What the label lists and what reports show
Omadacycline side effects
Omadacycline's FDA label: “The most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, headache and diarrhea.” FAERS holds 1,642 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (265 reports).
- No generic listed
Check it at the source: the omadacycline FDA label on DailyMed (effective May 27, 2026, Paratek Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, headache and diarrhea.
Table 5: Adverse Reactions Occurring in ≥2% of ABSSSI Patients Receiving NUZYRA in Pooled Trials 2 and 3
| Adverse Reaction | NUZYRA (N = 691) | Linezolid (N = 689) |
|---|---|---|
| Nausea In Trial 2, which included IV to oral dosing of NUZYRA, 40 (12%) patients… | 21.9 | 8.7 |
| Vomiting | 11.4 | 3.9 |
| Infusion site reactions Infusion site extravasation, pain, erythema, swelling,… | 5.2 | 3.6 |
| Alanine aminotransferase increased | 4.1 | 3.6 |
| Aspartate aminotransferase increased | 3.6 | 3.5 |
| Headache | 3.3 | 3.0 |
| Diarrhea | 3.2 | 2.9 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described in greater detail in the Warnings and Precautions section of labeling: Tooth Development and Enamel Hypoplasia [see Warnings and Precautions (5.1) ] Inhibition of Bone Growth [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Tetracycline Class Effects [see Warnings and Precautions ( 5.5 )] ABSSSI: The most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, headache and diarrhea. CABP : The most common adverse reactions (incidence ≥2%) are alanine aminotransferase increased, headache, hypertension, and aspartate aminotransferase increased. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Paratek Pharmaceuticals, Inc. at 1-833-727-2835 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, 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?
1,642 reports list omadacycline among the medicines taken, 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. Of the 16 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Omadacycline: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions