Adverse reactions : תופעות לוואי

4.8    Undesirable effects
Summary of the safety profile

The most commonly reported adverse reactions to idebenone are mild to moderate diarrhoea (usually not requiring the discontinuation of the treatment), nasopharyngitis, cough and back pain.

Tabulated list of adverse reactions

The following adverse reactions emerging from clinical trials in LHON patients or reported post- marketing in other indications are tabulated below. Frequency groupings are defined to the following convention: very common (≥1/10), common (≥1/100 to <1/10), not known (cannot be estimated from the available data).
System Organ Class         Preferred Term                                Frequency Infections and             Nasopharyngitis                               Very common Infestations               Bronchitis                                    Not known Blood and lymphatic        Agranulocytosis, anaemia,                     Not known system disorders           leukocytopenia, thrombocytopenia,
neutropenia
Metabolism and             Blood cholesterol increased, blood            Not known nutrition disorders        triglycerides increased
Nervous system             Seizure, delirium, hallucinations,
disorders                  agitation, dyskinesia, hyperkinesia,
poriomania, dizziness, headache,              Not known restlessness, stupor
Respiratory, thoracic      Cough                                         Very common and mediastinal disorders
Gastrointestinal           Diarrhoea                                     Common disorders                  Nausea, vomiting, anorexia, dyspepsia         Not known Hepatobiliary disorders    Alanine aminotransferase increased,
aspartate aminotransferase increased,
blood alkaline phosphatase increased,         Not known blood lactate dehydrogenase increased,
gamma- glutamyltransferase increased,
blood bilirubin increased, hepatitis
Skin and subcutaneous      Rash, pruritus                                Not known tissue disorders
Musculoskeletal and        Back pain                                     Common connective tissue          Pain in extremity                             Not known disorders
Renal and urinary          Azotaemia, chromaturia                        Not known disorders
General disorders and      Malaise                                       Not known administration site conditions

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