This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Vivitrol (Naltrexone) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (94)
Death (31)
Life Threatening Events (2)
Disability (1)
Reports by Reaction Type
Death (18),
Injection Site Pain (8),
Overdose (7),
Injection Site Reaction (7),
Depression (7),
Nausea (6),
Treatment Noncompliance (5),
Injection Site Abscess (5),
Insomnia (5),
Confusional State (4),
Headache (4),
Loss of Consciousness (4)
Below are a few examples of reports where side effects / adverse reactions may be related to Vivitrol (Naltrexone). For a complete list or a specific selection of reports, please use the links above.
Possible Vivitrol side effects in 41 year old female
Reported by a consumer/non-health professional from United States on 2012-08-09
Patient: 41 year old female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Vivitrol
Possible Vivitrol side effects in 26 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-09
Patient: 26 year old female
Reactions: Overdose, Drug Abuse
Adverse event resulted in: death
Drug(s) suspected as cause:
Vivitrol
Possible Vivitrol side effects in female
Reported by a physician from United States on 2012-08-02
Patient: female
Reactions: Breast Cancer Female
Drug(s) suspected as cause:
Vivitrol
Possible Vivitrol side effects in 27 year old female
Reported by a consumer/non-health professional from United States on 2012-08-02
Patient: 27 year old female, weighing 56.7 kg (124.7 pounds)
Reactions: Injection Site Pain, Fall, Tremor, Dysphemia, Incoherent, Injection Site Reaction, Injection Site Induration, Drug Screen False Positive
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vivitrol
Other drugs received by patient: Sinequan; Neurontin; Seroquel; Ibuprofen; Flexeril
Possible Vivitrol side effects in male
Reported by a physician from United States on 2012-07-31
Patient: male
Reactions: Implant Site Abscess
Drug(s) suspected as cause:
Vivitrol
Possible Vivitrol side effects in 21 year old male
Reported by a consumer/non-health professional from United States on 2012-07-31
Patient: 21 year old male
Reactions: Overdose, Ejection Fraction Decreased, Myocardial Infarction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vivitrol
Other drugs received by patient: Clonidine
Possible Vivitrol side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-24
Patient: male
Reactions: NO Therapeutic Response, Lower Limb Fracture
Drug(s) suspected as cause:
Vivitrol
Possible Vivitrol side effects in female
Reported by a individual with unspecified qualification from United States on 2012-07-24
Patient: female
Reactions: Breast Cancer Female
Drug(s) suspected as cause:
Vivitrol
Possible Vivitrol side effects in female
Reported by a physician from United States on 2012-07-23
Patient: female
Reactions: Breast Cancer Female
Drug(s) suspected as cause:
Vivitrol
Possible Vivitrol side effects in 28 year old male
Reported by a physician from United States on 2012-07-23
Patient: 28 year old male
Reactions: Mania, Insomnia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vivitrol
Dosage: (intramuscular)
Indication: Drug Dependence
Start date: 2012-05-14
Naltrexone Hydrochloride
Dosage: (intramuscular) ; (intramuscular) ; (intramuscular) ; (intramuscular)
Indication: Drug Dependence
Start date: 2012-05-14
End date: 2012-05-14
Naltrexone Hydrochloride
Dosage: (intramuscular) ; (intramuscular) ; (intramuscular) ; (intramuscular)
Indication: Drug Dependence
Start date: 2012-05-14
End date: 2012-05-14
Naltrexone Hydrochloride
Dosage: (intramuscular) ; (intramuscular) ; (intramuscular) ; (intramuscular)
Indication: Drug Dependence
Start date: 2012-05-14
End date: 2012-05-14
Naltrexone Hydrochloride
Dosage: (intramuscular) ; (intramuscular) ; (intramuscular) ; (intramuscular)
Indication: Drug Dependence
Start date: 2012-05-14
End date: 2012-05-14
Other drugs received by patient: Morphine; Nuvigil
Possible Vivitrol side effects in female
Reported by a physician from United States on 2012-07-23
Patient: female
Reactions: Injection Site Abscess, Injection Site Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vivitrol
Possible Vivitrol side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-12
Patient: male
Reactions: Laboratory Test Abnormal, Renal Failure, Gastrointestinal Disorder, General Symptom
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vivitrol
Possible Vivitrol side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-12
Patient: male, weighing 54.0 kg (118.8 pounds)
Reactions: Weight Decreased, Confusional State, Condition Aggravated, Blood Potassium Decreased, Social Avoidant Behaviour, Hallucination, Visual, Hypophagia, Poor Personal Hygiene, Depression
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vivitrol
Other drugs received by patient: Lexapro; Megace
Possible Vivitrol side effects in 42 year old male
