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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, <1/10; Uncommon >1/1000, <1/100; Rare >1/10,000, < 1/1000.
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/TBI and axillary hyperhidrosis: (See Table 14.)
Click on icon to see table/diagram/imageFrequency of specific adverse reactions by indication: In addition, the following adverse reactions specific to individual indications were reported: (See Tables 15, 16, 17 and 18.)
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Click on icon to see table/diagram/imageFocal 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 19.)
Click on icon to see table/diagram/imageDysphagia 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 20.)
Click on icon to see table/diagram/imageSide effects may occur due to deep or misplaced injections of Dysport paralysing other nearby muscle groups. (See Tables 21, 22 and 23.)
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