Drug information for FENTANYL-75

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
FILM, EXTENDED RELEASE; TRANSDERMAL 75MCG/HR Prescription AB  FENTANYL Fentanyl MYLAN TECHNOLOGIES 76258
2005-07-22 Review
2005-02-01 Letter
2004-06-24 Letter
FILM, EXTENDED RELEASE; TRANSDERMAL 75MCG/HR Prescription AB  FENTANYL Fentanyl WATSON LABS 76709
2007-08-24 Other Important Information from FDA
FILM, EXTENDED RELEASE; TRANSDERMAL 75MCG/HR Prescription AB  FENTANYL Fentanyl LAVIPHARM LABS 77051
2006-08-10 Other Important Information from FDA
FILM, EXTENDED RELEASE; TRANSDERMAL 75MCG/HR Prescription AB  FENTANYL Fentanyl ACTAVIS 77062
2007-08-24 Other Important Information from FDA
FILM, EXTENDED RELEASE; TRANSDERMAL 75MCG/HR Prescription AB  FENTANYL Fentanyl MALLINCKRODT INC 77154
FILM, EXTENDED RELEASE; TRANSDERMAL 75MCG/HR Prescription AB  FENTANYL Fentanyl TEVA PHARMS 77449
FILM, EXTENDED RELEASE; TRANSDERMAL 75MCG/HR Prescription AB  FENTANYL Fentanyl NOVEN 77775

Drug Adverse Effects information for FENTANYL-75

Role code Indications Reaction # Reports
PS ANKYLOSING SPONDYLITIS PRODUCT SUBSTITUTION ISSUE 1
PS ANKYLOSING SPONDYLITIS TACHYCARDIA 1
PS ANXIETY AORTIC ARTERIOSCLEROSIS 1
PS ANXIETY ARTERIOSCLEROSIS CORONARY ARTERY 1
PS ANXIETY HEPATIC STEATOSIS 1
PS ANXIETY LEFT VENTRICULAR HYPERTROPHY 1
PS ANXIETY OSTEOPOROSIS 1
PS ANXIETY OVERDOSE 1
PS ANXIETY PULMONARY OEDEMA 1
PS ANXIETY RENAL CYST 1
PS ANXIETY TOXICITY TO VARIOUS AGENTS 1
PS ANXIETY VISCERAL CONGESTION 1
PS ARTHRITIS PRODUCT SUBSTITUTION ISSUE 1
PS ARTHRITIS TACHYCARDIA 1
PS BACK PAIN ABDOMINAL PAIN UPPER 1
PS BACK PAIN BODY TEMPERATURE INCREASED 1
PS BACK PAIN CHILLS 1
PS BACK PAIN DECREASED APPETITE 1
PS BACK PAIN DEHYDRATION 1
PS BACK PAIN DRUG INEFFECTIVE 1
PS BACK PAIN DRUG WITHDRAWAL SYNDROME 1
PS BACK PAIN HEADACHE 1
PS BACK PAIN POSTOPERATIVE WOUND INFECTION 1
PS BACK PAIN VOMITING 1
PS FIBROMYALGIA ACCIDENTAL EXPOSURE 1
PS FIBROMYALGIA APPLICATION SITE BURN 1
PS FIBROMYALGIA APPLICATION SITE PRURITUS 1
PS FIBROMYALGIA APPLICATION SITE VESICLES 1
PS FIBROMYALGIA DIARRHOEA 1
PS FIBROMYALGIA HEADACHE 1
PS FIBROMYALGIA HYPERSENSITIVITY 1
PS FIBROMYALGIA NAUSEA 1
PS FIBROMYALGIA SCAB 1
PS FIBROMYALGIA SWOLLEN TONGUE 1
PS FIBROMYALGIA TONGUE EXFOLIATION 1
PS HYPERSENSITIVITY BRONCHITIS 1
PS HYPERSENSITIVITY CYSTITIS 1
