Omadacycline
Omadacycline (Nuzyra) is a tetracycline-class antibiotic used to treat community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections in adults.
🧬 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 →
📖 Omadacycline: Patient Information Guide
A plain-language walkthrough of Omadacycline — 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▾
Omadacycline (brand name Nuzyra) is a tetracycline-class antibiotic approved for adults with specific bacterial infections.
- Community-acquired bacterial pneumonia (CABP): Nuzyra treats lung infections caused by bacteria including Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible strains), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and others.
- Acute bacterial skin and skin structure infections (ABSSSI): Nuzyra treats serious skin infections caused by bacteria including Staphylococcus aureus (both methicillin-susceptible and methicillin-resistant strains, including MRSA), Streptococcus pyogenes, Enterococcus faecalis, and others.
- Nuzyra should only be used when a bacterial infection is confirmed or strongly suspected — using antibiotics unnecessarily contributes to antibiotic resistance.
⚙️How it works▾
Omadacycline is an antibacterial agent in the tetracycline class. Like other tetracyclines, it works by blocking bacteria's ability to produce proteins — a process they need to grow and reproduce. Without this ability, the bacteria cannot spread, and your immune system can clear the infection.
Omadacycline has been shown to work against both gram-positive and gram-negative bacteria, including some resistant strains like MRSA (methicillin-resistant Staphylococcus aureus). It is designed to overcome some of the resistance mechanisms that have made older tetracyclines less effective against certain bacteria.
💊How it's taken▾
Nuzyra is available as an intravenous (IV) infusion and as an oral tablet. Both forms use a loading-dose approach on the first day (or first two days for skin infections with the tablet), followed by once-daily dosing. Total treatment typically lasts 7 to 14 days.
- Nuzyra Tablets: Must be taken on a completely empty stomach — fast for at least 4 hours before your dose, take with water only, then avoid food and non-water drinks for 2 hours and dairy, antacids, or vitamins for 4 hours afterward.
- Nuzyra Injection: Given by a healthcare provider through an IV; the infusion time varies by dose and is managed by your care team.
- Follow your prescriber's schedule exactly — do not skip doses or stop early, even if you feel better.
🤒Side effects — in detail▾
The most commonly reported side effects with Nuzyra include:
- Nausea and vomiting
- Diarrhea
- Headache
- Infusion site reactions (with the IV form) — redness, pain, or irritation at the injection site
- Elevated liver enzymes (ALT and AST) detected on blood tests
- High blood pressure (more commonly noted in pneumonia patients)
Serious reactions — including severe allergic reactions, C. difficile–associated diarrhea (which can cause dangerous colitis), and heart rate changes — require prompt medical attention. Call your doctor right away if you experience severe or worsening diarrhea, difficulty breathing, swelling, or a rapid heartbeat.
⚠️Warnings & precautions▾
- Tooth discoloration and enamel damage in children: Nuzyra, like all tetracyclines, can permanently stain developing teeth yellow-gray-brown and cause enamel defects. This can happen if used during the second or third trimester of pregnancy, infancy, or in children under 8. Even short courses carry this risk.
- Slowed bone growth: Use during pregnancy (second and third trimester) or in young children may temporarily reduce bone growth rates. This effect has been shown to reverse after stopping the drug.
- C. difficile (C. diff) diarrhea: Like all antibiotics, Nuzyra can disrupt normal gut bacteria and allow C. difficile to overgrow, causing diarrhea ranging from mild to severe colitis. This can occur even weeks after finishing the antibiotic.
- Allergic reactions: Serious allergic reactions, including life-threatening anaphylaxis, have been reported with tetracycline antibiotics. Stop Nuzyra and seek emergency care if you develop hives, swelling, or trouble breathing.
- Other tetracycline-class effects: Effects seen with other tetracyclines — including sun sensitivity (photosensitivity), increased pressure in the skull, and liver or pancreas changes — may also occur with Nuzyra.
- Heart rate increase: Reversible, dose-dependent increases in heart rate have been seen in studies; the clinical significance is not fully known.
🔀What it interacts with▾
Several medications and substances can interact with Nuzyra — especially with the tablet form, where absorption is easily affected.
- Antacids (with aluminum, calcium, or magnesium): Bind to omadacycline in the gut and dramatically reduce how much is absorbed — avoid within 4 hours of your dose.
- Iron supplements: Also reduce tablet absorption — avoid within 4 hours.
- Bismuth subsalicylate (e.g., Pepto-Bismol): Reduces absorption of oral Nuzyra.
- Multivitamins with minerals: Can interfere with absorption — wait at least 4 hours after your Nuzyra tablet dose.
- Dairy products: Avoid for 2 hours after taking Nuzyra tablets, as they can reduce absorption.
- Blood thinners (anticoagulants, e.g., warfarin): Nuzyra may reduce the body's ability to break down these drugs, increasing bleeding risk; your anticoagulant dose may need adjustment.
- IV solutions with calcium or magnesium: Nuzyra injection must never be mixed or run through the same IV line simultaneously with solutions containing these minerals.
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▾
- Allergy to tetracyclines: Do not take Nuzyra if you are allergic to omadacycline, doxycycline, minocycline, or any other tetracycline antibiotic — this is a contraindication.
- Pregnancy: Nuzyra can harm a developing baby — causing permanent tooth staining, slowed bone growth, and potentially more serious harm. Animal studies showed fetal loss and birth defects. Avoid during pregnancy; use effective contraception while on treatment.
- Breastfeeding: Breastfeeding is not recommended while taking Nuzyra or for 4 days after the last dose, due to risk of tooth discoloration and bone effects in the infant.
- Children: Not recommended for children under 8 due to tooth and bone risks; safety and effectiveness in patients under 18 have not been established.
