LOW-VOLUME · HOSP-MID
omadacycline Side Effects
omadacycline (also sold as Nuzyra) is a LOW-VOLUME FAERS extract #476 of 524 by FAERS report count. Still opens on HOSP-MID: 22.3% mention hospitalization (329 reports).
Data updated 2026-05-15
- 1,476
- FAERS reports
Thinner FAERS book - still a temporal association ledger, not proof of cause. Methodology.
omadacycline: 22.3% mention hospitalization (329 reports). Death stamp DEATH-HEAVY; volume band LOW-VOLUME #476 of 524 by FAERS report count.
Thinner FAERS extract for omadacycline (Nuzyra) (1,476 reports #476 of 524 by FAERS report count). 22.3% mention hospitalization (329 reports). Sparse books still carry named reaction rows when present; not medical advice.
Counts from the openFDA FAERS extract (2017–2025). Stamps SIGNAL · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
NAUSEA leads 245 of 1,476 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (330 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (101 reports, 6.8%). Top co-reported reactions in that subset - voluntary, not causal.
| 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
Hospitalization mid-share (329, 22.3%). Co-reported reactions:
| 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 |
How to read omadacycline FAERS figures (SIGNAL · DEATH-HEAVY · HOSP-MID)
FAERS holds 1,476 voluntary reports linked to omadacycline (Nuzyra), 2017-2025. Death is listed on 101 (6.8%). Hospitalization appears on 329 (22.3%). Top co-reported indication: Mycobacterium Abscessus Infection.
Sparse extract - named reactions and SEX-BALANCED skew still differ by drug; not a complete safety profile.
Read with omadacycline
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-MID stamps.
ABS(total_reports) peer at 1,480 FAERS cases (Δ 4 heavier vs omadacycline); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 1,527 FAERS cases (Δ 51 heavier vs omadacycline); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 1,538 FAERS cases (Δ 62 heavier vs omadacycline); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 1,541 FAERS cases (Δ 65 heavier vs omadacycline); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 55.3 pp vs omadacycline's DEATH-HEAVY): CASELOAD · HOSP-MID.
omadacycline stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload SIGNAL and the label guide.