Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical trials enrolled 1,864 patients treated with CUBICIN and 1,416 treated with comparator.

Complicated Skin and Skin Structure Infection Trials

In Phase 3 complicated skin and skin structure infection trials, CUBICIN was discontinued in 15/534 (2.8%) patients due to an adverse reaction, while comparator was discontinued in 17/558 (3.0%) patients.

The rates of the most common adverse reactions, organized by body system, observed in cSSSI (4 mg/kg CUBICIN) patients are displayed in Table 4.

Drug-related adverse reactions (possibly or probably drug-related) that occurred in <1% of patients receiving CUBICIN in the cSSSI trials are as follows:

Body as a Whole: fatigue, weakness, rigors, flushing, hypersensitivity

Blood/Lymphatic System: leukocytosis, thrombocytopenia, thrombocytosis, eosinophilia, increased International Normalized Ratio (INR)

Cardiovascular System: supraventricular arrhythmia

Dermatologic System: eczema

Digestive System: abdominal distension, stomatitis, jaundice, increased serum lactate dehydrogenase

Metabolic/Nutritional System: hypomagnesemia, increased serum bicarbonate, electrolyte disturbance

Musculoskeletal System: myalgia, muscle cramps, muscle weakness, arthralgia

Nervous System: vertigo, mental status change, paresthesia

Special Senses: taste disturbance, eye irritation

Table 4.  Incidence of Adverse Reactions that Occurred in ≥2% of Patients in the CUBICIN Treatment Group and ≥ the Comparator Treatment Groups in Phase 3 cSSSI Trials Adverse Reaction Patients (%)
CUBICIN 4 mg/kg
(N=534) ComparatorComparator: vancomycin (1 g IV q12h) or an anti-staphylococcal semi-synthetic penicillin (i.e., nafcillin, oxacillin, cloxacillin, or flucloxacillin; 4 to 12 g/day IV in divided doses).
(N=558)
Gastrointestinal disorders   
    Diarrhea 5.2 4.3
Nervous system disorders   
    Headache 5.4 5.4
    Dizziness 2.2 2.0
Skin/subcutaneous disorders   
    Rash 4.3 3.8
Diagnostic investigations   
    Abnormal liver function tests 3.0 1.6
    Elevated CPK 2.8 1.8
Infections   
    Urinary tract infections 2.4 0.5
Vascular disorders   
    Hypotension 2.4 1.4
Respiratory disorders   
    Dyspnea 2.1 1.6

S. aureus Bacteremia/Endocarditis Trial

In the S. aureus bacteremia/endocarditis trial, CUBICIN was discontinued in 20/120 (16.7%) patients due to an adverse reaction, while comparator was discontinued in 21/116 (18.1%) patients.

Serious Gram-negative infections (including bloodstream infections) were reported in 10/120 (8.3%) CUBICIN-treated and 0/115 comparator-treated patients.  Comparator-treated patients received dual therapy that included initial gentamicin for 4 days.  Infections were reported during treatment and