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Zyvox

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Zyvox

Zyvox

Zyvox Side Effects Center

Pharmacy Editor: Charles Patrick Davis, MD, PhD

Zyvox (linezolid) is an antibacterial drug used to treat susceptible Gram positive infections (for example, Staphylococcus and Streptococcus spp.). Zyvox is available in other countries under the generic name linezolid. Common side effects of the drug include diarrhea, nausea, vomiting, headache, insomnia and constipation.

Zyvox (linezolid) is available in an IV form (strength is 2mg per ml), in tablets (strengths of 400 and 600mg) and in an oral suspension (strength is 100mg per 5ml). Dose depends on the form of the drug used, the type of infection and if the drug is used to treat children or adults; the treating doctor should determine the dose. This drug is not to be used to treat Gram-negative bacterial infections. Severe side effects include severe diarrhea, fungal infections, thrombocytopenia, myelosuppression, serotonin syndrome, neuropathies and angioedema. Zyvox has been used in the pediatric population with weight-adjusted dosing. Risk versus benefits should be considered before using Zyvox in pregnant or lactating females.

Our Zyvox Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Zyvox in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some people develop lactic acidosis while using linezolid. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

Call your doctor at once if you have any other serious side effects, such as:

  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • diarrhea that is watery or bloody;
  • blurred vision, trouble seeing colors
  • numbness, burning pain, or tingly feeling in your hands or feet; or
  • seizure (convulsions).

Less serious side effects may include:

  • headache, dizziness, sleep problems (insomnia);
  • nausea, vomiting, constipation;
  • discolored tongue, unusual or unpleasant taste in the mouth;
  • vaginal itching or discharge; or
  • yeast infection in the mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Zyvox (Linezolid) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Zyvox Overview - Patient Information: Side Effects

SIDE EFFECTS: Pain/redness/swelling at the injection site may occur. Also, diarrhea, headache, nausea, vomiting, dizziness, trouble sleeping, or constipation may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: deep/fast breathing, drowsiness, mental/mood changes, uncontrolled movements, tingling or numbness of hands/feet, easy bruising/bleeding, severe headache, vision changes (including loss of vision), persistent sore throat, unusual tiredness, seizure.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a resistant bacteria. This condition may occur weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (oral or vaginal fungal infection). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge or other new symptoms.

A very serious, sometimes fatal, condition called serotonin syndrome can occur when linezolid is taken with certain drugs that increase serotonin (see Drug Interactions section). Get medical help right away if you develop any of the following symptoms: hallucinations, unusual restlessness, loss of coordination, fast heartbeat, severe dizziness, sweating, shaking/shivering, unexplained fever, twitchy muscles, severe nausea/vomiting/diarrhea.

A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Zyvox (Linezolid)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Zyvox FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

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

Adults

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.

Of the patients treated for uncomplicated skin and skin structure infections (uSSSIs), 25.4% of ZYVOX-treated and 19.6% of comparator-treated patients experienced at least one drug-related adverse event. For all other indications, 20.4% of ZYVOX -treated and 14.3% of comparator-treated patients experienced at least one drug-related adverse event.

Table 2 shows the incidence of all-causality, treatment-emergent adverse reactions reported in at least 1% of adult patients in these trials by dose of ZYVOX.

Table 2: Incidence (%) of Treatment-Emergent Adverse Reactions Occurring in > 1% of Adult Patients Treated with ZYVOX in Comparator-Controlled Clinical Trials

ADVERSE REACTIONS Uncomplicated Skin and Skin Structure Infections All Other Indications
ZYVOX 400 mg by mouth every 12 hours
(n=548)
Clarithromycin 250 mg by mouth every 12 hours
(n=537)
ZYVOX 600 mg every 12 hours
(n=1498)
All Other Comparators*
(n=1464)
Headache 8.8 8.4 5.7 4.4
Diarrhea 8.2 6.1 8.3 6.4
Nausea 5.1 4.5 6.6 4.6
Vomiting 2 1.5 4.3 2.3
Dizziness 2.6 3 1.8 1.5
Rash 1.1 1.1 2.3 2.6
Anemia 0.4 0 2.1 1.4
Taste alteration 1.8 2 1 0.3
Vaginal moniliasis 1.8 1.3 1.1 0.5
Oral moniliasis 0.5 0 1.7 1
Abnormal liver function tests 0.4 0.2 1.6 0.8
Fungal infection 1.5 0.2 0.3 0.2
Tongue discoloration 1.3 0 0.3 0
Localized abdominal pain 1.3 0.6 1.2 0.8
Generalized abdominal pain 0.9 0.4 1.2 1
* Comparators included cefpodoxime proxetil 200 mg by mouth every 12 hours; ceftriaxone 1 g intravenously every 12 hours; dicloxacillin 500 mg by mouth every 6 hours; oxacillin 2 g intravenously every 6 hours; vancomycin 1 g intravenously every 12 hours.

Of the patients treated for uSSSIs, 3.5% of ZYVOX -treated and 2.4% of comparator-treated patients discontinued treatment due to drug-related adverse events. For all other indications, discontinuations due to drug-related adverse events occurred in 2.1% of ZYVOX -treated and 1.7% of comparator-treated patients. The most common reported drug-related adverse events leading to discontinuation of treatment were nausea, headache, diarrhea, and vomiting.

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 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.

Of the pediatric patients treated for uSSSIs, 19.2% of ZYVOX-treated and 14.1% of comparator-treated patients experienced at least one drug-related adverse event. For all other indications, 18.8% of ZYVOX-treated and 34.3% of comparator-treated patients experienced at least one drug-related adverse event.

