Dysport Adverse Reactions

General: Side effects related to spread of toxin distant from the site of administration have been reported, such as dry mouth, exaggerated muscle weakness, dysphagia, aspiration/aspiration pneumonia, with fatal outcome in some very rare cases (see Precautions). Hypersensitivity reactions have also been reported post-marketing.
The frequency of adverse reactions reported in placebo-controlled trials after a single administration is defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
The following adverse reactions were seen in patients treated across a variety of indications including blepharospasm, hemifacial spasm, torticollis, spasticity associated with either cerebral palsy or stroke/TBI and axilliary hyperhidrosis: see Table 13.

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Frequency of specific adverse reactions by indication: In addition, the following adverse reactions specific to individual indications were reported: see Tables 14, 15, 16 and 17.

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Focal spasticity of upper and lower limbs in paediatric cerebral palsy patients, two years of age or older: When treating upper and lower limbs concomitantly with Dysport at a total dose of up to 30 U/kg or 1000 U whichever is lower, there are no safety findings in addition to those expected from treating either upper limb or lower limb muscles alone. (See Table 18.)

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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. (See Table 19.)

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Side effects may occur due to deep or misplaced injections of Dysport temporarily paralysing other nearby muscle groups. (See Tables 20, 21 and 22.)

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Post-marketing experience: see Table 23.

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