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Prescription medication · Tetracycline Antibiotic

omadacycline

Also sold as Nuzyra. Nuzyra treats community-acquired bacterial pneumonia (CABP), a lung infection.

Data updated 2026-05-15

1,476
FDA reportsRarely reported
1
InteractionFew interactions
Rx
Availability

What the data shows

omadacycline (Nuzyra) is a prescription Tetracycline Antibiotic, among the least-reported drugs the FDA tracks (1,476 FDA reports), with 1 documented drug interaction.

Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.

omadacycline (Nuzyra) is a prescription Tetracycline Antibiotic. Nuzyra treats community-acquired bacterial pneumonia (CABP), a lung infection.

Nuzyra is an antibiotic medicine. It fights certain bacteria to treat infections.

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What it does

Nuzyra treats community-acquired bacterial pneumonia (CABP), a lung infection.

Common side effects

Nausea, Vomiting, Reactions where the IV was given

Key warnings

Nuzyra may cause an imbalance in the number of deaths in patients with pneumonia.

The sections below are summarized in plain English from omadacycline's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

Nuzyra is a tetracycline antibiotic. It stops bacteria from growing by interfering with their protein production. This helps your body fight off the infection.

How to Take It

Nuzyra can be given as an IV injection or taken as a pill. For pills, fast for 4 hours before taking it with water. After taking the pill, don't eat or drink anything (except water) for 2 hours. Also, avoid dairy, antacids, and multivitamins for 4 hours after taking the pill. Treatment lasts 7 to 14 days.

This is a plain-language summary of omadacycline's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.

Pregnancy & Breastfeeding

Nuzyra can cause tooth discoloration and bone problems in unborn babies. Breastfeeding is not recommended while using Nuzyra.

This is a plain-language summary of omadacycline's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

This is a plain-language summary of omadacycline's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.

Storage

Store Nuzyra at room temperature, away from moisture and heat. Do not freeze.

Side Effects (from patient reports)

Based on 1,476 FDA adverse event reports.

Most-reported reactions

Adverse reactions in FAERS for omadacycline, by number of reports

reports

What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.

Source FDA Adverse Event Reporting System (FAERS) As of 2025

Reports over time

Adverse-event reports filed for omadacycline each year to the FDA Adverse Event Reporting System (FAERS).

-1000100200300400500 20172019202020212022202320242025 391

Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.

Where omadacycline sits

omadacycline has more FDA adverse-event reports than 9% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.

fewest reports most reports

Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is omadacycline; the line is the median (50th percentile).

FDA Adverse Event Report Analysis

Detailed analysis of 1,476 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2017–2025.

Total Reports

1,476

Reports Mentioning Death

101

6.8% of reports — not proof of cause

Hospitalization Reports

329

Top Indication

Mycobacterium Abscessus Infection

Gender Distribution

Female 730 (55%)
Male 590 (45%)

Age Distribution

0–17 40
18–44 139
45–64 330
65–74 200
75+ 199

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
2 NAUSEA 245
3 VOMITING 152
5 DIARRHOEA 107
6 INCORRECT PRODUCT ADMINISTRATION DURATION 76
7 RASH 70
8 INCORRECT DOSE ADMINISTERED 68
9 DEATH 66
10 DYSPNOEA 65
11 FATIGUE 56
12 HOSPITALISATION 55
13 HEADACHE 52
14 PRURITUS 52
15 DRUG INEFFECTIVE FOR UNAPPROVED INDICATION 48
16 COUGH 44
18 ASPARTATE AMINOTRANSFERASE INCREASED 41

Reactions in Death Reports

DEATH 65
PNEUMONIA 11
DYSPNOEA 7
THERAPY INTERRUPTED 7
COUGH 6
HOSPITALISATION 6
WEIGHT DECREASED 6
DRUG DOSE TITRATION NOT PERFORMED 5
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION 5
LUNG DISORDER 5

Reactions in Hospitalization Reports

HOSPITALISATION 55
NAUSEA 37
DYSPNOEA 31
INCORRECT PRODUCT ADMINISTRATION DURATION 26
COUGH 24
THERAPY INTERRUPTED 23
VOMITING 23
CONDITION AGGRAVATED 22
PNEUMONIA 22
FATIGUE 17

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Nuzyra may cause an imbalance in the number of deaths in patients with pneumonia. The cause of this is not known, so your doctor will watch you closely. Nuzyra can also cause tooth discoloration and affect bone growth in children under 8 and unborn babies. Diarrhea can occur, so tell your doctor if you have diarrhea while taking Nuzyra.

Known Drug Interactions

( 7.1 ) Absorption of tetracyclines, including NUZYRA, is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations. 7.2 Antacids and Iron Preparations Absorption of oral tetracyclines, including NUZYRA, is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate, and iron containing preparations [see Dosage and Administration (2.1) ].

Mechanism: Bismuth subsalicylate interferes with how your body takes in the antibiotic, making the medicine less effective at fighting infection.

What to do: Avoid taking these two medicines at the same time so the antibiotic can work correctly.

This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.

Common Questions

What should I avoid while taking Nuzyra?
Avoid dairy products, antacids, and multivitamins for 4 hours after taking the pill.
Can I take Nuzyra with food?
Take Nuzyra tablets on an empty stomach, at least 4 hours after eating. After taking the pill, wait 2 hours before eating.
How long will I need to take Nuzyra?
The usual treatment time is 7 to 14 days.
What if I feel better before finishing all my Nuzyra?
Take Nuzyra for the full treatment time, even if you feel better. Stopping early may cause the infection to come back.
Can Nuzyra affect my teeth?
Nuzyra can cause permanent tooth discoloration if taken during tooth development (pregnancy to age 8).
Can Nuzyra affect my bones?
Nuzyra can temporarily slow bone growth if taken during pregnancy or in children under 8.
What should I do if I get diarrhea while taking Nuzyra?
Tell your doctor if you develop diarrhea while taking Nuzyra.
Can I take antacids with Nuzyra?
No, avoid antacids for 4 hours after taking Nuzyra tablets.
Will Nuzyra interact with other medications I'm taking?
Nuzyra can interact with blood thinners, so your doctor may need to adjust your dose. Also, antacids and iron supplements can affect how well Nuzyra works.
What happens if I take too much Nuzyra?
Call your doctor or seek medical attention immediately.
What are the common side effects of omadacycline?
The most commonly reported side effects of omadacycline include Nausea, Vomiting, Reactions where the IV was given, Increased liver enzyme levels, High blood pressure. Based on 1,476 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does omadacycline interact with other medications?
Yes, omadacycline has 1 known drug interactions. Notable interactions include bismuth subsalicylate. Always inform your doctor about all medications you are taking.
What drug class is omadacycline?
omadacycline belongs to the Tetracycline Antibiotic drug class. It requires a prescription (Rx). Nuzyra treats community-acquired bacterial pneumonia (CABP), a lung infection.
Is omadacycline safe during pregnancy?
Nuzyra can cause tooth discoloration and bone problems in unborn babies. Breastfeeding is not recommended while using Nuzyra. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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What the FDA Data Shows for omadacycline

The FDA label for omadacycline (sold under brand names such as Nuzyra) classifies it as a prescription-only medication in the Tetracycline Antibiotic class. Nuzyra treats community-acquired bacterial pneumonia (CABP), a lung infection. Official labeling lists 9 commonly reported side effects, including Nausea, Vomiting, Reactions where the IV was given.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 1,476 voluntary reports. The database also lists 1 documented drug interaction derived from FDA labeling, with the top-flagged interaction rated minor severity. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: March 31, 2025

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.

All federal data sources used on this page