Drug Information

Zyvox Side Effects

Generic Name: linezolid

Please note - some side effects for Zyvox may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Zyvox - for the Consumer

Zyvox

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zyvox:

Bad taste in mouth; constipation; diarrhea; dizziness; headache; nausea; tongue discoloration; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Zyvox:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; bloody stools; bloody vomit; chills; confusion; exaggerated reflexes; excitation; fast heartbeat; loss of coordination; mental or mood changes; muscle spasms; prolonged or repeated nausea or vomiting; seizures; severe or continuing diarrhea; sore throat or fever; stomach pain/cramps; sweating; swelling of the hands or feet; tingling or numbness of hands or feet; unusual bleeding or bruising; unusual tiredness or weakness; vaginal irritation or unusual discharge; vision changes; white patches in the mouth.

Zyvox Suspension

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zyvox Suspension:

Bad taste in mouth; constipation; diarrhea; dizziness; headache; nausea; tongue discoloration; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Zyvox Suspension:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; bloody stools; bloody vomit; chills; confusion; exaggerated reflexes; excitation; fast heartbeat; loss of coordination; mental or mood changes; muscle spasms; prolonged or repeated nausea or vomiting; seizures; severe or continuing diarrhea; sore throat or fever; stomach pain/cramps; sweating; swelling of the hands or feet; tingling or numbness of hands or feet; unusual bleeding or bruising; unusual tiredness or weakness; vaginal irritation or unusual discharge; vision changes; white patches in the mouth.

Zyvox Tablets

Bad taste in mouth; constipation; diarrhea; dizziness; headache; nausea; tongue discoloration; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Zyvox Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; bloody stools; bloody vomit; chills; excitation; fast heartbeat; loss of coordination; muscle spasms; prolonged or repeated nausea or vomiting; seizures; severe or continuing diarrhea; sore throat or fever; stomach pain/cramps; sweating; swelling of the hands or feet; tingling or numbness of hands or feet; unusual bleeding or bruising; unusual tiredness or weakness; vaginal irritation or unusual discharge; vision changes; white patches in the mouth.

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Zyvox Side Effects - for the Professional

Zyvox

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 * (n=2001)
* 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.
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 Comparators* (n=1464)
* Comparators 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. † The most commonly reported drug-related adverse events leading to discontinuation in patients treated with Zyvox were nausea, headache, diarrhea, and vomiting.
% of patients with 1 drug-related adverse event	25.4	19.6	20.4	14.3
% of patients discontinuing due to drug-related adverse events†	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 Infections*		All Other Indications†
Event	Zyvox (n=248)	Cefadroxil (n = 251)	Zyvox (n = 215)	Vancomycin (n=101)
* Patients 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. † Patients 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.
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 Infections*		All Other Indications†
Event	Zyvox (n=248)	Cefadroxil (n=251)	Zyvox (n=215)	Vancomycin (n=101)
* Patients 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. † Patients 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. ‡ These reports were of 'red-man syndrome', which were coded as anaphylaxis.
% 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	10.1‡

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.

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* Hematology Laboratory Value in Comparator-Controlled Clinical Trials with Zyvox
Laboratory Assay	Uncomplicated Skin and Skin Structure Infections		All Other Indications
Laboratory Assay	Zyvox 400 mg q12h	Clarithromycin 250 mg q12h	Zyvox 600 mg q12h	All Other Comparators†
* <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. † Comparators 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* Serum Chemistry Laboratory Value in Comparator-Controlled Clinical Trials with Zyvox
Laboratory Assay	Uncomplicated Skin and Skin Structure Infections		All Other Indications
Laboratory Assay	Zyvox 400 mg q12h	Clarithromycin 250 mg q12h	Zyvox 600 mg q12h	All Other Comparators†
* >2 x Upper Limit of Normal (ULN) for values normal at baseline; >2 x ULN and >2 x baseline for values abnormal at baseline. † Comparators 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* Hematology Laboratory Value in Comparator-Controlled Clinical Trials with Zyvox
Laboratory Assay	Uncomplicated Skin and Skin Structure Infections†		All Other Indications‡
Laboratory Assay	Zyvox	Cefadroxil	Zyvox	Vancomycin
* <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. † Patients 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. ‡ Patients 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.
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* Serum Chemistry Laboratory Value in Comparator-Controlled Clinical Trials with Zyvox
Laboratory Assay	Uncomplicated Skin and Skin Structure Infections†		All Other Indications‡
Laboratory Assay	Zyvox	Cefadroxil	Zyvox	Vancomycin
* >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. † Patients 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. ‡ Patients 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.
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. 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. 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. Convulsions have been reported with the use of Zyvox. Anaphylaxis, angioedema, and bullous skin disorders such as those described as Stevens Johnson syndrome have been reported. Superficial tooth discoloration has been reported with the use of linezolid. The discoloration was removable with professional dental cleaning (manual descaling) in cases with known outcome. 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.

