ANVISA Suspends All Clobutinol Syrups Over Serious Arrhythmia Risk
Summary
ANVISA determined on April 27, 2026, the suspension of sale and use of all medications containing clobutinol, an antitussive substance found in various syrups marketed in Brazil. The Pharmacovigilance Department concluded that risks associated with use of the products outweigh the benefits due to the risk of serious cardiac arrhythmia. The suspension is justified by the gravity of the arrhythmia risk and applies to all products containing this substance nationwide.
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GovPing monitors Brazil ANVISA for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 18 changes logged to date.
What changed
ANVISA issued Resolution RE 1.684/2026 ordering the immediate suspension of sale and use of all medications containing clobutinol, an antitussive substance used in various syrup products. The Pharmacovigilance Department determined that the serious risk of cardiac arrhythmia outweighs any therapeutic benefit, justifying the total market suspension.\n\nPharmaceutical companies marketing clobutinol-containing products in Brazil must immediately cease all commercialization and distribution. Healthcare providers should advise patients using these syrups to discontinue use and seek alternative treatments. This is a nationwide suspension covering all products with this active substance.
Archived snapshot
Apr 27, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
MEDICAMENTOS
Anvisa suspende venda de xarope por risco de arritmia grave
Produtos com a substância clobutinol não podem ser comercializados no país Compartilhe: Publicado em 27/04/2026 10h25 Atualizado em 27/04/2026 10h37
Foto: Freepik
A Agência Nacional de Vigilância Sanitária (Anvisa) determinou nesta segunda-feira (27/4) a suspensão de venda e uso de todos os medicamentos que contenham a substância c lobutinol, usada em diversos xaropes comercializados no Brasil.
Parecer da Gerência de Farmacovigilância da Agência avaliou que os ri scos associados ao uso dos produtos supera m os benefícios, devido ao risco de arritmia grave. Pela avaliação, a situação é suficientemente grave para justificar a suspensão do s medicamentos que contenham a substância.
Leia a Resolução (RE) 1.684/2026 no Diário Oficial da União.
Categoria Saúde e Vigilância Sanitária
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