Tedizolid
Tedizolid is an antibacterial ingredient used in Sivextro to treat acute bacterial skin and skin structure infections caused by certain gram-positive bacteria, including MRSA.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Tedizolid: Patient Information Guide
A plain-language walkthrough of Tedizolid — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Tedizolid (Sivextro) is an antibacterial used to treat a specific type of serious bacterial skin infection.
- Sivextro (oral tablet and IV injection) treats acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including MRSA, MSSA, Streptococcus pyogenes, Streptococcus agalactiae, the Streptococcus anginosus group, and Enterococcus faecalis
- Approved for adults and pediatric patients at least 26 weeks gestational age and weighing at least 1 kg
- Sivextro tablets are only approved for pediatric patients weighing at least 35 kg; the injectable form is used for smaller children
- Should only be used when a bacterial infection is proven or strongly suspected, to help prevent antibiotic resistance
⚙️How it works▾
Tedizolid belongs to a class of antibiotics called oxazolidinones. It works by blocking the very first step bacteria use to build proteins — a process bacteria need to survive and multiply. By interfering with this step, tedizolid prevents the bacteria from growing and helps your immune system clear the infection.
Tedizolid is actually given as a prodrug called tedizolid phosphate, which the body quickly converts to the active form (tedizolid) after it is taken by mouth or given by IV. Research in animal models showed that the presence of white blood cells (granulocytes) enhanced tedizolid's ability to kill Staphylococcus aureus, suggesting the drug works best alongside your own immune defenses.
💊How it's taken▾
Sivextro is taken once daily for six days — either as an oral tablet or as an IV infusion over one hour. The tablet can be taken with or without food. Your doctor may start you on the IV form in the hospital and switch you to the tablet to finish at home; no dose change is needed when making that switch.
- Pediatric patients weighing less than 35 kg must use the injectable form (not the tablet); dosing is weight-based and given twice daily for this group
- Pediatric patients weighing 35 kg or more may use the tablet or IV, once daily
- If you miss a once-daily oral dose, take it as soon as you remember — but only if your next dose is more than 8 hours away; otherwise, skip the missed dose and continue your regular schedule
🤒Side effects — in detail▾
Most people tolerate Sivextro well, but some side effects do occur.
- Nausea (most common, reported in about 7% of adults)
- Headache
- Diarrhea
- Vomiting
- Dizziness
- Infusion or injection site reactions (pain, swelling, redness, or phlebitis)
- In adolescents (12 to under 18 years), phlebitis and elevated liver enzymes were most commonly reported
- In younger children (under 12 years), infusion/injection site reactions and vomiting were most common
Get medical help right away if you develop signs of serotonin syndrome (agitation, rapid heartbeat, muscle twitching, sweating, confusion) or severe, persistent, or bloody diarrhea, which could signal a C. difficile infection.
⚠️Warnings & precautions▾
- Serotonin syndrome: Taking Sivextro with serotonergic drugs (medicines that boost serotonin, such as certain antidepressants) can trigger serotonin syndrome — a potentially serious reaction. Symptoms include agitation, confusion, rapid heart rate, muscle twitching, and sweating. Contact your doctor immediately if these occur.
- C. difficile-associated diarrhea: Like other antibiotics, Sivextro can lead to an overgrowth of Clostridioides difficile bacteria in the gut, causing severe diarrhea. This can happen during treatment or even weeks after finishing. Report persistent or bloody diarrhea to your doctor promptly.
- Patients with neutropenia (low white blood cell counts): The safety and effectiveness of Sivextro in people with neutropenia have not been established. If you have this condition, discuss it with your doctor before starting treatment.
- Antibiotic resistance: Sivextro should only be used for proven or strongly suspected bacterial infections to reduce the risk of creating drug-resistant bacteria.
🔀What it interacts with▾
Sivextro has two main drug interaction concerns to be aware of.
- Serotonergic agents (e.g., SSRIs, SNRIs, and other antidepressants that affect serotonin): Combining these with Sivextro raises the risk of serotonin syndrome. Your doctor should monitor you closely if both are needed.
- BCRP substrate drugs (e.g., methotrexate, topotecan, rosuvastatin): When Sivextro is taken by mouth, it inhibits a transporter in the gut called BCRP, which can raise blood levels of these co-administered drugs and increase their side effects. Your doctor may pause the other drug during your Sivextro course or monitor you more closely, especially if the other drug has a narrow margin of safety.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Pregnancy: Animal studies show tedizolid may cause fetal harm. There is not enough human data to fully assess the risk. Tell your doctor if you are pregnant or trying to become pregnant so you can weigh the risks and benefits together.
- Breastfeeding: Tedizolid appears in animal milk and may pass into human milk. Discuss the risks and benefits with your doctor before breastfeeding during treatment.
- Children under 35 kg: Sivextro tablets must not be given to children weighing less than 35 kg — the injectable (IV) form should be used instead, with weight-based dosing.
- Very premature or very small infants: Sivextro has not been studied in infants less than 26 weeks gestational age or weighing less than 1 kg.
- Neutropenia (low white blood cells): Safety and effectiveness have not been established in this group; inform your doctor if this applies to you.
- Liver or kidney impairment: No dose adjustment is required for either condition based on current data, but inform your doctor of any liver or kidney issues.
- Older adults: No dose adjustment is needed; pharmacokinetics are similar to those of younger adults.
- All current medications: Tell your doctor about all prescription and over-the-counter drugs you take, especially antidepressants, methotrexate, topotecan, or statins like rosuvastatin.