PS HYPERSENSITIVITY DRUG SCREEN POSITIVE 1
PS HYPERSENSITIVITY DYSPNOEA 1
PS INTERVERTEBRAL DISC DEGENERATION APPLICATION SITE PRURITUS 1
PS INTERVERTEBRAL DISC DEGENERATION APPLICATION SITE VESICLES 1
PS INTERVERTEBRAL DISC DEGENERATION DIARRHOEA 1
PS INTERVERTEBRAL DISC DEGENERATION HEADACHE 1
PS INTERVERTEBRAL DISC DEGENERATION HYPERSENSITIVITY 1
PS INTERVERTEBRAL DISC DEGENERATION NAUSEA 1
PS INTERVERTEBRAL DISC DEGENERATION SCAB 1
PS INTERVERTEBRAL DISC DEGENERATION SWOLLEN TONGUE 1
PS INTERVERTEBRAL DISC DEGENERATION TONGUE EXFOLIATION 1
PS NEUROPATHY PERIPHERAL APPLICATION SITE PRURITUS 1
PS NEUROPATHY PERIPHERAL APPLICATION SITE VESICLES 1
PS NEUROPATHY PERIPHERAL DIARRHOEA 1
PS NEUROPATHY PERIPHERAL HEADACHE 1
PS NEUROPATHY PERIPHERAL HYPERSENSITIVITY 1
PS NEUROPATHY PERIPHERAL NAUSEA 1
PS NEUROPATHY PERIPHERAL SCAB 1
PS NEUROPATHY PERIPHERAL SWOLLEN TONGUE 1
PS NEUROPATHY PERIPHERAL TONGUE EXFOLIATION 1
PS PAIN AGITATION 1
PS PAIN ANALGESIC DRUG LEVEL INCREASED 1
PS PAIN AORTIC ARTERIOSCLEROSIS 2
PS PAIN APHAGIA 1
PS PAIN ARTERIOSCLEROSIS CORONARY ARTERY 2
PS PAIN ASTHENIA 1
PS PAIN BLOOD PRESSURE INCREASED 1
PS PAIN BRONCHITIS 1
PS PAIN CHEST PAIN 1
PS PAIN CONFUSIONAL STATE 2
PS PAIN CONTUSION 1
PS PAIN CYSTITIS 1
PS PAIN DRUG LEVEL INCREASED 1
PS PAIN DRUG SCREEN POSITIVE 1
PS PAIN DRUG WITHDRAWAL SYNDROME 2
PS PAIN DYSPNOEA 4
PS PAIN FEELING ABNORMAL 1
PS PAIN FEELING JITTERY 2
PS PAIN GAIT DISTURBANCE 1
PS PAIN HEPATIC STEATOSIS 2
PS PAIN INCORRECT PRODUCT STORAGE 1
PS PAIN INFLUENZA 1
PS PAIN LEFT VENTRICULAR HYPERTROPHY 2
PS PAIN OSTEOPOROSIS 2
PS PAIN OVERDOSE 6
PS PAIN PRODUCT QUALITY ISSUE 1
PS PAIN PULMONARY OEDEMA 2
PS PAIN RENAL CYST 2
PS PAIN SPEECH DISORDER 2
PS PAIN TOXICITY TO VARIOUS AGENTS 5
PS PAIN TREMOR 1
PS PAIN URINARY TRACT INFECTION 1
PS PAIN VISCERAL CONGESTION 2
PS POST LAMINECTOMY SYNDROME ANGER 3
PS POST LAMINECTOMY SYNDROME FEELING ABNORMAL 3
PS POST LAMINECTOMY SYNDROME HYPERHIDROSIS 3
PS POST LAMINECTOMY SYNDROME MALAISE 3
PS POST LAMINECTOMY SYNDROME MOVEMENT DISORDER 3
PS POST LAMINECTOMY SYNDROME THINKING ABNORMAL 3
PS POST LAMINECTOMY SYNDROME TREMOR 3
PS POST LAMINECTOMY SYNDROME WITHDRAWAL SYNDROME 3
PS SPINAL COMPRESSION FRACTURE AGITATION 1
PS SPINAL COMPRESSION FRACTURE ASTHENIA 1
PS SPINAL COMPRESSION FRACTURE BLOOD PRESSURE INCREASED 1
