Drug information for BOTOX COSMETIC

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
VIAL; SINGLE-USE 100 UNITS/VIAL Prescription   OnabotulinumtoxinA onabotulinumtoxinA ALLERGAN 103000
2011-08-30 Letter

2011-08-30 Label

2011-07-08 Label

2010-10-20 Letter

2010-10-19 Label

2010-04-01 Other

2010-03-18 Letter

2010-03-17 Label

2009-12-18 Other

2009-11-16 Medication Guide

2009-08-07 Letter

2009-08-07 Letter

2009-08-07 Label

2009-08-07 Label

2008-08-12 Other Important Information from FDA

2004-09-15 Label

2004-07-21 Letter

2004-03-11 Review

2004-03-11 Letter

2004-03-11 Review

2004-03-11 Label

2004-03-11 Letter
VIAL; SINGLE-USE 50 UNITS/VIAL Prescription   OnabotulinumtoxinA onabotulinumtoxinA ALLERGAN   "

Drug Adverse Effects information for BOTOX COSMETIC

Role code Indications Reaction # Reports
PS ANTICOAGULANT THERAPY HYPOAESTHESIA 1
PS ANXIETY ANXIETY 1
PS ANXIETY DRY EYE 1
PS ANXIETY DRY MOUTH 1
PS ANXIETY DYSPHAGIA 1
PS ANXIETY HYPERTENSION 1
PS ANXIETY HYPOHIDROSIS 1
PS ANXIETY INSOMNIA 1
PS ANXIETY LETHARGY 1
PS ANXIETY MALAISE 1
PS ANXIETY THROAT IRRITATION 1
PS CONTRACEPTION ABDOMINAL PAIN UPPER 2
PS CONTRACEPTION ANXIETY 2
PS CONTRACEPTION ARTHRALGIA 2
PS CONTRACEPTION BACK PAIN 2
PS CONTRACEPTION DIARRHOEA 2
PS CONTRACEPTION DYSPHAGIA 2
PS CONTRACEPTION DYSPNOEA 2
PS CONTRACEPTION FATIGUE 2
PS CONTRACEPTION FEELING ABNORMAL 2
PS CONTRACEPTION GINGIVAL PAIN 2
PS CONTRACEPTION HEADACHE 2
PS CONTRACEPTION HYPERSENSITIVITY 2
PS CONTRACEPTION INFLUENZA 2
PS CONTRACEPTION JOINT DISLOCATION 2
PS CONTRACEPTION MUSCLE INJURY 2
PS CONTRACEPTION MUSCLE SPASMS 2
PS CONTRACEPTION MUSCLE TWITCHING 2
PS CONTRACEPTION MUSCULOSKELETAL CHEST PAIN 2
PS CONTRACEPTION MUSCULOSKELETAL PAIN 2
PS CONTRACEPTION MYALGIA 2
PS CONTRACEPTION NECK PAIN 2
PS CONTRACEPTION NEURALGIA 2
PS CONTRACEPTION PAIN IN EXTREMITY 2
PS CONTRACEPTION PAIN IN JAW 2
PS CONTRACEPTION PRURITUS GENERALISED 2
PS CONTRACEPTION TENDONITIS 2
PS CONTRACEPTION THROAT TIGHTNESS 2
PS CONTRACEPTION TOOTH DISORDER 2
PS CONTRACEPTION UPPER-AIRWAY COUGH SYNDROME 2
PS CONTRACEPTION URTICARIA 2
PS CONTRACEPTION VISION BLURRED 2
PS PRODUCT USED FOR UNKNOWN INDICATION ABORTION INDUCED 1
PS PRODUCT USED FOR UNKNOWN INDICATION PREGNANCY 1
PS SEASONAL ALLERGY ABDOMINAL DISCOMFORT 1
PS SEASONAL ALLERGY ABDOMINAL PAIN UPPER 3
PS SEASONAL ALLERGY ANXIETY 2
PS SEASONAL ALLERGY ARTHRALGIA 2
PS SEASONAL ALLERGY ASTHENIA 1
PS SEASONAL ALLERGY BACK PAIN 2
PS SEASONAL ALLERGY CHILLS 1
PS SEASONAL ALLERGY DIARRHOEA 2
PS SEASONAL ALLERGY DYSPHAGIA 2
PS SEASONAL ALLERGY DYSPNOEA 2
PS SEASONAL ALLERGY FATIGUE 3
PS SEASONAL ALLERGY FEELING ABNORMAL 3
