Omadacycline side effects: what 1,641 FDA adverse event reports show

Omadacycline · Nuzyra · 42 reaction terms · 1,332 drug–reaction co-reports · data 2026-09-14

Drug class

Tetracycline-class Antibacterial

FDA label (Established Pharmacologic Class)

Brand names

Nuzyra

openFDA label

Who reports

1,641 reports · 57% serious · 112 with death outcome · 56% female

openFDA FAERS counts, all years, deduplication not applied

Used for

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 str.

FDA label, Indications and Usage

What it is

NUZYRA contains omadacycline tosylate, an aminomethylcycline which is a semisynthetic derivative of the tetracycline class of antibacterial drugs, for intravenous or oral administration.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 28 strongest signals

Labeled adverse reaction 3Labeled (related wording) 1Reporting / coding artifact 10Lab value / disease marker 2Not in label — unassessed 12

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 14 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Incorrect product administration duration	88	55.6 45.4–68.2ROR 58.7 · χ² 4,649 / p <1e-300	54.8 EB05 45.8 · IC025 +5.1 3/3 methods agree	Reporting / coding artifact	serious n=47	no trial data cached
Drug resistance	39	19.4 14.2–26.5ROR 19.9 · χ² 663 / p 2e-146	19.2 EB05 14.6 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 13.0 · 92% clinician	no trial data cached
Electrocardiogram qt prolonged	43	15.3 11.4–20.5ROR 15.7 · χ² 560 / p 5e-124	15.1 EB05 11.6 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 15.7 · 100% clinician	no trial data cached
Hepatic function abnormal	42	14.5 10.7–19.5ROR 14.8 · χ² 514 / p 4e-114	14.3 EB05 10.9 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 13.9 · ♀ 16% (drug 56%) · 100% clinician	no trial data cached
Cytopenia	13	13.9 8.1–23.9ROR 14.0 · χ² 143 / p 3e-33	12.6 EB05 7.0 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 14.6	no trial data cached
Aspartate aminotransferase increased	54	13.0 10.0–16.9ROR 13.4 · χ² 587 / p 5e-130	12.8 EB05 10.1 · IC025 +3.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.0	no trial data cached
Dermatitis allergic	11	11.3 6.3–20.3ROR 11.3 · χ² 93 / p 3e-22	9.4 EB05 5.0 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 13.9	no trial data cached
Drug ineffective for unapproved indication	48	11.0 8.3–14.5ROR 11.3 · χ² 427 / p 3e-95	10.6 EB05 8.2 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 14.0	no trial data cached
Deafness	22	10.7 7.1–16.3ROR 10.9 · χ² 185 / p 2e-42	9.8 EB05 6.5 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 11.3	no trial data cached
Alanine aminotransferase increased	46	9.6 7.2–12.7ROR 9.8 · χ² 345 / p 2e-77	9.1 EB05 7.0 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.7 · 91% clinician	no trial data cached
Skin discolouration	34	9.5 6.8–13.2ROR 9.6 · χ² 249 / p 2e-56	8.8 EB05 6.5 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 5.1 · ♀ 80% (drug 56%)	no trial data cached
Blood bilirubin increased	20	9.4 6.1–14.6ROR 9.5 · χ² 143 / p 4e-33	8.4 EB05 5.5 · IC025 +2.2 3/3 methods agree	Lab value / disease marker	serious PRR 10.4 · 95% clinician	no trial data cached
Tinnitus (ringing in the ears)	32	8.9 6.3–12.5ROR 9.0 · χ² 216 / p 3e-49	8.2 EB05 6.0 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 8.2	no trial data cached
Haemoptysis	19	8.7 5.6–13.6ROR 8.8 · χ² 122 / p 1e-28	7.6 EB05 5.0 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 7.8	no trial data cached
Blood alkaline phosphatase increased	15	7.7 4.7–12.8ROR 7.8 · χ² 81 / p 1e-19	6.5 EB05 4.1 · IC025 +1.8 3/3 methods agree	Lab value / disease marker	serious PRR 7.2	no trial data cached
Drug eruption	10	7.2 3.9–13.4ROR 7.3 · χ² 48 / p 2e-12	5.7 EB05 3.2 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.6	no trial data cached
Poor quality sleep	12	7.2 4.1–12.6ROR 7.2 · χ² 58 / p 2e-14	5.8 EB05 3.5 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 7.8	no trial data cached
Osteomyelitis	10	7.1 3.8–13.1ROR 7.1 · χ² 46 / p 5e-12	5.6 EB05 3.2 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 7.3	no trial data cached
Off label use (used outside approved label)	437	6.4 5.9–7.0ROR 8.4 · χ² 2,085 / p <1e-300	6.4 EB05 5.9 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 6.3	no trial data cached
Therapy interrupted	33	6.1 4.4–8.6ROR 6.2 · χ² 136 / p 8e-32	5.7 EB05 4.2 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 12.4 · 82% consumer	no trial data cached
Skin lesion	13	6.1 3.5–10.5ROR 6.1 · χ² 50 / p 6e-13	5.1 EB05 3.2 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.7	no trial data cached
Transaminases increased	10	5.8 3.1–10.7ROR 5.8 · χ² 35 / p 2e-9	4.7 EB05 2.7 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 5.6	no trial data cached
