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),
Diplopia (7),
Off Label Use (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 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 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 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 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 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 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 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 France on 2012-05-09
Patient: female
Reactions: Henoch-Schonlein Purpura
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 2012-05-09
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 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 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 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 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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