Lithium carbonate Pregnancy: see this medicine in the DysNet teratogen register

ATC N05AN01 · WHO DDD 24 mmol (oral) · 400 mg prolonged-release tablet

Class: Antipsychotics (lithium). ATC code N05AN01 stands for "lithium" in the WHO index, whose DDD is 24 mmol by the oral route [1].

The WHO DDD is expressed in mmol of lithium; 400 mg of lithium carbonate contain 10.83 mmol of lithium. [2]

WHO Model List of Essential Medicines 2025: listed, core list [3].

Indications on the WHO list (1)
  • Bipolar or related disorders · core list · 24. Medicines for mental and behavioural disorders 24.2. Medicines for mood disorders 24.2.2. Medicines for bipolar disorders · first added 1977

The WHO electronic list states that the 2025 PDF lists are binding: adults’ list, children’s list.

Summary by country, in euros at the ECB rate of 9 October 2026 [4]
CountryPacksKind of figure Cost per DDDAnnual cost at the WHO standard dose
France 1 List price €0.44 €160.20
Spain 1 List price €0.42 €154.86
United Kingdom 1 Reimbursement tariff €0.49 €177.54 £150.49

Names, authorisations and literature

Trade names (21)
France (5)
TERALITHE, TERALITHE LP, GRANIONS DE LITHIUM*, LITHIODERM*, LITHIUM OLIGOSOL* [5] [6]
Spain (1)
PLENUR [7]
Italy (4)
CARBOLITHIUM, LITIO CARBONATO L.F.M., LITIO CARBONATO NOVA ARGENTIA, RESILIENT [6]
United States (1)
Lithobid [6]
United States, discontinued (5)
Eskalith, Eskalith Cr, Lithane, Lithonate, Lithotabs [6]
Canada (5)
APO-LITHIUM CARBONATE, CARBOLITH, LITHANE, LITHMAX, PMS-LITHIUM CARBONATE [6]
In other languages
carbonate de lithium (French); Lithiumcarbonat (German); Carbonato de litio (Spanish); Carbonato di litio (Italian); lithiumcarbonaat (Dutch); carbonato de lítio (Portuguese) [6]

Links lead to the official product page: the EPAR for the European Union, the public medicines database for France, the CIMA summary of product characteristics for Spain, the dm+d for the United Kingdom. An asterisk marks a name taken from the DysNet register only.

European public assessment reports, EPAR (0)

The European Medicines Agency's list holds no medicine with ATC code N05AN01: this medicine has no EPAR [8].

Literature (PubMed, 6,514 papers)

PubMed counts 6,514 papers on this medicine [9]. The selection gives the most recent of each type; the Method page says how it is made. See the search in PubMed ↗

Cochrane reviews (2)

  • Lavonas EJ, et al. Hemodialysis for lithium poisoning. Cochrane Database Syst Rev. 2015. PubMed 26374731 ↗ doi ↗
  • Cipriani A, et al. Lithium versus antidepressants in the long-term treatment of unipolar affective disorder. Cochrane Database Syst Rev. 2006. PubMed 17054174 ↗ doi ↗

All 2 results in PubMed ↗

Systematic reviews and meta-analyses (44)
  • Zhang H, et al. Comparing efficacy and safety of oral drugs in treatment of hyperthyroidism: a systematic review and network meta-analysis. PeerJ. 2026. PubMed 41623375 ↗ doi ↗
  • Yao P, et al. Efficacy of Different Combination Therapies for Mania in Bipolar Disorder: A Systematic Review and Meta-Analysis. Brain Behav. 2025. PubMed 41431288 ↗ doi ↗
  • Di Vincenzo F, et al. Psychopharmacological Therapy Positively Modulates Disease Activity in Inflammatory Bowel Disease: A Systematic Review. Int J Mol Sci. 2025. PubMed 40650291 ↗ doi ↗
  • Esati J, et al. Adverse Effects of Ultrasonic Instrumentation and Air Polishing on Dental Restorations: A Systematic Review of Laboratory Studies. J Esthet Restor Dent. 2025. PubMed 39908196 ↗ doi ↗
  • Abd-ElGawad M, et al. Determining the best dose of lithium carbonate as adjuvant therapy to radioactive iodine for the treatment of hyperthyroidism: a systematic review and meta-analysis. BMC Endocr Disord. 2025. PubMed 40410789 ↗ doi ↗