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Side Effects by Body System

General

Linezolid was evaluated in 2046 patients with 85% of adverse events reported as mild to moderate. Superinfection may occur in patients due to overgrowth of resistant organisms.

Gastrointestinal

A case of brown tooth discoloration was reversible after dental cleaning.

A 60-year-old man with spondylodiscitis developed a fatal case of Clostridium difficile colitis after a long-term course of linezolid therapy.

Gastrointestinal side effects of linezolid in relation to comparator therapy have included diarrhea (8.3% vs. 6.3%), nausea (6.2% vs. 4.6%), vomiting (3.7% vs. 2%), and constipation (2.2% vs. 2.1%). Taste alteration has been reported in 0.9% to 1.8% of patients. Oral moniliasis, dyspepsia, localized abdominal pain, superficial tooth discoloration, tongue discoloration, lingua villosa nigra, and pseudomembranous colitis have also been reported.

Hematologic

Hematological side effects have included myelosuppression (anemia, leukopenia, pancytopenia, and thrombocytopenia). Phase 3 studies have shown a 2.4% incidence of low platelet counts (less than 75% of lower limit of normal) in relation to 1.5% for comparator drugs. Four of these patients required platelet transfusions. Red cell hypoplasia (0.5%) and decreased hemoglobin and hematocrit (4.7%) have also been reported.

Complete blood counts should be monitored weekly in patients who receive linezolid, particularly in those who receive linezolid for longer than two weeks, those with preexisting myelosuppression, those receiving concomitant drugs that produce bone marrow suppression, or those with chronic infection who have received previous or concomitant antibiotic therapy. Discontinuation of therapy should be considered in patients who develop or have worsening myelosuppression.

In one case, linezolid was successfully restarted at a reduced dose after resolution of myelotoxicity.

Thrombocytopenia (platelets less than 100,000/mm3) has been reported in 32% of patients (n=19) receiving linezolid for more than 10 days. In another study (n=295), thrombocytopenia (platelets less than150 x 10(9)/L) occurred in 6.4% of patients and severe thrombocytopenia (platelets less than 50 x 10(9)/L) occurred in 0.3% receiving linezolid for more than 5 days. It has been suggested that the mechanism of linezolid-associated thrombocytopenia is immune-mediated.

In a study of patients with linezolid-associated thrombocytopenia, the administration of vitamin B6 was shown to help reverse the incidence of thrombocytopenia. Vitamin B6 was most effective when it was administered after linezolid treatment was held. Once hematologic levels were returned to baseline, concomitant administration of linezolid and vitamin B6 resulted in stable hemoglobin levels for the remainder of linezolid therapy.

Another study compared linezolid plus 50 mg vitamin B6 per day (n=31) with linezolid alone (n=62) administered to patients with cancer. This study concluded vitamin B6 was not beneficial in the prevention of leukopenia or thrombocytopenia, but found a possible trend towards the prevention of anemia.

Nervous system

Nervous system side effects of linezolid in relation to comparator therapy have included headache (6.5% vs. 5.5%), insomnia (2.5% vs. 1.7%), and dizziness (2% vs. 1.9%). Linezolid has been implicated in several case reports of peripheral and optic neuropathy, mainly in patients where the duration of therapy was longer than 28 days. Drowsiness, confusion, and seizure have also been reported. Serotonin syndrome has occurred in patients receiving concomitant serotonergic agents. At least one case of Bell's palsy has been reported.

Several cases of peripheral and/or optic neuropathy have been reported. For example, irreversible sensory loss and peripheral neuropathy have been reported in a patient after 6 months of linezolid therapy for actinomycosis. The time from the onset of linezolid treatment to the first sign of peripheral neuropathy averaged 4 months (range 10 days to 6 months) in 10 patients with only peripheral neuropathy. In all patients with peripheral neuropathy (n=16), complete recovery was not observed following linezolid discontinuation.

