Adverse reactions : תופעות לוואי

4.8   Undesirable effects
Summary of safety profile
In phase III clinical studies conducted in ALS patients treated with riluzole, the most commonly reported adverse reactions were asthenia, nausea and abnormal liver function tests.

Tabulated summary of adverse reactions
Undesirable effects ranked under headings of frequency are listed below, using the following convention: very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Very common          Common                Uncommon             Not known Blood and                                                       Anaemia              Severe lymphatic                                                                            neutropenia (see system disorders                                                                     section 4.4) 

Very common          Common               Uncommon            Not known Immune system                                                  Anaphylactoid disorders                                                      reaction, angioedema
Nervous system                            Headache,
disorders                                 dizziness,
oral paraesthesia,
somnolence
Cardiac                                   Tachycardia disorders

Respiratory,                                                   Interstitial lung thoracic and                                                   disease (see mediastinal                                                    section 4.4) disorders

Gastrointestinal     Nausea               Diarrhoea,           Pancreatitis disorders                                 abdominal pain,
vomiting
Skin and                                                                           Rash subcutaneous tissue disorders
Hepato-biliary       Abnormal liver                                                Hepatitis disorders            function tests
General              Asthenia             Pain disorders and administration site conditions

Description of selected adverse reactions
Hepato-biliary disorders
Increased alanine aminotransferase usually appeared within 3 months after the start of therapy with riluzole; they were usually transient and levels returned to below twice the ULN after 2 to 6 months while treatment was continued. These increases could be associated with jaundice. In patients (n=20) from clinical studies with increases in ALT to more than 5 times the ULN, treatment was discontinued and the levels returned to less than 2 times the ULN within 2 to 4 months in most cases (see section 4.4).
Study data indicate that Asian patients may be more susceptible to liver function test abnormalities - 3.2% (194/5995) of Asian patients and 1.8% (100/5641) of Caucasian patients.

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 at https://sideeffects.health.gov.il