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             Hypercholesterolae nutrition disorders                       appetite              mia,
hypertriglyceridaemi a, hypokalaemia
Psychiatric                               Somnolence,
disorders                                 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)
Gastrointestina          Abdominal           Constipation,
l disorders              pain, vomiting,     dyspepsia,
diarrhoea,          flatulence, dry nausea              mouth

Hepatobiliary            Alanine             Cholestasis (see     Hepatic failure (see disorders                aminotransfer       section 4.4),        section 4.4), ase increased       jaundice (see        hepatocellular
(see section        section 4.4),        necrosis (see
4.4), aspartate     bilirubin            section 4.4),
aminotransfer       increased (see       hepatitis (see ase increased       section 4.4)         section 4.4),
(see section                             hepatocellular
4.4), blood                              damage (see alkaline                                 section 4.4) phosphatase increased
(see section 4.4)

Skin and                 Rash (see           Drug eruption*       Lyell syndrome         Drug reaction subcutaneous             section             (see section 4.4),   (toxic epidermal       with tissue disorders         4.4)                urticaria (see       necrolysis) (see       eosinophilia section 4.4),        section 4.4),          and systemic pruritus,            Stevens-Johnson        symptoms increased            syndrome (see          (DRESS) sweating             section 4.4), acute generalised exanthematous- pustulosis (see section 4.4),
dermatitis exfoliative,
angioedema, face oedema, alopecia

Musculoskeletal                              Myalgia and connective tissue disorders
General disorders                            Fatigue, malaise,
and administration                           asthenia, fever site 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