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Samsca Side Effects

Generic Name: tolvaptan

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.

In Summary

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.

For the Consumer

Applies to tolvaptan: oral tablet

Oral route(Tablet)

Samsca(R) 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(R) 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:

More Common

Less Common

  • Anxiety
  • blood in the urine
  • bloody stools
  • blue lips, fingernails, or skin
  • bruising
  • chest pain
  • confusion
  • cough
  • coughing or vomiting blood
  • dark urine
  • dizziness or lightheadedness
  • fainting
  • fast, slow, irregular, or shallow heartbeat
  • fever
  • irregular, fast or slow, or shallow breathing
  • loss of consciousness
  • muscle cramp, spasm, pain, or stiffness
  • pain, redness, or swelling in the arm or leg
  • persistent bleeding or oozing from puncture sites, mouth, or nose
  • pink or red urine
  • rash
  • rectal bleeding
  • stomach tenderness
  • troubled breathing
  • sweating
  • vaginal bleeding

Incidence Not Known

  • Difficulty swallowing
  • general feeling of tiredness or weakness
  • headache
  • high blood pressure
  • hives, itching, skin rash
  • irritability
  • light-colored stools
  • muscle twitching
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • restlessness
  • seizures
  • stomach pain, continuing
  • swelling of the feet or lower legs
  • tightness in the chest
  • yellow eyes or skin

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

  • Difficulty having a bowel movement
  • lack or loss of strength

Less Common

For Healthcare Professionals

Applies to tolvaptan: oral kit, oral tablet

Cardiovascular

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

Gastrointestinal

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

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

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[Ref]

Dermatologic

Common (1% to 10%): Ecchymosis, pruritus

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

References

1. "Product Information. Samsca (tolvaptan)." Otsuka American Pharmaceuticals Inc, Rockville, MD.

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

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.

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