Prescription medicine
Omadacycline Brand names: Nuzyra
Omadacycline (Nuzyra) is a prescription medicine with an FDA approval on record since 2018. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the omadacycline FDA label on DailyMed (effective May 27, 2026, Paratek Pharmaceuticals, Inc.); the NDA 209816 record on Drugs@FDA; every omadacycline label on DailyMed.
Highlights of the record
FDA label of May 27, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageNUZYRA 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 s
Forms and strengths
- 150 mg
- 100 mg/5ml
Injection (powder) (lyophilized) for solution; film-coated tablet.
On the market
- Earliest approval on file
- October 2, 2018 Nuzyra, Paratek Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- October 31, 2037 Nuzyra tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,642 through July 30, 2026
What is omadacycline used for?
From the label: indications and usageNUZYRA 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. […]
FDA pharmacologic class: Tetracycline-class Antibacterial.
Source: FDA drug label (NUZYRA), Paratek Pharmaceuticals, Inc., effective May 27, 2026 (SPL set 51591524-4703-44c6-8bde-dce3e6a463d1), via openFDA; the full label on DailyMed
Is there a generic for omadacycline (Nuzyra)?
No generic omadacycline is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 8 patents for Nuzyra tablets: the compound patent runs to September 23, 2030, and the last listed entry to October 31, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 2037 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the omadacycline label say about other medicines?
The omadacycline label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Bismuth subsalicylate | drug interactions | … Absorption of tetracyclines, including NUZYRA, is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations. |
| Tetracycline | contraindications | CONTRAINDICATIONS NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients [see Warnings and Precautions (5.3) and Adverse Reactions (6.1) ]. |
Source: FDA drug label (NUZYRA), Paratek Pharmaceuticals, Inc., effective May 27, 2026 (SPL set 51591524-4703-44c6-8bde-dce3e6a463d1), via openFDA; the full label on DailyMed
What do FAERS reports show for omadacycline?
The FDA Adverse Event Reporting System holds 1,642 reports that list omadacycline among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 112 are coded as a death and 390 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Alternatives to omadacycline
- medicines labeled for the same conditions
- Other tetracycline-class antibacterials
- the pharmacologic class, with prices and generics
- Omadacycline side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other