PS SEASONAL ALLERGY GINGIVAL PAIN 2
PS SEASONAL ALLERGY HEADACHE 3
PS SEASONAL ALLERGY HYPERAESTHESIA 1
PS SEASONAL ALLERGY HYPERSENSITIVITY 2
PS SEASONAL ALLERGY HYPOAESTHESIA 1
PS SEASONAL ALLERGY IMMUNE SYSTEM DISORDER 1
PS SEASONAL ALLERGY INFLUENZA 2
PS SEASONAL ALLERGY INFLUENZA LIKE ILLNESS 1
PS SEASONAL ALLERGY JOINT DISLOCATION 2
PS SEASONAL ALLERGY MUSCLE INJURY 2
PS SEASONAL ALLERGY MUSCLE SPASMS 3
PS SEASONAL ALLERGY MUSCLE TWITCHING 2
PS SEASONAL ALLERGY MUSCULOSKELETAL CHEST PAIN 2
PS SEASONAL ALLERGY MUSCULOSKELETAL PAIN 2
PS SEASONAL ALLERGY MYALGIA 3
PS SEASONAL ALLERGY NAUSEA 1
PS SEASONAL ALLERGY NECK PAIN 2
PS SEASONAL ALLERGY NEURALGIA 2
PS SEASONAL ALLERGY PAIN IN EXTREMITY 2
PS SEASONAL ALLERGY PAIN IN JAW 2
PS SEASONAL ALLERGY PANIC ATTACK 1
PS SEASONAL ALLERGY PARAESTHESIA 1
PS SEASONAL ALLERGY PRURITUS GENERALISED 2
PS SEASONAL ALLERGY PYREXIA 1
PS SEASONAL ALLERGY RESPIRATORY TRACT INFECTION 1
PS SEASONAL ALLERGY SINUSITIS 1
PS SEASONAL ALLERGY TENDONITIS 2
PS SEASONAL ALLERGY THROAT TIGHTNESS 2
PS SEASONAL ALLERGY TOOTH DISORDER 2
PS SEASONAL ALLERGY UPPER-AIRWAY COUGH SYNDROME 2
PS SEASONAL ALLERGY URTICARIA 2
PS SEASONAL ALLERGY VISION BLURRED 3
PS SKIN COSMETIC PROCEDURE ABDOMINAL PAIN UPPER 1
PS SKIN COSMETIC PROCEDURE ANAPHYLACTIC SHOCK 1
PS SKIN COSMETIC PROCEDURE ANXIETY 1
PS SKIN COSMETIC PROCEDURE CHILLS 1
PS SKIN COSMETIC PROCEDURE DYSPHAGIA 1
PS SKIN COSMETIC PROCEDURE DYSPNOEA 1
PS SKIN COSMETIC PROCEDURE FEELING ABNORMAL 1
PS SKIN COSMETIC PROCEDURE INFLUENZA LIKE ILLNESS 1
PS SKIN COSMETIC PROCEDURE MUSCLE SPASMS 1
PS SKIN COSMETIC PROCEDURE MUSCLE TWITCHING 1
PS SKIN COSMETIC PROCEDURE NEURALGIA 1
PS SKIN COSMETIC PROCEDURE PARAESTHESIA 1
PS SKIN COSMETIC PROCEDURE PHARYNGEAL DISORDER 1
PS SKIN COSMETIC PROCEDURE PRURITUS 1
PS SKIN COSMETIC PROCEDURE RASH 1
PS SKIN COSMETIC PROCEDURE TOOTHACHE 1
PS SKIN COSMETIC PROCEDURE URTICARIA 1
PS SKIN COSMETIC PROCEDURE VISION BLURRED 1
PS SKIN WRINKLING ABDOMINAL DISCOMFORT 1
PS SKIN WRINKLING ABDOMINAL PAIN UPPER 3
PS SKIN WRINKLING ANAPHYLACTIC SHOCK 1
PS SKIN WRINKLING ANXIETY 3
PS SKIN WRINKLING APHAGIA 1
PS SKIN WRINKLING ARTHRALGIA 2
PS SKIN WRINKLING ASPHYXIA 1
PS SKIN WRINKLING ASTHENIA 2
PS SKIN WRINKLING BACK PAIN 2
PS SKIN WRINKLING BLOOD PRESSURE DECREASED 1
PS SKIN WRINKLING BLOOD PRESSURE INCREASED 1
PS SKIN WRINKLING CARDIAC FLUTTER 1
PS SKIN WRINKLING CHEST DISCOMFORT 1
PS SKIN WRINKLING CHILLS 2
PS SKIN WRINKLING DEPRESSION 1
PS SKIN WRINKLING DIARRHOEA 2
PS SKIN WRINKLING DISORIENTATION 1
PS SKIN WRINKLING DISTURBANCE IN ATTENTION 1
PS SKIN WRINKLING DIZZINESS 1
PS SKIN WRINKLING DRY EYE 1
