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.

Although the pressor activity of DDAVP is very low compared to its antidiuretic activity, large doses of DDAVP Tablets should be used with other pressor agents 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.

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