Home FDA labels 983a15fb-e0d8-4e75-aa92-ade42e5e625a FDA label 983a15fb-e0d8-4e75-aa92-ade42e5e625a openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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SPL set ID b3b68b3a-aa82-4464-8146-51d27861023d
SPL ID 983a15fb-e0d8-4e75-aa92-ade42e5e625a
Version 1
Effective date 2011-02-18
Source export date 2026-08-01
Source partition 7
Source file https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-08-01/29baabee7fa6726d72190670d84f1571113181a958a8119cbe97e8f0d1d955b2/drug-label-0007-of-0014.json.zip
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Import run 20260801T225920Z
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warnings WARNINGS: For intranasal use only. Desmopressin acetate nasal solution should only be used in patients where orally administered formulations are not feasible. Very rare cases of hyponatremia have been reported from world-wide postmarketing experience in patients treated with desmopressin acetate nasal solution (desmopressin acetate). Desmopressin acetate nasal solution is a potent antidiuretic which, when administered, may lead to water intoxication and/or hyponatremia. Unless properly diagnosed and treated hyponatremia can be fatal. Therefore, fluid restriction is recommended and should be discussed with the patient and/or guardian. Careful medical supervision is required. When desmopressin acetate nasal solution is administered, in particular in pediatric and geriatric patients, fluid intake should be adjusted downward in order to decrease the potential occurrence of water intoxication and hyponatremia (See PRECAUTIONS: , Pediatric Use: and Geriatric Use: .) All patients receiving desmopressin acetate nasal solution therapy should be observed for the following signs or symptoms associated with hyponatremia: headache, nausea/vomiting, decreased serum sodium weight gain, restlessness, fatigue, lethargy, disorientation, depressed reflexes, loss of appetite, irritability, muscle weakness, muscle spasms or cramps and abnormal mental status such as hallucinations, decreased consciousness and confusion. Severe symptoms may include one or a combination of the following: seizure, coma and/or respiratory arrest. 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. Desmopressin acetate nasal solution should be used with caution in patients with habitual or psychogenic polydipsia who may be more likely to drink excessive amounts of water, putting them at greater risk of hyponatremia.
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adverse reactions ADVERSE REACTIONS: Infrequently, high dosages of intranasal desmopressin acetate 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 percentage of patients having adverse experiences without regard to relationship to study drug from the pooled pivotal study data for nocturnal enuresis. Desmopressin Acetate Placebo (N=59) 20 μg (N=60) 40 μg (N=61) Adverse Reaction % % % BODY AS A WHOLE Abdominal Pain 0 2 2 Asthenia 0 0 2 Chills 0 0 2 Headache 0 2 5 Throat Pain 2 0 0 NERVOUS SYSTEM Depression 2 0 0 Dizziness 0 0 3 RESPIRATORY SYSTEM Epistaxis 2 3 0 Nostril Pain 0 2 0 Respiratory Infection 2 0 0 Rhinitis 2 8 3 CARDIOVASCULAR SYSTEM Vasodilation 2 0 0 DIGESTIVE SYSTEM Gastrointestinal Disorder 0 2 0 Nausea 0 0 2 SKIN & APPENDAGES Leg Rash 2 0 0 Rash 2 0 0 SPECIAL SENSES Conjunctivitis 0 2 0 Edema Eyes 0 2 0 Lachrymation Disorder 0 0 2 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.
adverse reactions table <table width="571" ID="id_039c22df-d733-46eb-aabf-72905d3646ce"> <caption ID="id_c25d56a0-effb-4311-9afe-030fc59bc859">Desmopressin Acetate</caption> <col width="47.1%"/> <col width="18.2%"/> <col width="17.3%"/> <col width="17.3%"/> <tbody> <tr ID="id_0c0879ea-7cee-49e9-987d-68687647c064"> <td align="left" valign="top" styleCode="Botrule Toprule Rrule Lrule"/> <td align="left" valign="top" styleCode="Botrule Rrule"> <content styleCode="bold">Placebo (N=59)</content> </td> <td align="left" valign="top" styleCode="Botrule Rrule"> <content styleCode="bold">20 μg (N=60)</content> </td> <td align="left" valign="top" styleCode="Botrule Rrule"> <content styleCode="bold">40 μg (N=61)</content> </td> </tr> <tr ID="id_f5f3d32c-be4f-4416-870a-0f5a9723b3ec"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> <content styleCode="bold">Adverse Reaction</content> </td> <td align="left" valign="top" styleCode="Botrule Rrule">%</td> <td align="left" valign="top" styleCode="Botrule Rrule">%</td> <td align="left" valign="top" styleCode="Botrule Rrule">%</td> </tr> <tr ID="id_6b89899c-6ea9-4b93-9d9e-a40aceee7027"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">BODY AS A WHOLE</td> <td align="left" valign="top" styleCode="Botrule Rrule"/> <td align="left" valign="top" styleCode="Botrule Rrule"/> <td align="left" valign="top" styleCode="Botrule Rrule"/> </tr> <tr ID="id_08891543-0e1c-4987-a976-5c36b4a11c85"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Abdominal Pain</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> <td align="left" valign="top" styleCode="Botrule Rrule">2</td> <td align="left" valign="top" styleCode="Botrule Rrule">2</td> </tr> <tr ID="id_2eff1dbb-0199-40f2-a5de-9fc2d0f9a994"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Asthenia</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> <td align="left" valign="top" styleCode="Botrule Rrule">2</td> </tr> <tr ID="id_301d1086-1158-4fd0-baeb-22d5d0d8565a"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Chills</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> <td align="left" valign="top" styleCode="Botrule Rrule">2</td> </tr> <tr ID="id_b264219e-ad8f-4177-bc28-12373e02e89b"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Headache</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> <td align="left" valign="top" styleCode="Botrule Rrule">2</td> <td