Samsca Side Effects

Generic Name: tolvaptan

Note: This page contains side effects data for the generic drug tolvaptan. It is possible that some of the dosage forms included below may not apply to the brand name Samsca.

It is possible that some side effects of Samsca may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to tolvaptan: oral tablet

As well as its needed effects, tolvaptan (the active ingredient contained in Samsca) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking tolvaptan, check with your doctor immediately:

More common
  • Abdominal or stomach pain
  • blurred vision
  • dry mouth
  • flushed, dry skin
  • frequent urination
  • fruit-like breath odor
  • increased hunger
  • increased thirst
  • increased urination
  • increased volume of pale, dilute urine
  • nausea
  • sweating
  • thirst
  • troubled breathing
  • unexplained weight loss
  • unusual tiredness or weakness
  • vomiting
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 tolvaptan side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Difficulty having a bowel movement (stool)
  • lack or loss of strength
Less common
  • Loss of appetite
  • weight loss

For Healthcare Professionals

Applies to tolvaptan: oral tablet

Cardiovascular

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

Gastrointestinal

Very common (10% or more): Dry mouth (up to 13%), nausea
Common (1% to 10%): Constipation, ischemic colitis, gastrointestinal bleeding, diarrhea

General

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

Genitourinary

Common (1% to 10%): Blood in urine
Uncommon (0.1% to 1%): Urethral hemorrhage, vaginal hemorrhage

Hematologic

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

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

Renal

Very common (10% or more): Pollakiuria and polyuria (11%)
Uncommon (0.1% to 1%): Renal impairment

Respiratory

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

Metabolic

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

Dermatologic

Common (1% to 10%): Ecchymosis, pruritus
Uncommon (0.1% to 1%): Pruritic rash

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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