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Dysport (Botulinum Toxin Type A) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Dysport (Botulinum Toxin Type A) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (114)
Death (7)
Life Threatening Events (5)
Disability (16)

Reports by Reaction Type

Dysphagia (18)Muscular Weakness (17)Neck Pain (12)Wrong Technique in Drug Usage Process (10)Drug Ineffective (10)Headache (8)Eyelid Ptosis (8)Asthenia (8)Fall (7)Off Label Use (7)Diplopia (7)Fatigue (7)

Below are a few examples of reports where side effects / adverse reactions may be related to Dysport (Botulinum Toxin Type A). For a complete list or a specific selection of reports, please use the links above.

Possible Dysport side effects in 61 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-05

Patient: 61 year old female

Reactions: Cellulitis, Oedema Peripheral, Animal Bite, Unevaluable Event, Tenderness, Erythema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Perlane-L (Hyaluronic Acid)
    Dosage: not reported (1 in 1 cycle(s))
    Indication: Skin Cosmetic Procedure
    Start date: 2012-05-10
    End date: 2012-05-10

Dysport
    Dosage: not reported (1 in 1 cycle(s))
    Indication: Skin Wrinkling
    Start date: 2012-05-10
    End date: 2012-05-10

Other drugs received by patient: Topical Numbing Cream (Anaesthetics, Local); Orencia (Cytokines and Immunomodulators)



Possible Dysport side effects in 50 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-23

Patient: 50 year old male

Reactions: Dysstasia, Hypotonia

Drug(s) suspected as cause:
Baclofen
    Dosage: 134 ug (134 ug, 1 in 1 d), intrathecal, 96 ug (96 ug, 1 in 1 d), intrathecal;
    Indication: Muscle Spasticity

Dysport
    Dosage: 1000 units (1000 units, single cycle), intramuscular
    Indication: Muscle Spasticity
    Start date: 2012-04-23
    End date: 2012-04-23



Possible Dysport side effects in 81 year old female

Reported by a consumer/non-health professional from United Kingdom on 2012-07-23

Patient: 81 year old female, weighing 66.7 kg (146.7 pounds)

Reactions: Off Label Use, Fatigue, Dyspnoea, Muscular Weakness, Hypoaesthesia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Dysport
    Dosage: 150 units (150 units, single cycle), parenteral
    Indication: Off Label Use
    Start date: 2012-04-19
    End date: 2012-04-19

Dysport
    Dosage: 150 units (150 units, single cycle), parenteral
    Indication: Head Titubation
    Start date: 2012-04-19
    End date: 2012-04-19



Possible Dysport side effects in 67 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-17

Patient: 67 year old male

Reactions: Diplopia, Respiratory Disorder, Dysphagia, Head Injury, Dysphonia, Muscular Weakness

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Botox
    Dosage: 15 units, single
    Indication: Facial Spasm
    Start date: 2012-03-30
    End date: 2012-03-30

Dysport
    Dosage: 150 units, single
    Indication: Muscle Spasms
    Start date: 2012-03-30
    End date: 2012-03-30

Other drugs received by patient: Mianserine; Pramipexole Dihydrochloride; Modopar Gel Levodopa; Dihydroergotamine Mesylate; Amantadine HCL; Thiocolchicoside; Madopar Dispersibl; Polyethylene Glycol; Trospium Chloride



Possible Dysport side effects in 40 year old female

Reported by a individual with unspecified qualification from United States on 2012-07-12

Patient: 40 year old female, weighing 61.2 kg (134.6 pounds)

Reactions: Hyperaesthesia, Haemophilus Test Positive, Corynebacterium Test Positive, Synovial Cyst

Drug(s) suspected as cause:
Unspecified Dermal Filler(all Other Therapeutic Products)
    Indication: Skin Cosmetic Procedure
    Start date: 2006-01-01

Dysport
    Dosage: not reported (not reported,every six months)
    Indication: Skin Wrinkling

Other drugs received by patient: Synthroid; Unspecified Vitamins(vitamins Nos)



Possible Dysport side effects in 61 year old female

Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-07-12

Patient: 61 year old female

Reactions: Cellulitis, Tooth Extraction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dysport
    Dosage: 4 units (4 units,single cycle), intramuscular, 56 units (56 units,single cycle),intramuscular
    Indication: Off Label Use
    Start date: 2012-01-27
    End date: 2012-01-27

