Vivitrol is an extended-release naltrexone injection. It's an opioid antagonist that's used to treat opioid use disorder and alcohol use disorder in adults. Vivitrol is prescribed as part of a holistic treatment plan that also includes therapy and support groups. This medication is given as a deep gluteal injection into the muscle on the buttock, typically once a month by a healthcare professional. Some common side effects of Vivitrol include pain or tenderness at the injection site, nausea, and headache. Vivitrol is brand name only and not available as a generic medication.
Drinking alcohol or taking opioids triggers opioid receptors in the brain. When this happens, the body releases dopamine, a chemical that makes you feel good. Taking these substances repeatedly to feel relaxation or pleasure can cause the body to become dependent on them.
Vivitrol is an opioid antagonist that blocks the body's opioid receptors. In doing so, Vivitrol blocks the feel-good effects of alcohol or opioids. This can help lower cravings for alcohol or opioids.
Source: DailyMed
Along with its needed effects, a medicine 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 or nurse immediately if any of the following side effects occur:
More common
Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
body aches or pain
chills
congestion
discouragement
dryness or soreness of the throat
ear congestion
fear
feeling sad or empty
headache
hoarseness
irritability
lack of appetite
loss of interest or pleasure
loss of voice
nervousness
rash
runny or stuffy nose
tender, swollen glands in the neck
trouble breathing
trouble concentrating
trouble sleeping
trouble swallowing
unusual tiredness or weakness
voice changes
Incidence not known
Arm, back, or jaw pain
black, tarry stools
bladder pain
bloody or cloudy urine
bloody stools
blurred vision
chest pain, discomfort, tightness, or heaviness
chills
confusion
cough producing mucus
decreased urination
difficult, burning, or painful urination
dilated neck veins
dizziness or lightheadedness
fainting
false or unusual sense of well-being
fast, irregular, pounding, or racing heartbeat or pulse
frequent urge to urinate
general feeling of discomfort or illness
hallucinations or seeing, hearing, or feeling things that are not there
headache, severe and throbbing
holding false beliefs that cannot be changed by fact
hyperventilation
increase in heart rate
increase in white blood cells
indigestion
irregular or rapid breathing
irritability
itching, pain, redness, swelling, tenderness, or warmth on the skin
joint or muscle pain
lower back or side pain
nervousness
numbness or tingling of the face, hands, or feet
pain or discomfort in the arms, jaw, back, or neck
pain, redness, or swelling in the arm or leg
pounding in the ears
redness and soreness of the eyes
restlessness
seizures
shaking
shivering
skin rash
slow or fast heartbeat
sores in the mouth
stomach cramps or pain
sunken eyes
sweating
swelling of the face, fingers, feet, or lower legs
swollen, painful, or tender lymph glands in the neck, armpit, or groin
thirst
tooth or gum pain
unusual excitement, nervousness, or restlessness
vomiting
vomiting of blood or material that looks like coffee grounds
watery or bloody diarrhea
wrinkled skin
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
Sleepiness or unusual drowsiness
Some side effects 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 with moving
muscle stiffness
swelling or redness in the joints
Incidence not known
Bleeding after defecation
bloated or full feeling
change in taste
decreased interest in sexual intercourse
drowsiness
excess air or gas in the stomach or intestines
feeling of warmth
feeling unusually cold
inability to have or keep an erection
increased sweating
loss in sexual ability, desire, drive, or performance
loss of taste
night sweats
passing gas
redness of the face, neck, arms, and occasionally, upper chest
relaxed and calm
sleepiness
sudden sweating
uncomfortable swelling around anus
unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Lowers opioid and alcohol cravings
Given once per month
Better option for people who don't want to take naltrexone tablets everyday
Need to go to clinic or HCP's office to receive the injections
Must be given by injection into the buttock muscle
Can cause bothersome injection site reactions, such as pain and swelling
It's important to set reminders for Vivitrol appointments so you can receive your injections on time. If you miss an appointment, call your HCP right away to reschedule.
Vivitrol isn't meant to be used alone for opioid use disorder or alcohol use disorder. It works best when used alongside therapy or counseling and support groups. Ask your healthcare team what your full treatment plan looks like.
Vivitrol commonly causes injection site reactions like redness, itching, swelling, and mild pain. Your healthcare team might recommend that you use ice packs to help ease some of these symptoms. But let them know right away if you notice more serious injection site reactions, like blisters or more intense pain. These might be signs that you need more medical attention.
You might feel nauseous after receiving Vivitrol. This side effect tends to be mild and should go away after a few days. To lessen nausea during this time, avoid spicy or greasy foods that can trigger nausea. You can also try to eat smaller meals more often throughout the day.
Vivitrol might make you feel sleepy or dizzy. Don't drive or do any activities that need a lot of attention until you know how this medication affects you.
Before starting Vivitrol, your healthcare team will work with you to safely stop all opioid medications, including certain cough medications and antidiarrheal medications. You're recommended to be free of all opioid medications for at least 7 to 10 days before treatment begins. Otherwise, you can experience serious opioid withdrawal symptoms, such as agitation and vomiting.
You're recommended to wear a medical alert identification (ID) if you're taking Vivitrol. This lets medical responders know that they should avoid giving you opioid medications.
