|Very common >1/10: Common >1/100, <1/10: Uncommon >1/1000, <1/100: Rare >1/10000, < 1/1000: Very rare <1/10000.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 section 4.4). |
GeneralIn the clinical trial programme, approximately 28% of the patients treated with Dysport experienced an adverse event.The following adverse reactions were seen in patients treated across a variety of indications including blepharospasm, hemifacial spasm, torticollis and spasticity associated with either cerebral palsy or stroke:
Nervous system disordersRare: Neuralgic amyotrophy
Skin and subcutaneous tissue disordersUncommon: Itching Rare: Skin rashes
General disorders and administration site conditionsCommon: Generalised weakness, fatigue, flu-like syndrome, pain / bruising at injection siteIn addition, the following adverse reactions specific to individual indications were reported:
Gastrointestinal disordersCommon: Dysphagia
Musculoskeletal and connective tissue disorders Common: Arm muscle weakness
Injury, poisoning and procedural complications Common: Accidental injury/falls
Paediatric cerebral palsy spasticity
Gastrointestinal disordersCommon: 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 fallingAccidental 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 Dysport to other muscles involved in ambulation and balance.
Nervous system disordersCommon: Headache, dizziness, facial paresis
Eye disorders Common: Blurred vision, reduced visual acuity Uncommon: Diplopia, ptosis
Respiratory, thoracic and mediastinal disordersCommon: Dysphonia, dyspnoeaRare: Aspiration
Gastrointestinal disordersVery common: Dysphagia, dry mouth
Musculoskeletal and connective tissue disorders Very Common: Muscle weaknessCommon: Neck pain, musculoskeletal pain, myalgia, pain in extremity, musculoskeletal stiffness Uncommon: Muscle atrophy, jaw disorderDysphagia 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 disordersCommon: Facial muscle weakness Uncommon: Facial paralysis
Eye disordersVery common: Ptosis Common: Diplopia, dry eyes, tearing Rare: Ophthalmoplegia
Skin and subcutaneous tissue disordersCommon: Eyelid oedema Rare: EntropionSide effects may occur due to deep or misplaced injections of Dysport temporarily paralysing other nearby muscle groups.
Post-marketing experienceThe 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.