Agomelatine 25mg tablets
Requires a prescription from a doctor or prescriber
Agomelatine is structurally closely related to melatonin.
Official documents, adverse reaction reporting, and safety monitoring
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Official medicine documents
Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
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Suspected adverse reactions reported for Agomelatine
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Report a side effect
Submit a Yellow Card report to the MHRA
Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
The European Medicines Agency (EMA) collects suspected adverse reaction reports from across the EU/EEA through the EudraVigilance system. Search for safety data on this medicine.
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Suspected adverse reactions reported for Agomelatine
About EudraVigilance
Learn about EU pharmacovigilance and safety monitoring
EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
14 branded products available
MHRA licensed products
View all licensed products for Agomelatine on the MHRA register
Valdoxan 25mg tablets
Valdoxan 25mg tablets
Agomelatine 25mg tablets
Agomelatine 25mg tablets
Agomelatine 25mg tablets
Agomelatine 25mg tablets
This is the NHS Drug Tariff indicative price used for reimbursement purposes. It may not reflect the price paid by patients or pharmacies.
View full Drug TariffSource: NHS Drug Tariff via NHSBSA. Derived from dm+d VMPP (Virtual Medicinal Product Pack) pricing data. Contains public sector information licensed under the Open Government Licence v3.0.
WHO defined daily dose (DDD)
25 mg
Not a recommended dose. The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. It is a statistical measure used for research and comparison purposes only.
Source: WHO Collaborating Centre for Drug Statistics Methodology, distributed via the NHS dm+d supplementary BNF/ATC mapping files (NHSBSA). Contains public sector information licensed under the Open Government Licence v3.0.
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Guidelines from the National Institute for Health and Care Excellence
NICE clinical guidance(2)
Agomelatine for the treatment of major depressive episodes (terminated appraisal) (TA231)
Vortioxetine for treating major depressive episodes (TA367)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
Check stock at pharmacies and supply information
Pharmacy stock checkers
Search for this medicine at major UK pharmacy chains. These links open the retailer's own website — results depend on their current online catalogue.
Supply & safety information
Official UK regulator monitoring and safety alerts
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. Shortage and safety information sourced from MHRA drug safety updates (gov.uk, Crown Copyright under OGL v3.0).
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF code shown is the factual mapping value distributed by NHS Business Services Authority (NHSBSA) in the dm+d supplementary file under OGL v3.0; it is not affiliated with, nor licensed from, the publishers of the British National Formulary. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 16 · Randomised trials: 10 · 2002–2025
Showing the 50 most relevant studies, sorted by most relevant.
David Taylor, Anna Sparshatt, Sanskriti Varma, et al.
BMJ, 2014
- Acetamides
- Antidepressive Agents
- Depression
Markus Koesters, Giuseppe Guaiana, Andrea Cipriani, et al.
The British Journal of Psychiatry, 2013
- Acetamides
- Antidepressive Agents
- Depressive Disorder, Major
Yicong Chen, Jianle Li, Mengshi Liao, et al.
International Clinical Psychopharmacology, 2023
A. Gędek, Szymon Modrzejewski, Michał Materna, et al.
International Journal of Molecular Sciences, 2024
Stefanou, Anastasios, Samara, Myrto T., Lappas, Andreas S., et al.
2025
Silka Dawn Freiesleben, Karolina Furczyk
Journal of Molecular Psychiatry, 2015
Yue-Han Guo, Le Zhou, Zihan Cui, et al.
Medicine, 2023
Dan J Stein, J. Khoo, F. Picarel-Blanchot, et al.
Advances in Therapy, 2021
Surendra Prasad Singh, Vidhi Singh, Nilamadhab Kar
The International Journal of Neuropsychopharmacology, 2011
- Acetamides
- Antidepressive Agents
- Depressive Disorder, Major
Sheng-Min Wang, Y. Woo, Nak-Young Kim, et al.
