Drug information for DYSPORT

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
INJECTABLE; INJECTION 300 UNITS/VIAL Prescription   abobotulinumtoxinA abobotulinumtoxinA IPSEN BIOPHARM LTD 125274
2011-08-17 Review
2011-08-17 Review
2011-08-17 Summary Review
2011-08-17 Summary Review
2009-12-18 Other
2009-11-18 Medication Guide
2009-06-04 Label
2009-06-04 Label
2009-05-07 Letter
2009-05-07 Letter
INJECTABLE; INJECTION 500 UNITS/VIAL Prescription   abobotulinumtoxinA abobotulinumtoxinA IPSEN BIOPHARM LTD   "

Drug Adverse Effects information for DYSPORT

Role code Indications Reaction # Reports
PS DYSTONIA BREAST PAIN 1
PS DYSTONIA CHILLS 1
PS DYSTONIA PYREXIA 1
PS MUSCLE SPASTICITY ASTHENIA 3
PS MUSCLE SPASTICITY BLOOD THYROID STIMULATING HORMONE DECREASED 1
PS MUSCLE SPASTICITY BOTULISM 1
PS MUSCLE SPASTICITY CATAPLEXY 2
PS MUSCLE SPASTICITY CONDITION AGGRAVATED 3
PS MUSCLE SPASTICITY CONVULSION 3
PS MUSCLE SPASTICITY DYSPHAGIA 2
PS MUSCLE SPASTICITY DYSPNOEA 1
PS MUSCLE SPASTICITY ELECTROCARDIOGRAM T WAVE ABNORMAL 1
PS MUSCLE SPASTICITY FALL 2
PS MUSCLE SPASTICITY FATIGUE 1
PS MUSCLE SPASTICITY GAIT DISTURBANCE 1
PS MUSCLE SPASTICITY LOSS OF CONSCIOUSNESS 2
PS MUSCLE SPASTICITY MALAISE 2
PS MUSCLE SPASTICITY MUSCULAR WEAKNESS 2
PS MUSCLE SPASTICITY THERAPEUTIC RESPONSE DECREASED 1
PS MYALGIA ASTHENIA 1
PS MYALGIA BACK PAIN 2
PS MYALGIA EPSTEIN-BARR VIRUS ANTIBODY POSITIVE 2
PS MYALGIA INFLUENZA LIKE ILLNESS 2
PS MYALGIA LETHARGY 1
PS MYALGIA MALAISE 1
PS MYALGIA MUSCLE SPASMS 2
PS MYALGIA NAUSEA 1
PS MYALGIA OFF LABEL USE 2
PS MYALGIA PELVIC FLOOR MUSCLE WEAKNESS 1
PS MYALGIA PRODUCT QUALITY ISSUE 1
PS MYALGIA URINARY RETENTION 2
PS OFF LABEL USE ABNORMAL SENSATION IN EYE 1
PS OFF LABEL USE ANGIOEDEMA 1
PS OFF LABEL USE ANXIETY 1
PS OFF LABEL USE ASTHENIA 1
PS OFF LABEL USE BACK PAIN 2
PS OFF LABEL USE BLOOD PRESSURE DECREASED 1
PS OFF LABEL USE BOTULISM 1
PS OFF LABEL USE CELLULITIS 1
PS OFF LABEL USE CHEST DISCOMFORT 1
PS OFF LABEL USE CONVULSION 2
PS OFF LABEL USE DEHYDRATION 1
PS OFF LABEL USE DIZZINESS 2
PS OFF LABEL USE DRUG INEFFECTIVE 3
PS OFF LABEL USE DRUG INTOLERANCE 1
PS OFF LABEL USE DRY MOUTH 1
PS OFF LABEL USE DYSPHAGIA 4
PS OFF LABEL USE DYSPHONIA 1
PS OFF LABEL USE DYSPNOEA 2
PS OFF LABEL USE EMPHYSEMA 1
PS OFF LABEL USE EPSTEIN-BARR VIRUS ANTIBODY POSITIVE 2
PS OFF LABEL USE EXOPHTHALMOS 1
PS OFF LABEL USE EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE) 1
PS OFF LABEL USE EYELID PTOSIS 1
PS OFF LABEL USE FATIGUE 2
PS OFF LABEL USE FEELING ABNORMAL 1
PS OFF LABEL USE GLARE 1
PS OFF LABEL USE HEADACHE 1
PS OFF LABEL USE HEART RATE DECREASED 1
PS OFF LABEL USE HYPERACUSIS 1
PS OFF LABEL USE HYPERSENSITIVITY 1
