ℹ️ Compiled from public regulatory records · Last regulator revision: June 1, 2026🚩 Report this page

Tolvaptan

Vasopressin Antagonists

Sold as SAMSCA · JINARC

GB MHRACA Health CanadaEU EMA

Drug class: Vasopressin Antagonists
Availability: See label
Routes: Oral
Markets covered: 3
Products on record: 57

Overview

Tolvaptan is an active pharmaceutical ingredient in the Vasopressin Antagonists group (C03XA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	41	May 1, 2026
CA Canada	Health Canada	13	January 29, 2026
EU European Union	EMA	3	June 1, 2026

GBUnited Kingdom· MHRA

41 products

Uses

GBOfficial regulatory label· revised May 1, 2026[1]

Tolvaptan tablets are indicated in adults for the treatment of hyponatraemia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH).

How to take

CACanada· Health Canada

13 products

Uses

CAOfficial regulatory label· revised March 22, 2025[2]

33 SAMSCA® Product Monograph Page 3 of 35 SAMSCA® (tolvaptan tablets) PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength Non-medicinal Ingredients Oral Tablets, 15 mg, 30 mg and 60 mg Corn starch, hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and FD&C Blue No.
2 Aluminum Lake as colorant INDICATIONS AND CLINICAL USE SAMSCA (tolvaptan) is indicated for the treatment of clinically important, non-hypovolemic. , serum sodium < 130 mEq/L, or symptomatic hyponatremia). SAMSCA should be limited to use by physicians experienced in the management of clinically important hyponatremia.
SAMSCA has not been studied in patients with serious neurological symptoms requiring urgent correction of serum sodium. Patients requiring urgent intervention to raise serum sodium to treat serious neurological symptoms associated with hyponatremia should not be treated with SAMSCA.

EUEuropean Union· EMA

3 products

Uses

EUOfficial regulatory label· revised June 1, 2026[3]

1).

How to take

EUOfficial regulatory label· revised June 1, 2026

Drug interactions

Known interactions involving Tolvaptan. Select one for details. This list is informational and not a complete interaction checker.

Amprenavir Apalutamide Atazanavir Berotralstat Boceprevir Carbamazepine Ceritinib Clarithromycin Cobicistat Conivaptan Delavirdine Enzalutamide Fosamprenavir Fosphenytoin Idelalisib Indinavir Itraconazole Ketoconazole Leflunomide Lomitapide Lonafarnib Lumacaftor Mifepristone Mipomersen Mitotane Nefazodone Nelfinavir Pexidartinib Phenobarbital Phenytoin Posaconazole Primidone Rifabutin Rifampin Rifapentine Ritonavir Saquinavir Telaprevir Telithromycin Teriflunomide Troleandomycin Tucatinib Voriconazole Abametapir Afatinib Aliskiren Alpelisib Amiloride Aminoglutethimide Amiodarone Amobarbital Apixaban Aprepitant Armodafinil Artesunate Asparaginase Azilsartan Bedaquiline Benazepril Bepridil Betrixaban Bexarotene Binimetinib Bosentan Bosutinib Brentuximab Vedotin Brigatinib Butabarbital Butalbital Cabozantinib Calaspargase Pegol Cannabidiol Capmatinib Captopril Cenobamate Ciprofloxacin Cladribine Clofarabine Cobimetinib Colchicine Crizotinib Cyclosporine Dabrafenib Daclatasvir Dalfopristin Daunorubicin Deferasirox Delafloxacin Desmopressin Dexamethasone Digoxin Diltiazem Docetaxel Doxorubicin Dronedarone Drospirenone Duvelisib Edoxaban Efavirenz Elagolix Eliglustat Empagliflozin Enalapril Encorafenib Epirubicin Eplerenone Eprosartan Erdafitinib Erlotinib Erythromycin Etoposide Etravirine Everolimus Fedratinib Felbamate Fexofenadine Flibanserin Fluconazole Fluvoxamine Fosaprepitant Fosinopril Fostamatinib Gilteritinib Glasdegib Griseofulvin Heparin Ibrutinib Idarubicin Imatinib Interferon Beta-1a Interferon Beta-1b Irbesartan Isavuconazonium Istradefylline Ivacaftor Ivosidenib Lapatinib Larotrectinib Lasmiditan Ledipasvir Lefamulin Lemborexant Letermovir Lisinopril Loperamide Lorlatinib Losartan Lurasidone Lusutrombopag Maraviroc Mephobarbital Methotrexate Metreleptin Miconazole Midostaurin Mitoxantrone Modafinil Moexipril Nafcillin Naldemedine Naltrexone Netupitant Nevirapine Nifedipine Nilotinib Niraparib Nitisinone Olmesartan Oxcarbazepine Paclitaxel Pazopanib Pegaspargase Peginterferon Beta-1a Pentobarbital Perindopril Phenylbutazone Ponatinib Potassium Acetate Potassium Bicarbonate Potassium Chloride Potassium Citrate Potassium Gluconate Potassium Iodide Potassium Perchlorate Pralsetinib Propafenone Quinapril Quinidine Quinine Ramipril Ranolazine Relugolix Remdesivir Ribociclib Rifaximin Rimegepant Riociguat Ripretinib Rivaroxaban Rolapitant Romidepsin Rucaparib Rufinamide Sarecycline Secobarbital Selexipag Selpercatinib Silodosin Sirolimus Sodium Bicarbonate Sodium Chloride Somapacitan Somatrem Somatropin Sorafenib Spironolactone Stiripentol Sulfinpyrazone Suvorexant Talazoparib Tamoxifen Telmisartan Telotristat Ethyl Terfenadine Thioguanine Ticagrelor Tipranavir Topotecan Trabectedin Trandolapril Triamterene Trimethoprim Troglitazone Ubrogepant Ulipristal Valsartan Vemurafenib Venetoclax Verapamil Vinblastine

Showing 240 of 250. Type above to find a specific drug.

Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]MHRA (UK) · PLGB200751484 · revised May 1, 2026
[2]Health Canada (DPD) · 02370468 · revised March 22, 2025
[3]European Medicines Agency · EMEA/H/C/002788 · revised June 1, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.