Reported by a physician from United States on 2012-07-10
Patient: 42 year old male, weighing 74.4 kg (163.7 pounds)
Reactions: Blood Alcohol Increased, Pneumonia, Angioedema, Drug Screen Positive, Anaphylactic Reaction, Urticaria, Apallic Syndrome, Sinus Bradycardia, Loss of Consciousness, Hypoxic-Ischaemic Encephalopathy, Decubitus Ulcer, Circulatory Collapse, Pulseless Electrical Activity
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vivitrol
Other drugs received by patient: Melatonin (Unknown Until Continuing); Ibuprofen (Unknown Until Continuing)
Possible Vivitrol side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-03
Patient: male
Reactions: Pain in Extremity, Lower Limb Fracture
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vivitrol
Possible Vivitrol side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-28
Patient: female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Vivitrol
Possible Vivitrol side effects in female
Reported by a physician from United States on 2012-06-28
Patient: female
Reactions: Abscess, Adverse Reaction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vivitrol
Possible Vivitrol side effects in 54 year old male
Reported by a consumer/non-health professional from United States on 2012-06-08
Patient: 54 year old male
Reactions: Alcohol Use, Loss of Consciousness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vivitrol
Possible Vivitrol side effects in female
Reported by a physician from United States on 2012-06-08
Patient: female
Reactions: Injection Site Mass, Injection Site Pain
Drug(s) suspected as cause:
Vivitrol
Possible Vivitrol side effects in 51 year old male
Reported by a physician from United States on 2012-06-08
Patient: 51 year old male
Reactions: Schizophrenia, Condition Aggravated
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vivitrol
Possible Vivitrol side effects in male
Reported by a physician from United States on 2012-06-08
Patient: male, weighing 61.2 kg (134.7 pounds)
Reactions: Myalgia, Delirium, Muscle Spasms, Aggression
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vivitrol
Other drugs received by patient: Suboxone; Lisinopril; Neurontin
Possible Vivitrol side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-01
Patient: male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Vivitrol
Possible Vivitrol side effects in 63 year old male
Reported by a physician from United States on 2012-05-22
Patient: 63 year old male, weighing 96.2 kg (211.6 pounds)
Reactions: Oedema Peripheral, Injection Site Pain, Injection Site Swelling
Drug(s) suspected as cause:
Vivitrol
Dosage: 380 mg q month im
Start date: 2012-02-02
Vivitrol
Dosage: 380 mg q month im
Start date: 2012-03-01
Possible Vivitrol side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-22
Patient: female, weighing 53.5 kg (117.8 pounds)
Reactions: Dyspnoea, Constipation, Amnesia, Muscle Twitching, Loss of Consciousness, Anxiety, Palpitations, Feeling Jittery, Heart Rate Increased, Depression, Depressed Mood
Drug(s) suspected as cause:
Vivitrol
Possible Vivitrol side effects in
Reported by a physician from United States on 2012-05-04
Patient:
Reactions: Overdose
Adverse event resulted in: death
Drug(s) suspected as cause:
Vivitrol
Possible Vivitrol side effects in female
Reported by a physician from United States on 2012-05-03
Patient: female, weighing 63.5 kg (139.7 pounds)
Reactions: Nausea, Insomnia, Condition Aggravated, Depression, Headache, Stevens-Johnson Syndrome
Drug(s) suspected as cause:
Lamictal
Dosage: (25 mg qd oral)
Administration route: Oral
Indication: Bipolar Disorder
Start date: 2012-03-09
End date: 2012-03-12
Vivitrol
Dosage: (380 mg 1x/month intramuscular)
Indication: Drug Dependence
Start date: 2012-03-09
Doxepin HCL
Dosage: (25 mg qd)
Indication: Insomnia
Start date: 2012-03-09
Doxepin HCL
Dosage: (25 mg qd)
Indication: Depression
Start date: 2012-03-09
Possible Vivitrol side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-01
Patient: female
Reactions: Dyspnoea, Constipation, Muscle Twitching, Loss of Consciousness, Anxiety, Palpitations, Feeling Jittery, Heart Rate Increased, Depression, Depressed Mood
Drug(s) suspected as cause:
Vivitrol
Possible Vivitrol side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-01
Patient: female
Reactions: Dysarthria, Unevaluable Event
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vivitrol
Possible Vivitrol side effects in 31 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-20
Patient: 31 year old male
Reactions: Drug Abuse
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vivitrol
Possible Vivitrol side effects in 21 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-20
Patient: 21 year old male
Reactions: Lung Disorder, Thermal Burn
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Vivitrol
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