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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