Dysport
    Dosage: 4 units (4 units,single cycle), intramuscular, 56 units (56 units,single cycle),intramuscular
    Indication: Skin Wrinkling
    Start date: 2012-01-27
    End date: 2012-01-27

Dysport
    Dosage: 4 units (4 units,single cycle), intramuscular, 56 units (56 units,single cycle),intramuscular
    Indication: Off Label Use
    Start date: 2012-02-10
    End date: 2012-02-10

Dysport
    Dosage: 4 units (4 units,single cycle), intramuscular, 56 units (56 units,single cycle),intramuscular
    Indication: Skin Wrinkling
    Start date: 2012-02-10
    End date: 2012-02-10

Methylmethacrylate(methylmethacrylate)(methylmethacrylate)
    Indication: Product Used FOR Unknown Indication



Possible Dysport side effects in 67 year old male

Reported by a consumer/non-health professional from France on 2012-07-09

Patient: 67 year old male

Reactions: Diplopia, Respiratory Disorder, Dysphagia, Dysphonia, Head Injury, Muscular Weakness

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Dysport
    Dosage: 150 units, single
    Indication: Muscle Spasms
    Start date: 2012-03-30
    End date: 2012-03-30

Botox
    Dosage: 15 units, single
    Indication: Facial Spasm
    Start date: 2012-03-30
    End date: 2012-03-30

Other drugs received by patient: Forlax; Amantadine HCL; Mianserine; Trospium Chloride; Modopar Gel Levodopa; Pramipexole Dihydrochloride; Dihydroergotamine Mesylate; Madopar Dispersibl; Thiocolchicoside



Possible Dysport side effects in female

Reported by a consumer/non-health professional from Slovenia on 2012-07-05

Patient: female

Reactions: Dysphagia, Tongue Paralysis

Drug(s) suspected as cause:
Dysport



Possible Dysport side effects in 64 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-05

Patient: 64 year old female

Reactions: Balance Disorder, Wrist Fracture, Vision Blurred, Fall, Asthenia

Drug(s) suspected as cause:
Dysport



Possible Dysport side effects in 40 year old female

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: 40 year old female, weighing 61.2 kg (134.6 pounds)

Reactions: Hyperaesthesia, Corynebacterium Test Positive, Haemophilus Test Positive, Culture Wound Positive, Synovial Cyst

Drug(s) suspected as cause:
Unspecified Dermal Filler (All Other Therapeutic Products)
    Indication: Skin Cosmetic Procedure

Dysport
    Dosage: every six months
    Indication: Skin Wrinkling
    Start date: 2006-01-01

Other drugs received by patient: Unspecified Vitamins (Vitamins Nos); Synthroid



Possible Dysport side effects in 61 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-11

Patient: 61 year old female, weighing 46.0 kg (101.2 pounds)

Reactions: Product Quality Issue, Off Label Use, Viith Nerve Paralysis

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Dysport

Dysport

Dysport
    Dosage: 80 units (80 units, single cycle), intramuscular
    Indication: Skin Wrinkling
    Start date: 2012-03-26
    End date: 2012-03-26

Dysport
    Dosage: 80 units (80 units, single cycle), intramuscular
    Indication: Off Label Use
    Start date: 2012-03-26
    End date: 2012-03-26

Other drugs received by patient: Multivitamin; Warfarin Sodium; Aspirin; Revatio; Veletri (Eporostenol Sodium); Tiazac



Possible Dysport side effects in 61 year old female

Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-05-31

Patient: 61 year old female

Reactions: Cellulitis, Tooth Extraction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Botulinum Toxin Type A

Dysport
    Dosage: 4 units (4 units, single cycle), intramuscular, 56 units (56 units, single cycle), intramuscular
    Indication: Skin Wrinkling
    Start date: 2012-01-27
    End date: 2012-01-27

Dysport
    Dosage: 4 units (4 units, single cycle), intramuscular, 56 units (56 units, single cycle), intramuscular
    Indication: Off Label Use
    Start date: 2012-01-27
    End date: 2012-01-27

