Drug information for FENTANYL-25

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
FILM, EXTENDED RELEASE; TRANSDERMAL 25MCG/HR Prescription AB  FENTANYL Fentanyl MYLAN TECHNOLOGIES 76258
2005-07-22 Review
2005-02-01 Letter
2004-06-24 Letter
FILM, EXTENDED RELEASE; TRANSDERMAL 25MCG/HR Prescription AB  FENTANYL Fentanyl WATSON LABS 76709
2007-08-24 Other Important Information from FDA
FILM, EXTENDED RELEASE; TRANSDERMAL 25MCG/HR Prescription AB  FENTANYL Fentanyl LAVIPHARM LABS 77051
2006-08-10 Other Important Information from FDA
FILM, EXTENDED RELEASE; TRANSDERMAL 25MCG/HR Prescription AB  FENTANYL Fentanyl ACTAVIS 77062
2007-08-24 Other Important Information from FDA
FILM, EXTENDED RELEASE; TRANSDERMAL 25MCG/HR Prescription AB  FENTANYL Fentanyl MALLINCKRODT INC 77154
FILM, EXTENDED RELEASE; TRANSDERMAL 25MCG/HR Prescription AB  FENTANYL Fentanyl TEVA PHARMS 77449
FILM, EXTENDED RELEASE; TRANSDERMAL 25MCG/HR Prescription AB  FENTANYL Fentanyl NOVEN 77775

Drug Adverse Effects information for FENTANYL-25

Role code Indications Reaction # Reports
PS ACCIDENTAL EXPOSURE ACCIDENTAL DRUG INTAKE BY CHILD 1
PS ACCIDENTAL EXPOSURE ACCIDENTAL EXPOSURE 1
PS ACCIDENTAL EXPOSURE ACCIDENTAL OVERDOSE 1
PS ACCIDENTAL EXPOSURE BLOOD PRESSURE DECREASED 1
PS ACCIDENTAL EXPOSURE COMA 1
PS ACCIDENTAL EXPOSURE CONVULSION 1
PS ACCIDENTAL EXPOSURE DIABETIC KETOACIDOSIS 1
PS ACCIDENTAL EXPOSURE HEART RATE INCREASED 1
PS ACCIDENTAL EXPOSURE HYPOTHERMIA 1
PS ACCIDENTAL EXPOSURE LEUKOENCEPHALOPATHY 1
PS ACCIDENTAL EXPOSURE MIOSIS 1
PS ACCIDENTAL EXPOSURE NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL 1
PS ACCIDENTAL EXPOSURE RESPIRATORY DEPRESSION 1
PS ACCIDENTAL EXPOSURE TOXICITY TO VARIOUS AGENTS 1
PS PRODUCT USED FOR UNKNOWN INDICATION CONFUSIONAL STATE 1
PS PRODUCT USED FOR UNKNOWN INDICATION MENTAL IMPAIRMENT 1
PS PRODUCT USED FOR UNKNOWN INDICATION OVERDOSE 1
PS PRODUCT USED FOR UNKNOWN INDICATION VOMITING 1
SS AFFECTIVE DISORDER ACCIDENTAL OVERDOSE 2
SS AFFECTIVE DISORDER ANXIETY 2
SS AFFECTIVE DISORDER APPLICATION SITE PRURITUS 2
SS AFFECTIVE DISORDER CONFUSIONAL STATE 2
SS AFFECTIVE DISORDER DISORIENTATION 2
SS AFFECTIVE DISORDER DIZZINESS 2
SS AFFECTIVE DISORDER FEELING DRUNK 2
SS AFFECTIVE DISORDER HYPERHIDROSIS 2
SS AFFECTIVE DISORDER MALAISE 2
SS AFFECTIVE DISORDER NAUSEA 2
SS AFFECTIVE DISORDER NERVOUSNESS 2
SS AFFECTIVE DISORDER PANIC REACTION 2
SS AFFECTIVE DISORDER PRURITUS GENERALISED 2
SS AFFECTIVE DISORDER RETCHING 2
SS AFFECTIVE DISORDER SYNCOPE 2
SS AFFECTIVE DISORDER VOMITING 2
SS ANXIETY ACCIDENTAL OVERDOSE 2
