Drug information for FENTANYL-50

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
FILM, EXTENDED RELEASE; TRANSDERMAL 50MCG/HR Prescription AB  FENTANYL Fentanyl MYLAN TECHNOLOGIES 76258
2005-07-22 Review

2005-02-01 Letter

2004-06-24 Letter
FILM, EXTENDED RELEASE; TRANSDERMAL 50MCG/HR Prescription AB  FENTANYL Fentanyl WATSON LABS 76709
2007-08-24 Other Important Information from FDA
FILM, EXTENDED RELEASE; TRANSDERMAL 50MCG/HR Prescription AB  FENTANYL Fentanyl LAVIPHARM LABS 77051
2006-08-10 Other Important Information from FDA
FILM, EXTENDED RELEASE; TRANSDERMAL 50MCG/HR Prescription AB  FENTANYL Fentanyl ACTAVIS 77062
2007-08-24 Other Important Information from FDA
FILM, EXTENDED RELEASE; TRANSDERMAL 50MCG/HR Prescription AB  FENTANYL Fentanyl MALLINCKRODT INC 77154
FILM, EXTENDED RELEASE; TRANSDERMAL 50MCG/HR Prescription AB  FENTANYL Fentanyl TEVA PHARMS 77449
FILM, EXTENDED RELEASE; TRANSDERMAL 50MCG/HR Prescription AB  FENTANYL Fentanyl NOVEN 77775

