Index of reports
> Cases with Off Label Use (7)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Dysport (Botulinum Toxin Type A) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.
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 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 individual with unspecified qualification from United States on 2012-03-22
Patient: 61 year old female, weighing 58.0 kg (127.6 pounds)
Reactions: Anxiety, Off Label Use, Sensory Disturbance, Muscular Weakness, Bladder Disorder, Feeling Abnormal
Drug(s) suspected as cause:
Dysport
Other drugs received by patient: Calcium Carbonate; Wellbutrin
Possible Dysport side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-16
Patient: female
Reactions: Eyelid Oedema, Headache, Paraesthesia, Burning Sensation, Off Label Use, Hyperaesthesia, Eyelid Function Disorder, Eyelid Ptosis, Cerebral Thrombosis, Neuralgia
Drug(s) suspected as cause:
Dysport
Dosage: not reported (not reported, single cycle), parenteral
Indication: Off Label Use
Start date: 2011-09-26
End date: 2011-09-26
Dysport
Dosage: not reported (not reported, single cycle), parenteral
Indication: Skin Wrinkling
Start date: 2011-09-26
End date: 2011-09-26
Dysport
Other drugs received by patient: Unnamed Numbing Agent (Anaesthetics FOR Topical Use)
Possible Dysport side effects in 49 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-14
Patient: 49 year old female, weighing 55.8 kg (122.8 pounds)
Reactions: Off Label Use, Product Quality Issue, Wrong Technique in Drug Usage Process, Angioedema, Dizziness
Drug(s) suspected as cause:
Dysport
Dosage: 85 units (85 units,single cycle)
Indication: Skin Wrinkling
Start date: 2011-08-23
End date: 2011-08-23
Dysport
Dosage: 85 units (85 units,single cycle)
Indication: Skin Cosmetic Procedure
Start date: 2011-08-23
End date: 2011-08-23
Dysport
Dosage: 85 units (85 units,single cycle)
Indication: Off Label Use
Start date: 2011-08-23
End date: 2011-08-23
Other drugs received by patient: Fish OIL (Fish Oil); Prilosec; Multivitamins (Multivitamin / 00831701 / ); Calcium W / Vitamin D NOS (Vitacal)
Possible Dysport side effects in 44 year old female
Reported by a health professional (non-physician/pharmacist) from Australia on 2011-10-26
Patient: 44 year old female, weighing 63.0 kg (138.6 pounds)
Reactions: Back Pain, Off Label Use, Product Quality Issue, Urinary Retention, Epstein-Barr Virus Antibody Positive, Muscle Spasms, Influenza Like Illness
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Dysport
Dosage: 300 units (300 units, single cycle), intramuscular
Indication: Off Label Use
Start date: 2011-08-13
End date: 2011-08-13
Dysport
Dosage: 300 units (300 units, single cycle), intramuscular
Indication: Myalgia
Start date: 2011-08-13
End date: 2011-08-13
Possible Dysport side effects in 44 year old female
Reported by a health professional (non-physician/pharmacist) from Australia on 2011-10-05
Patient: 44 year old female, weighing 63.0 kg (138.6 pounds)
Reactions: Back Pain, Nausea, Off Label Use, Malaise, Pelvic Floor Muscle Weakness, Urinary Retention, Epstein-Barr Virus Antibody Positive, Asthenia, Muscle Spasms, Lethargy, Influenza Like Illness
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Dysport
Dosage: 300 units (300 units, single cycle), intramuscular
Indication: Myalgia
Start date: 2011-08-13
End date: 2011-08-13
Dysport
Dosage: 300 units (300 units, single cycle), intramuscular
Indication: Off Label Use
Start date: 2011-08-13
End date: 2011-08-13
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