Bupropion / Naltrexone Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 10, 2024.

Applies to bupropion / naltrexone: oral tablet extended release.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during therapy. If you think you have become pregnant while using this medicine, tell your doctor right away.

Do not take naltrexone and bupropion combination with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking naltrexone and bupropion combination during the 2 weeks after you stop a MAO inhibitor. Wait 2 weeks after stopping naltrexone and bupropion combination before you start taking a MAO inhibitor. If you take them together or do not wait 2 weeks, you may have confusion, agitation, restlessness, stomach or bowel symptoms, a sudden high body temperature, an extremely high blood pressure, or severe seizures.

Do not use naltrexone and bupropion combination if you are also using Zyban® to quit smoking or Aplenzin® or Wellbutrin® for depression, because they also contain bupropion. Also, do not take this medicine if you are using or have used narcotic drugs (eg, buprenorphine, methadone, or other habit-forming painkillers) within the past 7 to 10 days.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

You have a higher risk of accidental overdose, serious injury, or death if you use heroin or any other narcotic medicine while you are being treated with naltrexone and bupropion combination. Also, naltrexone prevents you from feeling the effects of heroin if you use it.

Do not Stop taking bupropion / naltrexone without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. This is to decrease the chance of having certain side effects when you stop the medicine, such as agitation, anxiety, dizziness, a feeling of constant movement of self or surroundings, headaches, increased sweating, nausea, trembling or shaking, trouble with sleeping or walking, or unusual tiredness.

Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.

This medicine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, swelling of the face, tongue, or throat, trouble breathing, or chest pain.

Serious skin reactions (eg, Stevens-Johnson syndrome) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills with this medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor right away if blurred vision, eye pain, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

This medicine may increase the risk of hypoglycemia (low blood sugar) in patients with diabetes. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms of low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. You should check your blood sugar before you start treatment and while you are taking this medicine.

Drinking alcoholic beverages should be limited or avoided, if possible, with this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

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:

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]

See also:

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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer