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Bupropion / naltrexone Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 11, 2024.

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.

Serious side effects

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

Less common

Less common or rare

Rare

Incidence not known

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

Symptoms of overdose

Other side effects

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

Less common

Rare

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.[Ref]

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[Ref]

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.[Ref]

Nervous system

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

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

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

Uncommon (0.1% to 1%): Vertigo, motion sickness, disturbance in attention, lethargy, intention tremor, balance disorder, memory impairment, amnesia, mental impairment, presyncope/syncope, hernia, seizure

Postmarketing reports: Loss of consciousness[Ref]

Cardiovascular

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.[Ref]

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[Ref]

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[Ref]

Renal

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

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.[Ref]

Dermatologic

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

Uncommon (0.1% to 1%): Alopecia[Ref]

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[Ref]

Genitourinary

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

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

Hematologic

Uncommon (0.1% to 1%): Decreased hematocrit[Ref]

Immunologic

Common (1% to 10%): Influenza[Ref]

Metabolic

Uncommon (0.1% to 1%): Dehydration[Ref]

Musculoskeletal

Common (1% to 10%): Muscle strain

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

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[Ref]

Respiratory

Uncommon (0.1% to 1%): Pneumonia[Ref]

Frequently asked questions

References

1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Cerner Multum, Inc. Australian Product Information.

3. Product Information. Contrave (bupropion-naltrexone). Orexigen Therapeutics Inc. 2014.

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.