SS ANXIETY ANXIETY 2
SS ANXIETY APPLICATION SITE PRURITUS 2
SS ANXIETY CONFUSIONAL STATE 2
SS ANXIETY DISORIENTATION 2
SS ANXIETY DIZZINESS 2
SS ANXIETY FEELING DRUNK 2
SS ANXIETY HYPERHIDROSIS 2
SS ANXIETY MALAISE 2
SS ANXIETY NAUSEA 2
SS ANXIETY NERVOUSNESS 2
SS ANXIETY PANIC REACTION 2
SS ANXIETY PRURITUS GENERALISED 2
SS ANXIETY RETCHING 2
SS ANXIETY SYNCOPE 2
SS ANXIETY VOMITING 2
SS BACK DISORDER ACCIDENTAL OVERDOSE 6
SS BACK DISORDER ANXIETY 6
SS BACK DISORDER APPLICATION SITE PRURITUS 6
SS BACK DISORDER CONFUSIONAL STATE 6
SS BACK DISORDER DISORIENTATION 6
SS BACK DISORDER DIZZINESS 6
SS BACK DISORDER FEELING DRUNK 6
SS BACK DISORDER HYPERHIDROSIS 6
SS BACK DISORDER MALAISE 6
SS BACK DISORDER NAUSEA 6
SS BACK DISORDER NERVOUSNESS 6
SS BACK DISORDER PANIC REACTION 6
SS BACK DISORDER PRURITUS GENERALISED 6
SS BACK DISORDER RETCHING 6
SS BACK DISORDER SYNCOPE 6
SS BACK DISORDER VOMITING 6
SS BLOOD URIC ACID ACCIDENTAL OVERDOSE 2
SS BLOOD URIC ACID ANXIETY 2
SS BLOOD URIC ACID APPLICATION SITE PRURITUS 2
SS BLOOD URIC ACID CONFUSIONAL STATE 2
SS BLOOD URIC ACID DISORIENTATION 2
SS BLOOD URIC ACID DIZZINESS 2
SS BLOOD URIC ACID FEELING DRUNK 2
SS BLOOD URIC ACID HYPERHIDROSIS 2
SS BLOOD URIC ACID MALAISE 2
SS BLOOD URIC ACID NAUSEA 2
SS BLOOD URIC ACID NERVOUSNESS 2
SS BLOOD URIC ACID PANIC REACTION 2
SS BLOOD URIC ACID PRURITUS GENERALISED 2
SS BLOOD URIC ACID RETCHING 2
SS BLOOD URIC ACID SYNCOPE 2
SS BLOOD URIC ACID VOMITING 2
SS GASTROOESOPHAGEAL REFLUX DISEASE ACCIDENTAL OVERDOSE 2
SS GASTROOESOPHAGEAL REFLUX DISEASE ANXIETY 2
SS GASTROOESOPHAGEAL REFLUX DISEASE APPLICATION SITE PRURITUS 2
SS GASTROOESOPHAGEAL REFLUX DISEASE CONFUSIONAL STATE 2
SS GASTROOESOPHAGEAL REFLUX DISEASE DISORIENTATION 2
SS GASTROOESOPHAGEAL REFLUX DISEASE DIZZINESS 2
SS GASTROOESOPHAGEAL REFLUX DISEASE FEELING DRUNK 2
SS GASTROOESOPHAGEAL REFLUX DISEASE HYPERHIDROSIS 2
SS GASTROOESOPHAGEAL REFLUX DISEASE MALAISE 2
SS GASTROOESOPHAGEAL REFLUX DISEASE NAUSEA 2
SS GASTROOESOPHAGEAL REFLUX DISEASE NERVOUSNESS 2
SS GASTROOESOPHAGEAL REFLUX DISEASE PANIC REACTION 2
SS GASTROOESOPHAGEAL REFLUX DISEASE PRURITUS GENERALISED 2
SS GASTROOESOPHAGEAL REFLUX DISEASE RETCHING 2
SS GASTROOESOPHAGEAL REFLUX DISEASE SYNCOPE 2
SS GASTROOESOPHAGEAL REFLUX DISEASE VOMITING 2
SS HYPERTENSION ACCIDENTAL OVERDOSE 4
SS HYPERTENSION ANXIETY 4
SS HYPERTENSION APPLICATION SITE PRURITUS 4
SS HYPERTENSION CONFUSIONAL STATE 4
SS HYPERTENSION DISORIENTATION 4
SS HYPERTENSION DIZZINESS 4
SS HYPERTENSION FEELING DRUNK 4
SS HYPERTENSION HYPERHIDROSIS 4
