Zyvox (Linezolid) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Adult Patients

The safety of ZYVOX formulations was evaluated in 2046 adult patients enrolled in seven Phase 3 comparator-controlled clinical trials, who were treated for up to 28 days. In these studies, 85% of the adverse events reported with ZYVOX were described as mild to moderate in intensity. Table 6 shows the incidence of adverse events reported in at least 2% of patients in these trials. The most common adverse events in patients treated with ZYVOX were diarrhea (incidence across studies: 2.8% to 11.0%), headache (incidence across studies: 0.5% to 11.3%), and nausea (incidence across studies: 3.4% to 9.6%).

Table 6. Incidence (%) of Adverse Events Reported in ≥2% of Adult Patients in Comparator-Controlled Clinical Trials with ZYVOX

Event	ZYVOX (n=2046)	All Comparators Comparators included cefpodoxime proxetil 200 mg PO q12h; ceftriaxone 1 g IV q12h; clarithromycin 250 mg PO q12h; dicloxacillin 500 mg PO q6h; oxacillin 2 g IV q6h; vancomycin 1 g IV q12h. (n=2001)
Diarrhea	8.3	6.3
Headache	6.5	5.5
Nausea	6.2	4.6
Vomiting	3.7	2.0
Insomnia	2.5	1.7
Constipation	2.2	2.1
Rash	2.0	2.2
Dizziness	2.0	1.9
Fever	1.6	2.1

Other adverse events reported in Phase 2 and Phase 3 studies included oral moniliasis, vaginal moniliasis, hypertension, dyspepsia, localized abdominal pain, pruritus, and tongue discoloration.

Table 7 shows the incidence of drug-related adverse events reported in at least 1% of adult patients in these trials by dose of ZYVOX.

Table 7. Incidence (%) of Drug-Related Adverse Events Occurring in >1% of Adult Patients Treated with ZYVOX in Comparator-Controlled Clinical Trials

	Uncomplicated Skin and Skin Structure Infections		All Other Indications
Adverse Event	ZYVOX 400 mg PO q12h (n=548)	Clarithromycin 250 mg PO q12h (n=537)	ZYVOX 600 mg q12h (n=1498)	All Other ComparatorsComparators included cefpodoxime proxetil 200 mg PO q12h; ceftriaxone 1 g IV q12h; dicloxacillin 500 mg PO q6h; oxacillin 2 g IV q6h; vancomycin 1 g IV q12h. (n=1464)
% of patients with 1 drug-related adverse event	25.4	19.6	20.4	14.3
% of patients discontinuing due to drug-related adverse eventsThe most commonly reported drug-related adverse events leading to discontinuation in patients treated with ZYVOX were nausea, headache, diarrhea, and vomiting.	3.5	2.4	2.1	1.7
Diarrhea	5.3	4.8	4.0	2.7
Nausea	3.5	3.5	3.3	1.8
Headache	2.7	2.2	1.9	1.0
Taste alteration	1.8	2.0	0.9	0.2
Vaginal moniliasis	1.6	1.3	1.0	0.4
Fungal infection	1.5	0.2	0.1	<0.1
Abnormal liver function tests	0.4	0	1.3	0.5
Vomiting	0.9	0.4	1.2	0.4
Tongue discoloration	1.1	0	0.2	0
Dizziness	1.1	1.5	0.4	0.3
Oral moniliasis	0.4	0	1.1	0.4

Pediatric Patients

The safety of ZYVOX formulations was evaluated in 215 pediatric patients ranging in age from birth through 11 years, and in 248 pediatric patients aged 5 through 17 years (146 of these 248 were age 5 through 11 and 102 were age 12 to 17). These patients were enrolled in two Phase 3 comparator-controlled clinical trials and were treated for up to 28 days. In these studies, 83% and 99%, respectively, of the adverse events reported with ZYVOX were described as mild to moderate in intensity. In the study of hospitalized pediatric patients (birth through 11 years) with Gram-positive infections, who were randomized 2 to 1 (linezolid:vancomycin), mortality was 6.0% (13/215) in the linezolid arm and 3.0% (3/101) in the vancomycin arm. However, given the severe underlying illness in the patient population, no causality could be established. Table 8 shows the incidence of adverse events reported in at least 2% of pediatric patients treated with ZYVOX in these trials.

