Vivitrol Side Effects

Generic Name: naltrexone

Please note - some side effects for Vivitrol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Vivitrol - for the Consumer

Vivitrol

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Vivitrol:

Diarrhea; dizziness; drowsiness; headache; joint pain or stiffness; loss of appetite; mild nausea; mild pain, swelling, redness, itching, tenderness, or hard skin at the injection site; muscle cramps; sore throat; stomach pain; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; chest pain; dark urine; depression; fainting; fever; mental or mood changes; pale bowel movements; severe or persistent coughing; severe or persistent pain, swelling, redness, itching, tenderness, or hard skin at the injection site; severe or persistent stomach pain; shortness of breath; suicidal thoughts or actions; wheezing; yellowing of the skin or eyes.

Vivitrol Side Effects - for the Professional

Vivitrol

In all controlled and uncontrolled trials during the premarketing development of Vivitrol, more than 900 patients with alcohol and/or opioid dependence have been treated with Vivitrol. Approximately 400 patients have been treated for 6 months or more, and 230 for 1 year or longer.

Adverse Events Leading to Discontinuation of Treatment

In controlled trials of 6 months or less, 9% of patients treated with Vivitrol discontinued treatment due to an adverse event, as compared to 7% of the patients treated with placebo. Adverse events in the Vivitrol 380-mg group that led to more dropouts were injection site reactions (3%), nausea (2%), pregnancy (1%), headache (1%), and suicide-related events (0.3%). In the placebo group, 1% of patients withdrew due to injection site reactions, and 0% of patients withdrew due to the other adverse events.

Common Adverse Events

The table lists all adverse events, regardless of causality, occurring in ≥5% of patients with alcohol dependence, for which the incidence was greater in the combined Vivitrol group than in the placebo group. A majority of patients treated with Vivitrol in clinical studies had adverse events with a maximum intensity of “mild” or “moderate.”

Post-marketing Reports

Side Effects by Body System

General

General side effects have rarely included an opioid withdrawal-like symptom complex. This has been known to occur in a small number of patients receiving naltrexone. Symptoms include tearfulness, mild nausea, abdominal cramps, restlessness, bone or joint pain, myalgia, and nasal symptoms.

In one study, few symptoms were reported following the first week. However, stomach cramps, inability to sleep, and frightening thoughts were reported by 30% or more of subjects through the third week of therapy.

The effects of an opiate may be attenuated during self-administration of small doses of an opiate drug. Patients taking naltrexone may not benefit from opioid-containing medications, such as cough and cold preparations, antidiarrheal preparations, and opioid analgesics. However, patients treated with naltrexone may respond to lower doses of opioids than previously used. Patients self- administering large doses of an opiate drug could sustain serious injury (including coma) or die if high opiate plasma concentrations remain beyond the therapeutic effectiveness of naltrexone.

The opioid withdrawal-like symptom complex may be attributable to naltrexone or may represent occult opioid usage.

Nervous system

Nervous system side effects reported during treatment for alcohol dependence have included headache (7%), dizziness (4%), nervousness (4%), fatigue (4%), insomnia (3%), anxiety (2%), and somnolence (2%).

Nervous system side effects reported in greater than 10% of patients during treatment for opioid dependence have included headaches, nervousness, anxiety, difficulty sleeping, and low energy. Loss of appetite, increased energy, irritability, and dizziness have been reported in less than 10% of patients. Asthenia, agitation, hyperkinesia, nervousness, fatigue, restlessness, confusion, disorientation, and somnolence have been reported rarely.

Nervous system side effects associated with extended-release injectable solution have frequently included headache, dizziness, syncope, somnolence, insomnia, and sedation. Dysgeusia, attention disturbance, mental impairment, and convulsions have been reported rarely.

Psychiatric

Psychiatric side effects reported during treatment of alcohol dependence have included depression (up to 15%), suicidal ideation (up to 1%), and suicidal attempts.

Psychiatric side effects reported during treatment of opioid dependence have included feeling down (less than 10%). Depression, paranoia, hallucinations, bad dreams, and nightmares have been reported rarely. Anxiety and abnormal thinking have also been reported.

Psychiatric side effects associated with extended-release injectable suspension have frequently included anxiety, sleep disorder, and depression. Irritability, decreased libido, abnormal dreams, alcohol withdrawal syndrome, euphoric mood, and delirium have been reported rarely.

Depression and suicidal ideation or attempts have occurred in all study groups receiving naltrexone for treatment of alcohol dependence. These conditions also have been reported in data collected from postmarketing experience during treatment of opioid dependence.

Gastrointestinal

Gastrointestinal side effects reported during treatment for alcohol dependence have included nausea (10%) and vomiting (3%).

Gastrointestinal side effects reported in greater than 10% of patients during treatment for opioid dependence have included abdominal pain, abdominal cramps, nausea, and vomiting. Loss of appetite, diarrhea, constipation, and increased thirst have been reported in less than 10% of patients. Hemorrhoids, ulcer, diarrhea, excessive gas, increased appetite, and dry mouth have been reported rarely.