Drug Adverse Effects information for FENTANYL-50

Role code Indications Reaction # Reports
PS BACK PAIN CONVULSION 1
PS BACK PAIN DRUG INEFFECTIVE 1
PS BACK PAIN DRUG LEVEL INCREASED 1
PS BACK PAIN TOXICITY TO VARIOUS AGENTS 1
PS CANCER PAIN ABASIA 1
PS CANCER PAIN AMNESIA 1
PS CANCER PAIN ASTHENIA 1
PS CANCER PAIN BLOOD PRESSURE INCREASED 1
PS CANCER PAIN CONSCIOUSNESS FLUCTUATING 1
PS CANCER PAIN HEADACHE 1
PS CANCER PAIN INCOHERENT 1
PS CANCER PAIN MIOSIS 1
PS CANCER PAIN NAUSEA 1
PS CANCER PAIN SEDATION 1
PS CANCER PAIN SENSATION OF HEAVINESS 1
PS CANCER PAIN VOMITING 1
PS EPILEPSY CONVULSION 1
PS EPILEPSY DRUG INEFFECTIVE 1
PS HYPERTENSION ABASIA 2
PS HYPERTENSION AMNESIA 2
PS HYPERTENSION ASTHENIA 2
PS HYPERTENSION BLOOD PRESSURE INCREASED 2
PS HYPERTENSION CONSCIOUSNESS FLUCTUATING 2
PS HYPERTENSION HEADACHE 2
PS HYPERTENSION INCOHERENT 2
PS HYPERTENSION MIOSIS 2
PS HYPERTENSION NAUSEA 2
PS HYPERTENSION SEDATION 2
PS HYPERTENSION SENSATION OF HEAVINESS 2
PS HYPERTENSION VOMITING 2
PS INSOMNIA DRUG LEVEL INCREASED 1
PS INSOMNIA TOXICITY TO VARIOUS AGENTS 1
PS INTERVERTEBRAL DISC DEGENERATION BLISTER 1
PS INTERVERTEBRAL DISC DEGENERATION PRODUCT SUBSTITUTION ISSUE 1
PS INTERVERTEBRAL DISC DEGENERATION RASH 1
PS PAIN ANALGESIC DRUG LEVEL INCREASED 2
PS PAIN DEHYDRATION 2
PS PAIN DRUG INEFFECTIVE 4
PS PAIN DRUG LEVEL INCREASED 4
PS PAIN OVERDOSE 2
PS PAIN RENAL FAILURE 2
PS PAIN RENAL FAILURE ACUTE 2
PS PAIN TOXICITY TO VARIOUS AGENTS 6
PS PRODUCT USED FOR UNKNOWN INDICATION DEHYDRATION 9
PS PRODUCT USED FOR UNKNOWN INDICATION DRUG INEFFECTIVE 9
PS PRODUCT USED FOR UNKNOWN INDICATION RENAL FAILURE ACUTE 9
PS SCHIZOPHRENIA DRUG LEVEL INCREASED 1
PS SCHIZOPHRENIA TOXICITY TO VARIOUS AGENTS 1
SS ASTHMA AMNESIA 3
SS ASTHMA APPLICATION SITE IRRITATION 3
SS ASTHMA APPLICATION SITE RASH 3
SS ASTHMA ASTHMA 3
SS ASTHMA BALANCE DISORDER 3
SS ASTHMA CARDIAC ARREST 3
SS ASTHMA FEELING DRUNK 3
SS ASTHMA INCOHERENT 3
SS ASTHMA OVERDOSE 3
SS ASTHMA OXYGEN SATURATION DECREASED 3
SS ASTHMA PULSE ABSENT 3
SS BACK PAIN AMNESIA 2
SS BACK PAIN APPLICATION SITE IRRITATION 2
SS BACK PAIN APPLICATION SITE RASH 2
SS BACK PAIN ASTHMA 2
SS BACK PAIN BALANCE DISORDER 2
SS BACK PAIN CARDIAC ARREST 2
SS BACK PAIN CONVULSION 1
SS BACK PAIN DRUG INEFFECTIVE 1
SS BACK PAIN DRUG LEVEL INCREASED 1
SS BACK PAIN FEELING DRUNK 2
SS BACK PAIN INCOHERENT 2
SS BACK PAIN OVERDOSE 2
SS BACK PAIN OXYGEN SATURATION DECREASED 2
SS BACK PAIN PULSE ABSENT 2
SS BACK PAIN TOXICITY TO VARIOUS AGENTS 1
SS DIABETES MELLITUS AMNESIA 1
SS DIABETES MELLITUS APPLICATION SITE IRRITATION 1
SS DIABETES MELLITUS APPLICATION SITE RASH 1
SS DIABETES MELLITUS ASTHMA 1
SS DIABETES MELLITUS BALANCE DISORDER 1
SS DIABETES MELLITUS CARDIAC ARREST 1
SS DIABETES MELLITUS FEELING DRUNK 1
SS DIABETES MELLITUS INCOHERENT 1
SS DIABETES MELLITUS OVERDOSE 1
SS DIABETES MELLITUS OXYGEN SATURATION DECREASED 1
SS DIABETES MELLITUS PULSE ABSENT 1
SS EPILEPSY CONVULSION 1
SS EPILEPSY DRUG INEFFECTIVE 1
SS HYPERTENSION AMNESIA 1
SS HYPERTENSION APPLICATION SITE IRRITATION 1
SS HYPERTENSION APPLICATION SITE RASH 1
SS HYPERTENSION ASTHMA 1
SS HYPERTENSION BALANCE DISORDER 1
SS HYPERTENSION CARDIAC ARREST 1
SS HYPERTENSION FEELING DRUNK 1
SS HYPERTENSION INCOHERENT 1
SS HYPERTENSION OVERDOSE 1
SS HYPERTENSION OXYGEN SATURATION DECREASED 1
SS HYPERTENSION PULSE ABSENT 1
SS INSOMNIA DRUG LEVEL INCREASED 1
SS INSOMNIA TOXICITY TO VARIOUS AGENTS 1
SS PAIN DRUG LEVEL INCREASED 4
SS PAIN TOXICITY TO VARIOUS AGENTS 4
SS SCHIZOPHRENIA DRUG LEVEL INCREASED 1
SS SCHIZOPHRENIA TOXICITY TO VARIOUS AGENTS 1
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