Table 8. Incidence (%) of Adverse Events Reported in ≥2% of Pediatric Patients Treated with ZYVOX in Comparator-Controlled Clinical Trials

	Uncomplicated Skin and Skin Structure InfectionsPatients 5 through 11 years of age received ZYVOX 10 mg/kg PO q12h or cefadroxil 15 mg/kg PO q12h. Patients 12 years or older received ZYVOX 600 mg PO q12h or cefadroxil 500 mg PO q12h.		All Other IndicationsPatients from birth through 11 years of age received ZYVOX 10 mg/kg IV/PO q8h or vancomycin 10 to 15 mg/kg IV q6–24h, depending on age and renal clearance.
Event	ZYVOX (n=248)	Cefadroxil (n = 251)	ZYVOX (n = 215)	Vancomycin (n=101)
Fever	2.9	3.6	14.1	14.1
Diarrhea	7.8	8.0	10.8	12.1
Vomiting	2.9	6.4	9.4	9.1
Sepsis	0	0	8.0	7.1
Rash	1.6	1.2	7.0	15.2
Headache	6.5	4.0	0.9	0
Anemia	0	0	5.6	7.1
Thrombocytopenia	0	0	4.7	2.0
Upper respiratory infection	3.7	5.2	4.2	1.0
Nausea	3.7	3.2	1.9	0
Dyspnea	0	0	3.3	1.0
Reaction at site of injection or of vascular catheter	0	0	3.3	5.1
Trauma	3.3	4.8	2.8	2.0
Pharyngitis	2.9	1.6	0.5	1.0
Convulsion	0	0	2.8	2.0
Hypokalemia	0	0	2.8	3.0
Pneumonia	0	0	2.8	2.0
Thrombocythemia	0	0	2.8	2.0
Cough	2.4	4.0	0.9	0
Generalized abdominal pain	2.4	2.8	0.9	2.0
Localized abdominal pain	2.4	2.8	0.5	1.0
Apnea	0	0	2.3	2.0
Gastrointestinal bleeding	0	0	2.3	1.0
Generalized edema	0	0	2.3	1.0
Loose stools	1.6	0.8	2.3	3.0
Localized pain	2.0	1.6	0.9	0
Skin disorder	2.0	0	0.9	1.0

Table 9 shows the incidence of drug-related adverse events reported in more than 1% of pediatric patients (and more than 1 patient) in either treatment group in the comparator-controlled Phase 3 trials.

Table 9. Incidence (%) of Drug-related Adverse Events Occurring in >1% of Pediatric Patients (and >1 Patient) in Either Treatment Group in Comparator-Controlled Clinical Trials