Ask your healthcare team about getting naloxone, a medication that can reverse the effects of an opioid overdose. Receiving Vivitrol makes you more sensitive to opioid medications, which puts you at higher risk for serious side effects, such as slowed breathing. Naloxone can be life-saving in case of an accidental overdose.
Let your healthcare team know if you're pregnant or would like to become pregnant. There isn't much research about the safety of taking Vivitrol during pregnancy. Your care team can talk with you about options to treat opioid use disorder or alcohol use disorder during pregnancy.
Vivitrol can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: Taking opioid medications after completing Vivitrol therapy | Missing a dose of Vivitrol
When you stop taking opioid medications as part of treatment for opioid use disorder, your body can become more sensitive to opioids. For example, this can happen after you finish Vivitrol treatment or when the effects of Vivitrol wear off. If you take opioids again, you can experience life-threatening side effects, even at doses that your body tolerated before. Because of this risk, your healthcare team will likely prescribe naloxone to help reverse an opioid overdose in an emergency.
If you have or develop a condition where your healthcare team is considering treating you with opioid medications, let them know that you've received Vivitrol treatment in the past. They might need to prescribe non-opioid alternatives. But if your care team determines an opioid medication is needed (e.g., in a surgery), there needs to be trained staff on hand to monitor your vitals and give appropriate treatment in case you experience life-threatening side effects.
Tell your caregivers and loved ones about this risk of opioid overdose. Use naloxone and call 911 right away if you experience symptoms of an opioid overdose, such as extremely slowed breathing, extreme sleepiness, slow heartbeat, and cold or clammy skin.
Risk factors: Having taken opioid medications before or while taking Vivitrol
If you've been taking opioid medications, taking Vivitrol can cause serious withdrawal symptoms, including nausea and vomiting, sweating, and agitation.
To lower the risk of opioid withdrawal, your healthcare team will work with you to safely stop all opioid medications for at least 7-10 days before starting Vivitrol. If needed, they might ask you to start Vivitrol in a hospital setting so that a care team can monitor and treat you for any severe withdrawal symptoms. If you experience withdrawal symptoms at home, go to the hospital right away to get appropriate treatment.
If you're taking Vivitrol for alcohol use disorder, it's important that you let your healthcare team know if you've taken any opioid medications before starting Vivitrol.
Some people have reported liver problems after starting Vivitrol. It's likely that these liver problems were related to other health conditions, rather than to the use of Vivitrol. But there's a chance that sudden withdrawal from opioids can worsen existing liver problems.
Make sure to discuss your entire medical history with your healthcare team before starting this medication. They might want to monitor your liver labs more closely through blood draws if you have a history of liver problems. Call a healthcare professional right away if you notice any symptoms of liver damage. These symptoms can include tiredness, dark urine, upset stomach, stomach pain, or yellowing of the skin or whites of the eyes.
Some people have reported feeling depressed or having thoughts of suicide or self-harm while being treated for alcohol or opioid use disorder. Let your healthcare team know right away if you or a loved one notices a change in your mood while you're receiving Vivitrol treatment. Get medical attention right away if you experience severe depression or have any thoughts of hurting yourself.
Vivitrol should only be given by a trained healthcare professional (HCP) in an office or clinic setting. This medication commonly causes injection site reactions such as pain, tenderness, swelling, bruising, or itching. In rare cases, it can cause more severe reactions that might lead to serious tissue damage. Let your prescriber know if you experience blisters, an open wound, a large area of swelling, or intense pain, as these might be signs of a severe injection site reaction.
Some people have reported severe allergic reactions after using Vivitrol. These included symptoms such as hives, facial swelling, and anaphylaxis. Very rarely, people have also reported allergic pneumonia while receiving Vivitrol treatment. This condition led to symptoms such as wheezing or shortness of breath. Get medical help right away if you notice hives, rash, swelling of the lips or tongue, or trouble breathing after you use Vivitrol.
Adults: The typical dose is 380 mg injected into the buttock muscle once a month. Vivitrol is usually given by a healthcare professional (HCP) in a clinic or office setting. Your HCP will switch between the two sides of the buttocks for each monthly injection.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Currently taking opioids for pain
Currently physiologically dependent on opioid medications
Actively going through an opioid withdrawal
Haven't yet passed the naloxone challenge test
Positive urine test for opioids
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Garbutt, J. C., et al. (2005). Efficacy and tolerability of long-acting injectable naltrexone for alcohol dependence. Journal of the American Medical Association.
Kosten, T. R., et al. (2002). The neurobiology of opioid dependence: Implications for treatment. Science & Practice Perspectives.
Pahal, P., et al. (2023). Eosinophilic pneumonia. StatPearls.
Reus, V. I., et al. (n.d.). The American Psychiatric Association Practice Guideline for the pharmacological treatment of patients with alcohol use disorder. American Psychiatric Association.
Substance Abuse and Mental Health Services Administration. (2009). Chapter 5–Extended-release injectable naltrexone. Incorporating Alcohol Pharmacotherapies Into Medical Practice.
Substance Abuse and Mental Health Services Administration. (2018). Chapter 3C: Naltrexone. Medication for Opioid Use Disorder: For Healthcare and Addiction Professionals, Policymakers, Patients, and Families: Updated 2021.
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