linezolid
Pharmaranks rates Linezolid 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Linezolid is an oxazolidinone antibacterial used to treat Staphylococcal Infections, Streptococcal Infections, Bacterial Skin Diseases, Bacterial Pneumonia.
Oxazolidinone Antibacterial · by Macleods Pharms Ltd
Generic of Zyvox
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Linezolid
- Drug class
- Oxazolidinone Antibacterial
- Form
- Powder, Injectable, Solution, Suspension, Tablet
- Strength
- Linezolid 600MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Macleods Pharms Ltd
- Half-life
- about 4.3 to 5.4 hours (roughly 5 hours) in adults (how long it stays in your system)
- What the pharmacy pays
- ~$1.43 per ml — not your price
- FDA application
- ANDA210378
- Availability
- Discontinued (per FDA)
What is Linezolid?
From the FDA label:Linezolid Tablets, USP contain linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide. The empirical formula is C 16 H 20 FN 3 O 4 . Its molecular weight is 337.35, and its chemical structure is represented below: Linezolid Tablets, USP for oral administration contains 600 mg linezolid as a film-coated compressed tablet. Inactive ingredients are corn starch, microcrystalline cellulose, silicon dioxide, hydroxypropylcellulose, sodium starch glycolate, magnesium stearate. The coating material contains hypromellose, polyethylene glycol and titanium dioxide. The sodium (Na+) content is 2.52 mg per 600 mg tablet (0.1 mEq/tablet). FDA approved dissolution test specifications differ from USP. 777
How to use
Linezolid is sold in more than one form (Powder, Injectable, Solution, Suspension and Tablet), and each is dosed differently. The instructions below come from the FDA label for application ANDA210378 — follow the label that came with the product you were actually prescribed.
Dosage, Route, and Frequency of Administration Infection Pediatric Patients (Birth through 11 years of Age) Adults and Adolescents (12 years and Older) Duration (days) Nosocomial pneumonia 10 mg/kg oral every 8 hours 600 mg oral every 12 hours 10 to 14 Community-acquired pneumonia, including concurrent bacteremia Complicated skin and skin structure infections Vancomycin-resistant Enterococcus faecium infections, including concurrent bacteremia 10 mg/kg oral every 8 hours 600 mg oral every 12 hours 14 to 28 Uncomplicated skin and skin structure infections less than 5 yrs: 10 mg/kg oral every 8 hours 5-11 yrs: 10 mg/kg oral every 12 hours Adults: 400 mg oral every 12 hours Adolescents: 600 mg oral every 12 hours 10 to 14 2.1 General Dosage and Administration The recommended dosage for linezolid tablets formulations for the treatment of infections is described in Table 1. Table 1. Dosage Guidelines for Linezolid Tablets Infection * Dosage, Route and Frequency of Administration Recommended Duration of Treatment (consecutive days) Pediatric Patients † (Birth through 11 Years of Age) Adults and Adolescents (12 Years and Older) Nosocomial pneumonia 10 mg/kg oral ‡ every 8 hours 600 mg oral ‡ every 12 hours 10 to 14 Community-acquired pneumonia, including concurrent bacteremia Complicated skin and skin structure infections Vancomycin-resistant Enterococcus faecium infections,…
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: • Myelosuppression [see Warnings and Precautions ( 5.1 )] • Peripheral and Optic Neuropathy [see Warnings and Precautions ( 5.2 )] • Serotonin Syndrome [see Warnings and Precautions ( 5.3 )] • Clostridioides difficile-Associated Diarrhea [see Warnings and Precautions ( 5.5 )] • Lactic Acidosis [see Warnings and Precautions ( 5.7 )] • Convulsions [see Warnings and Precautions ( 5.8 )] • Rhabdomyolysis [see Warnings and Precautions ( 5.9 )] • Hypoglycemia [see Warnings and Precautions ( 5.10 )] Hyponatremia and/or Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) [ see Warnings and Precautions ( 5.11 )] Most common adverse reactions (>5% of adult and/or pediatric patients treated with linezolid tablets) include: diarrhea, vomiting, headache, nausea, and anemia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc. at 1-888-943-3210 or 1-855-926-3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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 linezolid tablets formulations was…
Warnings
Important safety information
Myelosuppression: Monitor complete blood counts weekly. Thrombocytopenia has been reported more often in patients with severe renal and in patients with moderate to severe hepatic impairment. Consider discontinuation in patients who develop or have worsening myelosuppression. ( 5.1 ) • Peripheral and Optic Neuropathy: Reported primarily in patients treated for longer than 28 days. If patients experience symptoms of visual impairment, prompt ophthalmic evaluation is recommended. ( 5.2 ) • Serotonin Syndrome: Monitor patients taking serotonergic agents, including antidepressants and opioids, for signs of serotonin syndrome. Patients taking serotonergic antidepressants should receive linezolid tablets only if no other therapies are available. Discontinue serotonergic antidepressants and monitor patients for signs and symptoms of both serotonin syndrome and antidepressant discontinuation. ( 5.3 ) • A mortality imbalance was seen in an investigational study in linezolid-treated patients with catheter-related bloodstream infections. ( 5.4 ) • Clostridioides difficile-Associated Diarrhea: Evaluate if diarrhea occurs. ( 5.5 ) • Potential interactions producing elevation of blood pressure: monitor blood pressure. ( 5.6 ) • Rhabdomyolysis: If signs or symptoms of rhabdomyolysis are observed, discontinue linezolid tablets and initiate appropriate therapy. ( 5.9 ) • Hypoglycemia: Postmarketing cases of symptomatic hypoglycemia have been reported in patients with diabetes mellitus receiving insulin or oral hypoglycemic agents. ( 5.10 ) • Hyponatremia and/or Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH): Monitor serum sodium levels regularly in patients at risk of hyponatremia and/or SIADH. ( 5.11 ) 5.1 Myelosuppression Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported in patients receiving linezolid. In cases where the outcome is known, when linezolid was discontinued, the affected hematologic parameters have risen toward pretreatment levels. Thrombocytopenia has been reported more often in patients with severe renal impairment, whether or not on dialysis, and in patients with moderate to severe hepatic impairment. 