Vivitrol Side Effects
Generic name: naltrexone
Note: This document provides detailed information about Vivitrol Side Effects associated with naltrexone. Some dosage forms listed on this page may not apply specifically to the brand name Vivitrol.
Applies to naltrexone: intramuscular powder for suspension extended release.
Other dosage forms:
Serious side effects of Vivitrol
Along with its needed effects, naltrexone (the active ingredient contained in Vivitrol) 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 while taking naltrexone:
More common side effects
- 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
- cough
- discouragement
- dryness or soreness of the throat
- ear congestion
- fear
- feeling sad or empty
- fever
- headache
- hoarseness
- irritability
- lack of appetite
- loss of interest or pleasure
- loss of voice
- nervousness
- rash
- runny or stuffy nose
- sneezing
- sore throat
- 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
- bloating
- bloody or cloudy urine
- bloody stools
- blurred vision
- chest pain, discomfort, tightness, or heaviness
- chills
- confusion
- constipation
- cough
- cough producing mucus
- decreased urination
- diarrhea
- difficult, burning, or painful urination
- dilated neck veins
- dizziness or lightheadedness
- dry mouth
- 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
- nausea
- 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
- weight gain
- wrinkled skin
Get emergency help immediately if any of the following symptoms of overdose occur while taking naltrexone:
Symptoms of overdose
- sleepiness or unusual drowsiness
Other side effects of Vivitrol
Some side effects of 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 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
- heartburn
- 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
- weight loss
For healthcare professionals
Applies to naltrexone: compounding powder, intramuscular powder for injection extended release, oral capsule, oral tablet.
Nervous system adverse events
- Very common (10% or more): Headache (25%), dizziness/syncope (13%)
- Common (1% to 10%): Somnolence/sedation
- Frequency not reported: Lethargy, cerebral arterial aneurysm, convulsions, disturbance in attention, dysgeusia, mental impairment, migraine, ischemic stroke, paresthesia[Ref]
Psychiatric
- Very common (10% or more): Insomnia/sleep disorder (14%), anxiety (12%)
- Common (1% to 10%): Depression
- Uncommon (0.1% to 1%): Suicide attempt/ideation
- Frequency not reported: Irritability, abnormal dreams, agitation, alcohol withdrawal syndrome, euphoric mood, delirium, libido decreased[Ref]
Gastrointestinal
- Very common (10% or more): Nausea (33%), vomiting NOS (14%), diarrhea (13%), abdominal pain (11%)
- Common (1% to 10%): Dry mouth, toothache
- Frequency not reported: Abdominal discomfort, colitis, constipation, flatulence, gastroesophageal reflux disease, gastrointestinal hemorrhage, hemorrhoids, pancreatitis acute, paralytic ileus[Ref]
Hepatic
- Very common (10% or more): Alanine aminotransferase increased (13%), aspartate aminotransferase increased (10%)
- Common (1% to 10%): Gamma-glutamyltransferase increased
- Frequency not reported: Lymphadenopathy including cervical adenitis, white blood cell count increased, cholecystitis acute, cholelithiasis[Ref]
Local
- Very common (10% or more): Injection site tenderness (45%), injection site induration (35%), injection site pain (17%), other injection site reaction (primarily nodules, swelling) (15%), injection site pruritus (10%)
- Common (1% to 10%): Injection site ecchymosis[Ref]
Musculoskeletal
- Very common (10% or more): Arthralgia/arthritis/joint stiffness (12%)
- Common (1% to 10%): Back pain/stiffness, muscle cramps
- Frequency not reported: Chills, joint stiffness, muscle spasms, myalgia, pain in limb[Ref]
Other
- Very common (10% or more): Asthenic conditions (23%)
- Frequency not reported: Chest pain, chest tightness, abortion missed[Ref]
Cardiovascular
- Frequency not reported: Angina pectoris, angina unstable, atrial fibrillation, cardiac failure congestive, coronary artery atherosclerosis, myocardial infarction, palpitations, deep vein thrombosis[Ref]
Respiratory
- Frequency not reported: Chronic obstructive pulmonary disease, dyspnea, pharyngolaryngeal pain, sinus congestion[Ref]
Dermatologic
- Common (1% to 10%): Rash
- Frequency not reported: Face edema, night sweats, pruritus, sweating increased[Ref]
Metabolic
- Very common (10% or more): Anorexia/appetite decreased NOS/appetite disorder NOS (14%)
- Frequency not reported: Weight decreased, weight increased, appetite increased, dehydration[Ref]
Renal
- Very common (10% or more): Abnormal creatinine phosphokinase levels (17%)[Ref]
Hematologic
- Frequency not reported: Eosinophil counts increased, decreased platelet count[Ref]
Ocular
- Frequency not reported: Conjunctivitis, vision blurred[Ref]
Hypersensitivity
- Frequency not reported: Hypersensitivity reaction (including angioneurotic edema and urticaria)
- Postmarketing reports: Anaphylaxis[Ref]
Immunologic
- Very common (10% or more): Pharyngitis (11%)
- Common (1% to 10%): Nasopharyngitis
- Frequency not reported: Seasonal allergies[Ref]
References
1. (2018) "Product Information. Vivitrol (naltrexone)." Alkermes, Inc
2. (2018) "Product Information. Naltrexone Hydrochloride (naltrexone)." Accord Biopharma Inc
Frequently asked questions
- What happens if you drink alcohol while taking naltrexone?
- What to avoid when taking naltrexone?
- Should I take naltrexone in the morning or at night?
- How long does naltrexone take to work?
- Can I take Xanax while on Vivitrol?
- Is naltrexone a controlled substance?
- How fast does Vivitrol work?
- How and where is the Vivitrol injection given?
- Does Vivitrol help with cravings?
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Vivitrol 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.