Omadacycline

NUZYRA is an antibacterial drug [see Microbiology (12.4) ].

• NUZYRA is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms ( 1 ): Community-acquired bacterial pneumonia (CABP) ( 1.1 ) Acute bacterial skin and skin structure infections (ABSSSI) ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.3 ) 1.1 Community-Acquired Bacterial Pneumonia NUZYRA is indicated for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae , Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae , Haemophilus parainfluenzae , Klebsiella pneumoniae, Legionella pneumophila , Mycoplasma pneumoniae, and Chlamydophila pneumoniae .ICD-10: J18.9

• NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients [see Warnings andPrecautions (5.3) and Adverse Reactions (6.1) ].contraindicated

Recommended Dosage of NUZYRA in CABP and ABSSSI Adult Patients ( 2.2 , 2.3 ): Infection Loading Doses Maintenance Dose CABP NUZYRA Injection: Day 1: 200 mg by intravenous infusion over 60 minutes OR 100 mg by intravenous infusion over 30 minutes twice ( 2.2 ) OR NUZYRA Tablets: Day 1: 300 mg orally twice ( 2.2 ) NUZYRA Injection: 100 mg by intravenous infusion over 30 minutes once daily OR NUZYRA Tablets: 300 mg orally once daily ( 2.2 ) ABSSSI NUZYRA Injection: Day 1: 200 mg by intravenous infusion over 60 minutes OR 100 mg by intravenous infusion over 30 minutes twice ( 2.3 ) OR NUZYRA Tablets: Day 1 and Day 2: 450 mg orally once daily ( 2.3 ) NUZYRA Injection: 100 mg by intravenous infusion over 30 minutes once daily OR NUZYRA Tablets: 300 mg orally once daily ( 2.3 ) CABP and ABSSSI : Treatment duration is 7 to 14 days. ( 2.2 , 2.3 ) Fast for at least 4 hours and then take NUZYRA tablets with water. After oral dosing, no food or drink (except water) is to be consumed for 2 hours and no dairy products, antacids, or multivitamins for 4 hours. ( 2.1 ) See full prescribing information for the preparation of NUZYRA IV and other administration instructions. ( 2.1 , 2.5 ) 2.1 Important Administration Instructions NUZYRA for Injection : Do NOT administer NUZYRA for injection with any solution containing multivalent cations, e.g., calcium and magnesium, through the same intravenous line [see Drug Interactions (7.2) ] . Co-infusion with other medications has not been studied [see Dosage and Administration (2.5) ] .

Tooth Discoloration and Enamel Hypoplasia : The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia. ( 5.1 , 8.1 , 8.4 ) Inhibition of Bone Growth: The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth. ( 5.2 , 8.1 , 8.4 ) Clostridioides difficile -Associated Diarrhea : Evaluate if diarrhea occurs. ( 5.4 ) 5.1 Tooth Discoloration and Enamel Hypoplasia The use of NUZYRA during tooth development (last half of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the tetracycline class drugs, but it has been observed following repeated short-term courses. Enamel hypoplasia has also been reported with tetracycline class drugs. Advise the patient of the potential risk to the fetus if NUZYRA is used during the second or third trimester of pregnancy [see Use in Specific Populations (8.1 , 8.4) ]. 5.2 Inhibition of Bone Growth The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth. All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature infants given oral tetracycline in doses of 25 mg/kg every 6 hours.

The following clinically significant adverse reactions are described in greater detail in the Warnings and Precautions section of labeling: Tooth Development and Enamel Hypoplasia [see Warnings and Precautions (5.1) ] Inhibition of Bone Growth [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Tetracycline Class Effects [see Warnings and Precautions ( 5.5 )] ABSSSI: The most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, headache and diarrhea. CABP : The most common adverse reactions (incidence ≥2%) are alanine aminotransferase increased, headache, hypertension, and aspartate aminotransferase increased. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Paratek Pharmaceuticals, Inc. at 1-833-727-2835 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. Overview of the Safety Evaluation of NUZYRA NUZYRA was evaluated in three Phase 3 pivotal clinical trials (Trial 1, Trial 2 and Trial 3) and one Phase 3 postmarketing clinical trial (Trial 4).

Lactation : Breastfeeding is not recommended during treatment with NUZYRA. ( 8.2 ) 8.1 Pregnancy Risk Summary NUZYRA, like other tetracycline class antibacterial drugs, may cause discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimester of pregnancy [see Warnings and Precautions ( 5.1 , 5.2) , Data, Use in Specific Populations ( 8.4 )]. The limited available data of NUZYRA use in pregnant women is insufficient to inform drug associated risk of major birth defects and miscarriages. Animal studies indicate that administration of omadacycline during the period of organogenesis resulted in fetal loss and/or congenital malformations in pregnant rats and rabbits at 7 times and 3 times the mean AUC exposure, respectively, of the clinical intravenous dose of 100 mg and the oral dose of 300 mg. Reductions in fetal weight occurred in rats at all administered doses (see Data ). In a fertility study, administration to rats during mating and early pregnancy resulted in embryo loss at 20 mg/kg/day; systemic exposure based on AUC was approximately equal to the clinical exposure level [see Nonclinical Toxicology ( 13.1) ] . Results of studies in rats with omadacycline have shown tooth discoloration. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