Clinical Psychopharmacology and Neuroscience, 2020
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
1 found
Half-life
2 hours
Mechanism
The novel antidepressant agent, agomelatine, behaves as an agonist at melatonin…
Food interactions
None known
Human targets
3 targets
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
5%
Half-life
2 hours
Protein binding
95%
Metabolism
90%
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
The development for the US market was discontinued in October 2011. It is currently sold in Australia under the Valdoxan trade name.
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 1035 interactions
How the body processes this drug — absorption, distribution, metabolism, and elimination
Proteins and enzymes this drug interacts with in the body
PMID:12970106 PMID:18703043 PMID:19057895 PMID:29398112 PMID:7895773
Also functions as a receptor for various drugs and psychoactive substances, including ergot alkaloid derivatives, 1-2,5,-dimethoxy-4-iodophenyl-2-aminopropane (DOI) and lysergic acid diethylamide (LSD) .
PMID:19057895 PMID:29398112
Ligand binding causes a conformation change that triggers signaling via guanine nucleotide-binding proteins (G proteins) and modulates the activity of downstream effectors .
PMID:18703043 PMID:29398112
HTR2C is coupled to G(q)/G(11) G alpha proteins and activates phospholipase C-beta, releasing diacylglycerol (DAG) and inositol 1,4,5-trisphosphate (IP3) second messengers that modulate the activity of phosphatidylinositol 3-kinase and promote the release of Ca(2+) ions from intracellular stores, respectively .
PMID:18703043 PMID:29398112
Beta-arrestin family members inhibit signaling via G proteins and mediate activation of alternative signaling pathways .
PMID:29398112
Regulates neuronal activity via the activation of short transient receptor potential calcium channels in the brain, and thereby modulates the activation of pro-opiomelanocortin neurons and the release of CRH that then regulates the release of corticosterone (By similarity). Plays a role in the regulation of appetite and eating behavior, responses to anxiogenic stimuli and stress (By similarity). Plays a role in insulin sensitivity and glucose homeostasis (By similarity)
Possibly involved in sleep induction, by melatonin activation of the potassium channel KCNMA1/BK and the dissociation of G-beta and G-gamma subunits, thereby decreasing synaptic transmission (By similarity)
Enzymes involved in drug metabolism — important for understanding drug interactions
ATC N06AX22
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Agomelatine
Additional database identifiers
ChemSpider
74141
BindingDB
50035179
PDB
AWY
ZINC
ZINC000000005608
HUGO Gene Nomenclature Committee (HGNC)
HGNC:5295
GenAtlas
HTR2C
GeneCards
HTR2C
GenBank Gene Database
M81778
GenBank Protein Database
338028
Guide to Pharmacology
8
UniProt Accession
5HT2C_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:7463
GenAtlas
MTNR1A
GeneCards
MTNR1A
GenBank Gene Database
U14108
GenBank Protein Database
602130
Guide to Pharmacology
287
UniProt Accession
MTR1A_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:7464
GenAtlas
MTNR1B
GeneCards
MTNR1B
GenBank Gene Database
U25341
GenBank Protein Database
971194
Guide to Pharmacology
288
UniProt Accession
MTR1B_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2596
GenAtlas
CYP1A2
GeneCards
CYP1A2
GenBank Gene Database
Z00036
Guide to Pharmacology
1319
UniProt Accession
CP1A2_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2623
GenAtlas
CYP2C9
GeneCards
CYP2C9
GenBank Gene Database
AY341248
Guide to Pharmacology
1326
UniProt Accession
CP2C9_HUMAN
DrugBank citations
If you use DrugBank data in your research, please cite the following publications:
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Structured knowledge from the free knowledge base
ATC classifications (Wikidata)
Linked open data from Wikidata (Q395229), a free and open knowledge base operated by the Wikimedia Foundation. Data is available under the Creative Commons CC0 1.0 Public Domain Dedication. WHO INN from the World Health Organization.