the FDA-approved drug label.