Delafloxacin
Delafloxacin is a fluoroquinolone antibiotic used in adults to treat acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia.
🧬 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 1 clinical label set 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 →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Delafloxacin (Baxdela) carries the FDA's most serious warning because fluoroquinolone antibiotics can cause disabling, potentially permanent side effects. These include tendon inflammation or rupture (most often the Achilles tendon at the heel, but also the shoulder, hand, and others), nerve damage in the hands and feet (peripheral neuropathy), and serious effects on the brain and mood — such as hallucinations, severe depression, confusion, and suicidal thoughts. These reactions can occur within hours or weeks of starting treatment and can happen to anyone, regardless of age or prior health. If you experience tendon pain or swelling, numbness or tingling, or any sudden mental health changes, stop Baxdela immediately and contact your healthcare provider. Baxdela should also be avoided entirely in anyone with myasthenia gravis (a disease causing muscle weakness), because it can severely worsen that condition.
📖 Delafloxacin: Patient Information Guide
A plain-language walkthrough of Delafloxacin — 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▾
Delafloxacin is an antibiotic approved for use in adults for the following infections:
- Acute bacterial skin and skin structure infections (ABSSSI) — serious bacterial skin infections, including those caused by MRSA (methicillin-resistant Staphylococcus aureus). Available as Baxdela tablets (oral) or Baxdela injection (IV).
- Community-acquired bacterial pneumonia (CABP) — bacterial pneumonia contracted outside of a hospital. Available as Baxdela tablets (oral) or Baxdela injection (IV).
Delafloxacin should only be used when a bacterial infection is proven or strongly suspected. It is not effective against viral infections like the flu or a common cold.
⚙️How it works▾
Delafloxacin is a fluoroquinolone antibiotic. It works by blocking two enzymes — DNA gyrase and topoisomerase IV — that bacteria need to copy, repair, and maintain their DNA. When these enzymes are blocked, the bacterial DNA breaks down and the bacteria can no longer survive or reproduce. This action works against both gram-positive bacteria (like Staphylococcus aureus, including MRSA) and gram-negative bacteria (like Escherichia coli and Pseudomonas aeruginosa).
Because delafloxacin is an antibiotic, it should only be used for confirmed or strongly suspected bacterial infections — using it unnecessarily contributes to antibiotic resistance, making future infections harder to treat.
💊How it's taken▾
Delafloxacin is taken every 12 hours — either as a Baxdela tablet by mouth or as a Baxdela IV infusion in a vein over 60 minutes, depending on what your doctor prescribes. For skin infections, treatment typically lasts 5 to 14 days; for pneumonia, 5 to 10 days. In some cases, treatment may begin with the IV form and then switch to oral tablets.
- The Baxdela tablet can be taken with or without food.
- Separate the Baxdela tablet from antacids, iron, zinc multivitamins, or sucralfate by at least 2 hours before or 6 hours after.
- If you miss a tablet dose, take it as soon as you remember — unless your next dose is less than 8 hours away, in which case skip the missed dose and continue your regular schedule.
- Patients with severe kidney disease may require dose adjustments; Baxdela is not recommended in end-stage renal disease.
🤒Side effects — in detail▾
The most commonly reported side effects with Baxdela include:
- Nausea
- Diarrhea
- Headache
- Vomiting
- Elevated liver enzymes (transaminase elevations — usually without symptoms, but monitored with blood tests)
- Dizziness
- Itching or rash
- Numbness or tingling (paresthesia)
Some side effects are serious and require you to stop Baxdela immediately: tendon pain or rupture, nerve damage (burning, tingling, weakness in hands or feet), severe mood or mental changes (hallucinations, depression, suicidal thoughts), seizures, or signs of a severe allergic reaction (throat swelling, difficulty breathing, hives). Do not wait — contact your doctor or seek emergency help right away if any of these occur.
⚠️Warnings & precautions▾
- Tendon damage: Fluoroquinolones including Baxdela can cause tendon inflammation and rupture — most often in the Achilles tendon, but also the shoulder, hand, and biceps. Risk is highest in adults over 60, those on corticosteroids, and organ transplant recipients. Stop Baxdela immediately if you feel tendon pain or swelling.