Dysphonia	25	5.5 3.7–8.1ROR 5.5 · χ² 87 / p 5e-21	5.0 EB05 3.6 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 9.6 · ♀ 80% (drug 56%) · 84% consumer	no trial data cached
Rash erythematous	19	5.2 3.3–8.1ROR 5.2 · χ² 60 / p 5e-15	4.6 EB05 3.1 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 7.3	no trial data cached
Hospitalisation	59	4.9 3.8–6.4ROR 5.1 · χ² 183 / p 5e-42	4.8 EB05 3.8 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 5.1 · 86% consumer	no trial data cached
Unevaluable event	28	4.7 3.3–6.8ROR 4.8 · χ² 79 / p 3e-19	4.4 EB05 3.2 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 5.1 · 79% consumer	no trial data cached
Intentional dose omission	10	4.7 2.5–8.7ROR 4.7 · χ² 25 / p 2e-7	3.9 EB05 2.3 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	serious PRR 9.7	no trial data cached
Incorrect dose administered	68	3.9 3.1–4.9ROR 4.0 · χ² 143 / p 3e-33	3.8 EB05 3.1 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 8.5	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Off label use (used outside approved label)	437	6.4 5.9–7.0ROR 8.4 · χ² 2,085 / p <1e-300	6.4 EB05 5.9 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 6.3	no trial data cached
Incorrect product administration duration	88	55.6 45.4–68.2ROR 58.7 · χ² 4,649 / p <1e-300	54.8 EB05 45.8 · IC025 +5.1 3/3 methods agree	Reporting / coding artifact	serious n=47	no trial data cached
Incorrect dose administered	68	3.9 3.1–4.9ROR 4.0 · χ² 143 / p 3e-33	3.8 EB05 3.1 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 8.5	no trial data cached
Hospitalisation	59	4.9 3.8–6.4ROR 5.1 · χ² 183 / p 5e-42	4.8 EB05 3.8 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 5.1 · 86% consumer	no trial data cached
Aspartate aminotransferase increased	54	13.0 10.0–16.9ROR 13.4 · χ² 587 / p 5e-130	12.8 EB05 10.1 · IC025 +3.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.0	no trial data cached
Drug ineffective for unapproved indication	48	11.0 8.3–14.5ROR 11.3 · χ² 427 / p 3e-95	10.6 EB05 8.2 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 14.0	no trial data cached
Alanine aminotransferase increased	46	9.6 7.2–12.7ROR 9.8 · χ² 345 / p 2e-77	9.1 EB05 7.0 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.7 · 91% clinician	no trial data cached
Electrocardiogram qt prolonged	43	15.3 11.4–20.5ROR 15.7 · χ² 560 / p 5e-124	15.1 EB05 11.6 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 15.7 · 100% clinician	no trial data cached
Hepatic function abnormal	42	14.5 10.7–19.5ROR 14.8 · χ² 514 / p 4e-114	14.3 EB05 10.9 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 13.9 · ♀ 16% (drug 56%) · 100% clinician	no trial data cached
Drug resistance	39	19.4 14.2–26.5ROR 19.9 · χ² 663 / p 2e-146	19.2 EB05 14.6 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 13.0 · 92% clinician	no trial data cached
Skin discolouration	34	9.5 6.8–13.2ROR 9.6 · χ² 249 / p 2e-56	8.8 EB05 6.5 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 5.1 · ♀ 80% (drug 56%)	no trial data cached
Therapy interrupted	33	6.1 4.4–8.6ROR 6.2 · χ² 136 / p 8e-32	5.7 EB05 4.2 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 12.4 · 82% consumer	no trial data cached
Tinnitus (ringing in the ears)	32	8.9 6.3–12.5ROR 9.0 · χ² 216 / p 3e-49	8.2 EB05 6.0 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 8.2	no trial data cached
Unevaluable event	28	4.7 3.3–6.8ROR 4.8 · χ² 79 / p 3e-19	4.4 EB05 3.2 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 5.1 · 79% consumer	no trial data cached
Dysphonia	25	5.5 3.7–8.1ROR 5.5 · χ² 87 / p 5e-21	5.0 EB05 3.6 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 9.6 · ♀ 80% (drug 56%) · 84% consumer	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Electrocardiogram qt prolonged — n=43, PRR 15.3
Hepatic function abnormal — n=42, PRR 14.5
Deafness — n=22, PRR 10.7
Skin discolouration — n=34, PRR 9.5
Tinnitus — n=32, PRR 8.9
Dysphonia — n=25, PRR 5.5

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Omadacycline?

In FDA FAERS, the most frequently co-reported reaction terms for Omadacycline are aspartate aminotransferase increased, alanine aminotransferase increased, electrocardiogram qt prolonged, hepatic function abnormal, skin discolouration, tinnitus. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Omadacycline have an FDA boxed warning?

No. The FDA label retrieved for Omadacycline has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Omadacycline causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 51591524-4703-44c6-8bde-dce3e6a463d1, effective 20260527; matched on openfda.generic_name.exact:"OMADACYCLINE")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 42 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.