Omadacycline
Pronunciation: oh-MAD-a-SYE-kleen.
- Generic name
- omadacycline
- Brand names
- Nuzyra (United States)
- Drug class
- Tetracycline-class antibacterial (aminomethylcycline)
- Form
- Lyophilized powder for IV infusion (100 mg per vial) or film-coated oral tablet (150 mg)
- Route
- Intravenous infusion or oral
- Legal status
- Prescription-only in the United States, its only confirmed market of authorisation.
Availability and supply rules vary by country
Trade names by country: United States
Australia: · Full directory
What omadacycline is and how it works
Omadacycline is a prescription antibiotic from the tetracycline class (specifically an aminomethylcycline), used to treat certain bacterial lung infections and skin infections in adults when caused by susceptible bacteria. (1)
Omadacycline does not carry a boxed warning, but it shares real risks common to tetracycline antibiotics: it can permanently discolor developing teeth and affect bone growth if used in the second half of pregnancy or in young children, can make skin more sensitive to sunlight, and can rarely affect the liver or pancreas. Always take it exactly as prescribed, and tell your prescriber about any pregnancy or if you are giving it to a child.
Mechanism of action: how omadacycline works
Omadacycline is a semisynthetic aminomethylcycline, a subclass of the tetracycline class, which inhibits bacterial protein synthesis by binding the 30S ribosomal subunit. It retains activity against certain efflux-pump and ribosomal-protection tetracycline-resistance mechanisms. (1)
What omadacycline is used for
Community-acquired bacterial pneumonia (CABP)
Treats lung infections (pneumonia) picked up outside a hospital, when caused by bacteria known to respond to omadacycline, including Streptococcus pneumoniae, methicillin-susceptible Staphylococcus aureus, Haemophilus influenzae, Legionella pneumophila, and Mycoplasma pneumoniae. (1)
Acute bacterial skin and skin structure infections (ABSSSI)
Treats serious skin infections caused by susceptible bacteria, including both methicillin-susceptible and methicillin-resistant Staphylococcus aureus (MRSA), Streptococcus pyogenes, and Enterococcus faecalis. (1)
Before taking omadacycline
Do not take / not appropriate for
- Do not take omadacycline if you are allergic to omadacycline, any tetracycline-class antibiotic, or any of its ingredients. (United States) (1)
Tell your clinician about
- Whether you are pregnant, planning to become pregnant, or breastfeeding.
- If this medicine is intended for a child, especially a child under 8 years old.
- Any history of liver problems or pancreatitis.
- All other medicines you take, especially blood thinners (anticoagulants), antacids, iron supplements, or multivitamins.
- Any known allergy to tetracycline antibiotics such as doxycycline or minocycline.
How to take omadacycline
- Take or receive omadacycline exactly as your prescriber directs, for the full course even if you start feeling better.
- If taking the oral tablet: fast for at least 4 hours beforehand, then take it with water only. Afterward, do not eat or drink anything except water for 2 hours, and avoid dairy products, antacids, or multivitamins for 4 hours, since these can reduce how much of the medicine your body absorbs.
- If receiving it by IV infusion, it will be given over 30-60 minutes by a healthcare professional, and never mixed in the same line as calcium- or magnesium-containing solutions.
- Tell your prescriber right away about new sunburn-like skin reactions, severe headache with vision changes, unusual bruising or bleeding, or signs of liver problems such as yellowing skin or eyes.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4)
Missed dose
Omadacycline is typically given as a short, supervised course in a healthcare or hospital setting. If you miss an oral dose, contact your prescriber or pharmacist for guidance rather than doubling your next dose.
Overdose
Seek medical attention if too much omadacycline is given or taken. The current US prescribing information states that no specific overdose treatment information is available; care would be supportive. A small proportion of the drug can be removed by dialysis. (1)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms.
Nausea and vomiting, especially with the oral loading dose (nausea reported in over 1 in 5 patients receiving the oral loading regimen for skin infections).
What to notice: Nausea and vomiting, especially with the oral loading dose (nausea reported in over 1 in 5 patients receiving the oral loading regimen for skin infections).
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Headache.
What to notice: Headache.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Increases in liver enzymes (ALT/AST) shown on blood tests.