PS OFF LABEL USE HYPOAESTHESIA 1
PS OFF LABEL USE HYPOPHAGIA 1
PS OFF LABEL USE IMPAIRED WORK ABILITY 1
PS OFF LABEL USE INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
PS OFF LABEL USE INCORRECT DOSE ADMINISTERED 2
PS OFF LABEL USE INFLAMMATION 1
PS OFF LABEL USE INFLUENZA LIKE ILLNESS 2
PS OFF LABEL USE INJECTION SITE SWELLING 1
PS OFF LABEL USE INSOMNIA 1
PS OFF LABEL USE LETHARGY 1
PS OFF LABEL USE MALAISE 1
PS OFF LABEL USE MEMORY IMPAIRMENT 1
PS OFF LABEL USE MIGRAINE 1
PS OFF LABEL USE MUSCLE SPASMS 3
PS OFF LABEL USE MUSCLE TIGHTNESS 1
PS OFF LABEL USE MUSCULAR WEAKNESS 1
PS OFF LABEL USE MUSCULOSKELETAL DISORDER 1
PS OFF LABEL USE MUSCULOSKELETAL PAIN 1
PS OFF LABEL USE NAUSEA 1
PS OFF LABEL USE NECK PAIN 1
PS OFF LABEL USE NEURALGIA 1
PS OFF LABEL USE NEUROPATHY PERIPHERAL 1
PS OFF LABEL USE OCULAR HYPERAEMIA 1
PS OFF LABEL USE OFF LABEL USE 3
PS OFF LABEL USE PARAESTHESIA 1
PS OFF LABEL USE PELVIC FLOOR MUSCLE WEAKNESS 1
PS OFF LABEL USE PHOTOPHOBIA 1
PS OFF LABEL USE PNEUMONIA 1
PS OFF LABEL USE PRODUCT QUALITY ISSUE 5
PS OFF LABEL USE REFUSAL OF TREATMENT BY PATIENT 1
PS OFF LABEL USE RESPIRATORY RATE DECREASED 1
PS OFF LABEL USE RETINAL HAEMORRHAGE 1
PS OFF LABEL USE SCAB 1
PS OFF LABEL USE SOMNOLENCE 1
PS OFF LABEL USE SWOLLEN TONGUE 1
PS OFF LABEL USE TACHYCARDIA 1
PS OFF LABEL USE TREMOR 1
PS OFF LABEL USE URINARY RETENTION 2
PS OFF LABEL USE WEIGHT DECREASED 1
PS OFF LABEL USE WRONG TECHNIQUE IN DRUG USAGE PROCESS 3
PS PRODUCT USED FOR UNKNOWN INDICATION CATAPLEXY 1
PS PRODUCT USED FOR UNKNOWN INDICATION CONDITION AGGRAVATED 1
PS PRODUCT USED FOR UNKNOWN INDICATION DYSPHAGIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION FALL 1
PS PRODUCT USED FOR UNKNOWN INDICATION HYPERSENSITIVITY 1
PS PRODUCT USED FOR UNKNOWN INDICATION LOSS OF CONSCIOUSNESS 1
PS PRODUCT USED FOR UNKNOWN INDICATION MALAISE 1
PS PRODUCT USED FOR UNKNOWN INDICATION MUSCULAR WEAKNESS 1
PS PRODUCT USED FOR UNKNOWN INDICATION PRODUCT QUALITY ISSUE 1
PS PRODUCT USED FOR UNKNOWN INDICATION THERAPEUTIC RESPONSE DECREASED 1
PS SKIN COSMETIC PROCEDURE ANGIOEDEMA 1
PS SKIN COSMETIC PROCEDURE CELLULITIS 1
PS SKIN COSMETIC PROCEDURE CEREBRAL THROMBOSIS 1
PS SKIN COSMETIC PROCEDURE DIZZINESS 1
PS SKIN COSMETIC PROCEDURE DRUG INEFFECTIVE 1
PS SKIN COSMETIC PROCEDURE DYSPHAGIA 3
PS SKIN COSMETIC PROCEDURE FACIAL BONES FRACTURE 1
PS SKIN COSMETIC PROCEDURE FALL 1
PS SKIN COSMETIC PROCEDURE INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
PS SKIN COSMETIC PROCEDURE INCORRECT DOSE ADMINISTERED 3
PS SKIN COSMETIC PROCEDURE OFF LABEL USE 1
PS SKIN COSMETIC PROCEDURE PRODUCT QUALITY ISSUE 3
PS SKIN COSMETIC PROCEDURE PRODUCT RECONSTITUTION ISSUE 1
