Registration Dossier
Registration Dossier
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EC number: 206-662-9 | CAS number: 364-62-5
Endpoint summary
Administrative data
Description of key information
Metoclopramide is known to sometimes cause short-term side effects on the nervous system that result in unintentional movements such as twitches and nervous tics and these are commoner in children and young people, and at high doses.
Extrapyramidal disorders constituted nearly half of all spontaneously reported adverse effects in a manufacturer database (1749 cases out of 4005, up to December 2011). There were also a significant number of reports of overdose in children, particularly with oral liquid formulations.
Metoclopramide. EMEA [Internet]. European Medicines agency. Available from: http://www.ema.europa.eu/ema/
For these adverse effects the substance is classified as STOT SE 1 H370.
Other nervous system side effects may occur when metoclopramide is used for prolonged periods and may occur more often in the elderly.
The reporting rate for these disorders was calculated to be 6 times higher in children than in adults, although it was not possible to accurately account for usage patterns in different age-groups. Elderly patients seemed to be more at risk of potentially irreversible tardive dyskinesia after longer term treatment.
These types of adverse effects are already considered for the classification as STOT SE 1; therefore, the substance is not classified for STOT RE.
Additional information
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