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, decreased serum sodium, weight increase, malaise, abdominal pain, muscle cramps, dizziness, confusion, decreased consciousness and in severe cases convulsions and coma.
The majority of other events are reported as non-serious.

The most commonly reported adverse reactions during treatment were nasal congestion (27%), high body temperature (15%), and rhinitis (12%). Other common adverse reactions were headache (9%), upper respiratory tract infection (9%), gastroenteritis (7%), abdominal pain (5%). Anaphylactic reactions have not been seen in clinical trials but spontaneous reports have been received.

Tabulated summary of adverse reactions:
The below table is based on the frequency of adverse drug reactions reported in clinical trials with nasal desmopressin, conducted in children and adults for treatment of CDI, PNE and RCCT (N=745), combined with the post-marketing experience for all indications. Reactions only seen in post- marketing or in other desmopressin formulations have been added in the ‘Not known’ frequency column.

MedDRA Organ           Very common            Common (≥1/100      Uncommon        Not known Class                  (≥1/10)                to <1/10)           (≥1/1,000 to <1/100)
Immune system                                                                     Allergic reaction disorders
Metabolism and                                                    Hyponatraemia   Dehydration*** nutrition disorders
Psychiatric                                   Insomnia, Affect                    Confusional state* disorders                                     lability**,
Nightmare**,
Nervousness**,
Aggression**
Nervous system                                Headache*                           Convulsions*, disorders                                                                         Coma*, Dizziness*,
Somnolence
Vascular disorders                                                                Hypertension Respiratory,           Nasal congestion,      Epistaxis, Upper                    Dyspnoea thoracic and           Rhinitis               respiratory tract mediastinal                                   infection ** disorders
Gastrointestinal                              Gastroenteritis,    Vomiting*       Diarrhoea disorders                                     Nausea*,
Abdominal pain*
Skin and                                                                          Pruritus, Rash, subcutaneous                                                                      Urticaria tissue disorders
Musculoskeletal                                                                   Muscle spasms* and connective tissue disorders
General disorders                                                                 Fatigue*, and administration                                                                Peripheral site conditions                                                                   oedema*, Chest pain, Chills
Investigations         Body temperature                                           Weight increased* increased**
* Reported in connection with hyponatraemia
**Reported primarily in children and adolescents
***Reported in the CDI indication
Description of selected adverse reactions:
The most serious adverse reaction with desmopressin is hyponatraemia, and in severe cases its complications, i.e. convulsions and coma. The cause of the potential hyponatraemia is the anticipated antidiuretic effect.

Paediatric population:
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 children special attention should be paid to the precautions addressed in section 4.4.

Other special populations:
Infants, elderly 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/