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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