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Vivitrol (Naltrexone) - Side Effect Reports to FDA

 
 



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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