Dysport
    Dosage: 4 units (4 units, single cycle), intramuscular, 56 units (56 units, single cycle), intramuscular
    Indication: Skin Wrinkling
    Start date: 2012-02-10
    End date: 2012-02-10

Dysport
    Dosage: 4 units (4 units, single cycle), intramuscular, 56 units (56 units, single cycle), intramuscular
    Indication: Off Label Use
    Start date: 2012-02-10
    End date: 2012-02-10



Possible Dysport side effects in female

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-05-24

Patient: female

Reactions: Convulsion

Drug(s) suspected as cause:
Dysport
    Dosage: 110 units (110 units, single cycle), intramuscular
    Indication: Off Label Use
    Start date: 2012-04-27
    End date: 2012-04-27

Dysport
    Dosage: 110 units (110 units, single cycle), intramuscular
    Indication: Skin Wrinkling
    Start date: 2012-04-27
    End date: 2012-04-27

Botulinum Toxin Type A



Possible Dysport side effects in female

Reported by a physician from United States on 2012-05-22

Patient: female, weighing 77.1 kg (169.6 pounds)

Reactions: Eyelid Oedema, Product Substitution Issue, Hypersensitivity, Visual Impairment, Eyelid Ptosis, Erythema

Drug(s) suspected as cause:
Dysport



Possible Dysport side effects in 61 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-17

Patient: 61 year old female, weighing 46.0 kg (101.2 pounds)

Reactions: Viith Nerve Paralysis

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Dysport
    Dosage: 80 units (80 units, single cycle), intramuscular
    Indication: Off Label Use
    Start date: 2012-03-26
    End date: 2012-03-26

Dysport
    Dosage: 80 units (80 units, single cycle), intramuscular
    Indication: Skin Wrinkling
    Start date: 2012-03-26
    End date: 2012-03-26

Other drugs received by patient: Veletri (Epoprostenol Sodium); Warfarin Sodium; Tiazac; Revatio; Multivitamin; Aspirin



Possible Dysport side effects in 63 year old female

Reported by a physician from United Kingdom on 2012-05-17

Patient: 63 year old female

Reactions: Dysphagia, Neck Pain, Musculoskeletal Pain

Drug(s) suspected as cause:
Dysport
    Dosage: 250 units (250 units, single cycle), intramuscular
    Indication: Torticollis
    Start date: 2011-07-07
    End date: 2011-07-07

Botulinum Toxin Type A



Possible Dysport side effects in 40 year old female

Reported by a consumer/non-health professional from United States on 2012-05-17

Patient: 40 year old female

Reactions: Corynebacterium Infection, Ovarian Cyst, Bronchitis Haemophilus

Drug(s) suspected as cause:
Dysport



Possible Dysport side effects in male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-05-17

Patient: male

Reactions: Pneumonia

Adverse event resulted in: death

Drug(s) suspected as cause:
Botulinum Toxin Type A

Dysport
    Dosage: not reported



Possible Dysport side effects in 45 year old female

Reported by a health professional (non-physician/pharmacist) from Ukraine on 2012-05-17

Patient: 45 year old female, weighing 80.0 kg (176.0 pounds)

Reactions: Guillain-Barre Syndrome, Influenza

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Dysport
    Dosage: 42 unit (42 units, single cycle)
    Indication: Skin Wrinkling
    Start date: 2011-11-23
    End date: 2011-11-23

Dysport
    Dosage: 42 unit (42 units, single cycle)
    Indication: Off Label Use
    Start date: 2011-11-23
    End date: 2011-11-23



Possible Dysport side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-15

Patient: female

Reactions: Henoch-Schonlein Purpura

Drug(s) suspected as cause:
Dysport



Possible Dysport side effects in

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-05-15

Patient:

Reactions: Pneumonia

Adverse event resulted in: death

Drug(s) suspected as cause:
Dysport
    Dosage: single cycle
    Indication: Drooling

Dysport
    Dosage: single cycle
    Indication: Off Label Use



Possible Dysport side effects in 45 year old female

Reported by a health professional (non-physician/pharmacist) from Ukraine on 2012-05-15

Patient: 45 year old female, weighing 80.0 kg (176.0 pounds)