At least 15 instances of serotonin syndrome have been reported in patients receiving linezolid during treatment with citalopram, sertraline, venlafaxine, fluoxetine, or paroxetine. Other concurrent drugs and/or comorbidities may have contributed to the patients developing serotonin syndrome. The time from the onset of linezolid treatment to the first sign of serotonin syndrome averaged 4 days (range 1 to 20 days) and from the first sign to stopping linezolid ranged from 1 to 16 days. The symptoms resolved within 1 to 9 days in 14 patients while one patient died suddenly. Three patients died. The first patient developed symptoms 3 weeks after concurrent treatment with linezolid and citalopram. The patient developed severe lactic acidosis followed by myocardial infarction, and after 3 further episodes of cardiac arrest, the patient died. The second patient stopped sertraline on day 1 and developed symptoms on day 9 of linezolid treatment. The patient had cardiopulmonary arrest, then anoxic brain injury, hypertension, tachycardia, and diarrhea, and died in 2 weeks. This patient had a similar incident 6 weeks earlier when linezolid and sertraline were administered. The third patient, who was receiving citalopram, developed symptoms on day 2 of linezolid treatment and died with cerebral hemorrhage one month following the start of serotonin syndrome despite stopping linezolid.

A 49-year-old male with multiple comorbidities was started on oral linezolid 600 mg twice a day following intravenous vancomycin for the treatment of osteomyelitis. On day 21 of linezolid treatment, the patient reported a strange sensation in his mouth without any pain, sores, or blisters. On day 22, the patient's left eye began to tear inexplicably and he was not able to drink properly. On day 23, left facial frowning and excessive tearing of his left eye was observed on examination. Left-sided facial weakness involving the upper and lower facial muscles was discovered on physical examination. Bell's palsy was diagnosed. Linezolid was discontinued and by day 90, the Bell's palsy completely resolved. Five months later, the patient was restarted on oral linezolid 600 mg twice a day following intravenous vancomycin treatment. On day 21 of linezolid treatment, the patient again developed upper and lower facial muscle weakness on his left side. The linezolid was discontinued and by day 35, the Bell's palsy had practically resolved. Four months following his second episode, the patient had no remaining symptoms.

Metabolic

Metabolic side effects have included lactic acidosis, hyperlactatemia, metabolic acidosis, hyponatremia, and hypokalemia.

At least 7 instances of lactic acidosis have been reported following linezolid therapy. The time from the onset of linezolid treatment to the first sign of lactic acidosis ranged from 1 to 16 weeks. Linezolid was stopped within 4 days of identifying lactic acidosis. Two of the 7 patients died despite stopping linezolid. The lactate levels normalized in the 5 surviving patients after stopping linezolid, but one of the patients had sequelae of blindness and disorientation.

Ocular

Several cases of peripheral and/or optic neuropathy have been reported. The time from the onset of linezolid treatment to the first sign of optic neuropathy averaged 10 months (range 1 to 48 months) in 6 patients with only optic neuropathy. The time to discontinuation of linezolid due to optic neuropathy averaged 11 months (range 1 to 56 months) following therapy initiation. Linezolid was stopped in 12 cases following the development of optic neuropathy; improvement or complete recovery was observed in all cases.

Ocular side effects have included optic neuropathy, sometimes in conjunction with peripheral neuropathy after long-term treatment (6 to 10 months). Partially irreversible bilateral optic neuritis has been reported in a patient after 41 weeks of linezolid therapy.

Dermatologic

Dermatological side effects of linezolid in relation to comparator therapy have included rash (2% vs. 2.2%). Pruritus and mild alopecia have also been reported.

Cardiovascular

Cardiovascular side effects have included increased and decreased blood pressure and supraventricular tachycardia (0.5%).

The potential for hypertensive crisis exists when linezolid is taken concurrently with foods high in tyramine due to the monoamine oxidase inhibiting properties of linezolid.

Genitourinary

Genitourinary side effects including vaginal moniliasis have been reported.

Hepatic

Hepatic side effects including abnormal liver function tests have been reported in 0.4% to 1.3% of patients.

Renal

Renal side effects have included exacerbation of renal failure (0.5%) and abnormal renal function.

Other

Other side effects have included elevated creatine phosphokinase (0.5%) and generalized edema.

Respiratory

Respiratory side effects have included at least one case of interstitial pneumonia.

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More resources:

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Micromedex Zyvox Systemic - Includes detailed dosage instructions.

FDA Zyvox

Facts & Comparisons Linezolid

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