Samsca Side Effects

Generic Name: tolvaptan

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

Side Effects of Samsca - for the Consumer

Samsca

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Samsca:

Constipation; decreased appetite; dry mouth; increased thirst; increased urination; nausea; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Samsca:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, bloody, or tarry stools; confusion; fainting; fever; mental or mood changes; seizures; severe or persistent dizziness, vomiting, or diarrhea; sluggishness; speech problems or loss of speech; symptoms of high blood sugar (eg, increased hunger, flushing, rapid breathing, fruit-like breath odor); trouble swallowing; uncontrolled muscle movements (eg, in the arms or legs); unusual drowsiness; weakness in the arms and legs; vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Top

Samsca Side Effects - for the Professional

Samsca

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse event information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

In multiple-dose, placebo-controlled trials, 607 hyponatremic patients (serum sodium <135 mEq/L) were treated with Samsca. The mean age of these patients was 62 years; 70% of patients were male and 82% were Caucasian. One hundred eighty nine (189) tolvaptan-treated patients had a serum sodium <130 mEq/L, and 52 patients had a serum sodium <125 mEq/L. Hyponatremia was attributed to cirrhosis in 17% of patients, heart failure in 68% and SIADH/other in 16%. Of these patients, 223 were treated with the recommended dose titration (15 mg titrated to 60 mg as needed to raise serum sodium).

Overall, over 4,000 patients have been treated with oral doses of tolvaptan in open-label or placebo-controlled clinical trials. Approximately 650 of these patients had hyponatremia; approximately 219 of these hyponatremic patients were treated with tolvaptan for 6 months or more.

The most common adverse reactions (incidence ≥5% more than placebo) seen in two 30‑day, double-blind, placebo-controlled hyponatremia trials in which tolvaptan was administered in titrated doses (15 mg to 60 mg once daily) were thirst, dry mouth, asthenia, constipation, pollakiuria or polyuria and hyperglycemia. In these trials, 10% (23/223) of tolvaptan-treated patients discontinued treatment because of an adverse event, compared to 12% (26/220) of placebo-treated patients; no adverse reaction resulting in discontinuation of trial medication occurred at an incidence of >1% in tolvaptan-treated patients.

Table 1 lists the adverse reactions reported in tolvaptan-treated patients with hyponatremia (serum sodium <135 mEq/L) and at a rate at least 2% greater than placebo-treated patients in two 30‑day, double-blind, placebo-controlled trials. In these studies, 223 patients were exposed to tolvaptan (starting dose 15 mg, titrated to 30 and 60 mg as needed to raise serum sodium). Adverse events resulting in death in these trials were 6% in tolvaptan-treated-patients and 6% in placebo-treated patients.

Table 1. Adverse Reactions (>2% more than placebo) in Tolvaptan-Treated Patients in Double-Blind, Placebo-Controlled Hyponatremia Trials

System Organ Class MedDRA Preferred Term	Tolvaptan 15 mg/day‑60 mg/day (N=223) n (%)	Placebo   (N=220) n (%)
The following terms are subsumed under the referenced ADR in Table 1:
* polydipsia; † diabetes mellitus; ‡ decreased appetite; § urine output increased, micturition urgency, nocturia
Gastrointestinal Disorders
Dry mouth	28 (13)	9 (4)
Constipation	16 (7)	4 (2)
General Disorders and Administration Site Conditions
Thirst*	35 (16)	11 (5)
Asthenia	19 (9)	9 (4)
Pyrexia	9 (4)	2 (1)
Metabolism and Nutrition Disorders
Hyperglycemia†	14 (6)	2 (1)
Anorexia‡	8 (4)	2 (1)
Renal and Urinary Disorders
Pollakiuria or polyuria§	25 (11)	7 (3)

In a subgroup of patients with hyponatremia (N=475, serum sodium <135 mEq/L) enrolled in a double-blind, placebo-controlled trial (mean duration of treatment was 9 months) of patients with worsening heart failure, the following adverse reactions occurred in tolvaptan-treated patients at a rate at least 2% greater than placebo: mortality (42% tolvaptan, 38% placebo), nausea (21% tolvaptan, 16% placebo), thirst (12% tolvaptan, 2% placebo), dry mouth (7% tolvaptan, 2% placebo) and polyuria or pollakiuria (4% tolvaptan, 1% placebo).

The following adverse reactions occurred in <2% of hyponatremic patients treated with Samsca and at a rate greater than placebo in double-blind placebo-controlled trials (N=607 tolvaptan; N=518 placebo) or in <2% of patients in an uncontrolled trial of patients with hyponatremia (N=111) and are not mentioned elsewhere in the label.

Blood and Lymphatic System Disorders: Disseminated intravascular coagulation

Cardiac Disorders: Intracardiac thrombus, ventricular fibrillation

Investigations: Prothrombin time prolonged

Gastrointestinal Disorders: Ischemic colitis

Metabolism and Nutrition Disorders: Diabetic ketoacidosis

Musculoskeletal and Connective Tissue Disorders: Rhabdomyolysis

Nervous System: Cerebrovascular accident

Renal and Urinary Disorders: Urethral hemorrhage

Reproductive System and Breast Disorders (female): Vaginal hemorrhage

Respiratory, Thoracic, and Mediastinal Disorders: Pulmonary embolism, respiratory failure

Vascular disorder: Deep vein thrombosis

Top

Side Effects by Body System - for Healthcare Professionals

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.

Renal

Renal side effects have included pollakiuria and polyuria.

Respiratory

Respiratory side effects have included pulmonary embolism and respiratory failure.

Top

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 information does not endorse drugs, diagnose patients, or recommend therapy. This drug 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 drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information 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 drugs you are taking, check with your doctor, nurse, or pharmacist.