Table 3 shows the incidence of all-causality, treatment-emergent adverse reactions 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 3: Incidence (%) of Treatment-Emergent Adverse Reactions Occurring in > 1% of Pediatric Patients (and > 1 Patient) in Either Treatment Group in Comparator-Controlled Clinical Trials

ADVERSE REACTIONS Uncomplicated Skin and Skin Structure Infections* All Other Indications†
ZYVOX
(n=248)
Cefadroxil
(n=251)
ZYVOX
(n=215)
Vancomycin
(n=101)
Diarrhea 7.8 8 10.8 12.1
Vomiting 2.9 6.4 9.4 9.1
Headache 6.5 4 0.9 0
Anemia 0 0 5.6 7.1
Thrombocytopenia 0 0 4.7 2
Nausea 3.7 3.2 1.9 0
Generalized abdominal pain 2.4 2.8 0.9 2
Localized abdominal pain 2.4 2.8 0.5 1
Loose stools 1.6 0.8 2.3 3
Eosinophilia 0.4 0.8 1.9 1
Pruritus at non-application site 0.8 0.4 1.4 2
Vertigo 1.2 0.4 0 0
* Patients 5 through 11 years of age received ZYVOX 10 mg/kg by mouth every 12 hours or cefadroxil 15 mg/kg by mouth every 12 hours. Patients 12 years or older received ZYVOX 600 mg by mouth every 12 hours or cefadroxil 500 mg by mouth every 12 hours.
† Patients from birth through 11 years of age received ZYVOX 10 mg/kg intravenously by mouth every 8 hours or vancomycin 10 to 15 mg/kg intravenously every 6-24 hours, depending on age and renal clearance.

Of the pediatric patients treated for uSSSIs, 1.6% of ZYVOX-treated and 2.4% of comparator-treated patients discontinued treatment due to drug-related adverse events. For all other indications, discontinuations due to drug-related adverse events occurred in 0.9% of ZYVOX-treated and 6.1% of comparator-treated patients.

Laboratory Abnormalities

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 AND PRECAUTIONS].

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 4, 5, 6, and 7.

Table 4: 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
ZYVOX 400 mg every 12 hours Clarithromycin 250 mg every 12 hours ZYVOX 600 mg every 12 hours All Other Comparators†
Hemoglobin (g/dL) 0.9 0 7.1 6.6
Platelet count (x 103/mm³) 0.7 0.8 3 1.8
WBC (x 103/mm³) 0.2 0.6 2.2 1.3
Neutrophils (x 103/mm³) 0 0.2 1.1 1.2
* < 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 by mouth every 12 hours; ceftriaxone 1 g intravenously every 12 hours; dicloxacillin 500 mg by mouth every 6 hours; oxacillin 2 g intravenously every 6 hours; vancomycin 1 g intravenously every 12 hours.

Table 5: 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
ZYVOX 400 mg every 12 hours Clarithromycin 250 mg every 12 hours ZYVOX 600 mg every 12 hours All Other Comparators†
AST (U/L) 1.7 1.3 5 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
Total bilirubin (mg/dL) 0.2 0 0.9 1.1
BUN (mg/dL) 0.2 0 2.1 1.5
Creatinine (mg/dL) 0.2 0 0.2 0.6
* > 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 by mouth every 12 hours; ceftriaxone 1 g intravenously every 12 hours; dicloxacillin 500 mg by mouth every 6 hours; oxacillin 2 g intravenously every 6 hours; vancomycin 1 g intravenously every 12 hours.

Table 6: 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‡
ZYVOX Cefadroxil ZYVOX Vancomycin
Hemoglobin (g/dL) 0 0 15.7 12.4
Platelet count (x 103/mm³) 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
* < 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 by mouth every 12 hours or cefadroxil 15 mg/kg by mouth every 12 hours. Patients 12 years or older received ZYVOX 600 mg by mouth every 12 hours or cefadroxil 500 mg by mouth every 12 hours.
‡ Patients from birth through 11 years of age received ZYVOX 10 mg/kg intravenously by mouth every 8 hours or vancomycin 10 to 15 mg/kg intravenously every 6-24 hours, depending on age and renal clearance.

Table 7: 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‡
ZYVOX Cefadroxil ZYVOX Vancomycin
ALT (U/L) 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 2.4 1
* > 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 by mouth every 12 hours or cefadroxil 15 mg/kg by mouth every 12 hours. Patients 12 years or older received ZYVOX 600 mg mouth every 12 hours or cefadroxil 500 mg by mouth every 12 hours.
‡ Patients from birth through 11 years of age received ZYVOX 10 mg/kg intravenously/by mouth every 8 hours or vancomycin 10 to 15 mg/kg intravenously every 6-24 hours, depending on age and renal clearance.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of ZYVOX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported during postmarketing use of ZYVOX [see WARNINGS AND PRECAUTIONS]. Peripheral neuropathy, and optic neuropathy sometimes progressing to loss of vision, have been reported in patients treated with ZYVOX [see WARNINGS AND PRECAUTIONS]. Lactic acidosis has been reported with the use of ZYVOX [see WARNINGS AND 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 WARNINGS AND PRECAUTIONS]. Convulsions have been reported with the use of ZYVOX [see WARNINGS AND PRECAUTIONS]. Anaphylaxis, angioedema, and bullous skin disorders such as those described as Stevens-Johnson syndrome have been reported. Superficial tooth discoloration and tongue discoloration have been reported with the use of linezolid. The tooth discoloration was removable with professional dental cleaning (manual descaling) in cases with known outcome. Hypoglycemia, including symptomatic episodes, has been reported [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Zyvox (Linezolid) »

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Zyvox - User Reviews

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