Adverse reactions : תופעות לוואי

4.8     Undesirable effects

Summary of safety profile:
Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported in association with fluconazole treatment (see section 4.4).

The most frequently (≥1/100 to <1/10) reported adverse reactions are headache, abdominal pain, diarrhoea, nausea, vomiting, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased and rash.

The following adverse reactions have been observed and reported during treatment with fluconazole with the following frequencies: 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).

System Organ Class             Common            Uncommon                   Rare               Not Known Blood and the                                  Anaemia               Agranulocytosis, lymphatic system                                                     leukopenia, disorders                                                            thrombocytopenia , neutropenia
Immune system                                                        Anaphylaxis disorders
Metabolism and                                 Decreased             Hypercholesterola nutrition disorders                            appetite              emia, hypertriglyceridae mia, hypokalemia
Psychiatric disorders                          Somnolence,
insomnia
Nervous system              Headache           Seizures,             Tremor disorders                                      paraesthesia,
dizziness, taste perversion
Ear and labyrinth                              Vertigo disorders
Cardiac disorders                                                    Torsade de pointes (see section 4.4), QT prolongation (see section 4.4)
Gastrointestinal            Abdominal          Constipation,
disorders                   pain, vomiting,    dyspepsia,
diarrhoea,         flatulence, dry nausea             mouth
Hepatobiliary               Alanine            Cholestasis (see      Hepatic failure disorders                   aminotransferas    section 4.4),         (see section 4.4), e increased (see   jaundice (see         hepatocellular section 4.4),      section 4.4),         necrosis (see aspartate          bilirubin             section 4.4),
aminotransferas    increased (see        hepatitis (see e increased (see   section 4.4)          section 4.4),
section 4.4),                            hepatocellular blood alkaline                           damage (see phosphatase                              section 4.4) increased (see section 4.4)
Skin and                    Rash (see          Drug eruption*        Lyell syndrome       Drug reaction with subcutaneous tissue         section 4.4)       (see section 4.4),    (toxic epidermal     eosinophilia and disorders                                      urticaria (see        necrolysis) (see     systemic symptoms section 4.4),         section 4.4),        (DRESS) pruritus, increased   Stevens-Johnson sweating              syndrome (see

                                                                   section 4.4), acute generalised exanthematous- pustulosis (see section 4.4),
exfoliative dermatitis,
angioedema, face oedema, alopecia
Musculoskeletal and                         Myalgia connective tissue disorders
General disorders and                       Fatigue, malaise,
administration site                         asthenia, fever conditions
* including Fixed Drug Eruption

Paediatric population
The pattern and incidence of adverse reactions and laboratory abnormalities recorded during paediatric clinical trials are comparable to those seen in adults.

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/