What to notice: Increases in liver enzymes (ALT/AST) shown on blood tests.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Infusion site reactions with the IV form.
What to notice: Infusion site reactions with the IV form.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Diarrhea.
What to notice: Diarrhea.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Increased blood pressure.
What to notice: Increased blood pressure.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Serious warnings
Tooth discoloration and enamel problems (in pregnancy and young children) — high caution
Symptoms: Not applicable to the person taking it directly -- this is a risk to a developing baby or young child's teeth.
Action: Tell your prescriber if you are pregnant (especially in the second half of pregnancy) or if this medicine is being considered for a child up to age 8, since it may permanently discolor developing teeth (yellow-gray-brown) and affect enamel. (1)
Effects on bone growth (in pregnancy and young children) — high caution
Symptoms: Not applicable to the person taking it directly -- this is a risk to a developing baby or young child.
Action: Tell your prescriber if you are pregnant (second or third trimester) or if this medicine is being considered for a child up to age 8, since it may reversibly slow bone growth. (1)
Serious allergic reaction — emergency
Symptoms: Swelling of the face, lips, tongue, or throat, difficulty breathing, or a severe rash.
Action: Seek emergency medical help immediately -- life-threatening allergic reactions have been reported with tetracycline-class antibiotics. (1)
Severe diarrhea (possible C. difficile infection) — high caution
Symptoms: Watery or bloody diarrhea, stomach cramps, or fever, which can start during treatment or even weeks after stopping.
Action: Contact your prescriber promptly -- do not treat diarrhea yourself with anti-diarrheal medicine until you have checked with your prescriber, since this can rarely be a serious bowel infection. (1)
Increased sun sensitivity (photosensitivity) — moderate caution
Symptoms: Sunburn-like reactions occurring more easily or severely than usual.
Action: Limit sun exposure, use sun protection, and contact your prescriber if you develop an unusual skin reaction. (1)
Severe headache with vision changes (pseudotumor cerebri) — high caution
Symptoms: Severe headache, blurred or double vision, or other visual disturbances.
Action: Contact your prescriber promptly or seek urgent care -- this rare tetracycline-class effect involves raised pressure around the brain and needs prompt evaluation. (1)
Liver problems or pancreatitis — high caution
Symptoms: Yellowing of the skin or eyes, dark urine, severe stomach pain, or unusual tiredness.
Action: Contact your prescriber promptly -- tetracycline-class antibiotics have been associated with abnormal liver tests and, rarely, pancreatitis. (1)
Interactions
- Anticoagulants (blood thinners): omadacycline may increase their effect, and a downward dose adjustment of the anticoagulant may be needed. (1)
- Antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate, and iron-containing products can reduce how much oral omadacycline your body absorbs -- space these apart from your dose as directed (avoid for 4 hours after an oral dose). (1)
- The IV form must never be given through the same line as a solution containing calcium or magnesium. (1)
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Use during the second and third trimester of pregnancy may cause permanent discoloration of the baby's developing teeth and reversible inhibition of bone growth. Tell your prescriber if you are pregnant or think you might be pregnant so the risks and benefits can be discussed. (1) (2) (3) (4)
Breastfeeding
Breastfeeding is not recommended during treatment with omadacycline and for 4 days after the last dose. (1) (2) (3) (4)
Children
May cause permanent tooth discoloration and reversible bone-growth inhibition in children up to age 8; use in this age group requires careful clinician judgment of risks versus benefits. (1) (2) (3) (4)
Elderly
The current US label does not describe a specific dose adjustment for older adults in the sources reviewed for this dossier, but overall clinical response should be monitored as with any antibiotic course. (1) (2) (3) (4)
Hepatic_impairment
Discuss with your prescriber if you have known liver problems, since tetracycline-class antibiotics have been associated with abnormal liver function and rare serious liver injury. (1) (2) (3) (4)
Renal_impairment
Specific renal dose-adjustment guidance was not identified in the sources reviewed for this dossier; discuss with your prescriber if you have kidney problems. (1) (2) (3) (4)
Source_ids
Monitoring
Before starting
- Pregnancy status in anyone who could become pregnant
- Age (particularly for children up to 8 years old)
- Known allergy to tetracycline-class antibiotics
- Baseline liver function where clinically relevant
- Review of other medicines, especially anticoagulants and antacids/iron/multivitamins
During treatment
- Watch for signs of allergic reaction, severe diarrhea, unusual sun sensitivity, or visual changes with headache.
