Summary

Commonly reported side effects of bupropion/naltrexone include: constipation, dizziness, headache, insomnia, nausea, and vomiting. Other side effects include: anxiety, diarrhea, increased blood pressure, tremor, depression, hypertension, and xerostomia. Continue reading for a comprehensive list of adverse effects.

Applies to bupropion / naltrexone: oral tablet extended release.

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

• 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

• 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

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

Rare

• 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

• Difficulty having a bowel movement

Less common

• 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

• 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

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]