- Older adults: No dose adjustment needed; no significant differences in safety or effectiveness were found in older patients in clinical trials, though individual sensitivity may vary.
- Kidney impairment: No dose adjustment required, even in severe kidney disease or dialysis.
- Liver impairment: No dose adjustment required for any level of liver impairment.
- Male fertility: Animal studies showed effects on the testes and reduced sperm counts; the relevance to humans is unknown.
🚑If you take too much▾
There is no specific treatment established for a Nuzyra overdose. If you think you or someone else has taken too much, contact poison control or seek emergency medical care immediately. Following an intravenous dose, a small amount of omadacycline can be removed through dialysis, but this is not a standard treatment approach.
📡Pharmacodynamics — effects in the body▾
Omadacycline does not appear to significantly prolong the QTc interval (the heart's electrical recovery time) at the recommended doses, which sets it apart from some other antibiotics. However, studies in healthy volunteers showed reversible, dose-dependent increases in heart rate — meaning the faster the dose, the more the heart rate may rise, though it returns to normal. This effect is thought to occur because omadacycline interacts with muscarinic M2 receptors in the heart — receptors that normally help slow heart rate — partially blocking their activity.
🔬Pharmacokinetics — how your body processes it▾
Omadacycline is not broken down (metabolized) by the body — it circulates and is eliminated unchanged. After an oral tablet dose, the body absorbs about 34.5% of the drug, with peak levels reached around 2.5 hours. The drug has a half-life of roughly 15 to 16 hours, meaning it takes that long for the body to clear half of it — supporting once-daily dosing. It is mainly eliminated through the feces when taken orally, and through both urine and feces after IV dosing. Food eaten before an oral dose — especially high-fat or dairy-containing meals — can significantly reduce absorption, which is why strict fasting rules apply. Food eaten 2 hours or more after a dose does not substantially affect absorption.
📦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) . Do not freeze.
📄 Written from Omadacycline’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 Omadacycline — the kind of thing our pharmacy team would talk through with you at the counter.
What is Nuzyra actually treating — is it for any type of infection? ▾
Why do I have to take the tablet on such an empty stomach? That seems strict. ▾
I take a blood thinner — is that going to be a problem? ▾
Is it safe to take Nuzyra if I'm pregnant or breastfeeding? ▾
I've been getting diarrhea since starting Nuzyra — should I be worried? ▾
How long do I need to take Nuzyra, and what if I start feeling better early? ▾
Is Omadacycline available over the counter? ▾
When was Omadacycline first available? ▾
Who makes Omadacycline? ▾
💬 Answers drafted from Omadacycline’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 Omadacycline comes
Omadacycline 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
- Nuzyra Injection is used to treat community-acquired bacterial pneumonia (CABP) in adults
- Nuzyra Injection is used to treat acute bacterial skin and skin structure infections (ABSSSI) in adults
- Nuzyra Injection is given by a healthcare provider through an IV line — never self-administered
- Nuzyra Injection must not be mixed or infused through the same IV line as solutions containing calcium or magnesium
- If the IV line is shared, it should be flushed with saline or dextrose solution before and after each Nuzyra infusion
- Nuzyra Injection is given as a loading dose on day 1, then once daily; your care team will manage the infusion schedule
Tablet
How this form is used
- Nuzyra Tablets are used to treat community-acquired bacterial pneumonia (CABP) in adults
- Nuzyra Tablets are used to treat acute bacterial skin and skin structure infections (ABSSSI) in adults
- Nuzyra Tablets must be taken on an empty stomach — fast for at least 4 hours before your dose and take with water only
- After taking Nuzyra Tablets, wait at least 2 hours before eating or drinking anything other than water
- Avoid dairy products, antacids, and multivitamins for at least 4 hours after taking Nuzyra Tablets, as they reduce absorption
- Nuzyra Tablets are taken as a loading dose (higher dose on the first 1–2 days), then once daily; follow your prescriber's exact schedule
📊 Omadacycline across the U.S. market
How Omadacycline 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 (3) — 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 Omadacycline is used
A general measure of how commonly Omadacycline 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 Omadacycline 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 Omadacycline prescribed? Of the 1,596 medications we measure, Omadacycline ranks #1,178 by Medicaid prescriptions — more than 26% of them.
Utilization by Omadacycline 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.
omadacycline 150 MG Oral Tablet Most dispensed
Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2059274
omadacycline 100 MG Injection
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2059288
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 Omadacycline, 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 3 of 6 listed Omadacycline NDCs with Medicaid activity.
🔍 Compare Omadacycline products
A representative set of FDA-listed product records for Omadacycline — 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 | ||||
| 100 mg/5 mL | — | LSNE, Inc | DRUG FOR FURTHER PROCESSING | View NDC → |
| 100 mg/5 mL | Intravenous | Paratek Pharmaceuticals, Inc. × 2 listings | NDA | View NDC → |
| 100 mg/5 mL | — | Patheon Italia S.p.A. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 💊Tablet | ||||
| 150 mg | Oral | Paratek Pharmaceuticals, Inc. × 2 listings | NDA | View NDC → |
| 150 mg | — | Patheon Pharmaceuticals Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | Carbogen Amcis Ag | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Dynamit Nobel GmbH Explosivstoff- und Systemtechnik | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Finorga | BULK INGREDIENT | View NDC → |
Showing 10 of 10 products — FDA National Drug Code Directory. See every product, package size and price: browse all 10 Omadacycline 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 Omadacycline — 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 Omadacycline 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 Omadacycline 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 2059269 2 dose forms · 2 strengths
Look up RxCUI 2059269 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 Omadacycline 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
Omadacycline belongs to the Tetracycline-class 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. Paratek Pharmaceuticals, Inc. 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.