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 pre-existing myelosuppression, those with severe renal impairment or moderate to severe hepatic impairment, those receiving concomitant drugs that produce bone marrow suppression, or those with a chronic infection who have received previous or concomitant antibacterial drug therapy. Discontinuation of therapy with linezolid should be considered in patients who develop or have worsening myelosuppression [see Adverse Reactions ( 6.2 )]. 5.2 Peripheral and Optic Neuropathy Peripheral and optic neuropathies have been reported in patients treated with linezolid tablets, primarily in those patients treated for longer than the maximum recommended duration of 28 days. In cases of optic neuropathy that progressed to loss of vision, patients were treated for extended periods beyond the maximum recommended duration. Visual blurring has been reported in some patients treated with linezolid tablets for less than 28 days. Peripheral and optic neuropathy has also been reported in children. If patients experience symptoms of visual impairment, such as changes in visual acuity, changes in color vision, blurred vision, or visual field defect, prompt ophthalmic evaluation is recommended. Visual function should be monitored in all patients taking linezolid tablets for extended periods (≥ 3 months) and in all patients reporting new visual symptoms regardless of length of therapy with linezolid tablets. If peripheral or optic neuropathy occurs, the continued use of linezolid tablets in these patients should be weighed against the potential risks. 5.3 Serotonin Syndrome Spontaneous reports of serotonin syndrome including fatal cases associated with the co-administration of linezolid tablets and serotonergic agents, including antidepressants such as selective serotonin reuptake inhibitors (SSRIs), have been reported. Unless clinically appropriate and patients are carefully observed for signs and/or symptoms of serotonin syndrome or neuroleptic malignant syndrome-like (NMS-like) reactions, linezolid should not be administered to patients with carcinoid syndrome and/or patients taking any of the following medications: serotonin re-uptake inhibitors, tricyclic antidepressants, bupropion, buspirone, serotonin 5-HT1 receptor agonists (triptans), and opioids, including meperidine [see Drug Interactions ( 7 ) and Clinical Pharmacology ( 12.3 )]. In some cases, a patient already receiving a serotonergic antidepressant or buspirone may require urgent treatment with linezolid. If alternatives to linezolid are not available and the potential benefits of linezolid outweigh the risks of serotonin syndrome or NMS-like reactions, the serotonergic antidepressant should be stopped promptly and linezolid administered. The patient should be monitored for two weeks (five weeks if fluoxetine was taken) or until 24 hours after the last dose of linezolid, whichever comes first. Symptoms of serotonin syndrome or NMS-like reactions include hyperthermia, rigidity, myoclonus, autonomic instability, and mental status changes that include extreme agitation progressing to delirium and coma. The patient should also be monitored for discontinuation symptoms of the antidepressant (see package insert of the specified agent(s) for a description of the associated discontinuation symptoms). 5.4 Mortality Imbalance in an Investigational Study in Patients with Catheter-Related Bloodstream Infections, Including Those with Catheter-site Infections An imbalance in mortality was seen in patients treated with linezolid relative to vancomycin/dicloxacillin/oxacillin in an open-label study in seriously ill patients with intravascular catheter-related infections [78/363 (21.5%) vs. 58/363 (16.0%); odds ratio 1.426, 95% CI 0.970, 2.098]. While causality has not been established, this observed imbalance occurred primarily in linezolid-treated patients in whom either Gram-negative pathogens, mixed Gram-negative and Gram-positive pathogens, or no pathogen were identified at baseline, but was not seen in patients with Gram-positive infections only. Linezolid are not approved and should not be used for the treatment of patients with catheter-related bloodstream infections or catheter-site infections. Linezolid have no clinical activity against Gram-negative pathogens and are not indicated for the treatment of Gram-negative infections. It is critical that specific Gram-negative therapy be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected [see Indications and Usage ( 1 )]. 5.5 Clostridioides difficile- Associated Diarrhea Clostridioides difficile-Associated Diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including linezolid tablets, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C.…
Who should not take Linezolid
Known hypersensitivity to linezolid or any of the other product components. ( 4.1 ) Patients taking any monoamine oxidase inhibitors (MAOI) or within two weeks of taking an MAOI. ( 4.2 ) 4.1 Hypersensitivity Linezolid tablets formulations are contraindicated for use in patients who have known hypersensitivity to linezolid or any of the other product components. 4.2 Monoamine Oxidase Inhibitors Linezolid should not be used in patients taking any medicinal product which inhibits monoamine oxidases A or B (e.g., phenelzine, isocarboxazid) or within two weeks of taking any such medicinal product.