PS SPINAL COMPRESSION FRACTURE CONTUSION 1
PS SPINAL COMPRESSION FRACTURE DRUG WITHDRAWAL SYNDROME 1
PS SPINAL COMPRESSION FRACTURE FEELING ABNORMAL 1
PS SPINAL COMPRESSION FRACTURE FEELING JITTERY 1
PS SPINAL COMPRESSION FRACTURE GAIT DISTURBANCE 1
PS SPINAL COMPRESSION FRACTURE PRODUCT QUALITY ISSUE 1
PS SPINAL COMPRESSION FRACTURE URINARY TRACT INFECTION 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 MULTIPLE MYELOMA AUTONOMIC NEUROPATHY 1
SS MULTIPLE MYELOMA DIZZINESS 1
SS MULTIPLE MYELOMA FALL 1
SS MULTIPLE MYELOMA NEURALGIA 1
SS MULTIPLE MYELOMA NEUROPATHY PERIPHERAL 1
SS MULTIPLE MYELOMA PARAESTHESIA 1
SS MULTIPLE MYELOMA VISUAL IMPAIRMENT 1
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 PAIN ABDOMINAL DISCOMFORT 3
SS PAIN APPLICATION SITE ULCER 3
SS PAIN ASTHENIA 3
SS PAIN BACK PAIN 3
SS PAIN BLOOD GLUCOSE INCREASED 3
SS PAIN CHEST DISCOMFORT 3
SS PAIN DEHYDRATION 2
SS PAIN DIARRHOEA 3
SS PAIN DRUG INEFFECTIVE 4
SS PAIN DYSPHORIA 3
SS PAIN DYSPNOEA 3
SS PAIN GALLBLADDER DISORDER 3
SS PAIN GASTRITIS 3
SS PAIN HEPATIC ENZYME INCREASED 3
SS PAIN HYPERHIDROSIS 3
SS PAIN ILEUS 3
SS PAIN MALAISE 3
SS PAIN NAUSEA 3
SS PAIN NECK PAIN 3
SS PAIN NO THERAPEUTIC RESPONSE 3
SS PAIN PAIN 3
SS PAIN PRODUCT ADHESION ISSUE 3
SS PAIN RENAL FAILURE 2
SS PAIN RENAL FAILURE ACUTE 2
SS PAIN SKIN DISORDER 3
SS PAIN STRESS ULCER 3
SS PAIN URINARY TRACT INFECTION 3
SS PAIN VOMITING 3
SS PAIN WEIGHT DECREASED 3
SS PAIN WRONG TECHNIQUE IN DRUG USAGE PROCESS 3
SS PAIN MANAGEMENT AMNESIA 2
SS PAIN MANAGEMENT ARTHRALGIA 2
SS PAIN MANAGEMENT CONSTIPATION 2
SS PAIN MANAGEMENT DRUG EFFECT DECREASED 2
SS PAIN MANAGEMENT DRUG EFFECT INCREASED 2
SS PAIN MANAGEMENT DRUG INEFFECTIVE 2
SS PAIN MANAGEMENT HYPERHIDROSIS 2
SS PAIN MANAGEMENT LOSS OF LIBIDO 2
SS PAIN MANAGEMENT MOVEMENT DISORDER 2
SS PAIN MANAGEMENT PRODUCT ADHESION ISSUE 2
SS PAIN MANAGEMENT SOMNOLENCE 2
SS PAIN MANAGEMENT STRESS 2
SS PAIN MANAGEMENT TACHYCARDIA 2
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 DEHYDRATION 9
SS PRODUCT USED FOR UNKNOWN INDICATION DISORIENTATION 6
SS PRODUCT USED FOR UNKNOWN INDICATION DIZZINESS 6
SS PRODUCT USED FOR UNKNOWN INDICATION DRUG INEFFECTIVE 9
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 RENAL FAILURE ACUTE 9
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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