Event	Uncomplicated Skin and Skin Structure InfectionsPatients 5 through 11 years of age received ZYVOX 10 mg/kg PO q12h or cefadroxil 15 mg/kg PO q12h. Patients 12 years or older received ZYVOX 600 mg PO q12h or cefadroxil 500 mg PO q12h.		All Other IndicationsPatients from birth through 11 years of age received ZYVOX 10 mg/kg IV/PO q8h or vancomycin 10 to 15 mg/kg IV q6–24h, depending on age and renal clearance.
	ZYVOX (n=248)	Cefadroxil (n=251)	ZYVOX (n=215)	Vancomycin (n=101)
% of patients with ≥1 drug-related adverse event	19.2	14.1	18.8	34.3
% of patients discontinuing due to a drug-related adverse event	1.6	2.4	0.9	6.1
Diarrhea	5.7	5.2	3.8	6.1
Nausea	3.3	2.0	1.4	0
Headache	2.4	0.8	0	0
Loose stools	1.2	0.8	1.9	0
Thrombocytopenia	0	0	1.9	0
Vomiting	1.2	2.4	1.9	1.0
Generalized abdominal pain	1.6	1.2	0	0
Localized abdominal pain	1.6	1.2	0	0
Anemia	0	0	1.4	1.0
Eosinophilia	0.4	0.4	1.4	0
Rash	0.4	1.2	1.4	7.1
Vertigo	1.2	0.4	0	0
Oral moniliasis	0	0	0.9	4.0
Fever	0	0	0.5	3.0
Pruritus at non-application site	0.4	0	0	2.0
Anaphylaxis	0	0	0	10.1These reports were of 'red-man syndrome', which were coded as anaphylaxis.

Laboratory Changes

ZYVOX has been associated with thrombocytopenia when used in doses up to and including 600 mg every 12 hours for up to 28 days. In Phase 3 comparator-controlled trials, the percentage of adult patients who developed a substantially low platelet count (defined as less than 75% of lower limit of normal and/or baseline) was 2.4% (range among studies: 0.3 to 10.0%) with ZYVOX and 1.5% (range among studies: 0.4 to 7.0%) with a comparator. In a study of hospitalized pediatric patients ranging in age from birth through 11 years, the percentage of patients who developed a substantially low platelet count (defined as less than 75% of lower limit of normal and/or baseline) was 12.9% with ZYVOX and 13.4% with vancomycin. In an outpatient study of pediatric patients aged from 5 through 17 years, the percentage of patients who developed a substantially low platelet count was 0% with ZYVOX and 0.4% with cefadroxil. Thrombocytopenia associated with the use of ZYVOX appears to be dependent on duration of therapy, (generally greater than 2 weeks of treatment). The platelet counts for most patients returned to the normal range/baseline during the follow-up period. No related clinical adverse events were identified in Phase 3 clinical trials in patients developing thrombocytopenia. Bleeding events were identified in thrombocytopenic patients in a compassionate use program for ZYVOX; the role of linezolid in these events cannot be determined (see WARNINGS).

Changes seen in other laboratory parameters, without regard to drug relationship, revealed no substantial differences between ZYVOX and the comparators. These changes were generally not clinically significant, did not lead to discontinuation of therapy, and were reversible. The incidence of adult and pediatric patients with at least one substantially abnormal hematologic or serum chemistry value is presented in Tables 10, 11, 12, and 13.

Table 10. Percent of Adult Patients who Experienced at Least One Substantially Abnormal<75% (<50% for neutrophils) of Lower Limit of Normal (LLN) for values normal at baseline;
<75% (<50% for neutrophils) of LLN and of baseline for values abnormal at baseline. Hematology Laboratory Value in Comparator-Controlled Clinical Trials with ZYVOX

Laboratory Assay	Uncomplicated Skin and Skin Structure Infections		All Other Indications
	ZYVOX 400 mg q12h	Clarithromycin 250 mg q12h	ZYVOX 600 mg q12h	All Other ComparatorsComparators included cefpodoxime proxetil 200 mg PO q12h; ceftriaxone 1 g IV q12h; dicloxacillin 500 mg PO q6h; oxacillin 2 g IV q6h; vancomycin 1 g IV q12h.
Hemoglobin (g/dL)	0.9	0.0	7.1	6.6
Platelet count (x 103/mm3)	0.7	0.8	3.0	1.8
WBC (x 103/mm3)	0.2	0.6	2.2	1.3
Neutrophils (x 103/mm3)	0.0	0.2	1.1	1.2

Table 11. Percent of Adult Patients who Experienced at Least One Substantially Abnormal>2 x Upper Limit of Normal (ULN) for values normal at baseline;
>2 x ULN and >2 x baseline for values abnormal at baseline. Serum Chemistry Laboratory Value in Comparator-Controlled Clinical Trials with ZYVOX

