FDA label 0195eb35-7d6b-4b9d-9368-eea8dbd5f1e7

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
bbe883f5-5054-46db-8d34-c35038aeb0a8
SPL ID
0195eb35-7d6b-4b9d-9368-eea8dbd5f1e7
Version
2
Effective date
2010-12-22
Source export date
2026-09-28
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:30:53

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS For intranasal use only. Patients who do not have need of antidiuretic hormone for its antidiuretic effect, in particular those who are young or elderly, should be cautioned to ingest only enough fluid to satisfy thirst, in order to decrease the potential occurrence of water intoxication and hyponatremia. Fluid intake should be adjusted downward, particularly in very young and elderly patients, in order to decrease the potential occurrence of water intoxication and hyponatremia. 1 Particular attention should be paid to the possibility of the rare occurrence of an extreme decrease in plasma osmolality that may result in seizures which could lead to coma. Stimate ® Nasal Spray should not be used to treat patients with Type IIB von Willebrand's disease since platelet aggregation may be induced.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS 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 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, hyponatremia and coma. 11

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.