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Index of reports
> Serious Reactions (17)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Vivitrol (Naltrexone) serious reactions. The selected reports were submitted to the FDA during the sample period of about a year.
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 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 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 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 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 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 male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-20
Patient: male, weighing 90.7 kg (199.6 pounds)
Reactions: Injection Site Induration, Injection Site Reaction, Injection Site Pain, Injection Site Infection, Infusion Site Swelling
Drug(s) suspected as cause:
Vivitrol
Other drugs received by patient: Wellbutrin
Possible Vivitrol side effects in
Reported by a consumer/non-health professional from United States on 2012-04-12
Patient:
Reactions: Nausea, Insomnia, Condition Aggravated, Depression, Headache, Stevens-Johnson Syndrome
Drug(s) suspected as cause:
Vivitrol
Dosage: 380 mg 1x/month intramuscular
Indication: Drug Dependence
Start date: 2012-03-09
Doxepin HCL
Dosage: 25 mg qd
Indication: Depression
Start date: 2012-03-09
Doxepin HCL
Dosage: 25 mg qd
Indication: Insomnia
Start date: 2012-03-09
Lamictal
Dosage: 25 mg qd, oral
Administration route: Oral
Indication: Bipolar Disorder
Start date: 2012-03-09
End date: 2012-03-12
Possible Vivitrol side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-22
Patient: male, weighing 101.6 kg (223.5 pounds)
Reactions: Injection Site Mass, Subcutaneous Abscess, Staphylococcal Infection, Injection Site Reaction, Injection Site Pain
Drug(s) suspected as cause:
Vivitrol
Other drugs received by patient: Albuterol; Zocor; Synthroid; Omeprazole; Voltaren; Gabapentin; Metformin HCL; Coreg; Lisinopril; Zyrtec; Levothroid; Fluoxetine; Aspirin; Trazodone HCL; Hydroxyzine Pamoate; Advair Diskus 100 / 50; Divalproex Sodium
Possible Vivitrol side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-16
Patient: female, weighing 97.5 kg (214.6 pounds)
Reactions: Injection Site Haematoma, FAT Necrosis, Skin Lesion, Injection Site Abscess Sterile
Drug(s) suspected as cause:
Vivitrol
Other drugs received by patient: Lotrel ( TO Unknown); Lipitor ( TO Unknown); Nebivolol ( TO Unknown)
Possible Vivitrol side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-12
Patient: female
Reactions: Injection Site Abscess
Drug(s) suspected as cause:
Vivitrol
Possible Vivitrol side effects in 55 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-04
Patient: 55 year old male
Reactions: Injection Site Abscess, Injection Site Reaction
Drug(s) suspected as cause:
Vivitrol
Possible Vivitrol side effects in female
Reported by a physician from United States on 2011-11-07
Patient: female, weighing 95.3 kg (209.6 pounds)
Reactions: Anxiety, Necrotising Panniculitis, Foreign Body Reaction, Injection Site Reaction, Injection Site Pain, Injection Site Abscess Sterile
Drug(s) suspected as cause:
Vivitrol
Dosage: (380 mg 1x/month intramuscular
Indication: Alcoholism
Start date: 2011-07-26
End date: 2011-08-29
Vivitrol
Other drugs received by patient: Xanax; Zoloft
Possible Vivitrol side effects in male
Reported by a physician from United States on 2011-10-31
Patient: male, weighing 92.1 kg (202.6 pounds)
Reactions: Injection Site Abscess
Drug(s) suspected as cause:
Vivitrol
Other drugs received by patient: Seroquel; Mirapex; Tramadol HCL; Klonopin
Possible Vivitrol side effects in 51 year old female
Reported by a physician from United States on 2011-10-19
Patient: 51 year old female
Reactions: Pain in Extremity, Abscess Sterile, Injection Site Reaction, Injection Site Swelling, Infection
Drug(s) suspected as cause:
Vivitrol
Dosage: 380 mg 1x/mo intramuscular
Indication: Product Used FOR Unknown Indication
Vivitrol
Possible Vivitrol side effects in 51 year old female
Reported by a physician from United States on 2011-10-07
Patient: 51 year old female
Reactions: Abscess Sterile
Drug(s) suspected as cause:
Vivitrol
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