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)
Ccommon (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).
Common                  Uncommon                       Rare
System Organ Class                                                                                      Not known Blood and the lymphatic                             Anaemia                    Agranulocytosis, system disorders                                                               leukopenia, thrombocytopenia,
neutropenia
Immune system                                                                  Anaphylaxis disorders
Metabolism and nutrition                            Decreased appetite         Hypercholesterolaemia, disorders                                                                      hypertriglyceridaemia, hypokalemia
Psychiatric disorders                               Somnolence, insomnia Nervous system             Headache                 Seizures, paraesthesia, Tremor disorders                                           dizziness, taste perversion
Ear and labyrinth disorders                                           Vertigo

Cardiac disorders
Torsade de pointes (see section 4.4), QT prolongation (see section 4.4)
Gastrointestinal           Abdominal pain,          Constipation,
disorders                  vomiting, diarrhoea,     dyspepsia, flatulence, nausea                   dry mouth
Hepatobiliary disorders    Alanine                  Cholestasis (see           Hepatic failure (see aminotransferase         section 4.4), jaundice     section 4.4),
increased (see section   (see section 4.4),         hepatocellular necrosis 4.4), aspartate          bilirubin increased        (see section 4.4), aminotransferase         (see section 4.4)          hepatitis (see section increased (see section                              4.4), hepatocellular 4.4), blood alkaline                                damage (see section 4.4) phosphatase increased
(see section 4.4)
Skin and subcutaneous      Rash (see section 4.4)   Drug eruption*             Lyell syndrome (toxic      Drug tissue disorders                                     (see section 4.4),        epidermal necrolysis)      reaction with urticaria (see section     (see section 4.4),         eosinophilia
4.4) pruritus, increased   Stevens-Johnson            and sweating                   syndrome (see section      systemic
4.4), acute generalised    symptoms exanthematous-             (DRESS) 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/