Adverse reactions : תופעות לוואי

4.8    Undesirable effects

In 3,142 adult patients (1817 of which received Doribax) evaluated for safety in phase 2 and phase 3 clinical trials, adverse reactions due to Doribax 500 mg every 8 hours occurred at a rate of 32%.
Doribax was discontinued because of adverse drug reactions in 0.1% of patients overall. Adverse drug reactions that led to Doribax discontinuation were nausea (0.1%), diarrhoea (0.1%), pruritus (0.1%), vulvomycotic infection (0.1%), hepatic enzyme increased (0.2%) and rash (0.2%). The most common adverse reactions were headache (10%), diarrhoea (9%) and nausea (8%).

Adverse drug reactions due to Doribax 500 mg are listed below by frequency category. Frequency categories are defined as follows: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Adverse Drug Reactions Identified During Clinical Trials with Doribax Infections and infestation        Common: oral candidiasis, vulvomycotic infection Immune system disorders           Uncommon: hypersensitivity reactions (see section 4.4) Nervous system disorders          Very common: headache
Vascular disorders                Common: phlebitis
Gastrointestinal disorders        Common: nausea, diarrhoea
Uncommon: C. difficile colitis (see section 4.4)
Hepato-biliary disorders          Common: hepatic enzyme increased
Skin and subcutaneous tissue      Common: pruritus, rash disorders

Adverse Drug Reactions Identified During Post-marketing Experience with Doribax Blood and the lymphatic system    Frequency not known: neutropenia disorders
Immune system disorders           Frequency not known: anaphylaxis (see section 4.4)