Vaprisol Side Effects

Please note - some side effects for Vaprisol 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 Vaprisol - for the Consumer

Vaprisol

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 Vaprisol:

Constipation; diarrhea; dry mouth; headache; increased thirst; nausea; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; confusion; drowsiness; fast or irregular heartbeat; fever; increased or painful urination; increased sweating; mental or mood changes; muscle pain, weakness, or cramping; pain, irritation, redness, or swelling at the injection site; rapid breathing; severe or persistent dizziness; severe or persistent increase in thirst; tremor; unusual tiredness or weakness; white patches in the mouth.

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.

Vaprisol Side Effects - for the Professional

Vaprisol

The following adverse reactions are discussed elsewhere in labeling:

• Osmotic demyelination syndrome [see Warnings and Precautions (5.2)]
• Infusion site reactions [see Warnings and Precautions (5.7)]

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.

The most common adverse reactions reported with Vaprisol administration were infusion site reactions. In studies in patients and healthy volunteers, infusion site reactions occurred in 73% and 63% of subjects treated with Vaprisol 20 mg/day and 40 mg/day, respectively, compared to 4% in the placebo group. Infusion site reactions were the most common type of adverse event leading to discontinuation of Vaprisol. Discontinuations from treatment due to infusion site reactions were more common among Vaprisol-treated patients (3%) than among placebo-treated patients (0%). Some serious infusion site reactions did occur [see Dosage and Administration (2.1) and Warnings and Precautions (5.7)].

The adverse reactions presented in Table 1 are derived from 72 healthy volunteers and 243 patients with euvolemic or hypervolemic hyponatremia who received Vaprisol 20 mg IV as a loading dose followed by 40 mg/day IV for 2 to 4 days, from 37 patients with euvolemic or hypervolemic hyponatremia who received Vaprisol 20 mg IV as a loading dose followed by 20 mg/day IV for 2 to 4 days in an open-label study, and from 40 healthy volunteers and 29 patients with euvolemic or hypervolemic hyponatremia who received placebo. The adverse reactions occurred in at least 5% of patients treated with Vaprisol and at a higher incidence for Vaprisol-treated patients than for placebo-treated patients.

 Although a dose of 80 mg/day of Vaprisol was also studied, it was associated with a higher incidence of infusion site reactions and a higher rate of discontinuation for adverse events than was the 40 mg/day Vaprisol dose. The maximum recommended daily dose of Vaprisol (after the loading dose) is 40 mg/day.

Heart failure with hypervolemic hyponatremia

In clinical trials where Vaprisol was administered to 79 hypervolemic hyponatremic patients with underlying heart failure and intravenous placebo administered to 10 patients, adverse cardiac failure events, atrial dysrhythmias, and sepsis occurred more frequently among patients treated with Vaprisol (32%, 5% and 8% respectively) than among patients treated with placebo (20%, 0% and 0% respectively) [see Warnings and Precautions (5.1)].

Side Effects by Body System - for Healthcare Professionals

Local

Local side effects have included injection site reactions including erythema, pain, phlebitis, swelling, and cannulae site reactions.

Gastrointestinal

Gastrointestinal side effects have included constipation, diarrhea, dry mouth, nausea, vomiting, oral candidiasis, and thirst.

Cardiovascular

Cardiovascular side effects have included atrial fibrillation, orthostatic hypotension, hypotension, peripheral edema, and hypertension.

Metabolic

Metabolic side effects have included dehydration, hypokalemia, hypomagnesemia, and hyponatremia.

Hematologic

Hematologic side effects have included anemia.

Renal

Renal side effects have included hematuria, polyuria, and, pollakiuria.

Genitourinary

Genitourinary side effects have included urinary tract infection.

Nervous system

Nervous system side effects have included headache.

Psychiatric

Psychiatric side effects have included insomnia and confusion.

General

General side effects have included pain and pyrexia.

Endocrine

Endocrine side effects have included hypoglycemia and hyperglycemia.

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