Overdose — what happens if you take too much
In the event of overdosage, supportive care is advised, with maintenance of glomerular filtration. Hemodialysis may facilitate more rapid elimination of linezolid. In a Phase 1 clinical trial, approximately 30% of a dose of linezolid was removed during a 3-hour hemodialysis session beginning 3 hours after the dose of linezolid was administered. Data are not available for removal of linezolid with peritoneal dialysis or hemoperfusion. Clinical signs of acute toxicity in animals were decreased activity and ataxia in rats and vomiting and tremors in dogs treated with 3,000 mg/kg/day and 2,000 mg/kg/day, respectively.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Monoamine oxidase inhibitors and potential for interaction with adrenergic and serotonergic agents. ( 4.2 , 5.3 , 5.6 , 7 , 12.3 ) 7.1 Monoamine Oxidase Inhibitors Linezolid is a reversible, nonselective inhibitor of monoamine oxidase [see Contraindications ( 4.2 ) and Clinical Pharmacology ( 12.3 )]. 7.2 Adrenergic and Serotonergic Agents Linezolid has the potential for interaction with adrenergic and serotonergic agents [see Warnings and Precautions ( 5.3 , 5.6 ) and Clinical Pharmacology ( 12.3 )].
Storing Linezolid, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Use within 21 days after constitution.”
How long does Linezolid stay in your body?
The elimination half-life of linezolid is about 4.3 to 5.4 hours (roughly 5 hours) in adults — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. Not a prodrug. Linezolid's two primary metabolites (aminoethoxyacetic acid and hydroxyethyl glycine) are INACTIVE, so no active metabolite outlasts the parent — the ~5 hour figure is the full story for antibacterial exposure. Populations named by the label: elderly (65+) — pharmacokinetics not significantly altered, no dose adjustment. Renal impairment — the parent drug's PK is UNCHANGED (so its half-life is not prolonged), but the two inactive metabolites accumulate with worsening renal function; both parent and metabolites are removed by hemodialysis, so dose after dialysis. Hepatic impairment — not altered in mild-to-moderate (Child-Pugh A/B); severe impairment has not been studied.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Linezolid label — DailyMed (Section 12.3 Pharmacokinetics, Table 8).
Drug class
May treat (source: NIH RxClass)
Dosage forms
Powder, Injectable, Solution, Suspension and Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Linezolid treat?
- Linezolid (Linezolid) may be used to treat staphylococcal infections, streptococcal infections, bacterial skin diseases, bacterial pneumonia, soft tissue infections, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Linezolid rated?
- pharmaranks gives Linezolid a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Linezolid cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $1.43 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Linezolid?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Linezolid. To pay less, Linezolid is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Linezolid?
- Linezolid is marketed by Macleods Pharms Ltd. You can see Macleods Pharms Ltd's full profile, rating, and other products on pharmaranks.
- Is Linezolid a brand-name or generic drug?
- Linezolid is a generic medication; its active ingredient is Linezolid. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Linezolid available over the counter?
- No. Linezolid is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Linezolid come in?
- Linezolid is currently marketed as powder, injectable, solution, suspension and tablet, per the FDA's National Drug Code Directory.
- What class of drug is Linezolid?
- Linezolid is classified as oxazolidinone antibacterial, per the FDA's Established Pharmacologic Class.
- Is Linezolid FDA-registered?
- Linezolid is on record with the U.S. FDA under application number ANDA210378. You can verify this on its official FDA label.
- Has Linezolid been recalled by the FDA?
- Linezolid has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Linezolid safe?
- There's no single safe-or-not verdict. pharmaranks gives Linezolid a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Linezolid?
- Linezolid's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in the labeling: • Myelosuppression [see Warnings and Precautions ( 5.1 )] • Peripheral and Optic Neuropathy [see Warnings and Precautions ( 5.2 )] • Serotonin Syndrome [see Warnings and Precautions ( 5.3 )] • Clostridioi… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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linezolid
70/100