Naltrexone

Your safety is our first priority. Learn more about key medication details, side effects, and other important info about your treatment at the link below.

You may receive a compounded version of naltrexone if your provider determines it is medically appropriate for you. Compounded naltrexone has not been reviewed or approved by the FDA and does not undergo safety, effectiveness, or manufacturing review.

Important safety information
Common Side effects
  • Abdominal pain
  • Nausea
  • Vomiting

Important Safety Information

NALTREXONE + VITAMIN B12 is a compounded product and is not FDA-approved. The FDA does not verify the safety or effectiveness of compounded drugs
NALTREXONE is a prescription medication that is FDA approved to: treat alcohol dependence prevent relapse to opioid dependence, after opioid detoxification.
VITAMIN B12 is a dietary supplement utilized in many areas of the body principally for the proper function of your red blood cells, nerve cells, energy levels and mood. Additionally it is used to supplement B12 when other drugs may possibly decrease its level.
NALTREXONE + VITAMIN B12 is a prescription medicine that is prescribed off-label and may help some adults with overweight and obesity lose weight and keep the weight off.
IMPORTANT SAFETY INFORMATION NALTREXONE + VITAMIN B12 can cause serious side effects, including:
  • Risk of opioid overdose. You can accidentally overdose in two ways.
    • NALTREXONE + VITAMIN B12 blocks the effects of opioids, such as heroin or opioid pain medicines, examples include, but are not limited to; morphine (MS Contin), hydrocodone (Vicodin), oxycodone (Oxycontin), hydromorphone (Percocet), codeine, or tramadol. Do not try to overcome this blocking effect by taking large amounts of opioids—this can lead to serious injury, coma, or death.
    • After you receive a dose of NALTREXONE + VITAMIN B12, its blocking effect slowly decreases and completely goes away over time. If you have used opioid street drugs or opioid-containing medicines in the past, using opioids in amounts that you used before treatment with NALTREXONE + VITAMIN B12 can lead to overdose and death. You may also be more sensitive to the effects of lower amounts of opioids:
      • after you have gone through detoxification
      • when your next NALTREXONE + VITAMIN B12 dose is due
      • if you miss a dose of NALTREXONE + VITAMIN B12
      • after you stop NALTREXONE + VITAMIN B12 treatment
  • Tell your family and the people closest to you of this increased sensitivity to opioids and the risk of overdose.
Talk to your healthcare provider about naloxone, a medicine that is available to patients for the emergency treatment of an opioid overdose. Call 911 or get emergency medical help right away in all cases of known or suspected opioid overdose, even if naloxone is administered.
  • Sudden opioid withdrawal. To avoid sudden opioid withdrawal, you must stop taking any type of opioid, including street drugs; prescription pain medicines; cough, cold, or diarrhea medicines that contain opioids; or opioid-dependence treatments, including buprenorphine or methadone, for at least 7 to 14 days before starting NALTREXONE + VITAMIN B12. Sudden opioid withdrawal can be severe and may require hospitalization.
  • Liver damage or hepatitis. NALTREXONE + VITAMIN B12 can cause liver damage or hepatitis. Tell your healthcare provider if you have any of these symptoms during treatment with NALTREXONE + VITAMIN B12:
    • stomach area pain lasting more than a few days
    • dark urine
    • yellowing of the whites of your eyes
    • tiredness
  • Your healthcare provider may need to stop treating you with NALTREXONE + VITAMIN B12 if you get signs or symptoms of a serious liver problem.
You must stop taking opioids before you start taking NALTREXONE + VITAMIN B12. It is not known if NALTREXONE + VITAMIN B12 is safe and effective in children.
Who should not take NALTREXONE + VITAMIN B12?
Do not take NALTREXONE + VITAMIN B12 if you:
  • are using or have a physical dependence on opioid-containing medicines, such as but not limited to, morphine (MS Contin), hydrocodone (Vicodin), oxycodone (Oxycontin), hydromorphone (Percocet), codeine, or tramadol. or opioid street drugs, such as heroin.
  • are having opioid withdrawal symptoms. Opioid withdrawal symptoms may happen when you have been taking opioid containing medicines or opioid street drugs regularly and then stop. Symptoms of opioid withdrawal may include: anxiety, sleeplessness, yawning, fever, sweating, teary eyes, runny nose, goosebumps, shakiness, hot or cold flushes, muscle aches, muscle twitches, restlessness, nausea and vomiting, diarrhea, or stomach cramps.
  • are allergic to NALTREXONE + VITAMIN B12 or any of the inactive ingredients in NALTREXONE + VITAMIN B12. See the medication guide for the full list of ingredients.
What should I tell my healthcare provider before taking NALTREXONE + VITAMIN B12? Before you take NALTREXONE + VITAMIN B12, tell your healthcare provider if you:
  • have liver problems, use or abuse street (illegal) drugs, have hemophilia or other bleeding problems, have kidney problems, or have any other medical conditions.
  • are pregnant or plan to become pregnant. It is not known if NALTREXONE + VITAMIN B12 will harm your unborn baby. are breastfeeding. NALTREXONE + VITAMIN B12 passes into breast milk. Talk - to your healthcare provider about whether you will breastfeed or take NALTREXONE + VITAMIN B12. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take any opioid-containing medicines for pain, cough or colds, or diarrhea.
What are other possible serious side effects of NALTREXONE + VITAMIN B12?
NALTREXONE + VITAMIN B12 can cause serious side effects, including:
Depressed mood. Sometimes this leads to suicide, or suicidal thoughts, and suicidal behavior. Tell your family members and people closest to you that you are taking NALTREXONE + VITAMIN B12.
Pneumonia. Some people receiving NALTREXONE + VITAMIN B12 treatment have had a type of pneumonia that is caused by an allergic reaction. If this happens to you, you may need to be treated in the hospital.
Serious allergic reactions. Serious allergic reactions can happen during or soon after an injection of NALTREXONE + VITAMIN B12. Tell your healthcare provider or get medical help right away if you have any of these symptoms:
  • skin rash
  • swelling of your face, eyes, mouth, or tongue
  • trouble breathing or wheezing
  • chest pain
  • feeling dizzy or faint
Common side effects of NALTREXONE + VITAMIN B12 may include:
  • nausea
  • sleepiness
  • headache
  • dizziness
  • vomiting
  • decreased appetite
  • painful joints
  • muscle cramps
  • cold symptoms
  • trouble sleeping
  • toothache
These are not all the side effects of NALTREXONE + VITAMIN B12. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. You are encouraged to report all side effects to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. This is only a summary of the most important information about NALTREXONE + VITAMIN B12.
Need more information? Ask your healthcare provider or pharmacist.