PS SKIN WRINKLING DRY MOUTH 1
PS SKIN WRINKLING DYSARTHRIA 1
PS SKIN WRINKLING DYSPHAGIA 5
PS SKIN WRINKLING DYSPNOEA 3
PS SKIN WRINKLING EMOTIONAL DISTRESS 1
PS SKIN WRINKLING EYE PAIN 1
PS SKIN WRINKLING EYELID PTOSIS 2
PS SKIN WRINKLING FACIAL PARESIS 2
PS SKIN WRINKLING FATIGUE 5
PS SKIN WRINKLING FEELING ABNORMAL 3
PS SKIN WRINKLING FLUSHING 1
PS SKIN WRINKLING FOREIGN BODY 1
PS SKIN WRINKLING GINGIVAL PAIN 2
PS SKIN WRINKLING GRAND MAL CONVULSION 1
PS SKIN WRINKLING HEADACHE 7
PS SKIN WRINKLING HEART RATE INCREASED 1
PS SKIN WRINKLING HYPERAESTHESIA 1
PS SKIN WRINKLING HYPERSENSITIVITY 3
PS SKIN WRINKLING HYPERTENSION 1
PS SKIN WRINKLING HYPOAESTHESIA 2
PS SKIN WRINKLING HYPOHIDROSIS 1
PS SKIN WRINKLING ILEUS PARALYTIC 1
PS SKIN WRINKLING IMMUNE SYSTEM DISORDER 1
PS SKIN WRINKLING IMPAIRED WORK ABILITY 1
PS SKIN WRINKLING INFLUENZA 2
PS SKIN WRINKLING INFLUENZA LIKE ILLNESS 2
PS SKIN WRINKLING INSOMNIA 2
PS SKIN WRINKLING JOINT DISLOCATION 2
PS SKIN WRINKLING LETHARGY 1
PS SKIN WRINKLING LOSS OF CONSCIOUSNESS 1
PS SKIN WRINKLING MALAISE 2
PS SKIN WRINKLING MUSCLE INJURY 2
PS SKIN WRINKLING MUSCLE SPASMS 3
PS SKIN WRINKLING MUSCLE TWITCHING 2
PS SKIN WRINKLING MUSCULAR WEAKNESS 2
PS SKIN WRINKLING MUSCULOSKELETAL CHEST PAIN 2
PS SKIN WRINKLING MUSCULOSKELETAL PAIN 2
PS SKIN WRINKLING MYALGIA 3
PS SKIN WRINKLING NAUSEA 2
PS SKIN WRINKLING NECK PAIN 3
PS SKIN WRINKLING NEURALGIA 2
PS SKIN WRINKLING PAIN IN EXTREMITY 2
PS SKIN WRINKLING PAIN IN JAW 2
PS SKIN WRINKLING PALPITATIONS 2
PS SKIN WRINKLING PANIC ATTACK 1
PS SKIN WRINKLING PARAESTHESIA 1
PS SKIN WRINKLING PHARYNGEAL OEDEMA 2
PS SKIN WRINKLING PRURITUS GENERALISED 2
PS SKIN WRINKLING PYREXIA 1
PS SKIN WRINKLING RESPIRATORY TRACT INFECTION 1
PS SKIN WRINKLING SINUSITIS 1
PS SKIN WRINKLING SKIN ATROPHY 1
PS SKIN WRINKLING SKIN WRINKLING 1
PS SKIN WRINKLING STRESS 1
PS SKIN WRINKLING SWOLLEN TONGUE 1
PS SKIN WRINKLING TENDONITIS 2
PS SKIN WRINKLING THROAT IRRITATION 1
PS SKIN WRINKLING THROAT TIGHTNESS 2
PS SKIN WRINKLING TOOTH DISORDER 2
PS SKIN WRINKLING UPPER-AIRWAY COUGH SYNDROME 2
PS SKIN WRINKLING URINARY INCONTINENCE 1
PS SKIN WRINKLING URTICARIA 2
PS SKIN WRINKLING VENTRICULAR EXTRASYSTOLES 1
PS SKIN WRINKLING VIITH NERVE PARALYSIS 1
PS SKIN WRINKLING VISION BLURRED 3
PS SKIN WRINKLING WEIGHT DECREASED 1
SS ANTICOAGULANT THERAPY HYPOAESTHESIA 1
SS GROWTH OF EYELASHES DRUG INEFFECTIVE 1
SS SKIN WRINKLING DRUG INEFFECTIVE 1
SS SKIN WRINKLING GRAND MAL CONVULSION 1
SS SKIN WRINKLING HYPOAESTHESIA 1
C GROWTH OF EYELASHES MADAROSIS 1
C HORMONE REPLACEMENT THERAPY MADAROSIS 1
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