Laboratory Assay	Uncomplicated Skin and Skin Structure Infections		All Other Indications
	ZYVOX 400 mg q12h	Clarithromycin 250 mg q12h	ZYVOX 600 mg q12h	All Other ComparatorsComparators included cefpodoxime proxetil 200 mg PO q12h; ceftriaxone 1 g IV q12h; dicloxacillin 500 mg PO q6h; oxacillin 2 g IV q6h; vancomycin 1 g IV q12h.
AST (U/L)	1.7	1.3	5.0	6.8
ALT (U/L)	1.7	1.7	9.6	9.3
LDH (U/L)	0.2	0.2	1.8	1.5
Alkaline phosphatase (U/L)	0.2	0.2	3.5	3.1
Lipase (U/L)	2.8	2.6	4.3	4.2
Amylase (U/L)	0.2	0.2	2.4	2.0
Total bilirubin (mg/dL)	0.2	0.0	0.9	1.1
BUN (mg/dL)	0.2	0.0	2.1	1.5
Creatinine (mg/dL)	0.2	0.0	0.2	0.6

Table 12. Percent of Pediatric Patients who Experienced at Least One Substantially Abnormal<75% (<50% for neutrophils) of Lower Limit of Normal (LLN) for values normal at baseline;
<75% (<50% for neutrophils) of LLN and <75% (<50% for neutrophils, <90% for hemoglobin if baseline <LLN) of baseline for values abnormal at baseline. Hematology Laboratory Value in Comparator-Controlled Clinical Trials with ZYVOX

Laboratory Assay	Uncomplicated Skin and Skin Structure InfectionsPatients 5 through 11 years of age received ZYVOX 10 mg/kg PO q12h or cefadroxil 15 mg/kg PO q12h. Patients 12 years or older received ZYVOX 600 mg PO q12h or cefadroxil 500 mg PO q12h.		All Other IndicationsPatients from birth through 11 years of age received ZYVOX 10 mg/kg IV/PO q8h or vancomycin 10 to 15 mg/kg IV q6–24h, depending on age and renal clearance.
	ZYVOX	Cefadroxil	ZYVOX	Vancomycin
Hemoglobin (g/dL)	0.0	0.0	15.7	12.4
Platelet count (x 103/mm3)	0.0	0.4	12.9	13.4
WBC (x 103/mm3)	0.8	0.8	12.4	10.3
Neutrophils (x 103/mm3)	1.2	0.8	5.9	4.3

Table 13. Percent of Pediatric Patients who Experienced at Least One Substantially Abnormal>2 x Upper Limit of Normal (ULN) for values normal at baseline; >2 x ULN and >2 (>1.5 for total bilirubin) x baseline for values abnormal at baseline. Serum Chemistry Laboratory Value in Comparator-Controlled Clinical Trials with ZYVOX

Laboratory Assay	Uncomplicated Skin and Skin Structure InfectionsPatients 5 through 11 years of age received ZYVOX 10 mg/kg PO q12h or cefadroxil 15 mg/kg PO q12h. Patients 12 years or older received ZYVOX 600 mg PO q12h or cefadroxil 500 mg PO q12h.		All Other IndicationsPatients from birth through 11 years of age received ZYVOX 10 mg/kg IV/PO q8h or vancomycin 10 to 15 mg/kg IV q6–24h, depending on age and renal clearance.
	ZYVOX	Cefadroxil	ZYVOX	Vancomycin
ALT (U/L)	0.0	0.0	10.1	12.5
Lipase (U/L)	0.4	1.2	---	---
Amylase (U/L)	---	---	0.6	1.3
Total bilirubin (mg/dL)	---	---	6.3	5.2
Creatinine (mg/dL)	0.4	0.0	2.4	1.0

