Acetato de ulipristal para fibromas uterinos
Esmya
Revisado por pares por Sid DajaniÚltima actualización por Michael Stewart, MRPharmSÚltima actualización 20 Sept 2024
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Clinical author's note: Michael Stewart 04/03/2021: following a temporary licence suspension and review into liver safety, additional restrictions and safety measures are now in place for Esmya® (ulipristal).
Rare cases of serious liver damage have occurred in people taking Esmya® (ulipristal) for uterine fibroids
Blood tests are needed before, during and after treatment with Esmya® to check your liver is working normally
If you notice any signs of liver damage, including yellowing of the skin or eyes, dark urine, or nausea or vomiting, stop taking Esmya® and contact your doctor immediately
Your doctor will discuss both the risks and benefits of your treatment. A patient alert card describing the risk of liver injury should be given to you with your packet of medicine.
Clinical author's note: Michael Stewart 20/02/2018: temporary safety measures have been put in place for Esmya® (ulipristal) following five reports of serious liver injury in women taking this medicine for uterine fibroids. Contact your doctor or pharmacist for advice if you have any concerns. This issue does not affect ulipristal when taken as a single one-off dose for emergency contraception using EllaOne®.
Ulipristal acetate is a female hormone treatment.
Take one tablet daily.
The most common side-effects are no periods, hot flushes, and headache.
De un vistazo
Ulipristal acetate (Esmya®) is a medicine for treating heavy or painful periods caused by uterine fibroids.
It works by blocking the effects of the hormone progesterone, which helps shrink fibroids.
You will take one tablet daily for up to four months, possibly on two occasions.
Blood tests are needed before, during, and after treatment to check your liver function.
Avoid grapefruit juice and use barrier contraception while taking this medicine and for 12 days after.
If you notice signs of liver damage like yellow skin or dark urine, stop the medicine and contact your doctor.
About ulipristal acetate for uterine fibroids
Tipo de medicamento | A progesterone receptor modulator |
Usado para | Fibroids in the uterus |
También llamado | Esmya® |
Disponible como | Comprimidos |
Ulipristal acetate works by blocking the effects of the female hormone progesterone. There are two brands of ulipristal acetate tablets available. The two brands of tablet have different uses and contain different amounts of ulipristal acetate. Low-strength tablets (Esmya® brand containing 5 mg ulipristal acetate) are used to treat heavy or painful periods caused by uterine fibroids. This leaflet discusses ulipristal acetate when it is prescribed for this purpose. More information is available about the higher strength of ulipristal acetate tablet (EllaOne® brand) in the medicine leaflet called Anticoncepción hormonal de emergencia.
Fibroids (which are also known as myomas) are non-cancerous growths in the womb (uterus). They can sometimes cause heavy or painful periods, tummy swelling and urinary problems. Surgery is the most common treatment for fibroids which cause symptoms. Ulipristal acetate is prescribed to reduce the size of the fibroids before the surgery.
The female hormone progesterone is thought to play a role in the development of fibroids. Ulipristal acetate works by blocking the effects of progesterone. This stops the fibroids from growing and they shrink in size.
Before taking ulipristal acetate for uterine fibroids
Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking ulipristal acetate for uterine fibroids it is important that your doctor knows:
Si estás embarazada o amamantando.
If you have severe asthma.
Si tienes algún problema con el funcionamiento de tu hígado, o algún problema con el funcionamiento de tus riñones.
If you have breast cancer, or cancer of the womb (uterus), neck of the womb (cervix), or ovaries.
Si alguna vez has tenido una reacción alérgica a un medicamento.
Si está tomando otros medicamentos. Esto incluye cualquier medicamento que esté tomando y que esté disponible para comprar sin receta, así como medicamentos herbales y complementarios.
How to take ulipristal acetate for uterine fibroids
Before you start the treatment, read the manufacturer's printed information leaflet from inside the pack. It will give you more information about ulipristal acetate and will provide you with a full list of the side-effects which you may experience from taking it.
