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               Common           Uncommon               Rare            Not Known Class
Blood and the                             Anaemia            Agranulocytosis lymphatic system                                             , leukopenia, disorders                                                    thrombocytopen ia, neutropenia
Immune system                                                Anaphylaxis disorders
Metabolism and                            Decreased          Hypercholestero nutrition                                 appetite           laemia,
disorders                                                    hypertriglycerid aemia,
hypokalemia
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)
Gastrointestinal       Abdominal pain,    Constipation disorders              vomiting,          dyspepsia,
diarrhoea,         flatulence, dry nausea             mouth
Hepatobiliary          Alanine            Cholestasis (see   Hepatic failure disorders              aminotransferase   section 4.4),      (see section increased (see     jaundice (see      4.4),
section 4.4),      section 4.4),      hepatocellular aspartate          bilirubin          necrosis (see aminotransferase   increased (see     section 4.4),
increased (see     section 4.4)       hepatitis (see section 4.4),                         section 4.4),
blood alkaline                        hepatocellular phosphatase                           damage (see increased (see                        section 4.4) section 4.4)
Skin and               Rash (see          Drug eruption*     Toxic epidermal     Drug reaction subcutaneous           section 4.4)       (see section       necrolysis, (see    with tissue disorders                          4.4), urticaria    section 4.4),       eosinophilia and (see section       Stevens-Johnson     systemic
System Organ               Common            Uncommon                Rare             Not Known Class
4.4), pruritus,     syndrome (see       symptoms increased           section 4.4),       (DRESS) sweating            acute generalised exanthematous- pustulosis (see section 4.4),
dermatitis exfoliative,
angioedema,
face oedema,
alopecia
Musculoskeletal                            Myalgia and connective tissue disorders
General disorders                          Fatigue,
and                                        malaise,
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, excluding the genital candidiasis indication, 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 event should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il.