Postmarketing Experience

Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported during postmarketing use of ZYVOX (see WARNINGS). Peripheral neuropathy, and optic neuropathy sometimes progressing to loss of vision, have been reported in patients treated with ZYVOX. Lactic acidosis has been reported with the use of ZYVOX (see PRECAUTIONS). Although these reports have primarily been in patients treated for longer than the maximum recommended duration of 28 days, these events have also been reported in patients receiving shorter courses of therapy. Serotonin syndrome has been reported in patients receiving concomitant serotonergic agents, including antidepressants such as selective serotonin reuptake inhibitors (SSRIs) and ZYVOX (see PRECAUTIONS). Convulsions have been reported with the use of ZYVOX (see PRECAUTIONS). Anaphylaxis, angioedema, and bullous skin disorders such as those described as Stevens Johnson syndrome have been reported. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to ZYVOX, or a combination of these factors. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made and causal relationship cannot be precisely established.

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO ZYVOX

Possible Zyvox side effects / adverse reactions in 86 year old female

Reported by a pharmacist from United States on 2007-01-03

Patient: 86 year old female

Reactions: Thrombocytopenia

Adverse event resulted in: hospitalization

Suspect drug(s):
Heparin
    Dosage: 5000 units bid sq
    Indication: Atrial Fibrillation
    Start date: 2005-12-21
    End date: 2005-12-24

Zyvox
    Dosage: 600 mg q12 iv
    Indication: Urosepsis
    Start date: 2005-12-26
    End date: 2006-01-04

Possible Zyvox side effects / adverse reactions in 79 year old male

Reported by a pharmacist from United Kingdom on 2007-01-11

Patient: 79 year old male

Reactions: Blood Potassium Increased

Suspect drug(s):
Zyvox
    Indication: Lower Respiratory Tract Infection

Zyvox
    Indication: Sepsis

Imipenem

Ramipril

Other drugs received by patient: Drug, Unspecified

Possible Zyvox side effects / adverse reactions in 74 year old female

Reported by a pharmacist from United States on 2007-01-16

Patient: 74 year old female weighing 33.0 kg (72.6 pounds)

Reactions: Dystonia, Pain, Sepsis

Suspect drug(s):
Celexa
    Dosage: 20 mg daily po [several months]
    Administration route: Oral
    Indication: Depression

Zyvox
    Dosage: 600 mg bid po
    Administration route: Oral
    Indication: Drug USE FOR Unknown Indication
    Start date: 2006-12-05

Possible Zyvox side effects / adverse reactions in 8 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2007-01-17

Patient: 8 year old male

Reactions: Pyrexia, Serum Sickness, Toxic Skin Eruption

Adverse event resulted in: hospitalization

Suspect drug(s):
Zyvox
    Indication: Pyrexia

Ciprofloxacin
    Indication: Pyrexia

Ceftazidime
    Indication: Pyrexia

Piperacillin and Tazobactam
    Indication: Pyrexia

Amikacin
    Indication: Pyrexia

Vancomycin
    Indication: Pyrexia

Possible Zyvox side effects / adverse reactions in 85 year old female

Reported by a physician from Japan on 2007-01-19

Patient: 85 year old female

Reactions: Delirium

Suspect drug(s):
Zyvox

Possible Zyvox side effects / adverse reactions in 8 year old male

Reported by a physician from France on 2007-01-22

Patient: 8 year old male

Reactions: Drug Eruption, Urticaria Papular, Pyrexia, Serum Sickness

Adverse event resulted in: hospitalization

Suspect drug(s):
Ciprofloxacin
    Indication: Pyrexia

Fortum
    Indication: Pyrexia

Tazocilline
    Indication: Pyrexia

Zyvox
    Indication: Pyrexia

Amikacin
    Indication: Pyrexia

Vancomycin
    Indication: Pyrexia

Other drugs received by patient: Tienam

Possible Zyvox side effects / adverse reactions in 71 year old female

Reported by a physician from Japan on 2007-01-24

Patient: 71 year old female weighing 47.0 kg (103.4 pounds)

