Stimate Side Effects

Generic Name: desmopressin,desmopressin acetate

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

Stimate Spray

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 Stimate Spray:

Cough; facial flushing; mild stomach cramps; nosebleed; runny or stuffy nose; sore throat.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); calf or leg pain, tenderness, or swelling; chest pain; confusion; coughing up blood; fainting; fast or irregular heartbeat; hallucinations; loss of appetite; mental or mood changes (eg, agitation, irritability); muscle weakness, spasms, or cramps; nausea; numbness of an arm or leg; one-sided weakness; personality changes; restlessness; seizures; severe or persistent headache or dizziness; severe, persistent, or recurring nosebleed; slurred speech; swelling of the hands, ankles, or feet; swelling of the head of the penis; unusual tiredness or sluggishness; unusual weight gain; vision problems; vomiting.

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.

Stimate Side Effects - for the Professional

Stimate

Infrequently, DDAVP® Injection has produced transient headache, nausea, mild abdominal cramps and vulval pain. These symptoms disappeared with reduction in dosage. Occasional facial flushing has been reported with the administration of DDAVP® Injection. Infrequently, high doses 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.

In addition to those listed above, the following have also been reported in clinical trials with Stimate® Nasal Spray: Somnolence, dizziness, itchy or light-sensitive eyes, insomnia, chills, warm feeling, pain, chest pain, palpitations, tachycardia, dyspepsia, edema, vomiting, agitation and balanitis.1-4

DDAVP® Injection (desmopressin acetate) has infrequently produced changes in blood pressure causing either a slight elevation or a transient fall with a compensatory increase in heart rate. Severe allergic reactions including anaphylaxis have been reported rarely with DDAVP® Injection.

Post Marketing

There have been rare reports of convulsions from hyponatremia associated with concomitant use of desmopressin and the following medications: oxybutynin and imipramine.

See WARNINGS for the possibility of water intoxication, hyponatremia and coma.11

To report SUSPECTED ADVERSE REACTIONS, contact CSL Behring Pharmacovigilance at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Side Effects by Body System - for Healthcare Professionals

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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