Metabolism

The pharmacokinetic parameters of NUZYRA after single and multiple oral and intravenous doses are summarized in Table 6 . Table 6: Mean (SD) Pharmacokinetic Parameters of NUZYRA in Healthy Adult Subjects Dose and Route of Administration 100 mg IV 300 mg Oral 450 mg Oral C max = maximum plasma concentration, AUC = area under concentration-time curve, IV = intravenous, ND = not determined, T max = time to C max PK Parameters All PK parameters presented as mean (standard deviation), Number of Subjects, unless otherwise specified C max ng/mL Single dose 1507 (582) (n=63) 548 (146) (n=103) 874 (232…

No specific information is available on the treatment of overdosage with NUZYRA. Following a 100 mg single dose intravenous administration of omadacycline, 8.9% of dose is recovered in the dialysate.

• Oct 2, 2018NDANDA209816Paratek Pharms
• Oct 2, 2018NDANDA209817Paratek Pharms

1. 1Off Label Use42427%
2. 2Nausea25316%
3. 3Vomiting15610%
4. 4Drug Ineffective1177.5%
5. 5Diarrhoea1117.1%
6. 6Incorrect Product Administration Duration835.3%
7. 7Rash734.7%
8. 8Dyspnoea724.6%
9. 9Death704.5%
10. 10Incorrect Dose Administered684.4%
11. 11Fatigue603.9%
12. 12Hospitalisation593.8%
13. 13Pruritus573.7%
14. 14Headache533.4%
15. 15Cough503.2%

The 10 most recently updated of 22 ClinicalTrials.gov registrations naming Omadacycline as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Bacteriophage Therapy for Mycobacterium Abscessus Pulmonary Infection
  Enrolling by invitation · Phase 1 · Interventional · 1 enrolled · Vancouver Coastal Health
  NCT07228702updated 2026-06-03
• To Evaluate the Clinical Efficacy and Safety of Omadacycline in the Treatment of Mycobacterium Abscessus Infection.
  Enrolling by invitation · Observational · 200 enrolled · Beijing Chest Hospital
  NCT07615309updated 2026-05-29
• Pharmacokinetics of Omadacycline in Cystic Fibrosis
  Completed · Phase 4 · Interventional · 9 enrolled · Paul Beringer
  NCT04460586updated 2026-05-08
• Real-World Efficacy and Safety Analysis of Omadacycline for the Treatment of Diabetic Foot Infections and Acute Osteomyelitis
  Completed · Observational · 42 enrolled · Methodist Health System
  NCT04714411updated 2026-03-27
• Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections
  Completed · Phase 1 · Interventional · 23 enrolled · Paratek Pharmaceuticals Inc
  NCT05217537updated 2026-03-09
• Controlled Trial of Omadacycline Randomized Treatment Given for Bone and Joint Infection
  Active not recruiting · Phase 2 · Interventional · 180 enrolled · Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  NCT05753215updated 2026-01-14
• Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)
  Completed · Phase 2 · Interventional · 66 enrolled · Paratek Pharmaceuticals Inc
  NCT04922554updated 2025-07-30
• Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia
  Completed · Phase 3 · Interventional · 670 enrolled · Paratek Pharmaceuticals Inc
  NCT04779242updated 2025-04-09
• Microbiome Effect of Omadacycline on Healthy Volunteers
  Completed · Phase 1 · Interventional · 32 enrolled · University of Houston
  NCT06030219updated 2025-03-25
• Effects of Intravenous (IV) Omadacycline on Gut Microbiome
  Completed · Phase 4 · Interventional · 8 enrolled · Wake Forest University Health Sciences
  NCT05515562updated 2025-03-17

Frequently asked questions

How does Omadacycline work?

NUZYRA is an antibacterial drug [see Microbiology (12.4) ].

What is Omadacycline used for?

According to FDA labeling, Omadacycline carries indications including: NUZYRA is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms ( 1 ): Community-acquired bacterial pneumonia (CABP) ( 1.1 ) Acute bacterial skin and skin structure infections (ABSSSI) ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.3 ) 1.1 Community-Acquired Bacterial Pneumonia NUZYRA is indicated for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae , Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae , Haemophilus parainfluenzae , Klebsiella pneumoniae, Legionella pneumophila , Mycoplasma pneumoniae, and Chlamydophila pneumoniae .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Omadacycline?

Omadacycline is classified as Tetracyclines, Tetracycline-class Antibacterial, Protein Synthesis Inhibitors, Decreased Protein Synthesis.

What are the brand names for Omadacycline?

Omadacycline is marketed under brand names including Nuzyra.

What are the contraindications for Omadacycline?

Omadacycline labeling lists contraindications including: NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients [see Warnings andPrecautions (5.3) and Adverse Reactions (6.1) ].. Always consult the full prescribing information and a clinician.