Adverse reactions : תופעות לוואי

4.8 UNDESIRABLE EFFECTS
Summary of the safety profile
The most serious adverse reaction with desmopressin is hyponatraemia, which may cause headache, nausea, vomiting, , weight increase, malaise, memory impairment, vertigo, falls, dizziness, confusion, and in severe cases convulsions and coma.
The majority of adults treated for nocturia who develop hyponatraemia have developed low serum sodium after three days of dosing. In adults the risk of hyponatraemia increases with increasing dose of desmopressin and the risk has been found to be more prominent in women.
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 (nausea (4%), vomiting (1%), abdominal pain (3%), diarrhoea (2%) and constipation (1%)). Less common is an influence of the sleep pattern/consciousness level presenting itself as e.g. insomnia (0.96%), somnolence (0.4%) or asthenia (0.06%). Anaphylactic reactions have not been seen in clinical trials but spontaneous reports have been received.
In children the most commonly reported adverse reaction during treatment was headache (1%), less common were psychiatric disorders (affect lability (0.1%), aggression (0.1%), anxiety (0.05%), mood swings (0.05%), nightmare (0.05%)) which generally abated after treatment discontinuation and gastrointestinal disorders (abdominal pain (0.65%), nausea (0.35%), vomiting (0.2%) and diarrhoea (0.15%)). Anaphylactic reactions have not been seen in clinical trials but spontaneous reports have been received.Tabulated summary of adverse reactions

Adults
Based on 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 in post marketing have been added in the ‘Not known’-frequency column.

MedDRA              Very          Common             Uncommon          Rare            Not known Organ Class         common        1-10%)             0.1-1%)           0.1-0.01%) (>10%)
Immune system                                                                          Anaphylactic disorders                                                                              reaction Metabolism and                    Hyponatraemia*                                       Dehydration**, nutrition                                                                              Hypernatraemia** disorders
Psychiatric                                          Insomnia          Confusional disorders                                                              state* Nervous system      Headache* Dizziness*             Somnolence,                       Convulsions*, disorders                                            paraesthesia                      Asthenia**, Coma*
Eye disorders                                        Visual impairment
Ear and                                            Vertigo* labyrinth disorders
Cardiac                                            Palpitations disorders
Vascular                        Hypertension       Orthostatic disorders                                          hypotension
Respiratory,                                       Dyspnoea thoracic and mediastinal disorders
Gastrointestinal                Nausea*            ,
disorders                       Abdominal          Dyspepsia,
pain*              Flatulence,
Diarrhoea          bloating and
Constipation,      distension
Vomiting*,
Skin and                                           Sweating,        Dermatitis subcutaneous                                       Pruritus,        allergic tissue disorders                                   Rash,
Urticaria
Renal and                       Bladder and urinary disorders               urethral symptoms
General                         Oedema disorders and                   Fatigue            Malaise*,
administration                                     Chest pain,
site conditions                                    Influeza like illness
Investigations                                     Weight increased*,
Hepatic enzyme increased,
Hypokalaemia

* Hyponatraemia may cause headache, abdominal pain, nausea, vomiting, weight increase, dizziness, confusion, malaise, memory impairment, vertigo, falls and in severe cases convulsions and coma ** Only seen in the CDI indication

Children and Adolescents:
Based on the frequency of adverse drug reactions reported in clinical trials conducted in children and adolescents with oral desmopressin for treatment of Primary Nocturnal Enuresis (N = 1923). Reactions only seen in post marketing have been added in the ‘Not known’-frequency column.
MedDRA                 Very       Common          Uncommon          Rare                Not known Organ Class            common 1-10%)              0.1-1%)           0.1-0.01%) (>10%)
Immune system                                                                           Anaphylactic disorders                                                                               reaction Metabolism and                                                                          Hyponatraemia* nutrition disorders
Psychiatric                                       Affect            Anxiety             Abnormal disorders                                         lability**,       symptoms,           behaviour, Aggression*** Nightmare****, Emotional
Mood                disorder,
swings****
Depression,
Hallucination,
Insomnia
Nervous system                      Headache*                        Somnolence,         Disturbance in disorders                                                                                attention, Psychomotor hyperactivity,
Convulsions*
Vascular disorders                                                   Hypertension Respiratory,                                                                             Epistaxis thoracic and mediastinal disorders
Gastrointestinal                                   Abdominal disorders                                          pain*
Nausea*
Diarrhoea
Vomiting*,

Skin and                                                                                 Dermatitis subcutaneous tissue                                                                      allergic, Rash, disorders                                                                                Sweating, Urticaria
Renal and urinary                                  Bladder and disorders                                          urethral symptoms
General disorders                                  Oedema            Irritability and administration                                 peripheral site conditions                                    Fatigue


* Hyponatraemia may cause headache, abdominal pain, nausea, vomiting, weight increase, dizziness, confusion, malaise, memory impairment, vertigo, falls and in severe cases convulsions and coma ** Post marketing reported equally in children and adolescents (<18 years) *** Post marketing almost exclusively reported in children and adolescents (<18 years) ****Post marketing reported primarily in children (<12 years) 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.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/