Reactions: Hepatic Function Abnormal, Renal Impairment, Drug Ineffective, Sepsis, Condition Aggravated, Infection

Adverse event resulted in: death

Suspect drug(s):
Funguard(micafungin) Injection
    Dosage: 150 mg, iv drip; see image
    Indication: Systemic Candida
    Start date: 2006-08-20
    End date: 2006-08-22

Funguard(micafungin) Injection
    Dosage: 150 mg, iv drip; see image
    Indication: Systemic Candida
    Start date: 2006-08-23
    End date: 2006-08-28

Funguard(micafungin) Injection
    Dosage: 150 mg, iv drip; see image
    Indication: Systemic Candida
    Start date: 2006-08-29
    End date: 2006-09-12

Zyvox
    Dosage: 1200 mg
    Indication: Drug USE FOR Unknown Indication
    Start date: 2006-08-28
    End date: 2006-09-04

Other drugs received by patient: Diflucan; Vfend; Meropen (Meropenem); Targocid; Ceftazidime; Sulfamethoxazole + Trimethoprim; Exacin (Isepamicin Sulfate); Habekacin (Arbekacin); Tienam (Imipenem, Cilastatin Sodium); Neutrogin (Lenograstim); Venilon (Immunoglobin Human Normal)

Possible Zyvox side effects / adverse reactions in 85 year old female

Reported by a physician from Japan on 2007-01-26

Patient: 85 year old female

Reactions: Delirium

Suspect drug(s):
Zyvox

Possible Zyvox side effects / adverse reactions in 92 year old male

Reported by a physician from Japan on 2007-01-26

Patient: 92 year old male

Reactions: Tachycardia

Suspect drug(s):
Zyvox

Other drugs received by patient: Sevoflurane; Catabon; Propofol; Zantac; Flumarin

Possible Zyvox side effects / adverse reactions in 55 year old male

Reported by a physician from Japan on 2007-01-29

Patient: 55 year old male weighing 51.0 kg (112.2 pounds)

Reactions: Intracranial Venous Sinus Thrombosis, Convulsion

Adverse event resulted in: hospitalization

Suspect drug(s):
Primaxin
    Indication: Infection
    Start date: 2006-08-25
    End date: 2006-09-02

Zyvox
    Indication: Infection
    Start date: 2006-08-30
    End date: 2006-09-05

Micafungin Sodium
    Indication: Infection
    Start date: 2006-08-30
    End date: 2006-09-05

Possible Zyvox side effects / adverse reactions in 76 year old male

Reported by a individual with unspecified qualification from Japan on 2007-01-30

Patient: 76 year old male weighing 68.2 kg (150.0 pounds)

Reactions: Dehydration, Pancytopenia

Adverse event resulted in: hospitalization

Suspect drug(s):
Zyvox
    Administration route: Oral
    Indication: Device Related Infection
    Start date: 2005-12-27
    End date: 2006-01-05

Zyvox
    Administration route: Oral
    Indication: Device Related Infection
    Start date: 2005-12-27
    End date: 2006-01-05

Other drugs received by patient: Zantac; Magnesium Oxide; Aspirin; Artist; Warfarin Sodium; Selbex; Lasix

Possible Zyvox side effects / adverse reactions in 65 year old male

Reported by a pharmacist from United States on 2007-01-30

Patient: 65 year old male weighing 125.6 kg (276.3 pounds)

Reactions: Thrombocytopenia, Ill-Defined Disorder

Adverse event resulted in: life threatening event

Suspect drug(s):
Zyvox

Other drugs received by patient: Demerol; Metronidazole; Levaquin; Drug, Unspecified; Solu-Cortef; Protonix; Valium