Reactions: Guillain-Barre Syndrome, Apparent Life Threatening Event

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Dysport



Possible Dysport side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-15

Patient: female

Reactions: Vision Blurred, Eye Swelling, Eye Infection, Multiple Sclerosis, Eye Pain, Deformity of Orbit

Drug(s) suspected as cause:
Dysport
    Dosage: 50 units (50 units, single cycle), 50 units (50 units, single cycle)
    Indication: Skin Wrinkling
    Start date: 2012-02-22
    End date: 2012-02-22

Dysport
    Dosage: 50 units (50 units, single cycle), 50 units (50 units, single cycle)
    Indication: Off Label Use
    Start date: 2012-02-22
    End date: 2012-02-22

Dysport
    Dosage: 50 units (50 units, single cycle), 50 units (50 units, single cycle)
    Indication: Skin Wrinkling
    Start date: 2011-08-10
    End date: 2011-08-10

Dysport
    Dosage: 50 units (50 units, single cycle), 50 units (50 units, single cycle)
    Indication: Off Label Use
    Start date: 2011-08-10
    End date: 2011-08-10

Other drugs received by patient: Lipitor; YAZ; Perlane (Hyaluronic Acid)



Possible Dysport side effects in 40 year old female

Reported by a consumer/non-health professional from United States on 2012-05-09

Patient: 40 year old female

Reactions: Submandibular Mass, Haemophilus Test Positive, Corynebacterium Test Positive, Synovial Cyst

Drug(s) suspected as cause:
Botox Cosmetic
    Dosage: unk
    Indication: Skin Wrinkling
    Start date: 2011-01-01
    End date: 2011-01-01

Dysport
    Indication: Skin Wrinkling

Other drugs received by patient: Synthroid



Possible Dysport side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-09

Patient: female

Reactions: Henoch-Schonlein Purpura

Drug(s) suspected as cause:
Dysport



Possible Dysport side effects in female

Reported by a consumer/non-health professional from Australia on 2012-05-02

Patient: female

Reactions: Dysphagia, Stridor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dysport
    Dosage: 1500 units (1500 units, single cycle), parenteral
    Indication: Dystonia

Dysport
    Dosage: 1500 units (1500 units, single cycle), parenteral
    Indication: Off Label Use



Possible Dysport side effects in 48 year old female

Reported by a consumer/non-health professional from United States on 2012-04-30

Patient: 48 year old female, weighing 54.4 kg (119.7 pounds)

Reactions: Asthenopia, Upper-Airway Cough Syndrome, Eye Swelling, Viith Nerve Paralysis, Influenza Like Illness

Drug(s) suspected as cause:
Dysport



Possible Dysport side effects in 44 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-30

Patient: 44 year old female, weighing 60.8 kg (133.7 pounds)

Reactions: Wrong Technique in Drug Usage Process, Blepharospasm, Injection Site Pain, Eye Swelling, Reaction To Preservatives

Drug(s) suspected as cause:
Dysport



Possible Dysport side effects in 61 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-18

Patient: 61 year old female, weighing 58.0 kg (127.6 pounds)

Reactions: Anxiety, Viral Infection, Wrong Technique in Drug Usage Process, Palpitations, Sensory Disturbance, Muscular Weakness, Hypotonic Urinary Bladder

Drug(s) suspected as cause:
Dysport
    Dosage: 12 units (12 units, single cyle)
    Indication: Off Label Use
    Start date: 2012-02-24
    End date: 2012-02-24

Dysport
    Dosage: 12 units (12 units, single cyle)
    Indication: Skin Wrinkling
    Start date: 2012-02-24
    End date: 2012-02-24

Other drugs received by patient: Numbing Cream NOS (Anaesthetics FOR Topical Use); Calcium Carbonate; Wellbutrin; AN Unspecified Statin (Hmg COA Reductase Inhibitors)



Possible Dysport side effects in 29 year old female

Reported by a consumer/non-health professional from United States on 2012-04-16

Patient: 29 year old female, weighing 56.7 kg (124.7 pounds)

Reactions: Asthma, Blood Creatine Phosphokinase Increased, Aphasia, Thirst, Thinking Abnormal, Eyelid Ptosis, Feeling Abnormal, Aphonia, Lethargy

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Dysport

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