El medicamento LEDAGA 160 MICROGRAMOS/G GEL con los principios activos CLORMETINA tiene la siguiente información en la sección 4.8
Resumen del perfil de seguridad

En un ensayo controlado y aleatorizado (n = 128 pacientes expuestos a Ledaga durante una mediana de 52 semanas), las reacciones adversas a Ledaga más frecuentes fueron reacciones cutáneas: dermatitis (54,7 %; p. ej., irritación, eritema, exantema, urticaria, quemazón y dolor), prurito (20,3 %), infecciones (11,7 %), formación de úlceras y ampollas (6,3 %) e hiperpigmentación de la piel(5,5 %). Se notificaron reacciones de hipersensibilidad cutánea en el 2,3 % de los pacientes tratados.

Tabla de reacciones adversas

A continuación se presentan las reacciones adversas a Ledaga notificadas en un ensayo controlado con principio activo en pacientes con LCCT-MF. Las frecuencias se definen mediante la siguiente convención: muy frecuentes (≥1/10); frecuentes (≥1/100 a <1/10); poco frecuentes (≥1/1.000 a < 1/100); raras (≥1/10.000 a <1/1.000); muy raras (<1/10.000); frecuencia no conocida (no puede estimarse a partir de los datos disponibles). Dentro de cada grupo de frecuencias, las reacciones adversas se presentan en orden decreciente de gravedad.

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)

Pacientes de edad avanzada

En el ensayo clínico controlado, el 31 % (79/255) de la población del estudio tenía 65 años o más. El perfil de seguridad observado en los pacientes de edad avanzada coincidió con el observado en la población total de pacientes.

Notificación de sospechas de reacciones adversas

Es importante notificar sospechas de reacciones adversas al medicamento tras su autorización. Ello permite una supervisión continuada de la relación beneficio/riesgo del medicamento. Se invita a los profesionales sanitarios a notificar las sospechas de reacciones adversas a través del Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano: www.notificaRAM.es