All 44 results in PubMed ↗

Practice guidelines (6)
  • Miller RG, et al. Practice parameter update: the care of the patient with amyotrophic lateral sclerosis: drug, nutritional, and respiratory therapies (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2009. PubMed 19822872 ↗ doi ↗
  • Grunze H, et al. The World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the biological treatment of bipolar disorders: update 2009 on the treatment of acute mania. World J Biol Psychiatry. 2009. PubMed 19347775 ↗ doi ↗
  • Yatham LN, et al. Canadian Network for Mood and Anxiety Treatments (CANMAT) guidelines for the management of patients with bipolar disorder: update 2007. Bipolar Disord. 2006. PubMed 17156158 ↗ doi ↗

All 6 results in PubMed ↗

Names and identifiers
INN
source ↗
CAS
554-13-2
ATC
N05AN01 (systemic)
SNOMED CT
16977003, 387095003
RxNorm
42351 ↗
Wikidata
Q410174 ↗
Wikipedia
en.wikipedia.org/wiki/Lithium_carbonate ↗

Names and identifiers taken from the DysNet register [6].

Health technology assessments (1)

The opinions of the assessment bodies of the pilot countries and of Germany, with a link to each opinion. The status shown is the one each body publishes.

France, HAS Transparency Committee (1)

SMR: actual clinical benefit. ASMR: improvement in actual clinical benefit, from I (major) to V (none). Opinions taken from the BDPM [5].

  • CT-14569 · 2 March 2016 · Renouvellement d'inscription (CT) · SMR Important · TERALITHE, TERALITHE LP
    Wording of the opinion, in French

    SMR : Le service médical rendu par TERALITHE reste important dans les indications de l’AMM.

England, NICE (0)

NICE has published no technology appraisal that names this medicine among the technologies appraised [10].

Scotland, SMC (0)

The Scottish Medicines Consortium has published no advice on this medicine [11].

Germany, G-BA (0)

The G-BA has run no early benefit assessment (AMNOG) of this medicine on its own [12].

Spain, AEMPS therapeutic positioning reports (0)

The AEMPS database of therapeutic positioning reports holds no report on this medicine [13].

How the figure is computed

Example, France: the pack TERALITHE LP 400 mg, comprimé sécable à libération prolongée, plaquette(s) PVC PVDC de 60 comprimé(s), costs €11.88. It holds 649.61 mmol, which is 27.07 DDD. The cost per DDD is €11.88 ÷ 27.07 = €0.44, and the annual cost at the WHO standard dose, list price, is that cost × 365 = €160.20.

France

Public price in France, including VAT and the per-pack dispensing fee. Source [5], read on 9 October 2026. ATC match: through the active substance (BDPM substance code), since the BDPM gives no ATC code.

Show the 1 pack
ProductPackPrice DDD per packCost per DDDAnnual cost at the WHO standard doseSource line
TERALITHE LP 400 mg, comprimé sécable à libération prolongéeLABORATOIRES DELBERT plaquette(s) PVC PVDC de 60 comprimé(s) €11.88 27.07 €0.44 €160.20 CIS 67292476 / CIP13 3400933727369substance code 04403 (CARBONATE DE LITHIUM) in CIS_COMPO_bdpm

Spain

Retail price including VAT (PVP IVA). Source [14][7], read on 9 October 2026. ATC match: ATC code of each national code, checked in CIMA.

Show the 1 pack
ProductPackPrice DDD per packCost per DDDAnnual cost at the WHO standard doseSource line
PLENUR 400 MG COMPRIMIDOS DE LIBERACION MODIFICADA, 100 comprimidosFAES FARMA, S.A. 100 comprimidos €19.14 45.11 €0.42 €154.86 Código Nacional 700523AEMPS CIMA, registration 48932

United Kingdom

Drug Tariff basic price paid to the pharmacy, excluding VAT (Part VIIIA Category C). Source [15][16], read on 9 October 2026. ATC match: ATC code of the virtual product (VMP) in the dm+d.

