Note: This document contains side effect information about tolvaptan. Some of the dosage forms listed on this page may not apply to the brand name Samsca.
Common side effects of Samsca include: polyuria, increased thirst, pollakiuria, and xerostomia. Other side effects include: constipation, fever, hyperglycemia, increased serum alanine aminotransferase, and anorexia. See below for a comprehensive list of adverse effects.
Applies to tolvaptan: oral tablet
Oral route (Tablet)
Samsca® should be initiated and re-initiated in patients only in a hospital where serum sodium can be monitored closely. Too-rapid correction of hyponatremia (eg, greater than 12 mEq/L/24 hours) can cause osmotic demyelination resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma, and death. Slower rates of correction may be advisable in susceptible patients (eg, those with severe malnutrition, alcoholism, or advanced liver disease).Samsca® Not For Use For Autosomal Dominant Polycystic Kidney Disease (ADPKD): Because of the risk of hepatoxicity, tolvaptan should not be used for ADPKD outside of the FDA-approved REMS.
Oral route (Tablet)
Warning: Risk Of Serious Liver Injury:Jynarque(TM) (tolvaptan) can cause serious and potentially fatal liver injury. Acute liver failure requiring liver transplantation has been reported.Measure ALT, AST and bilirubin before initiating treatment, at 2 weeks and 4 weeks after initiation, then monthly for the first 18 months and every 3 months thereafter. Prompt action in response to laboratory abnormalities, signs, or symptoms indicative of hepatic injury can mitigate, but not eliminate, the risk of serious hepatotoxicity.Because of the risks of serious liver injury, Jynarque(TM) is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy (REMS) called the Jynarque(TM) REMS Program.
Along with its needed effects, tolvaptan (the active ingredient contained in Samsca) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking tolvaptan:
Incidence not known
Some side effects of tolvaptan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Applies to tolvaptan: oral kit, oral tablet
Common (1% to 10%): Intracardiac thrombus, ventricular fibrillation, orthostatic hypotension
Very common (10% or more): Dry mouth (up to 13%), nausea
Common (1% to 10%): Constipation, ischemic colitis, gastrointestinal bleeding, diarrhea
The most frequently reported side effects included thirst, dry mouth (up to 13%), asthenia, constipation, pollakiuria or polyuria and hyperglycemia.
Common (1% to 10%): Blood in urine
Uncommon (0.1% to 1%): Urethral hemorrhage, vaginal hemorrhage
Common (1% to 10%): Prolonged prothrombin time, disseminated intravascular coagulation
Common (1% to 10%): Rhabdomyolysis
Common (1% to 10%): Cerebrovascular accident, syncope, dizziness, headache
Uncommon (0.1% to 1%): Dysgeusia
Postmarketing reports: Osmotic demyelination syndrome
Very common (10% or more): Pollakiuria and polyuria (11%)
Uncommon (0.1% to 1%): Renal impairment
Common (1% to 10%): Pulmonary embolism, respiratory failure
Common (1% to 10%): Hyperglycemia, anorexia, diabetic ketoacidosis, dehydration, hyperkalemia, decreased appetite, creatinine increased, hypernatremia, hypoglycemia, hyperuricemia
Common (1% to 10%): Ecchymosis, pruritus
Uncommon (0.1% to 1%): Pruritic rash
Common: Alanine aminotransferase increased, aspartate aminotransferase increased, bilirubin increased
Postmarketing reports: Hypersensitivity reactions including anaphylactic shock and generalized rash
Very common (10% or more): Thirst (up to 18%)
Common (1% to 10%): Asthenia, pyrexia, malaise
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Samsca