Gastrointestinal side effects associated with extended-release injectable solution have frequently included nausea, vomiting, diarrhea, abdominal pain, and dry mouth. Constipation, toothache, tooth abscess, flatulence, gastroesophageal reflux, hemorrhoids, colitis, gastrointestinal hemorrhage, paralytic ileus, gastroenteritis, and perirectal abscess have been reported rarely.

Hepatic

Hepatic side effects have included hepatocellular injury, hepatitis, and elevated liver transaminases and bilirubin.

Hepatic side effects associated with extended-release injectable suspension have rarely included cholelithiasis, increased aspartate aminotransferase (AST) level, increased alanine aminotransferase (ALT) level, and acute cholecystitis.

In clinical studies, doses greater than 50 mg a day consistently resulted in more frequent and more significant elevations of serum transaminase levels when compared to placebo.

Patients who develop liver disease from other cause or who take naltrexone in excess may be more prone to hepatocellular injury.

Musculoskeletal

Musculoskeletal side effects reported in greater than 10% of patients during treatment for opioid dependence have included joint and muscle pain. Tremors, twitching, and painful shoulders, legs or knees have been reported rarely.

Musculoskeletal side effects associated with extended-release injectable suspension have frequently included arthralgia, arthritis, joint stiffness, and muscle cramps. Limb pain, muscle spasms, and joint stiffness have been reported rarely.

Respiratory

Respiratory side effects, during treatment of opioid dependence, have rarely included: nasal congestion, itching, rhinorrhea, sneezing, sore throat, excess mucous, sinus trouble, heavy breathing, hoarseness, cough, and shortness of breath.

Respiratory side effects associated with extended-release injectable solution have frequently included upper respiratory infection and pharyngitis. Pharyngolaryngeal pain, dyspnea, sinus congestion, bronchitis, pneumonia, and chronic obstructive airways disease have been reported rarely.

Cardiovascular

Cardiovascular side effects reported during treatment of opioid dependence have rarely included nose bleeds, phlebitis, edema, increased blood pressure, EKG changes, palpitations and tachycardia.

Cardiovascular side effects associated with extended release injectable suspension have rarely included palpitations, atrial fibrillation, myocardial infarction, angina pectoris, unstable angina, congestive cardiac failure, ischemic stroke, cerebral arterial aneurysm, hypertension, deep venous thrombosis, pulmonary embolism, hot flushes, and coronary artery atherosclerosis.

Genitourinary

Genitourinary side effects reported in greater than 10% of patients during treatment of opioid dependence have included delayed ejaculation and decreased potency. Increased frequency of or discomfort during urination and increased or decreased sexual interest has been reported rarely.

Genitourinary side effects associated with extended-release injectable solution have rarely included urinary tract infection.

Dermatologic

Dermatologic side effects reported during treatment of opioid dependence have rarely included oily skin, pruritus, acne, athlete's foot, cold sores, alopecia, and rash.

Dermatologic side effects associated with extended-release injectable suspension have rarely included rash, increased sweating, night sweats, cellulitis, and pruritus.

Ocular

Ocular side effects reported during treatment of opioid dependence have rarely included blurred vision, burning, and increased sensitivity to light.

Ocular side effects associated with extended-release injectable suspension have rarely included conjunctivitis.

Other

Other side effects associated with treatment of opioid dependence have rarely included feeling of "clogged" ears, aching, and tinnitus.

Other side effects reported during treatment of opioid dependence have rarely included chills, weight loss, weight gain, yawning, fever, head "pounding", inguinal pain, swollen glands, "side" pains, cold feet, and "hot spells".

Other side effects associated with extended-release injectable suspension have frequently included asthenia and back pain/stiffness. Pyrexia, lethargy, rigors, chest pain/tightness, influenza, seasonal allergy, missed abortion, and decreased weight have been reported rarely.

Endocrine

Endocrine side effects associated with opioid antagonists have included a change in the baseline levels of hypothalamic, pituitary gland, and gonadal hormones. The clinical significance of these changes is unknown.

Other

Other side effects reported during ultra-rapid opioid detoxification programs with naltrexone have included withdrawal signs and symptoms and fatalities. The cause of death is unknown.

Hematologic

Hematologic side effects have included a single case report of idiopathic thrombocytopenic purpura. This patient may have been previously sensitized to naltrexone.

Hematologic side effects associated with extended-release injectable suspension have rarely included increased white blood cell count.

Local

Local side effects associated with extended-release injectable suspension have frequently included tenderness, pruritus, ecchymosis, nodules, swelling, and pain at injection site.

The FDA has received 196 reports of injection site reactions including cellulitis, induration, hematoma, abscess, sterile abscess, and necrosis. Sixteen patients required surgical intervention ranging from incision and drainage in the cases of abscesses to extensive surgical debridement in the cases that resulted in tissue necrosis.

Metabolic

Metabolic side effects associated with extended-release injectable suspension have frequently included anorexia, decreased appetite, and other appetite disorders. Increased appetite, heat exhaustion, dehydration, and hypercholesterolemia have been reported rarely.

Hypersensitivity

Hypersensitivity side effects associated with extended-release injectable solution have rarely included reactions such as angioneurotic edema and urticaria.

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