Dysport Adverse Reactions

Very common >1/10; Common >1/100, <1/10; Uncommon >1/1000, <1/100; Rare > 1 /10 000, < 1/1000; Very rare <1 /10 000.
Side effects related to spread of toxin distant from the site of administration have been reported (exaggerated muscle weakness, dysphagia, aspiration/aspiration pneumonia, with fatal outcome in some very rare cases) (see Precautions).
General: In the clinical trial programme, approximately 28% of the patients treated with Botulinum toxin type A experienced an adverse event.
The following adverse reaction were seen in patients treated across variety of indications including blepharospasm, hemifacial spasm, torticollis and spasticity associated with either cerebral palsy or stroke: Nervous system disorders: Rare: Neuralgic amyotrophy.
Skin and subcutaneous tissue disorders: Uncommon: Itching.
Rare: Skin rashes.
General disorders and administration site conditions: Common: Generalised weakness, fatigue, flu-like syndrome, pain/bruising at injection site.
In addition, the following adverse reactions specific to individual indication were reported: Arm spasticity: Gastrointestinal disorders: Common: Dysphagia.
Musculoskeletal and connective tissue disorders: Common: Arm muscle weakness.
Injury poisoning and procedural complications: Common: Accidental injury/falls.
Paediatric cerebral palsy spasticity: Gastrointestinal disorders: Common: Diarrhoea.
Musculoskeletal and connective tissue disorders: Common: Leg muscle weakness, muscle pain.
Renal and urinary disorders: Common: Urinary incontinence.
General disorders and administration site conditions: Common: Abnormal gait.
Injury poisoning and procedural complications: Common: Accidental injury due to falling.
Accidental injury due to falling and abnormal gait may have been due to the over-weakening of the target muscle and/or the local spread of Botulinum Toxin Type A to other muscles involved in ambulation and balance.
Spasmodic torticollis: Nervous system disorders: Common: Headache, dizziness, facial paresis.
Eye disorders: Common: Blurred vision, visual acuity reduced.
Uncommon: Diplopia, ptosis.
Respiratory thoracic and mediastinal disorders: Common: Dysphonia, dyspnoea.
Rare: Aspiration.
Gastrointestinal disorders: Very common: Dysphagia, dry mouth.
Musculoskeletal and connective tissue disorders: Very Common: Muscle weakness.
Common: Neck pain, musculoskeletal pain, myalgia, pain in extremity, musculoskeletal stiffness.
Uncommon: Muscle atrophy, jaw disorder.
Dysphagia appeared to be dose related and occurred most frequently following injection into the sternomastoid muscle. A soft diet may be required until symptoms resolve.
These side effects may be expected to resolve within two to four weeks.
Blepharospasm and hemifacial spasm: Nervous system disorders: Common: Facial muscle weakness.
Uncommon: Facial paralysis.
Eye disorders: Very common: Ptosis.
Common: Diplopia, dry eyes, tearing.
Rare: Ophthalmoplegia.
Skin and subcutaneous tissue disorders: Common: Eyelid oedema.
Rare: Entropion.
Side effects may occur due to deep or misplaced injections of Botulinum Toxin Type A temporarily paralysing other nearby muscle groups.
Glabellar Lines: (See Table 4.)

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Post-marketing experience: The profile of adverse reactions reported to the Company during post-marketing use reflects the pharmacology of the product and those seen during clinical trials. In addition, hypersensitivity reactions have been reported.