DDAVP Side Effects

Generic Name: Desmopressin

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.

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 Nasal Spray

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 percentage 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 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.

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