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 Class                                                                                            Known Blood and the                                 Anaemia              Agranulocytosis, lymphatic system                                                   leukopenia, disorders                                                          thrombocytopenia, neutropenia
Immune system                                                      Anaphylaxis disorders
Metabolism and                                Decreased            Hypercholesterolaemia, nutrition disorders                           appetite             hypertriglyceridaemia, 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, nausea   flatulence, dry mouth
Hepatobiliary            Alanine             Cholestasis (see     Hepatic failure (see disorders                aminotransferase    section 4.4),        section 4.4), increased (see      jaundice (see        hepatocellular necrosis section 4.4),       section 4.4),        (see section 4.4),
aspartate           bilirubin            hepatitis (see section aminotransferase    increased (see       4.4), hepatocellular increased (see      section 4.4)         damage (see section section 4.4),                            4.4) blood alkaline phosphatase increased (see section 4.4)
Skin and                 Rash (see section   Drug eruption*       Toxic epidermal             Drug subcutaneous             4.4)                (see section 4.4),   necrolysis, (see section    reaction tissue disorders                             urticaria (see       4.4), Stevens-Johnson       with section 4.4),        syndrome (see section       eosinophilia pruritus,            4.4), acute generalised     and increased            exanthematous-              systemic sweating             pustulosis (see section     symptoms
4.4), dermatitis            (DRESS) 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, 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