Minirin Adverse Reactions

Tablet/Melt oral lyophilisate: Summary of the safety profile: The most serious adverse reaction with desmopressin is hyponatraemia, see under "Description of selected adverse reactions" as follows.
In adults the most commonly reported adverse reaction during treatment was headache (12%). Other common adverse reactions were hyponatraemia (6%), dizziness (3%), hypertension (2%) and gastrointestinal disorders (<10%). Anaphylactic reactions have not been seen in clinical trials but spontaneous reports have been received.
In children the most commonly reported adverse reaction was headache (1%). Less common were psychiatric disorders (<1%), which generally abated after treatment discontinuation and gastrointestinal disorders (<1%). Anaphylactic reactions have not been seen in clinical trials but spontaneous reports have been received.
Tabulated summary of adverse reactions: Adults: The frequency of adverse drug reactions reported in clinical trials with oral desmopressin conducted in adults for treatment of nocturia (N=1557) combined with the post marketing experience for all adult indications (incl. central diabetes insipidus). Reactions only seen post marketing have been added in the 'Not known'-frequency column. (See Table 1.)

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Paediatric Population: The frequency of adverse drug reactions reported in clinical trials with oral desmopressin conducted in children and adolescents for treatment of primary nocturnal enuresis (N = 1923). Events only seen in post marketing have been added in the 'Not known' frequency column. (See Table 2.)

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Special populations: Elderly patients and patients with low serum sodium levels may have an increased risk of developing hyponatraemia (see Precautions).
Description of selected adverse reactions: The most serious adverse reaction with desmopressin is hyponatraemia, which may cause headache, abdominal pain, nausea, vomiting, weight increase, dizziness, confusion, malaise, vertigo and in serious cases convulsions and coma. The cause of the potential hyponatraemia is the anticipated antidiuretic effect. Hyponatraemia is reversible and in children it is often seen to occur in relation to changes in daily routines affecting fluid intake and/or perspiration. In adult study subjects treated for nocturia, the majority of those developing low serum sodium, developed this after 3 days of treatment or after dose increase. Special precautions should be observed in adults as well as in children, see Precautions.
Solution for injection: A few percent of treated patients can be expected to experience side such as fatigue, headache, nausea and stomach pain. (See Table 3.)

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Treatment without concomitant restriction of fluid intake may lead to water retention/hyponatremia with accompanying signs and symptoms (headache, nausea/vomiting, decreased serum sodium, weight gain, and in serious cases, convulsions).
Post marketing experience: Isolated cases of allergic skin reactions and more severe general allergic reactions have been reported.