PS SKIN COSMETIC PROCEDURE ROTATOR CUFF SYNDROME 1
PS SKIN COSMETIC PROCEDURE SCAB 1
PS SKIN COSMETIC PROCEDURE WRONG TECHNIQUE IN DRUG USAGE PROCESS 3
PS SKIN WRINKLING ABNORMAL SENSATION IN EYE 2
PS SKIN WRINKLING ANGIOEDEMA 1
PS SKIN WRINKLING ANXIETY 2
PS SKIN WRINKLING BLOOD PRESSURE DECREASED 1
PS SKIN WRINKLING CELLULITIS 1
PS SKIN WRINKLING CHEST DISCOMFORT 3
PS SKIN WRINKLING CONVULSION 3
PS SKIN WRINKLING DEHYDRATION 2
PS SKIN WRINKLING DIZZINESS 3
PS SKIN WRINKLING DRUG INEFFECTIVE 5
PS SKIN WRINKLING DRUG INTOLERANCE 2
PS SKIN WRINKLING DRY MOUTH 2
PS SKIN WRINKLING DYSPHAGIA 2
PS SKIN WRINKLING DYSPNOEA 3
PS SKIN WRINKLING EMPHYSEMA 1
PS SKIN WRINKLING EXOPHTHALMOS 1
PS SKIN WRINKLING EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE) 1
PS SKIN WRINKLING EYE SWELLING 1
PS SKIN WRINKLING EYELID PTOSIS 2
PS SKIN WRINKLING FATIGUE 2
PS SKIN WRINKLING FEELING ABNORMAL 2
PS SKIN WRINKLING GLARE 2
PS SKIN WRINKLING HEADACHE 3
PS SKIN WRINKLING HEART RATE DECREASED 1
PS SKIN WRINKLING HYPERACUSIS 2
PS SKIN WRINKLING HYPERSENSITIVITY 1
PS SKIN WRINKLING HYPOAESTHESIA 2
PS SKIN WRINKLING HYPOPHAGIA 2
PS SKIN WRINKLING IMPAIRED WORK ABILITY 2
PS SKIN WRINKLING INFLAMMATION 2
PS SKIN WRINKLING INJECTION SITE SWELLING 1
PS SKIN WRINKLING INSOMNIA 2
PS SKIN WRINKLING LOCAL SWELLING 1
PS SKIN WRINKLING MEMORY IMPAIRMENT 1
PS SKIN WRINKLING MIGRAINE 2
PS SKIN WRINKLING MUSCLE SPASMS 2
PS SKIN WRINKLING MUSCLE TIGHTNESS 2
PS SKIN WRINKLING MUSCULOSKELETAL DISORDER 2
PS SKIN WRINKLING MUSCULOSKELETAL PAIN 4
PS SKIN WRINKLING NECK PAIN 4
PS SKIN WRINKLING NEOPLASM MALIGNANT 1
PS SKIN WRINKLING NEURALGIA 2
PS SKIN WRINKLING NEUROPATHY PERIPHERAL 2
PS SKIN WRINKLING OCULAR HYPERAEMIA 1
PS SKIN WRINKLING OFF LABEL USE 1
PS SKIN WRINKLING PARAESTHESIA 2
PS SKIN WRINKLING PHOTOPHOBIA 2
PS SKIN WRINKLING PNEUMONIA 1
PS SKIN WRINKLING PRODUCT QUALITY ISSUE 3
PS SKIN WRINKLING PRODUCT RECONSTITUTION ISSUE 1
PS SKIN WRINKLING REFUSAL OF TREATMENT BY PATIENT 1
PS SKIN WRINKLING RESPIRATORY DISORDER 1
PS SKIN WRINKLING RESPIRATORY RATE DECREASED 1
PS SKIN WRINKLING RETINAL HAEMORRHAGE 2
PS SKIN WRINKLING SCAB 1
PS SKIN WRINKLING SOFT TISSUE MASS 1
PS SKIN WRINKLING SOMNOLENCE 2
PS SKIN WRINKLING SWOLLEN TONGUE 1
PS SKIN WRINKLING TREMOR 2
PS SKIN WRINKLING VIITH NERVE PARALYSIS 1
PS SKIN WRINKLING VITREOUS FLOATERS 1
PS SKIN WRINKLING WEIGHT DECREASED 2
PS SKIN WRINKLING WRONG TECHNIQUE IN DRUG USAGE PROCESS 2
PS TENDONITIS BOTULISM 1
PS TENDONITIS DYSPHAGIA 1
PS TENDONITIS DYSPHONIA 1
PS TENDONITIS DYSPNOEA 1
PS TENDONITIS FATIGUE 1
PS TENDONITIS MUSCULAR WEAKNESS 1
PS TENDONITIS TACHYCARDIA 1
PS TORTICOLLIS APALLIC SYNDROME 1