Possible Zyvox side effects / adverse reactions in 61 year old male

Reported by a consumer/non-health professional from Spain on 2007-01-31

Patient: 61 year old male

Reactions: Anaemia, Leukopenia

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Augmentin '125'
    Administration route: Oral
    Indication: Pulmonary Tuberculosis
    Start date: 2006-01-12

Zyvox
    Dosage: 600mg twice per day
    Administration route: Oral
    Indication: Pulmonary Tuberculosis
    Start date: 2006-01-12
    End date: 2006-06-08

Claritromicina
    Dosage: 500mg twice per day
    Administration route: Oral
    Indication: Drug USE FOR Unknown Indication
    Start date: 2006-01-12

Ameride
    Administration route: Oral
    Indication: Pulmonary Tuberculosis
    Start date: 2006-01-12

Other drugs received by patient: Myambutol; Moxifloxacin HCL

Possible Zyvox side effects / adverse reactions in 77 year old female

Reported by a pharmacist from United States on 2007-01-31

Patient: 77 year old female weighing 34.0 kg (74.8 pounds)

Reactions: Thrombocytopenia

Suspect drug(s):
Zyvox
    Dosage: 600 mg po q 12 hours
    Administration route: Oral
    Indication: Sepsis
    Start date: 2007-01-06
    End date: 2007-01-15

Zyvox
    Dosage: 600 mg po q 12 hours
    Administration route: Oral
    Indication: Sepsis
    Start date: 2007-01-15
    End date: 2007-01-16

Possible Zyvox side effects / adverse reactions in 18 year old female

Reported by a physician from Sweden on 2007-02-02

Patient: 18 year old female

Reactions: Abdominal Pain, Pancreatitis

Adverse event resulted in: hospitalization

Suspect drug(s):
Zyvox

Other drugs received by patient: Dalacin

Possible Zyvox side effects / adverse reactions in 84 year old male

Reported by a physician from Japan on 2007-02-02

Patient: 84 year old male

Reactions: Gastritis

Suspect drug(s):
Zyvox
    Dosage: daily dose:1200mg
    Indication: Post Procedural Infection
    Start date: 2006-12-20
    End date: 2006-12-24

Zyvox
    Administration route: Oral
    Indication: Post Procedural Infection

Possible Zyvox side effects / adverse reactions in 12 month old male

Reported by a physician from United Kingdom on 2007-02-06

Patient: 12 month old male

Reactions: Deafness

Suspect drug(s):
Zyvox
    Indication: Meningitis

Gentamicin Sulfate
    Indication: Meningitis

Possible Zyvox side effects / adverse reactions in 76 year old male

Reported by a individual with unspecified qualification from Japan on 2007-02-13

Patient: 76 year old male weighing 68.2 kg (150.0 pounds)

Reactions: Pancytopenia, Decreased Appetite

Adverse event resulted in: hospitalization

Suspect drug(s):
Zyvox
    Administration route: Oral
    Indication: Device Related Infection
    Start date: 2005-12-27
    End date: 2006-01-05

Zyvox
    Administration route: Oral
    Indication: Device Related Infection
    Start date: 2005-12-27
    End date: 2006-01-05

Other drugs received by patient: Zantac; Magnesium Oxide; Aspirin; Artist; Warfarin Sodium; Selbex; Lasix

Possible Zyvox side effects / adverse reactions in 75 year old female

Reported by a physician from Ireland on 2007-02-13

Patient: 75 year old female

Reactions: Haematuria, Platelet Count Decreased, Ill-Defined Disorder

Adverse event resulted in: hospitalization

Suspect drug(s):
Zyvox

Possible Zyvox side effects / adverse reactions in 75 year old male

Reported by a physician from Japan on 2007-02-14

Patient: 75 year old male

Reactions: Pseudomembranous Colitis

Suspect drug(s):
Zyvox
    Dosage: daily dose:1200mg
    Indication: Skin Infection

Zyvox
    Indication: Staphylococcal Infection

Tienam