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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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:
Seek medical attention right away if any of these SEVERE side effects occur when using Vaprisol:Constipation; diarrhea; dry mouth; headache; increased thirst; nausea; trouble sleeping; vomiting.
TopSevere 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; pain, irritation, or swelling at injection site; rapid breathing; severe or persistent dizziness; severe or persistent increase in thirst; tremor; unusual tiredness or weakness; white patches in the mouth.
Vaprisol Side Effects - for the Professional
Vaprisol
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 52.5% of subjects treated with Vaprisol 40 mg/day compared to 3.3% in the placebo group. The majority of the reactions were mild and did not lead to discontinuation of drug. However, some serious infusion site reactions did occur, and infusion site reactions were the most common type of adverse event leading to discontinuation of Vaprisol.
The adverse reactions presented in Table 5 are derived from 72 healthy volunteers and 111 patients with euvolemic hyponatremia who received Vaprisol 20 mg IV as a loading dose followed by 40 mg/day IV for 2 to 4 days and from 40 healthy volunteers and 21 patients with euvolemic hyponatremia who received placebo. The adverse reactions occurred in at least 2% of patients treated with Vaprisol and at a higher incidence for Vaprisol-treated patients than for placebo-treated patients.
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| Term* |
Placebo N=61 n (%) |
40 mg N=183 n (%) |
| Blood and Lymphatic System Disorders | ||
| Anemia NOS | 2 (3.3%) | 7 (3.8%) |
| Cardiac Disorders | ||
| Atrial Fibrillation | 0 | 5 (2.7%) |
| Gastrointestinal Disorders | ||
| Constipation | 2 (3.3%) | 9 (4.9%) |
| Diarrhea NOS | 0 | 10 (5.5%) |
| Dry mouth | 2 (3.3%) | 8 (4.4%) |
| Nausea | 2 (3.3%) | 7 (3.8%) |
| Vomiting NOS | 0 | 12 (6.6%) |
| General Disorders and Administration Site Conditions | ||
| Cannula site reaction | 0 | 10 (5.5%) |
| Edema peripheral | 1 (1.6%) | 10 (5.5%) |
| Infusion site erythema | 0 | 9 (4.9%) |
| Infusion site pain | 1 (1.6%) | 14 (7.7%) |
| Infusion site phlebitis | 0 | 29 (15.8%) |
| Infusion site reaction | 0 | 37 (20.2%) |
| Infusion site swelling | 1 (1.6%) | 5 (2.7%) |
| Pain NOS | 0 | 4 (2.2%) |
| Pyrexia | 0 | 7 (3.8%) |
| Thirst | 1 (1.6%) | 18 (9.8%) |
| Infections and Infestations | ||
| Oral candidiasis | 0 | 4 (2.2%) |
| Pneumonia NOS | 0 | 5 (2.7%) |
| Urinary tract infection NOS | 1 (1.6%) | 6 (3.3%) |
| Metabolism and Nutritional Disorders | ||
| Dehydration | 0 | 4 (2.2%) |
| Hyperglycemia NOS | 0 | 5 (2.7%) |
| Hypoglycemia NOS | 0 | 6 (3.3%) |
| Hypokalemia | 1 (1.6%) | 18 (9.8%) |
| Hypomagnesemia | 0 | 4 (2.2%) |
| Hyponatremia | 0 | 6 (3.3%) |
| Nervous system disorders | ||
| Headache | 2 (3.3%) | 22 (12.0%) |
| Psychiatric Disorders | ||
| Confusional state | 1 (1.6%) | 7 (3.8%) |
| Insomnia | 0 | 6 (3.3%) |
| Renal and urinary disorders | ||
| Hematuria | 1 (1.6%) | 4 (2.2%) |
| Pollakiuria | 0 | 11 (6.0%) |
| Polyuria | 0 | 9 (4.9%) |
| Skin and subcutaneous disorders | ||
| Erythema | 0 | 5 (2.7%) |
| Vascular Disorders | ||
| Hypertension NOS | 0 | 10 (5.5%) |
| Hypotension NOS | 1 (1.6%) | 5 (2.7%) |
| Orthostatic hypotension | 0 | 10 (5.5%) |
| Phlebitis NOS | 1 (1.6%) | 9 (4.9%) |
The safety of Vaprisol in hyponatremic patients with underlying congestive heart failure has not been established.
TopSide Effects by Body System
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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