PS TORTICOLLIS ASPIRATION 1
PS TORTICOLLIS BRONCHOPNEUMONIA 1
PS TORTICOLLIS CHOKING 2
PS TORTICOLLIS COMA 1
PS TORTICOLLIS DYSPHAGIA 1
PS TORTICOLLIS FALL 1
PS TORTICOLLIS GENERAL PHYSICAL HEALTH DETERIORATION 1
PS TORTICOLLIS HYPOXIC-ISCHAEMIC ENCEPHALOPATHY 2
PS TORTICOLLIS LOWER RESPIRATORY TRACT INFECTION 1
PS TORTICOLLIS MYOCLONUS 1
PS TORTICOLLIS OBSTRUCTIVE AIRWAYS DISORDER 1
PS TORTICOLLIS RESPIRATORY ARREST 2
PS TORTICOLLIS SOMNOLENCE 1
SS OFF LABEL USE ABNORMAL SENSATION IN EYE 1
SS OFF LABEL USE ANXIETY 1
SS OFF LABEL USE CHEST DISCOMFORT 1
SS OFF LABEL USE CONVULSION 1
SS OFF LABEL USE DEHYDRATION 1
SS OFF LABEL USE DIZZINESS 1
SS OFF LABEL USE DRUG INEFFECTIVE 1
SS OFF LABEL USE DRUG INTOLERANCE 1
SS OFF LABEL USE DRY MOUTH 1
SS OFF LABEL USE DYSPHAGIA 1
SS OFF LABEL USE DYSPNOEA 1
SS OFF LABEL USE EYELID PTOSIS 1
SS OFF LABEL USE FATIGUE 1
SS OFF LABEL USE FEELING ABNORMAL 1
SS OFF LABEL USE GLARE 1
SS OFF LABEL USE HEADACHE 1
SS OFF LABEL USE HYPERACUSIS 1
SS OFF LABEL USE HYPOAESTHESIA 1
SS OFF LABEL USE HYPOPHAGIA 1
SS OFF LABEL USE IMPAIRED WORK ABILITY 1
SS OFF LABEL USE INFLAMMATION 1
SS OFF LABEL USE INSOMNIA 1
SS OFF LABEL USE MIGRAINE 1
SS OFF LABEL USE MUSCLE SPASMS 1
SS OFF LABEL USE MUSCLE TIGHTNESS 1
SS OFF LABEL USE MUSCULOSKELETAL DISORDER 1
SS OFF LABEL USE NEURALGIA 1
SS OFF LABEL USE NEUROPATHY PERIPHERAL 1
SS OFF LABEL USE PARAESTHESIA 1
SS OFF LABEL USE PHOTOPHOBIA 1
SS OFF LABEL USE SOMNOLENCE 1
SS OFF LABEL USE TREMOR 1
SS OFF LABEL USE WEIGHT DECREASED 1
SS SKIN WRINKLING ABNORMAL SENSATION IN EYE 2
SS SKIN WRINKLING ANXIETY 2
SS SKIN WRINKLING CHEST DISCOMFORT 2
SS SKIN WRINKLING CONVULSION 2
SS SKIN WRINKLING DEHYDRATION 2
SS SKIN WRINKLING DIZZINESS 2
SS SKIN WRINKLING DRUG INEFFECTIVE 2
SS SKIN WRINKLING DRUG INTOLERANCE 2
SS SKIN WRINKLING DRY MOUTH 2
SS SKIN WRINKLING DYSPHAGIA 2
SS SKIN WRINKLING DYSPNOEA 2
SS SKIN WRINKLING EYELID PTOSIS 2
SS SKIN WRINKLING FATIGUE 2
SS SKIN WRINKLING FEELING ABNORMAL 2
SS SKIN WRINKLING GLARE 2
SS SKIN WRINKLING HEADACHE 2
SS SKIN WRINKLING HYPERACUSIS 2
SS SKIN WRINKLING HYPOAESTHESIA 2
SS SKIN WRINKLING HYPOPHAGIA 2
SS SKIN WRINKLING IMPAIRED WORK ABILITY 2
SS SKIN WRINKLING INFLAMMATION 2
SS SKIN WRINKLING INSOMNIA 2
SS SKIN WRINKLING MIGRAINE 2
SS SKIN WRINKLING MUSCLE SPASMS 2
SS SKIN WRINKLING MUSCLE TIGHTNESS 2
SS SKIN WRINKLING MUSCULOSKELETAL DISORDER 2
SS SKIN WRINKLING NEURALGIA 2
SS SKIN WRINKLING NEUROPATHY PERIPHERAL 2
SS SKIN WRINKLING PARAESTHESIA 2
SS SKIN WRINKLING PHOTOPHOBIA 2
SS SKIN WRINKLING SOMNOLENCE 2
SS SKIN WRINKLING TREMOR 2
SS SKIN WRINKLING WEIGHT DECREASED 2
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