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Initiate and Re-Initiate in a Hospital and Monitor Serum Sodium

  • Tolvaptan should be initiated and re-initiated in patients only in a hospital where serum sodium can be monitored closely.
  • Too rapid correction of hyponatremia (e.g., >12 mEq/L/24 hours) can cause osmotic demyelination resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma and death.
  • In susceptible patients, including those with severe malnutrition, alcoholism or advanced liver disease, slower rates of correction may be advisable.

Not for use for Autosomal Dominant Polycystic Kidney Disease (ADPKD)

  • Because of risk of hepatoxicity, tolvptan should not be used for ADPKD outside of the FDA-approved REMS.


FDA and Industry Communications

Index to FDA Drug Safety Information

Approved Risk Evaluation and Mitigation Strategies (REMS)

JYNARQUE (Tolvaptan) Oral

Patient Counseling Information



Medication Guides

Patient Medication Guide - SAMSCA

Patient Medication Guide - JYNARQUE

Package Inserts


Updated May 2018