🚑If you take too much▾
If too much Sivextro is taken, the medication should be stopped and supportive care given by a healthcare team. Hemodialysis (a kidney-filtering treatment sometimes used in poisoning) does not meaningfully remove tedizolid from the body, so it is not a useful option in overdose situations.
📡Pharmacodynamics — effects in the body▾
Research in animal infection models showed that tedizolid's effectiveness is best predicted by the ratio of its total drug exposure (AUC) to the minimum concentration needed to inhibit bacterial growth (MIC) — meaning sustained drug levels matter more than peak levels. In animal studies using S. aureus infections, the presence of white blood cells (granulocytes) significantly enhanced the antibiotic's ability to kill bacteria, suggesting tedizolid works best when the immune system is also functioning.
🔬Pharmacokinetics — how your body processes it▾
Tedizolid phosphate is a prodrug — it is inactive until the body's enzymes convert it to tedizolid, the active form, after oral or IV administration. The oral tablet is very well absorbed, with about 91% bioavailability, and can be taken with or without food without affecting how much drug reaches the bloodstream. Tedizolid has a half-life of about 12 hours, reaches steady-state levels within about three days of once-daily dosing, and is mostly eliminated through the liver — about 82% leaves the body via feces and 18% via urine, primarily as an inactive metabolite.
📦How to store it▾
SIVEXTRO Tablets and SIVEXTRO for Injection should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .
📄 Written from Tedizolid’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Tedizolid — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Sivextro being used to treat? ▾
Can I take the tablet with food, or does it have to be on an empty stomach? ▾
What side effects should I actually watch out for? ▾
I take an antidepressant. Is that a problem with Sivextro? ▾
It's only a 6-day course — do I really need to finish all of it? ▾
Is Sivextro safe if I'm pregnant or breastfeeding? ▾
Is Tedizolid available over the counter? ▾
When was Tedizolid first available? ▾
Who makes Tedizolid? ▾
💬 Answers drafted from Tedizolid’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Tedizolid comes
Tedizolid is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Sivextro for injection is used to treat acute bacterial skin and skin structure infections (ABSSSI) via intravenous infusion in adults and eligible pediatric patients
- Sivextro for injection is approved for pediatric patients from at least 26 weeks gestational age and weighing at least 1 kg, including those weighing less than 35 kg who cannot use the tablet form
- Sivextro for injection is given as an intravenous (IV) infusion over one hour, once daily for six days in adults and pediatric patients weighing at least 35 kg
- Sivextro for injection is given twice daily in pediatric patients weighing less than 35 kg, with dosing based on the child's weight
- Sivextro injection must be reconstituted and diluted by a healthcare professional before administration; it should not be shaken vigorously to avoid foaming
- No dose adjustment is needed when switching from Sivextro IV infusion to Sivextro oral tablet
Tablet
How this form is used
- Sivextro tablets are used to treat acute bacterial skin and skin structure infections (ABSSSI) in adults and in pediatric patients weighing at least 35 kg
- Sivextro tablets may be taken with or without food
- Sivextro tablets are taken once daily for six days
- Sivextro tablets should NOT be given to pediatric patients weighing less than 35 kg
- If you miss a dose, take it as soon as possible — but only if at least 8 hours remain before your next scheduled dose; if less than 8 hours remain, skip the missed dose and resume your regular schedule
📊 Tedizolid across the U.S. market
How Tedizolid appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Tedizolid is used
A general measure of how commonly Tedizolid is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Tedizolid is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Tedizolid prescribed? Of the 1,596 medications we measure, Tedizolid ranks #1,504 by Medicaid prescriptions — more than 6% of them.
Utilization by Tedizolid product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
tedizolid phosphate 200 MG Oral Tablet
Summed across the 2 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1540862
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Tedizolid, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 7 listed Tedizolid NDCs with Medicaid activity.
🔍 Compare Tedizolid products
A representative set of FDA-listed product records for Tedizolid — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 200 mg/4 mL | Intravenous | Merck Sharp & Dohme LLC × 3 listings | NDA | View NDC → |
| 200 mg/4 mL | Intravenous | Nabriva Therapeutics US, Inc. | NDA | View NDC → |
| 200 mg/4 mL | — | Patheon Italia S.p.A | DRUG FOR FURTHER PROCESSING | View NDC → |
| 💊Tablet | ||||
| 200 mg | Oral | Merck Sharp & Dohme LLC × 3 listings | NDA | View NDC → |
| 200 mg | Oral | Nabriva Therapeutics US, Inc. | NDA | View NDC → |
| 200 mg | — | Patheon Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 💊Bulk drug substance | ||||
| 15 kg/15 kg | — | Curia New York, Inc. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Metrochem API Private Limited | BULK INGREDIENT | View NDC → |
Showing 12 of 12 products — FDA National Drug Code Directory. See every product, package size and price: browse all 12 Tedizolid NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Tedizolid — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Tedizolid in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Tedizolid went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1540825 2 dose forms · 2 strengths
-
Dose form (SCDF) Injection RxCUI 1724288In current FDA listingsClinical drug / strength (SCD) phosphate 200 MGRxCUI 1540886 -
Dose form (SCDF) Oral Tablet RxCUI 1540861In current FDA listingsClinical drug / strength (SCD) phosphate 200 MGRxCUI 1540862
Look up RxCUI 1540825 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Tedizolid is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Tedizolid belongs to the Oxazolidinone Antibacterial class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Merck Sharp & Dohme LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.