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 cause of the potential hyponatraemia is the anticipated antidiuretic effect. The 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 both adults and children special attention should be paid to the precautions addressed in section 4.4.
Tabulated summary of adverse reactions
The table below is based on the frequency of adverse drug reactions reported in clinical trials with oral desmopressin conducted in children and adolescents for treatment of Primary Nocturnal Enuresis (PNE) (N = 1923).
System Organ Class | Common (≥ 1/100 to < 1/10) | Uncommon (≥ 1/1,000 to < 1/100) | Rare (≥ 1/10,000 to < 1/1,000) |
Psychiatric disorders | | Affect lability Aggression | Anxiety symptoms, Nightmare, Mood swings |
Nervous system disorders | Headache | | Somnolence |
Vascular disorders | | | Hypertension |
Gastrointestinal disorders | | Abdominal pain, Nausea, Vomiting, Diarrhoea, | |
Renal and urinary disorders | | Bladder and urethral symptoms | |
General disorders and administration site conditions | | Oedema peripheral, Fatigue | Irritability |
In case of hyponatraemia, the treatment of hyponatraemia should be individualised (see section 4.9).
Caution should be taken when substances with increased risk of water retention are taken concurrently with Desmopressin, since the concurrent use may increase the risk of hyponatraemia (see section 4.4).
Anaphylactic reactions, Psychomotor hyperactivity and some Psychiatric reactions such as abnormal behaviour, emotional disorder, depression, hallucination & insomnia, have not been seen in clinical trials but spontaneous reports have been received.
In children, psychiatric disorders including affect lability, aggression, anxiety, mood swings & nightmare are generally reversed upon treatment discontinuation.
Isolated cases of allergic skin reactions and more severe general allergic reactions have been reported.
Other special populations:
Elderly patients and patients with serum sodium levels in the lower range of normal may have an increased risk of developing hyponatraemia (see section 4.4).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google play or Apple App store.