- Nerve damage (peripheral neuropathy): Burning, tingling, numbness, or weakness in the limbs can occur and may be permanent. Stop Baxdela at the first sign and tell your doctor.
- Mental health effects: Baxdela can cause hallucinations, severe anxiety, depression, suicidal thoughts, confusion, insomnia, and other psychiatric reactions — sometimes after the very first dose.
- Myasthenia gravis: Baxdela must be avoided in patients with this muscle-weakening condition — it can cause life-threatening worsening, including respiratory failure.
- Serious allergic reactions: Anaphylaxis (a severe, whole-body allergic reaction) can occur even after the first dose. Stop Baxdela and get emergency help immediately.
- C. difficile diarrhea: Antibiotic use can cause a serious bowel infection. Seek medical attention for persistent or severe diarrhea during or after treatment.
- Blood sugar changes: Diabetic patients taking insulin or oral diabetes medicines may experience dangerous highs or lows in blood sugar. Monitor carefully.
- Aortic aneurysm risk: There is an increased risk of aortic aneurysm (a dangerous bulge in the main artery) within two months of fluoroquinolone use, particularly in older adults. Use Baxdela only when no alternative is available if you have a known aortic aneurysm.
🔀What it interacts with▾
Delafloxacin can interact with several medications and supplements — tell your doctor and pharmacist about everything you take:
- Antacids (containing aluminum or magnesium): Significantly reduce tablet absorption — separate by at least 2 hours before or 6 hours after Baxdela tablet.
- Iron supplements and multivitamins with iron or zinc: Same absorption interference — use the same timing separation for tablets.
- Sucralfate: Can reduce Baxdela tablet absorption — separate doses.
- Didanosine (a HIV medication, buffered forms): Can interfere with Baxdela tablet absorption — separate doses.
- Oral diabetes medications (e.g., glyburide) or insulin: Fluoroquinolones can cause blood sugar fluctuations — monitor blood glucose closely.
- IV solutions with calcium or magnesium: Must not be run through the same IV line as Baxdela injection.
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▾
- Do not take Baxdela if you are allergic to delafloxacin or any other fluoroquinolone antibiotic (such as ciprofloxacin, levofloxacin, or moxifloxacin).
- Do not take Baxdela if you have myasthenia gravis — it can cause severe and potentially life-threatening muscle weakness.
- Tell your doctor if you have a history of tendon problems, tendinitis, or tendon rupture.
- Tell your doctor if you have epilepsy, seizure disorder, or other nervous system conditions — Baxdela may lower the seizure threshold.
- Tell your doctor if you have kidney disease — dosage adjustment may be needed, and Baxdela is not recommended in end-stage renal disease.
- Liver disease does not require a dose change, but tell your doctor if you have hepatic impairment.
- Older adults (60+) are at increased risk for tendon rupture — this risk is even higher with corticosteroid use.
- Baxdela is not recommended for patients under 18 years of age.
- Pregnancy: limited human safety data are available. Discuss risks and benefits with your doctor.
- Breastfeeding: it is not known whether delafloxacin passes into human breast milk. Discuss with your doctor before breastfeeding.
🚑If you take too much▾
If too much Baxdela is taken, treatment focuses on supportive care and careful monitoring — there is no specific antidote. Hemodialysis (a kidney-filtering treatment) removes only a small portion of delafloxacin from the body. If you think you or someone else has taken too much, contact a poison control center or emergency services right away.
📡Pharmacodynamics — effects in the body▾
Delafloxacin kills bacteria by targeting their DNA-replication enzymes, and its effectiveness is best predicted by how long and how well drug levels stay above the minimum needed to inhibit bacterial growth (measured as the fAUC/MIC ratio). Studies in healthy volunteers found that Baxdela does not meaningfully affect the heart's electrical rhythm (QTc interval) — even at doses three times the normal IV dose — which is a favorable safety feature compared to some other antibiotics in its class. Testing also showed Baxdela does not cause significant sensitivity to sunlight (phototoxicity) at therapeutic doses.
