Adverse reactions : תופעות לוואי

4.8 Undesirable effects

The safety of domperidone was evaluated in clinical trials and post marketing experience. The clinical trials included 1,275 patients with dyspepsia, gastro-oesophageal reflux disorder (GERD), Irritable Bowel Syndrome (IBS), nausea and vomiting or other related conditions in 31 double-blind, placebo-controlled studies. All patients were at least 15 years old and received at least one dose of Motilium (domperidone base). The median total daily dose was 30 mg (range 10 to 80 mg), and median duration of exposure was 28 days (range 1 to 28 days). Studies in diabetic gastroparesis or symptoms secondary to chemotherapy or parkinsonism were excluded.


The following terms and frequencies are applied: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), and very rare (<1/10,000). Where frequency can not be estimated from clinical trials data, it is recorded as “Not known”.


System Organ Class                                                    Adverse Drug Reaction Frequency
Common               Uncommon                Not known
Immune system disorders                                                                  Anaphylactic      reaction (including anaphylactic shock)
Psychiatric disorders                                               Loss of libido Anxiety
Agitation
Nervousness
Nervous system disorders                                            Dizziness            Convulsion Somnolence           Restless legs syndrome*
Headache
Extrapyramidal disorder
Eye disorders                                                                            Oculogyric crisis Cardiac disorders                                                                        Ventricular arrhythmias, QTc-prolongation,
Torsade de Pointes,
Sudden cardiac death,

                                                                                               (see section 4.4)
Gastrointestinal disorders                          Dry mouth         Diarrhoea Skin and subcutaneous tissue disorder                                 Rash                     Angioedema Pruritus
Urticaria
Renal and urinary disorders                                                                    Urinary retention Reproductive system and breast disorders                              Galactorrhoea            Gynaecomastia, Breast pain              Amenorrhoea
Breast tenderness
General disorders and administration site                             Asthenia conditions
Investigations                                                                                 Liver function test abnormal,
Blood prolactin increased
*exacerbation of restless legs syndrome in patients with Parkinson’s disease 

In 45 clinical studies where domperidone was used at higher dosages, for longer duration and for additional indications including diabetic gastroparesis, the frequency of adverse events (apart from dry mouth) was considerably higher. This was particularly evident for pharmacologically predictable events related to increased prolactin. In addition to the reactions listed above, akathisia, breast discharge, breast enlargement, breast swelling, depression, hypersensitivity, lactation disorder, and irregular menstruation were also noted.


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.

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/