Bupropion / Naltrexone Side Effects

Medically reviewed by Drugs.com. Last updated on May 5, 2024.

Applies to bupropion / naltrexone: oral tablet extended release.

Important warnings This medicine can cause some serious health issues

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 side effects

• blurred vision
• discouragement
• dizziness
• fear or nervousness
• feeling sad or empty
• headache
• irritability
• lack of appetite
• loss of interest or pleasure
• pounding in the ears
• slow or fast heartbeat
• trouble concentrating
• trouble sleeping
• unusual tiredness or weakness

Less common side effects

• bladder pain
• bloody or cloudy urine
• difficult, burning, or painful urination
• fast, irregular, pounding, or racing heartbeat or pulse
• frequent urge to urinate
• lower back or side pain
• shakiness in the legs, arms, hands, or feet
• trembling or shaking of the hands or feet

Less common or rare side effects

• chest pain or discomfort
• nausea
• pain or discomfort in the arms, jaw, back, or neck
• sweating
• vomiting

Rare side effects

• changes in behavior
• thoughts of killing oneself

Incidence not known

• aggressive or angry
• anxiety
• blistering, peeling, or loosening of the skin
• chills
• clay colored stools
• cough
• dark urine
• delusions of persecution, mistrust, suspiciousness, or combativeness
• diarrhea
• difficulty with moving
• difficulty with swallowing
• dry mouth
• false beliefs that cannot be changed by facts
• feeling that others are watching you or controlling your behavior
• feeling, seeing, or hearing things that are not there
• fever
• hives, itching, or rash
• hyperventilation
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• muscle stiffness
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red, irritated eyes
• restlessness
• severe mood or mental changes
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stomach pain or tenderness
• swelling of the feet or lower legs
• tightness in the chest
• unusual behavior
• yellow eyes or skin

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

Symptoms of overdose

• blue lips, fingernails, or skin
• change in or loss of consciousness
• confusion
• decreased awareness or responsiveness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• muscle cramps or spasms
• severe sleepiness

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 side effects

• difficulty having a bowel movement

Less common side effects

• change or loss of taste
• continuing ringing or buzzing or other unexplained noise in the ears
• feeling of warmth
• hearing loss
• increased sweating
• redness of the face, neck, arms, and occasionally, upper chest
• stomach pain

Rare side effects

• feeling of constant movement of self or surroundings
• indigestion
• sensation of spinning
• severe nausea or vomiting
• thinning of the hair or hair loss

For healthcare professionals

Applies to bupropion / naltrexone: oral tablet extended release.

General adverse events

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

• 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]

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

Cardiovascular

• 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]

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]

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

• Does naltrexone cause weight gain?

Further information

Bupropion/naltrexone side effects can vary depending on the individual. 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.

Medical Disclaimer