🔬Pharmacokinetics — how your body processes it▾
After taking the Baxdela tablet by mouth, delafloxacin is absorbed within about an hour, and food does not affect how much gets into the bloodstream. The body breaks it down primarily through a process called glucuronidation (attaching a sugar molecule to make it easier to eliminate), with most of the drug leaving unchanged through urine and feces. The half-life — the time it takes the body to clear half the drug — is roughly 4 to 8.5 hours with oral dosing. Delafloxacin distributes well throughout the body, including into the lungs, which supports its use in pneumonia.
📦How to store it▾
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) . stored for up to 24 hours under refrigerated or controlled room temperature and then further diluted for intravenous infusion.
📄 Written from Delafloxacin’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 Delafloxacin — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Baxdela used for? ▾
Can I take the tablet with food, and what should I avoid taking it with? ▾
What side effects are most likely, and which ones should make me call my doctor right away? ▾
I've heard fluoroquinolone antibiotics can damage tendons. Should I be worried? ▾
I have diabetes — is there anything special I need to watch for? ▾
Is Baxdela safe during pregnancy or while breastfeeding? ▾
Is Delafloxacin available over the counter? ▾
When was Delafloxacin first available? ▾
Who makes Delafloxacin? ▾
💬 Answers drafted from Delafloxacin’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 Delafloxacin comes
Delafloxacin is available in 3 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
- Baxdela injection is used in adults to treat acute bacterial skin and skin structure infections (ABSSSI)
- Baxdela injection is used in adults to treat community-acquired bacterial pneumonia (CABP)
- Baxdela injection is given as a slow IV infusion over 60 minutes, every 12 hours
- Baxdela injection must not be mixed in the same IV line with solutions containing calcium or magnesium
- Baxdela injection must not be co-infused with other medications through the same line
- Patients with severe kidney impairment receiving Baxdela injection should have kidney function closely monitored
Tablet
How this form is used
- Baxdela tablet is used in adults to treat acute bacterial skin and skin structure infections (ABSSSI)
- Baxdela tablet is used in adults to treat community-acquired bacterial pneumonia (CABP)
- Baxdela tablet may be used as a step-down option after initial Baxdela IV infusion, at the prescriber's discretion
- Baxdela tablets can be taken with or without food
- Baxdela tablets are taken every 12 hours — follow your prescriber's schedule
- Take Baxdela tablet at least 2 hours before or 6 hours after antacids (with aluminum or magnesium), iron, zinc-containing multivitamins, or sucralfate
- If you miss a Baxdela tablet dose, take it as soon as possible — but only if your next dose is more than 8 hours away
Oral solution
📊 Delafloxacin across the U.S. market
How Delafloxacin 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 (1) — 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 Delafloxacin is used
A general measure of how commonly Delafloxacin 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 Delafloxacin 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 Delafloxacin prescribed? Of the 1,596 medications we measure, Delafloxacin ranks #1,587 by Medicaid prescriptions — more than 1% of them.
Utilization by Delafloxacin 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.
delafloxacin 450 MG Oral Tablet
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1927677
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 Delafloxacin, 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 1 of 4 listed Delafloxacin NDCs with Medicaid activity.
🔍 Compare Delafloxacin products
A representative set of FDA-listed product records for Delafloxacin — 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 | ||||
| 300 mg/10.5 mL | Intravenous | Melinta Therapeutics, LLC × 3 listings | NDA | View NDC → |
| 💊Oral solution | ||||
| 300 mg/10.5 mL | — | Patheon Italia S.p.A. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 💊Tablet | ||||
| 450 mg | Oral | Melinta Therapeutics, LLC × 3 listings | NDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | ScinoPharm Taiwan Ltd. | BULK INGREDIENT | View NDC → |
Showing 8 of 8 products — FDA National Drug Code Directory. See every product, package size and price: browse all 8 Delafloxacin 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 Delafloxacin — 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 Delafloxacin 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 Delafloxacin 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 1927663 2 dose forms · 2 strengths
Look up RxCUI 1927663 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 Delafloxacin 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
Delafloxacin belongs to the Fluoroquinolone 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 1 FDA-filed SPL label set 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. Melinta Therapeutics, 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.