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Tolvaptan Side Effects

In Summary

Commonly reported side effects of tolvaptan 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

Along with its needed effects, tolvaptan 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

  • Abdominal or stomach tenderness
  • anxiety
  • blood in the urine
  • bloody stools
  • blue lips, fingernails, or skin
  • bruising
  • chest pain
  • confusion
  • cough
  • coughing or vomiting blood
  • dark-colored urine
  • dizziness or lightheadedness
  • fainting
  • fast, slow, irregular or shallow heartbeat
  • fever
  • irregular, fast or slow, or shallow breathing
  • loss of consciousness
  • muscle cramps or spasms
  • muscle 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
  • shortness of breath
  • sudden shortness of breath or troubled breathing
  • sweating
  • vaginal bleeding

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 (stool)
  • lack or loss of strength

Less Common

For Healthcare Professionals

Applies to tolvaptan: 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. 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

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

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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