What the label lists and what reports show
Eravacycline side effects
Eravacycline's FDA label: “Most common adverse reactions (incidence ≥ 3%) are infusion site reactions, nausea, and vomiting.” FAERS holds 243 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 blood fibrinogen decreased (17 reports).
- No generic listed
Check it at the source: the eravacycline FDA label on DailyMed (effective March 31, 2025, Tetraphase Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥ 3%) are infusion site reactions, nausea, and vomiting.
Table 1: Selected Adverse Reactions Reported in ≥ 1% of Patients Receiving XERAVA in the Phase 3 cIAI Trials (Trial 1 and Trial 2)
| Adverse Reactions | XERAVA XERAVA dose equals 1 mg/kg every 12 hours IV. N=520 n (%) | Comparators Comparators include ertapenem 1 g every 24 hours IV and meropenem 1 g every 8… |
|---|---|---|
| Infusion site reactions Infusion site reactions include: catheter/vessel puncture site… | 40 (7.7) | 10 (1.9) |
| Nausea | 34 (6.5) | 3 (0.6) |
| Vomiting | 19 (3.7) | 13 (2.5) |
| Diarrhea | 12 (2.3) | 8 (1.5) |
| Hypotension | 7 (1.3) | 2 (0.4) |
| Wound dehiscence | 7 (1.3) | 1 (0.2) |
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: Hypersensitivity Reactions [Warning and Precautions ( 5.1 )] Tooth Discoloration [ Warning and Precautions ( 5.2 )] Inhibition of Bone Growth [Warning and Precautions ( 5.3 )] Clostridioides difficile -Associated Diarrhea [Warning and Precautions ( 5.4 )] Tetracycline Class Adverse Reactions [Warning and Precautions ( 5.5 )] Most common adverse reactions (incidence ≥ 3%) are infusion site reactions, nausea, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Tetraphase Pharmaceuticals, Inc., at 1-800-651-3861 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. XERAVA was evaluated in 3 active-controlled clinical trials (Trial 1, Trial 2, and Trial 3) in adults with cIAI. These trials included two Phase 3 trials (Trial 1 and Trial 2) and one Phase 2 trial (Trial 3, NCT01265784). The Phase 3 trials included 520 patients treated with XERAVA and 517 patients treated with comparator antibacterial drugs (ertapenem or meropenem). …
Source: FDA drug label, Tetraphase Pharmaceuticals, Inc., effective March 31, 2025 (SPL set a4b188d4-f467-470c-ad7b-25ffbdd8862a), via openFDA; the full label on DailyMed
What do FAERS reports show?
243 reports list eravacycline among the medicines taken, each a report of something that happened, not proof the medicine caused it; 43 are coded as a death and 68 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 20 reactions below, 3 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.
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?
- Eravacycline: 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