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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.

Although the pressor activity of desmopressin acetate is very low, its use with other pressor agents should be done only with careful patient monitoring. The concomitant administration of drugs that may increase the risk of water intoxication with hyponatremia (e.g., tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, NSAIDS, lamotrigine and carbamazepine) should be performed with caution.

DDAVP® Injection has been used with epsilon aminocaproic acid without adverse effects.

REFERENCES

1. RHÔNE-POULENC RORER STUDY RG-83884-141:An Open-Label Pharmacokinetic Comparison of Desmopressin Acetate Administration by Intranasal (1.5 mg/mL) and Intravenous Routes: A Dose-Proportionality Trial.

2. RHÔNE-POULENC RORER STUDY RG-83884-142:Nasal Spray Desmopressin (DDAVP). A simple Technique for Treatment of Mild Hemophilia A and von Willebrand's disease.

3. RHÔNE-POULENC RORER STUDY RG-83884-143:Intranasal Desmopressin (DDAVP) by spray in Mild Hemophilia A and von Willebrand's disease Type I.

4. RHÔNE-POULENC RORER STUDY RG-83884-144:Evaluation of Intranasal Spray DDAVP in Patients with Mild or Moderate Hemophilia A or von Willebrand's disease: Inpatient Trial.

11. RHÔNE-POULENC RORER PHARMACEUTICALS INC. ADVERSE REACTION REPORT No. 01-003827; Coma, grand mal seizure, etc.

Last reviewed on RxList: 10/3/2011
This monograph has been modified to include the generic and brand name in many instances.