- Anticoagulant effect may need closer monitoring, with dose adjustment if required.
- Liver enzymes may be checked if clinically indicated.
Storage
Store and handle according to the product packaging and your pharmacist's instructions; the IV form requires reconstitution and dilution by a healthcare professional before use.
Study the drug class: Tetracyclines
Professional information
Clinician-facing context only, sourced from the current US FDA Nuzyra prescribing information (most recent revision 2026-05-27); verify against the current full local label before prescribing.
United States
Indication: Community-acquired bacterial pneumonia (CABP) / acute bacterial skin and skin structure infections (ABSSSI)
Dose summary: CABP: loading dose day 1 (200 mg IV over 60 min, or 100 mg IV over 30 min twice, or 300 mg orally twice), then 100 mg IV or 300 mg orally once daily; 7-14 days total. ABSSSI: loading dose days 1-2 (200 mg IV over 60 min, or 100 mg IV over 30 min twice, or 450 mg orally once daily for 2 days), then 100 mg IV or 300 mg orally once daily; 7-14 days total.
Renal context: Specific renal dose-adjustment guidance was not identified in the sources reviewed for this dossier. (1)
Overdose note
No specific overdose treatment information is available in the current label. Following a 100 mg single IV dose, approximately 8.9% of the dose is recovered in dialysate. (1)
Frequently asked questions
Does omadacycline (Nuzyra) have a boxed warning?
No. The current US FDA label for Nuzyra (omadacycline) does not carry a boxed warning. A related 'mortality imbalance' precaution that previously appeared in the Warnings and Precautions section was formally removed from the label in a May 2026 revision. (1)
Can omadacycline affect a child's teeth?
Yes. Like other tetracycline-class antibiotics, omadacycline can permanently discolor developing teeth (a yellow-gray-brown color) and affect enamel if used during the second half of pregnancy or in children up to about age 8, when teeth are still developing. (1)
Is Nuzyra available outside the United States?
Based on the regulator sources checked, Nuzyra (omadacycline) is authorised only in the United States. Its European Union marketing-authorisation application was withdrawn by the manufacturer in 2019 before a decision was made, no listing was found in the UK electronic medicines compendium, and it was not found in Health Canada's Drug Product Database. Availability in Australia and New Zealand could not be directly confirmed. (1) (2) (3) (4)
What is the mechanism of action of omadacycline?
Omadacycline is a semisynthetic aminomethylcycline, a subclass of the tetracycline class, which inhibits bacterial protein synthesis by binding the 30S ribosomal subunit. It retains activity against certain efflux-pump and ribosomal-protection tetracycline-resistance mechanisms. (1)
What is the generic name of Omadacycline?
The generic name is omadacycline. It is sold under brand names including Nuzyra (United States). (1)
What class of drug is omadacycline?
Omadacycline is classed as: Tetracycline-class antibacterial (aminomethylcycline). (1)
References
- NUZYRA (omadacycline) for injection, for intravenous use; NUZYRA (omadacycline) tablets, for oral use -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information · United States · accessed 2026-07-30 · source 1
- Nuzyra, INN: omadacycline -- Questions and answers on the withdrawal of the application for marketing authorisationEuropean Medicines Agency (EMA) · European Union · accessed 2026-07-30 · source 2
- emc search results for "omadacycline"electronic medicines compendium (emc), United Kingdom · United Kingdom · accessed 2026-07-30 · source 3
- Health Canada Drug Product Database -- live API query, brand name "nuzyra"Health Canada Drug Product Database (DPD) API · Canada · accessed 2026-07-30 · source 4
- Attempted live queries of the TGA ARTG search and Medsafe product/data-sheet searchTherapeutic Goods Administration (TGA), Australia / Medsafe, New Zealand -- attempted direct queries · Australia, New Zealand · accessed 2026-07-30 · source 5
Brand names by country
Single-ingredient omadacycline names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- NUZYRA100 mg/5mL, 150 mg · paratek pharmaceuticals, inc.