What is the warning for agomelatine?

Agomelatine is a medication that is used to treat depression in adults. While it is generally well-tolerated by most individuals, there are some warnings and precautions that should be considered before starting treatment with agomelatine:

  1. Liver function: Agomelatine can affect liver function, and individuals with pre-existing liver disease or elevated liver enzymes should be monitored closely while taking the medication. In rare cases, agomelatine can cause severe liver injury, and individuals experiencing symptoms such as jaundice, abdominal pain, or dark urine should seek medical attention immediately.
  2. Suicidal thoughts and behavior: Like other antidepressant medications, agomelatine may increase the risk of suicidal thoughts and behavior, particularly in children, adolescents, and young adults. Individuals should be closely monitored for signs of suicidal ideation or behavior while taking agomelatine.
  3. Pregnancy: The safety of agomelatine during pregnancy is not well-established, and it should only be used during pregnancy if the potential benefits outweigh the potential risks to the fetus.
  4. Other medications: Agomelatine may interact with other medications, particularly those that affect liver function or serotonin activity in the brain. Individuals should inform their healthcare provider of all medications, supplements, and herbal remedies they are taking before starting treatment with agomelatine.

It is important to discuss potential risks and benefits with a healthcare provider before starting treatment with agomelatine. Individuals should also follow all instructions for taking the medication and report any concerning side effects or changes in mood or behavior to their healthcare provider.

There are various forms of drugs available, such as tablets or liquids, and each may have a separate patient information leaflet (PIL) for different doses. It is important to refer to the PIL for the specific form and dose of the drug that you have been prescribed.

You can search for further information and PILs on websites such as:

  • The British National Formulary (BNF)
  • Electronic medicines compendium (emc)
  • The National Library of Medicine's DailyMed
  • The Food and Drug Administration (FDA) 
  • Different drug forms like tablets or liquids have specific patient information leaflets (PIL) for various doses. Refer to the PIL for your prescribed drug form and dose.

    Search for PILs on websites like:


    • ANSM (Agence nationale de sécurité du médicament et des produits de santé): ansm.sante.fr


    • AEMPS (Agencia Española de Medicamentos y Productos Sanitarios): aemps.gob.es


    • BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte): bfarm.de


    For questions about your medication:

    • Consult your doctor, a healthcare professional, or a pharmacist


    • Contact SOS Médecins: 3624
    • For mental health support, contact SOS Suicide: 01 45 39 40 00

    Belgium (French)

    Switzerland (French)

    • La Main Tendue: 143
    • Website: 143.ch

    Canada (French)

    • Centre de prévention du suicide du Québec: 1 866 APPELLE (1 866 277-3553)
    • Website: cpsquebec.ca


    • Contact emergency number: 112
    • For mental health support, contact Teléfono de la Esperanza: 717 003 717


    • Contact emergency number: 112
    • For mental health support, contact Telefonseelsorge: 0800 111 0 111 or 0800 111 0 222


    • Contact emergency number: 112
    • For mental health support, contact Telefono Amico: 199 284 284


    • Contact emergency number: 112
    • For mental health support, contact 113 Zelfmoordpreventie: 0800 0113


    • Contact emergency number: 112
    • For mental health support, contact Sos Voz Amiga: 21 354 45 45, 91 280 26 69, or 96 352 46 60

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