SS HYPERTENSION MALAISE 4
SS HYPERTENSION NAUSEA 4
SS HYPERTENSION NERVOUSNESS 4
SS HYPERTENSION PANIC REACTION 4
SS HYPERTENSION PRURITUS GENERALISED 4
SS HYPERTENSION RETCHING 4
SS HYPERTENSION SYNCOPE 4
SS HYPERTENSION VOMITING 4
SS MUSCLE SPASMS ACCIDENTAL OVERDOSE 2
SS MUSCLE SPASMS ANXIETY 2
SS MUSCLE SPASMS APPLICATION SITE PRURITUS 2
SS MUSCLE SPASMS CONFUSIONAL STATE 2
SS MUSCLE SPASMS DISORIENTATION 2
SS MUSCLE SPASMS DIZZINESS 2
SS MUSCLE SPASMS FEELING DRUNK 2
SS MUSCLE SPASMS HYPERHIDROSIS 2
SS MUSCLE SPASMS MALAISE 2
SS MUSCLE SPASMS NAUSEA 2
SS MUSCLE SPASMS NERVOUSNESS 2
SS MUSCLE SPASMS PANIC REACTION 2
SS MUSCLE SPASMS PRURITUS GENERALISED 2
SS MUSCLE SPASMS RETCHING 2
SS MUSCLE SPASMS SYNCOPE 2
SS MUSCLE SPASMS VOMITING 2
SS OSTEOARTHRITIS ANXIETY 4
SS OSTEOARTHRITIS BURNING SENSATION 4
SS OSTEOARTHRITIS DRUG ADMINISTRATION ERROR 4
SS OSTEOARTHRITIS DYSPNOEA 4
SS OSTEOARTHRITIS PNEUMONIA 4
SS PAIN ANXIETY 4
SS PAIN BURNING SENSATION 4
SS PAIN DYSPNOEA 4
SS PAIN PNEUMONIA 4
SS PRODUCT USED FOR UNKNOWN INDICATION ACCIDENTAL OVERDOSE 6
SS PRODUCT USED FOR UNKNOWN INDICATION ANXIETY 6
SS PRODUCT USED FOR UNKNOWN INDICATION APPLICATION SITE PRURITUS 6
SS PRODUCT USED FOR UNKNOWN INDICATION CONFUSIONAL STATE 6
SS PRODUCT USED FOR UNKNOWN INDICATION DISORIENTATION 6
SS PRODUCT USED FOR UNKNOWN INDICATION DIZZINESS 6
SS PRODUCT USED FOR UNKNOWN INDICATION FEELING DRUNK 6
SS PRODUCT USED FOR UNKNOWN INDICATION HYPERHIDROSIS 6
SS PRODUCT USED FOR UNKNOWN INDICATION MALAISE 6
SS PRODUCT USED FOR UNKNOWN INDICATION NAUSEA 6
SS PRODUCT USED FOR UNKNOWN INDICATION NERVOUSNESS 6
SS PRODUCT USED FOR UNKNOWN INDICATION PANIC REACTION 6
SS PRODUCT USED FOR UNKNOWN INDICATION PRURITUS GENERALISED 6
SS PRODUCT USED FOR UNKNOWN INDICATION RETCHING 6
SS PRODUCT USED FOR UNKNOWN INDICATION SYNCOPE 6
SS PRODUCT USED FOR UNKNOWN INDICATION VOMITING 6
SS RHEUMATOID ARTHRITIS ACCIDENTAL OVERDOSE 6
SS RHEUMATOID ARTHRITIS ANXIETY 6
SS RHEUMATOID ARTHRITIS APPLICATION SITE PRURITUS 6
SS RHEUMATOID ARTHRITIS CONFUSIONAL STATE 6
SS RHEUMATOID ARTHRITIS DISORIENTATION 6
SS RHEUMATOID ARTHRITIS DIZZINESS 6
SS RHEUMATOID ARTHRITIS FEELING DRUNK 6
SS RHEUMATOID ARTHRITIS HYPERHIDROSIS 6
SS RHEUMATOID ARTHRITIS MALAISE 6
SS RHEUMATOID ARTHRITIS NAUSEA 6
SS RHEUMATOID ARTHRITIS NERVOUSNESS 6
SS RHEUMATOID ARTHRITIS PANIC REACTION 6
SS RHEUMATOID ARTHRITIS PRURITUS GENERALISED 6
SS RHEUMATOID ARTHRITIS RETCHING 6
SS RHEUMATOID ARTHRITIS SYNCOPE 6
SS RHEUMATOID ARTHRITIS VOMITING 6
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