Show the 1 pack
ProductPackPrice DDD per packCost per DDDAnnual cost at the WHO standard doseSource line
Lithium carbonate 400mg modified-release tablets 100 tablet £18.60 45.11 £0.41 £150.49€177.54 VMPP SNOMED 1269111000001100dm+d browser, VMP 2491

References

  1. WHO Collaborating Centre for Drug Statistics Methodology. ATC/DDD Index 2026 [Internet]. Oslo: Norwegian Institute of Public Health; [updated 2026 Jan 20; cited 2026 Oct 9]. Available from: https://atcddd.fhi.no/atc_ddd_index/
  2. WHO Collaborating Centre for Drug Statistics Methodology. DDD: definition and general considerations [Internet]. Oslo: Norwegian Institute of Public Health; [cited 2026 Oct 9]. Available from: https://atcddd.fhi.no/ddd/
  3. World Health Organization. Electronic Essential Medicines List (eEML) [Internet]. Geneva: WHO; [cited 2026 Oct 9]. Available from: https://list.essentialmeds.org/
  4. European Central Bank. Euro foreign exchange reference rates, 9 October 2026 [Internet]. Frankfurt am Main: ECB; 2026 [cited 2026 Oct 9]. Available from: https://www.ecb.europa.eu/stats/policy_and_exchange_rates/euro_reference_exchange_rates/html/index.en.html
  5. Base de données publique des médicaments [Internet]. Paris: Ministère du Travail, de la Santé, des Solidarités et des Familles; 2026 [updated 2026 Oct 8; cited 2026 Oct 9]. Available from: https://base-donnees-publique.medicaments.gouv.fr/telechargement
  6. DysNet, the dysmelia network. Teratogen register [Internet]. [place unknown]: DysNet; 2026 [updated 2026 Sep 12; cited 2026 Oct 9]. Available from: https://www.dysnet.org/knowledge/teratogens/
  7. Agencia Española de Medicamentos y Productos Sanitarios. CIMA: Centro de información de medicamentos [Internet]. Madrid: AEMPS; [cited 2026 Oct 9]. Available from: https://cima.aemps.es/cima/
  8. European Medicines Agency. Download medicine data [Internet]. Amsterdam: EMA; 2026 [updated 2026 Oct 9; cited 2026 Oct 9]. Available from: https://www.ema.europa.eu/en/medicines/download-medicine-data
  9. PubMed [Internet]. Bethesda (MD): National Library of Medicine (US); [cited 2026 Oct 9]. Available from: https://pubmed.ncbi.nlm.nih.gov/
  10. National Institute for Health and Care Excellence. Technology appraisal guidance [Internet]. London: NICE; [cited 2026 Oct 9]. Available from: https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance
  11. Scottish Medicines Consortium. Medicines advice [Internet]. Glasgow: SMC; [cited 2026 Oct 9]. Available from: https://scottishmedicines.org.uk/medicines-advice/
  12. Gemeinsamer Bundesausschuss. Nutzenbewertung nach § 35a SGB V: Apixaban [Internet]. Berlin: G-BA; [cited 2026 Oct 9]. Available from: https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/
  13. Agencia Española de Medicamentos y Productos Sanitarios. Informes de posicionamiento terapéutico [Internet]. Madrid: AEMPS; [cited 2026 Oct 9]. Available from: https://www.aemps.gob.es/medicamentos-de-uso-humano/evaluacion-de-tecnologias-sanitarias/informes-de-posicionamiento-terapeutico/
  14. Ministerio de Sanidad. Nomenclátor de facturación de octubre 2026 [Internet]. Madrid: Ministerio de Sanidad; 2026 [cited 2026 Oct 9]. Available from: https://www.sanidad.gob.es/profesionales/nomenclator.do
  15. NHS Business Services Authority. Drug Tariff Part VIIIA, October 2026 [Internet]. Newcastle upon Tyne: NHSBSA; 2026 [cited 2026 Oct 9]. Available from: https://www.nhsbsa.nhs.uk/pharmacies-gp-practices-and-appliance-contractors/drug-tariff/drug-tariff-part-viii
  16. NHS Business Services Authority. dm+d browser: NHS dictionary of medicines and devices [Internet]. Newcastle upon Tyne: NHSBSA; [updated 2026 Oct 1; cited 2026 Oct 9]. Available from: https://dmd-browser.nhsbsa.nhs.uk/