Nocdurna Adverse Reactions

Summary of the safety profile: Based on the frequency of adverse drug reactions reported in clinical studies with NOCDURNA for nocturia indication conducted in male subjects (50 mcg; N=222) and in female subjects (25 mcg; N=219) the most commonly reported adverse reaction during treatment was dry mouth (13%), headache (3%), hyponatraemia (3%), and dizziness (2%).
Description of selected adverse reactions: The most serious adverse reaction with desmopressin is hyponatraemia, which is associated with headache, nausea, vomiting, decreased serum sodium, weight increase, malaise, abdominal pain, muscle cramps, dizziness, confusion, decreased consciousness and in severe cases convulsions and coma. The hyponatraemia is an antidiuretic effect, arising from increased water re-absorption by the renal tubules and osmotic dilution of plasma. In studies with adult subjects treated for nocturia, the majority of the subjects developed low serum sodium within the first days of treatment or in relation to dose increase. Special attention should be paid to the precautions addressed in Precautions.
Females have a higher risk of hyponatraemia which may be due to increased sensitivity of the kidney tubules to vasopressin and its analogues in women compared with men. The risk of hyponatraemia is minimised by recommendation of a lower dose in women. The risk of hyponatraemia in the over 65 years age group is further reduced by monitoring of serum sodium in this age group (see Dosage & Administration and Precautions).
Tabulated list of adverse reactions: The table 2 as follows shows the frequencies of adverse reactions reported. The frequencies are defined as follows: very common (≥1/10), common (≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100). (See Table 2.)

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