DDAVP Side Effects

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

DDAVP

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with DDAVP . Seek medical attention right away if any of these SEVERE side effects occur when using DDAVP:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; fainting; loss of appetite; mental or mood changes (eg, agitation, irritability); muscle weakness, spasms, or cramps; nausea; personality changes; seizures; swelling; unusual headache or restlessness; unusual tiredness or sluggishness; unusual weight gain; vomiting.

DDAVP Solution

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with DDAVP Solution. Seek medical attention right away if any of these SEVERE side effects occur when using DDAVP Solution:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, redness, swelling, or pain at the injection site; calf pain, tenderness, or swelling; chest pain; confusion; coughing up blood; fainting; loss of appetite; mental or mood changes (eg, agitation, irritability); muscle weakness, spasms, or cramps; nausea; one-sided numbness or weakness; personality changes; seizures; severe or persistent dizziness; slurred speech; swelling; unusual headache or restlessness; unusual tiredness or sluggishness; unusual weight gain; vision problems; vomiting.

DDAVP Spray (Non-refrigerated)

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 DDAVP Spray (Non-refrigerated):

Runny or stuffy nose.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; fainting; loss of appetite; mental or mood changes (eg, agitation, irritability); muscle weakness, spasms, or cramps; nausea; personality changes; recurrent or severe nosebleeds; seizures; severe or persistent nasal pain; swelling; unusual headache or restlessness; unusual tiredness or sluggishness; unusual weight gain; vomiting.

DDAVP Tube

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 DDAVP Tube:

Runny or stuffy nose.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; fainting; loss of appetite; mental or mood changes (eg, agitation, irritability); muscle weakness, spasms, or cramps; nausea; personality changes; recurrent or severe nosebleeds; seizures; severe or persistent nasal pain; swelling; unusual headache or restlessness; unusual tiredness or sluggishness; unusual weight gain; vomiting.

DDAVP Side Effects - for the Professional

DDAVP

Infrequently, DDAVP has produced transient headache, nausea, mild abdominal cramps and vulval pain. These symptoms disappeared with reduction in dosage. Occasionally, injection of DDAVP has produced local erythema, swelling or burning pain. Occasional facial flushing has been reported with the administration of DDAVP. DDAVP Injection has infrequently produced changes in blood pressure causing either a slight elevation or a transient fall and a compensatory increase in heart rate. Severe allergic reactions including anaphylaxis have been reported rarely with DDAVP Injection.

See WARNINGS for the possibility of water intoxication and hyponatremia.

Post Marketing: There have been rare reports of thrombotic events (acute cerebrovascular thrombosis, acute myocardial infarction) following DDAVP Injection in patients predisposed to thrombus formation, and rare reports of hyponatremic convulsions associated with concomitant use with the following medications: oxybutinin and imipramine.

DDAVP Rhinal Tube

Infrequently, high dosages of intranasal DDAVP have produced transient headache and nausea. Nasal congestion, rhinitis and flushing have also been reported occasionally along with mild abdominal cramps. These symptoms disappeared with reduction in dosage. Nosebleed, sore throat, cough and upper respiratory infections have also been reported.

The following table lists the percent of patients having adverse experiences without regard to relationship to study drug from the pooled pivotal study data for nocturnal enuresis.

Post Marketing: There have been rare reports of hyponatremic convulsions associated with concomitant use with the following medications: oxybutinin and imipramine.

See WARNINGS for the possibility of water intoxication and hyponatremia.

DDAVP Tablets

Infrequently, large doses of the intranasal formulations of DDAVP and DDAVP Injection have produced transient headache, nausea, flushing and mild abdominal cramps. These symptoms have disappeared with reduction in dosage.

Central Diabetes Insipidus

In long-term clinical studies in which patients with diabetes insipidus were followed for periods up to 44 months of DDAVP Tablet therapy, transient increases in AST (SGOT) no higher than 1.5 times the upper limit of normal were occasionally observed. Elevated AST (SGOT) returned to the normal range despite continued use of DDAVP Tablets.

Primary Nocturnal Enuresis

The only adverse event occurring in ≥3% of patients in controlled clinical trials with DDAVP Tablets that was probably, possibly, or remotely related to study drug was headache (4% DDAVP, 3% placebo).

Other

The following adverse events have been reported; however their relationship to DDAVP has not been established: abnormal thinking, diarrhea, and edema-weight gain. See WARNINGS for the possibility of water intoxication and hyponatremia.

Post Marketing: There have been rare reports of hyponatremic convulsions associated with concomitant use with the following medications: oxybutinin and imipramine.

Side Effects by Body System

Cardiovascular

One review of the literature found that the incidence of thrombotic events associated with the use of DDAVP to reduce blood loss and transfusion requirements in surgical patients was not significantly higher than placebo. In any case, the incidence of thrombosis is rare. One review found only 10 reports of thrombosis over a 4-year period, covering 433,000 doses of DDAVP.

Cardiovascular side effects have infrequently included transient and slight elevations or reductions in blood pressure, a compensatory change in heart rate, and facial flushing with injections of desmopressin (DDAVP). Vasodilation and water retention have occurred. There have been rare reports of thrombotic events (acute cerebral thrombosis, acute myocardial infarction) in some patients after DDAVP injection. At least one case of fatal left coronary thrombosis has been associated with the use of DDAVP.

Nervous system

The risk factors for DDAVP-induced hyponatremia include stress, surgery, anesthesia, narcotics (endogenous release of ADH), vomiting (loss of sodium), liver disease (hindered metabolism of DDAVP), overhydration with hyponatremic fluids, and advanced age. In some cases, fluid restriction, avoidance of hyponatremic solutions, and close monitoring of serum electrolytes and urine output for at least 15 to 20 hours after the administration of DDAVP may be beneficial.

Nervous system side effects have included seizures and/or coma as a result of severe water intoxication and hyponatremia. Other nervous system side effects have included headache and dizziness in less than 3% of patients. DDAVP nasal spray has been infrequently associated with somnolence, lethargy, paresthesias, fatigue, confusion, stupor, malaise, diaphoresis, itchy or light-sensitive eyes, insomnia, chills, warm feeling, and agitation.

Hematologic

Hematologic side effects have included platelet aggregation and thrombocytopenia. These have been seen almost uniquely in patients with von Willebrand's disease Type IIB (DDAVP is contraindicated in these patients).

Local

Local side effects of injections of DDAVP have included intravenous site erythema, swelling, and burning.

Respiratory

Respiratory side effects of intranasal DDAVP have included rhinitis, epistaxis, and nostril pain in 2% to 10% of patients. Apnea and cardiac arrest occurred in one patient.

Gastrointestinal

Gastrointestinal side effects have included mild abdominal cramps and nausea in 2% of patients. Dyspepsia and vomiting have rarely been associated with DDAVP nasal spray.

Hypersensitivity

Hypersensitivity reactions have rarely included anaphylaxis.

Psychiatric

Psychiatric side effects have included a single case of paranoid psychosis associated with the use of DDAVP nasal spray.

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