Drug side effects
omadacycline Side Effects
The reactions most often reported to the FDA for omadacycline (also sold as Nuzyra), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 1,476
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2017 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of omadacycline come from 1,476 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 1,476 reports to the FDA Adverse Event Reporting System (FAERS) for omadacycline (Nuzyra): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
1,476
Reports Mentioning Death
101
6.8% of reports — not proof the medicine caused the death
Hospitalizations
329
22.3% of reports
Top Indication
Mycobacterium Abscessus Infection
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 101 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | 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 |
| PRODUCTIVE COUGH | 5 |
| CONDITION AGGRAVATED | 4 |
| DYSPHONIA | 4 |
| INCORRECT PRODUCT ADMINISTRATION DURATION | 4 |
| RESPIRATORY FAILURE | 4 |
| ACUTE RESPIRATORY FAILURE | 3 |
| HALLUCINATION | 3 |
| INCORRECT DOSE ADMINISTERED | 3 |
Reactions in Hospitalization Reports
Top reactions in 329 reports where hospitalization was an outcome.
| Reaction | 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 |
| DIARRHOEA | 16 |
| ASPARTATE AMINOTRANSFERASE INCREASED | 15 |
| DEATH | 15 |
| DRUG INEFFECTIVE FOR UNAPPROVED INDICATION | 15 |
| HEPATIC FUNCTION ABNORMAL | 14 |
| INCORRECT DOSE ADMINISTERED | 14 |
| MALAISE | 14 |
Nearby, Related Medications
What the FAERS Data Reveals About omadacycline Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 1,476 voluntary reports linked to omadacycline and its brand equivalents (Nuzyra), spanning 2017 through 2025. Of those, 101 (6.8%) listed death as an outcome and 329 (22.3%) involved hospitalization. The most common indication reported alongside adverse events was Mycobacterium Abscessus Infection.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 55% were female and 45% male; age distribution skews toward 45-64, with 330 reports in that bracket. The single most reported reaction is nausea with 245 submissions, followed by vomiting and diarrhoea.
How to read these numbers
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to omadacycline's 1,476.
Read our methodology - how this data is sourced, computed, and verified.