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tolvaptan

Jinarc, Samsca · ATC code C03XA01

Key facts
Active substance
tolvaptan
Drug class
Vasopressin receptor antagonist
ATC code
C03XA01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Jinarc 15 mg tablets / Jinarc 30 mg tablets / Jinarc 45 mg tablets · Samsca 7.5 mg tablets / Samsca 15 mg tablets / Samsca 30 mg tablets
Marketing authorisation holder
Otsuka Pharmaceutical Netherlands B.V.
Information as of
2026-10-27

Key facts

Tolvaptan is a vasopressin V2 receptor antagonist used in adults with rapidly progressing autosomal dominant polycystic kidney disease (Jinarc) and hyponatremia due to SIADH (Samsca).

What it is used for

  • Jinarc: slows cyst development and renal insufficiency in ADPKD (CKD stage 1 to 4 at start) with rapid progression, adults
  • Samsca: hyponatremia secondary to SIADH in adults

Dosing

  • Jinarc: twice daily split dose; start 45 mg + 15 mg, titrate at least weekly to 60 mg + 30 mg and target 90 mg + 30 mg.
  • Jinarc: morning dose at least 30 minutes before breakfast, second dose 8 hours later.
  • Jinarc with strong CYP3A inhibitors: reduced once-daily dose (30 mg or 15 mg); also reduced with moderate inhibitors.
  • Samsca: start in hospital at 15 mg once daily, up to a maximum of 60 mg; consider 7.5 mg if at risk of overly rapid correction.
  • Do not take with grapefruit juice; drink sufficient water.

Contraindications

  • Hypersensitivity to the active substance, benzazepine or benzazepine derivatives
  • Anuria, volume depletion, hypernatraemia, inability to perceive thirst
  • Jinarc: elevated liver enzymes or liver injury before starting; Samsca: hypovolemic hyponatremia
  • Pregnancy and breast-feeding

Important warnings

  • Jinarc: idiosyncratic hepatic toxicity, including acute liver failure requiring transplantation; strict liver monitoring
  • Samsca: too rapid sodium correction can cause osmotic demyelination; monitor sodium and volume status closely
  • Dehydration; access to water must be ensured
  • Urinary outflow obstruction (e.g. prostatic hypertrophy) increases risk of acute retention

Side effects

  • Jinarc: thirst (55%), polyuria (38%), nocturia (29%), pollakiuria (23%)
  • Jinarc: ALT elevation (4.4%), AST elevation (3.1%)
  • Samsca: thirst (18%), dry mouth (9%), pollakiuria (6%)
  • Others: dehydration, hypernatraemia, nausea, constipation

Interactions

  • Strong and moderate CYP3A inhibitors (e.g. ketoconazole, clarithromycin, fluconazole, diltiazem, verapamil) increase tolvaptan exposure
  • Grapefruit juice doubles peak concentrations
  • Potent CYP3A inducers (e.g. rifampicin) decrease exposure and efficacy
  • Samsca: other sodium-raising treatments increase the risk of overly rapid correction

Pregnancy and breastfeeding

  • Contraindicated in pregnancy; women of childbearing potential must use contraception.
  • Contraindicated during breast-feeding.

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • JinarcOtsuka Pharmaceutical Netherlands B.V. · EMEA/H/C/002788
  • SamscaOtsuka Pharmaceutical Netherlands B.V. · EMEA/H/C/000980
  • Tolvaptan Accord · genericAccord Healthcare S.L.U. · EMEA/H/C/005961

Source: European Medicines Agency (EMA), product information

Austria

  • TolvaptanSandoz Gmbh, Teva B.V, +pharma Arzneimittel Gmbh · 6 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • Tolvaptan1 A Pharma Gmbh, Betapharm Arzneimittel Gmbh, Ratiopharm Gmbh, Ascend Gmbh · 8 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • JidrenBİOFARMA İLAÇ SAN. VE TİC. A.Ş. · 8 register entries
  • JinarcABDİ İBRAHİM OTSUKA İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • SamscaABDİ İBRAHİM OTSUKA İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • TolvadiSABA İLAÇ SAN. VE TİC. A.Ş. · 4 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 18 more European countries
Belgium
Tolvaptan
Croatia
Gurdatol, Tolvaptan Siadh Stada, Tolvaptan Stada
Czechia
Tolvaptan Stada
Estonia
Tolvaptan Stada
France
Tolvaptan Biogaran, Tolvaptan Eg, Tolvaptan Sandoz, Tolvaptan Teva, Tolvaptan Zentiva
Greece
Gurdatol, Pokydy, Tolvaptan, Vaptelia
Iceland
Gurdatol, Jinarc, Samsca, Tolvaptan, Vaptelia
Ireland
Tolvaptan Ascend
Italy
Tolvaptan Teva
Latvia
Tolvaptan Stada
Liechtenstein
Jinarc, Samsca, Tolvaptan Accord
Lithuania
Tolvaptan Stada
Netherlands
Tolvaptan Sandoz, Tolvaptan Teva
Norway
Jinarc, Samsca, Tolvaptan Accord, Tolvaptan Hexal, Tolvaptan Sandoz, Tolvaptan Teva, Tolvaptan Zentiva
Poland
Tolvaptan Sandoz
Portugal
Tolvaptano Stada
Spain
Tolvaptan Stadafarma, Tolvaptán Sandoz, Tolvaptán Stada, Tolvaptán Stadafarma, Tolvaptán Teva, Tolvaptán Tevagen
Sweden
Tolvaptan Hexal, Tolvaptan Sandoz, Tolvaptan Teva, Tolvaptan Zentiva

EMA – Article 57 product data (EU/EEA), 2026-10-28

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Sources

  1. European Medicines Agency. Jinarc – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/jinarc-epar-product-information_en.pdf
  2. European Medicines Agency. Samsca – EPAR, Product Information (OF THE TEXT {MM/YYYY} Detailed information on this medicinal). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/samsca-epar-product-information_en.pdf
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  5. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  6. Wikidata (CC0): ATC C03XA.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.