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, abdominal pain, nausea, vomiting, weight increase, dizziness, confusion, malaise, memory impairment, vertigo, falls 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*               Dyspepsia,
disorders                        Abdominal             Flatulence,
pain*                 bloating and
Diarrhoea             distension
Constipation,
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, 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)
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/