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.

Some side effects of Samsca may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to tolvaptan: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking tolvaptan (the active ingredient contained in Samsca) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have any of these signs that your hyponatremia is being reversed too quickly:

• problems with speech or muscle control;

• trouble swallowing;

• trouble moving your arms and legs;

• mood changes; and

• seizure (convulsions).

Stop using tolvaptan and call your doctor at once if you have:

• weakness or fainting;

• black, bloody, or tarry stools;

• coughing up blood or vomit that looks like coffee grounds;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• dehydration (feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin).

Common side effects may include:

• dry mouth;

• increased thirst or urination;

• constipation; or

• loss of appetite, fruity breath odor, drowsiness, dry skin, nausea, vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to tolvaptan: oral tablet

Cardiovascular

Cardiovascular side effects have included deep vein thrombosis, intracardiac thrombus, deep vein thrombosis, and ventricular fibrillation.

Endocrine

Endocrine side effects have included diabetic ketoacidosis, hyperglycemia, and anorexia.

Gastrointestinal

Gastrointestinal side effects have included dry mouth, nausea, ischemic colitis, and constipation.

General

General side effects have included thirst, asthenia, and pyrexia.

Genitourinary

Genitourinary side effects have included urethral hemorrhage and vaginal hemorrhage.

Hematologic

Hematologic side effects have included prolonged prothrombin time and disseminated intravascular coagulation.

Musculoskeletal

Musculoskeletal side effects have included rhabdomyolysis.

Nervous system

Nervous system side effects have included cerebrovascular accidents. Postmarketing reports have included osmotic demyelination syndrome.

Renal

Renal side effects have included pollakiuria and polyuria.

Respiratory

Respiratory side effects have included pulmonary embolism and respiratory failure.

Metabolic

Metabolic side effects have included postmarketing reports of hypernatremia.

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