align="left" valign="top" styleCode="Botrule Rrule">5</td> </tr> <tr ID="id_ca0e07d5-f008-498a-8362-dddb6c66b65f"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Throat Pain</td> <td align="left" valign="top" styleCode="Botrule Rrule">2</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> </tr> <tr ID="id_167249fc-1d47-4c28-a320-f8ae41664d0e"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">NERVOUS SYSTEM</td> <td align="left" valign="top" styleCode="Botrule Rrule"/> <td align="left" valign="top" styleCode="Botrule Rrule"/> <td align="left" valign="top" styleCode="Botrule Rrule"/> </tr> <tr ID="id_77307bb2-24e6-42a3-9f79-52266b7805fd"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Depression </td> <td align="left" valign="top" styleCode="Botrule Rrule">2</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> </tr> <tr ID="id_b4238738-956d-4244-8a2c-883f709c4372"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Dizziness</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> <td align="left" valign="top" styleCode="Botrule Rrule">3</td> </tr> <tr ID="id_f074742c-1d92-48f4-88d9-cac00e639c11"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">RESPIRATORY SYSTEM</td> <td align="left" valign="top" styleCode="Botrule Rrule"/> <td align="left" valign="top" styleCode="Botrule Rrule"/> <td align="left" valign="top" styleCode="Botrule Rrule"/> </tr> <tr ID="id_660a21cf-c29b-4bea-b46a-00b9ca57ca49"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Epistaxis</td> <td align="left" valign="top" styleCode="Botrule Rrule">2</td> <td align="left" valign="top" styleCode="Botrule Rrule">3</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> </tr> <tr ID="id_a00221d4-6057-4388-a700-d05945537d66"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Nostril Pain</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> <td align="left" valign="top" styleCode="Botrule Rrule">2</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> </tr> <tr ID="id_13a89bff-44e7-4ee4-ba43-c96d7c47ec47"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Respiratory Infection</td> <td align="left" valign="top" styleCode="Botrule Rrule">2</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> </tr> <tr ID="id_0feadfac-3499-463c-be20-d0baf083c0ea"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Rhinitis</td> <td align="left" valign="top" styleCode="Botrule Rrule">2</td> <td align="left" valign="top" styleCode="Botrule Rrule">8</td> <td align="left" valign="top" styleCode="Botrule Rrule">3</td> </tr> <tr ID="id_fd2e68fe-cdfd-4119-a291-62dc77a74523"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">CARDIOVASCULAR SYSTEM</td> <td align="left" valign="top" styleCode="Botrule Rrule"/> <td align="left" valign="top" styleCode="Botrule Rrule"/> <td align="left" valign="top" styleCode="Botrule Rrule"/> </tr> <tr ID="id_257cf868-584a-47c0-beb6-621eed643825"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Vasodilation</td> <td align="left" valign="top" styleCode="Botrule Rrule">2</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> </tr> <tr ID="id_7d09b0bf-ab4e-4b13-88a7-deea6cedfebe"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">DIGESTIVE SYSTEM</td> <td align="left" valign="top" styleCode="Botrule Rrule"/> <td align="left" valign="top" styleCode="Botrule Rrule"/> <td align="left" valign="top" styleCode="Botrule Rrule"/> </tr> <tr ID="id_326cb738-bc5c-4d6a-ac01-66240fda78ca"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Gastrointestinal Disorder</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> <td align="left" valign="top" styleCode="Botrule Rrule">2</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> </tr> <tr ID="id_9ea8a7df-1180-42a7-9289-1eae9f4c3818"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Nausea</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> <td align="left" valign="top" styleCode="Botrule Rrule">2</td> </tr> <tr ID="id_a4d5f88e-c5b9-4a86-9c90-c7e8e7114c3f"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">SKIN & APPENDAGES</td> <td align="left" valign="top" styleCode="Botrule Rrule"/> <td align="left" valign="top" styleCode="Botrule Rrule"/> <td align="left" valign="top" styleCode="Botrule Rrule"/> </tr> <tr ID="id_c2faf1e8-3186-4507-9cf2-63310b8682cb"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Leg Rash</td> <td align="left" valign="top" styleCode="Botrule Rrule">2</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> </tr> <tr ID="id_b191e006-8eff-4637-b057-ad555062daf4"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Rash</td> <td align="left" valign="top" styleCode="Botrule Rrule">2</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> </tr> <tr ID="id_2b377f63-a508-4598-ab8e-074e56a7bcd4"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">SPECIAL SENSES</td> <td align="left" valign="top" styleCode="Botrule Rrule"/> <td align="left" valign="top" styleCode="Botrule Rrule"/> <td align="left" valign="top" styleCode="Botrule Rrule"/> </tr> <tr ID="id_2afac562-dcfc-4249-aeaa-c3bbbc800ad6"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Conjunctivitis</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> <td align="left" valign="top" styleCode="Botrule Rrule">2</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> </tr> <tr ID="id_ecf28c34-165e-400d-835e-3576a1e95295"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Edema Eyes</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> <td align="left" valign="top" styleCode="Botrule Rrule">2</td> <td align="left" valign="top" styleCode="Botrule Rrule">0</td> </tr> <tr ID="id_2093789f-86d5-44b5-9d11-db573f63597c"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> Lachrymation Disorder</td> <td align="left" valign="top" styleCode="Rrule">0</td> <td align="left" valign="top" styleCode="Rrule">0</td> <td align="left" valign="top" styleCode="Botrule Rrule">2</td> </tr> </tbody> </table>