Take ulipristal acetate exactly as your doctor tells you to. You will be asked to start taking the tablets during a week you are having a period. Continue to take one 5 mg tablet each day. You will be prescribed the tablets for a maximum of four months, possibly on two occasions.
You can take ulipristal acetate tablets before or after food. Swallow the tablets with a drink of water.
If you forget to take a dose, take it as soon as you remember unless you are more than 12 hours late. If you are more than 12 hours late, leave out the forgotten dose and take your next tablet at the usual time. Do not take two tablets together to make up for a missed dose.
Obteniendo el máximo de tu tratamiento
Intenta mantener tus citas regulares con tu médico. Esto es para que tu médico pueda verificar tu progreso.
You should avoid getting pregnant both while you are taking ulipristal acetate and for at least 12 days after stopping taking it. Please use a barrier method of contraception (such as a condom), as hormonal methods of contraception are not suitable with ulipristal acetate. If you need further contraceptive advice, please speak with your doctor.
Do not drink grapefruit juice while you are on ulipristal acetate. This is because a chemical in grapefruit juice can increase the amount of ulipristal acetate in your bloodstream. This could make side-effects more likely.
Can ulipristal acetate tablets cause problems?
Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with ulipristal acetate. You will find a full list in the manufacturer's information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine but speak with your doctor or pharmacist if any of the following continue or become troublesome.
Very common ulipristal acetate side-effects (these affect more than 1 in 10 women) | ¿Qué puedo hacer si experimento esto? |
No periods during the treatment and for a few weeks afterwards, thickening of the lining of the womb (uterus) | Your doctor will discuss these with you before you start the treatment |
Common ulipristal acetate side-effects (these affect fewer than 1 in 10 women) | ¿Qué puedo hacer si experimento esto? |
Headache, other aches or pains | Bebe mucha agua y pide a tu farmacéutico que te recomiende un analgésico adecuado. Si el dolor persiste, informa a tu médico |
Sensación de mareo o cansancio | No conduzca ni utilice herramientas o máquinas mientras esté afectado |
Sensación de malestar (náuseas), dolor de barriga (abdominal) | Stick to simple meals - avoid rich and spicy foods |
Acne, increased weight, breast tenderness, hot flushes | Si alguno de estos se vuelve problemático, hable con su médico |
Importante: rare cases of serious liver damage have occurred in people taking Esmya® (ulipristal) for uterine fibroids:
Blood tests are needed before, during and after treatment with Esmya® to check your liver is working normally.
If you notice any signs of liver damage, including yellowing of the skin or eyes, dark urine, or nausea or vomiting, stop taking Esmya® and contact your doctor immediately.
Si experimenta cualquier otro síntoma que crea que puede deberse a las tabletas, por favor hable con su médico o farmacéutico para obtener más consejos.
How to store ulipristal acetate
Mantenga todos los medicamentos fuera del alcance y la vista de los niños.
Almacenar en un lugar fresco y seco, lejos del calor y la luz directos.
Información importante sobre todos los medicamentos
Información importante sobre todos los medicamentos
Nunca tome más de la dosis prescrita. Si sospecha que usted u otra persona podría haber tomado una sobredosis de este medicamento, acuda al departamento de accidentes y emergencias de su hospital local. Lleve el envase con usted, incluso si está vacío.
Este medicamento es para ti. Nunca lo des a otras personas, incluso si su condición parece ser la misma que la tuya.
If you are having an operation or dental treatment, please tell the person carrying out the treatment which medicines you are taking.
If you buy any medicines, check with a doctor or pharmacist that they are suitable for you to take with your other medicines.
No guardes medicamentos caducados o no deseados. Llévalos a tu farmacia local, que se encargará de desecharlos por ti.
Si tienes alguna pregunta sobre este medicamento, consulta a tu farmacéutico.
Informar efectos secundarios de un medicamento o vacuna
Si experimenta efectos secundarios, puede reportarlos en línea a través de Sitio web de Yellow Card.

¿Inseguro sobre mezclar medicamentos?
Verifica posibles interacciones entre medicamentos, suplementos y alimentos antes de tomarlos juntos.
