Adverse reactions : תופעות לוואי

4.8    Undesirable effects
Summary of the safety profile

The most common adverse reactions are vomiting (1.2%), nausea (2.7%) and constipation (1.2%).

Tabulated summary of adverse reactions
Table 1 displays adverse reactions associated with twice daily administration of fidaxomicin in the treatment of C. difficile infection, reported in at least two patients, presented by system organ class.

The frequency of adverse reactions is defined as follows: 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). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Table 1:    Summary of adverse reactions by MedDRA system organ class 
MedDRA                 Common                    Uncommon                  Frequency not known system organ class
Immune                                           rash, pruritus         hypersensitivity reactions system                                                                  (angioedema, dyspnea) disorders
Metabolism                                    decreased appetite and nutrition disorders
Nervous                                      dizziness, headache,
system                                            dysgeusia disorders
Gastrointestinal   vomiting, nausea,        abdominal distention,
disorders            constipation           flatulence, dry mouth

Description of selected adverse reactions

Acute hypersensitivity reactions, such as angioedema and dyspnea, have been reported during post-marketing (see section 4.3 and 4.4).

Paediatric population

The safety and efficacy of fidaxomicin has been evaluated in 136 patients from birth to less than 18 years of age. Frequency, type and severity of adverse reactions in children are expected to be the same as in adults. In addition to the ADRs shown in table 1, two cases of urticaria were reported.


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/