Drug information for VIVITROL
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
FOR SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
380MG/VIAL
Prescription
(Reference Drug)
NALTREXONE
Naltrexone
ALKERMES
21897
2010-10-13 Letter
2010-10-13 Label
2010-10-13 Other
2010-04-01 Other
2010-04-01 Other
2010-03-31 Medication Guide
2010-03-26 Medication Guide
2010-03-26 Medication Guide
2010-03-26 Label
2010-03-26 Label
2010-03-25 Letter
2010-03-25 Letter
2008-08-12 Other Important Information from FDA
2008-01-16 Review
2007-11-08 Letter
2007-11-07 Label
2006-04-21 Letter
2006-04-14 Label
Drug Adverse Effects information for VIVITROL
Role code
Indications
Reaction
# Reports
PS
ALCOHOLISM
ABSCESS
1
PS
ALCOHOLISM
ACCIDENT
1
PS
ALCOHOLISM
AMNESIA
1
PS
ALCOHOLISM
ANXIETY
1
PS
ALCOHOLISM
CEREBROVASCULAR ACCIDENT
1
PS
ALCOHOLISM
CHILLS
1
PS
ALCOHOLISM
CONFUSIONAL STATE
1
PS
ALCOHOLISM
DEATH
2
PS
ALCOHOLISM
DIZZINESS
1
PS
ALCOHOLISM
FOREIGN BODY REACTION
1
PS
ALCOHOLISM
HEAD INJURY
1
PS
ALCOHOLISM
HEADACHE
1
PS
ALCOHOLISM
HYPERHIDROSIS
1
PS
ALCOHOLISM
INJECTION SITE ABSCESS
2
PS
ALCOHOLISM
INJECTION SITE ABSCESS STERILE
1
PS
ALCOHOLISM
INJECTION SITE PAIN
1
PS
ALCOHOLISM
INJECTION SITE REACTION
1
PS
ALCOHOLISM
INTENTIONAL SELF-INJURY
1
PS
ALCOHOLISM
MALAISE
1
PS
ALCOHOLISM
MUSCULOSKELETAL STIFFNESS
1
PS
ALCOHOLISM
NAUSEA
1
PS
ALCOHOLISM
NECROTISING PANNICULITIS
1
PS
ALCOHOLISM
TRANSIENT GLOBAL AMNESIA
1
PS
ALCOHOLISM
TREATMENT NONCOMPLIANCE
1
PS
ALCOHOLISM
VISUAL IMPAIRMENT
1
PS
ALCOHOLISM
WHITE BLOOD CELL COUNT INCREASED
1
PS
DRUG DEPENDENCE
ANXIETY
1
PS
DRUG DEPENDENCE
ARTHRALGIA
1
PS
DRUG DEPENDENCE
BLOOD CREATININE INCREASED
1
PS
DRUG DEPENDENCE
DEATH
1
PS
DRUG DEPENDENCE
DIARRHOEA
1
PS
DRUG DEPENDENCE
DRUG DEPENDENCE
1
PS
DRUG DEPENDENCE
DRUG EFFECT DECREASED
1
PS
DRUG DEPENDENCE
FALL
1
PS
DRUG DEPENDENCE
HEAD INJURY
1
PS
DRUG DEPENDENCE
HEADACHE
1
PS
DRUG DEPENDENCE
HYPERTENSION
1
PS
DRUG DEPENDENCE
JOINT INJURY
1
PS
DRUG DEPENDENCE
OVERDOSE
3
PS
DRUG DEPENDENCE
PNEUMONIA
1
PS
DRUG DEPENDENCE
PSYCHOTIC DISORDER
1
PS
DRUG DEPENDENCE
TREATMENT NONCOMPLIANCE
1
PS
DRUG DEPENDENCE
VOMITING
1
PS
DRUG DEPENDENCE
WITHDRAWAL SYNDROME
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
ABSCESS STERILE
2
PS
PRODUCT USED FOR UNKNOWN INDICATION
DEATH
2
PS
PRODUCT USED FOR UNKNOWN INDICATION
INFECTION
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
INJECTION SITE REACTION
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
INJECTION SITE SWELLING
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
PAIN IN EXTREMITY
1
SS
ALCOHOLISM
ANXIETY
1
SS
ALCOHOLISM
FOREIGN BODY REACTION
1
SS
ALCOHOLISM
INJECTION SITE ABSCESS STERILE
1
SS
ALCOHOLISM
INJECTION SITE PAIN
1
SS
ALCOHOLISM
INJECTION SITE REACTION
1
SS
ALCOHOLISM
NECROTISING PANNICULITIS
1
SS
ASTHMA
ASTHMA
4
SS
ASTHMA
HYPOKALAEMIA
4
SS
DRUG DEPENDENCE
ASTHMA
6
SS
DRUG DEPENDENCE
HYPOKALAEMIA
6
SS
PRODUCT USED FOR UNKNOWN INDICATION
ABSCESS STERILE
1
SS
PRODUCT USED FOR UNKNOWN INDICATION
INFECTION
1
SS
PRODUCT USED FOR UNKNOWN INDICATION
INJECTION SITE REACTION
1
SS
PRODUCT USED FOR UNKNOWN INDICATION
INJECTION SITE SWELLING
1
SS
PRODUCT USED FOR UNKNOWN INDICATION
PAIN IN EXTREMITY
1
C
ALCOHOLISM
ACCIDENT
1
C
ALCOHOLISM
HEAD INJURY
1
C
ALCOHOLISM
INTENTIONAL SELF-INJURY
1
C
ALCOHOLISM
TREATMENT NONCOMPLIANCE
1
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