Preguntas frecuentes
Can I take ulipristal acetate if I am approaching menopause?
The article states that ulipristal acetate (Esmya®) is used to treat heavy or painful periods caused by uterine fibroids. It does not provide information specifically about its use or suitability for women approaching menopause. If you have concerns about your menopausal status and fibroid treatment, your doctor can advise you.
What should I do if I get pregnant while taking ulipristal acetate?
The article advises avoiding pregnancy both during treatment and for at least 12 days after stopping ulipristal acetate, and to use a barrier method of contraception. It does not specify what to do if pregnancy occurs despite these precautions. You should speak with your doctor for advice if you suspect you are pregnant while taking this medicine.
How long will it take for the fibroids to shrink after starting ulipristal acetate?
The article explains that ulipristal acetate works by blocking the effects of progesterone, which stops fibroids from growing and causes them to shrink in size. However, it does not specify an exact timeframe for when this shrinkage will become noticeable. Your doctor will monitor your progress during treatment.
Are there any alternative treatments for fibroids if ulipristal acetate is not suitable for me?
The article mentions that surgery is the most common treatment for fibroids that cause symptoms, and ulipristal acetate is prescribed to reduce the size of fibroids before surgery. It also lists conditions that might make ulipristal acetate unsuitable, such as liver problems or certain cancers. It does not detail specific alternative non-surgical treatments beyond ulipristal acetate. Your doctor can discuss all suitable treatment options with you.
Can ulipristal acetate affect my mood or mental health?
The article lists common side-effects of ulipristal acetate, including headache, dizziness, tiredness, nausea, abdominal pain, acne, increased weight, breast tenderness, and hot flushes. It does not mention any side-effects related to mood changes or mental health. If you experience any symptoms you are concerned about, you should speak with your doctor.
Can I resume my hormonal contraception after stopping ulipristal acetate?
The article states that hormonal methods of contraception are not suitable while taking ulipristal acetate and advises using a barrier method. It also says to avoid pregnancy for at least 12 days after stopping the medication. It does not specify when it would be safe to resume hormonal contraception. You should speak with your doctor for further contraceptive advice.
What happens if I stop taking ulipristal acetate earlier than prescribed?
The article instructs to take ulipristal acetate exactly as your doctor tells you, and to continue for a maximum of four months, possibly on two occasions. It does not explain the consequences of stopping the treatment early. It is important to discuss any changes to your medication schedule with your doctor to ensure effective treatment and avoid potential issues.
Lecturas adicionales y referencias
- Manufacturer's PIL, Esmya® 5 mg tablets (ulipristal acetate); Gedeon Richter (UK) Ltd, The electronic Medicines Compendium. Dated January 2021.
- Medicamentos Completos BNF 89ª Edición; Asociación Médica Británica y Sociedad Real de Farmacia de Gran Bretaña, Londres.
Sobre el autorVer biografía completa

Michael Stewart, MRPharmS
Gerente de Revisión de Folletos de Medicamentos – Contratista, Farmacéutico
BPharm (Hons), MRPharmS
Michael es un farmacéutico comunitario que ejerce en Midlands y South Yorkshire con más de 20 años de experiencia asesorando sobre medicamentos y condiciones médicas. Tiene una sólida formación en capacitación en atención médica, habiendo producido e impartido cursos de formación para equipos de farmacia y personal de entornos de atención residencial, incluidas enfermeras. También ha contribuido a juntas asesoras de farmacia para la gestión de condiciones de baja gravedad en la comunidad.
Acerca del revisor

Sid Dajani
Sultan Dajani se graduó en la Escuela de Farmacia de Londres en 1994 y se convirtió en el miembro más joven elegido para el consejo de la Sociedad Real de Farmacia desde su fundación en 1842.
Historial del artículo
La información en esta página está escrita y revisada por pares por clínicos calificados.
Artículo también disponible en Inglés, Alemán, Español, Francés, Italiano, Portugués, Hindi, Hebreo, Árabe, y Sueco.
Next review due: 25 Sept 2027
20 Sept 2024 | Última versión

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