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Samsca Side Effects

Generic name: tolvaptan

Medically reviewed by Drugs.com. Last updated on Nov 15, 2023.

Note: This document contains side effect information about tolvaptan. Some dosage forms listed on this page may not apply to the brand name Samsca.

Applies to tolvaptan: oral tablet.

Warning

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.

Serious side effects of Samsca

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:

More common

Less common

Incidence not known

Other side effects of Samsca

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:

More common

Less common

For Healthcare Professionals

Applies to tolvaptan: oral kit, oral tablet.

Cardiovascular

Common (1% to 10%): Intracardiac thrombus, ventricular fibrillation, orthostatic hypotension, syncope[Ref]

Gastrointestinal

Very common (10% or more): Dry mouth (up to 13%), nausea, dysgeusia

Common (1% to 10%): Constipation, ischemic colitis, gastrointestinal bleeding, diarrhea[Ref]

General

The most frequently reported side effects included thirst, dry mouth (up to 13%), asthenia, constipation, pollakiuria or polyuria and hyperglycemia.[Ref]

Genitourinary

Common (1% to 10%): Blood in urine

Uncommon (0.1% to 1%): Urethral hemorrhage, vaginal hemorrhage[Ref]

Hematologic

Common (1% to 10%): Prolonged prothrombin time, disseminated intravascular coagulation[Ref]

Musculoskeletal

Common (1% to 10%): Rhabdomyolysis, arthralgia, myalgia

Nervous system

Common (1% to 10%): Cerebrovascular accident, syncope, dizziness, headache

Uncommon (0.1% to 1%): Dysgeusia

Postmarketing reports: Osmotic demyelination syndrome[Ref]

Renal

Very common (10% or more): Pollakiuria and polyuria (11%)

Uncommon (0.1% to 1%): Renal impairment[Ref]

Respiratory

Common (1% to 10%): Pulmonary embolism, respiratory failure[Ref]

Metabolic

Common (1% to 10%): Hyperglycemia, anorexia, diabetic ketoacidosis, dehydration, hyperkalemia, decreased appetite, creatinine increased, hypernatremia, hypoglycemia, hyperuricemia, weight gain[Ref]

Dermatologic

Common (1% to 10%): Ecchymosis, pruritus, dry skin, urticaria

Uncommon (0.1% to 1%): Pruritic rash[Ref]

Hepatic

Common: Alanine aminotransferase increased, aspartate aminotransferase increased, bilirubin increased

Hypersensitivity

Postmarketing reports: Hypersensitivity reactions including anaphylactic shock and generalized rash

Other

Very common (10% or more): Thirst (up to 18%)

Common (1% to 10%): Asthenia, pyrexia, malaise

Frequently asked questions

References

1. Gerlo S, Verdood P, Kooijman R. Tumor necrosis factor-alpha activates the extrapituitary PRL promoter in myeloid leukemic cells. J Neuroimmunol. 2006;172(1-2):206-10.

2. Product Information. Samsca (tolvaptan). Otsuka American Pharmaceuticals Inc. 2009.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer