What the label lists and what reports show
Oritavancin side effects
Oritavancin's FDA label: “The most common adverse reactions (≥3%) in patients treated with oritavancin products were headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea.” FAERS holds 297 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 multiple use of single-use product (109 reports).
- No generic listed
Check it at the source: the oritavancin FDA label on DailyMed (effective December 18, 2025, Melinta Therapeutics, LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥3%) in patients treated with oritavancin products were headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea.
Table 1: Incidence of Selected Adverse Reactions Occurring in ≥1.5% of Patients Receiving Oritavancin in the Pooled ABSSSI Clinical Trials
| Adverse Reactions | Oritavancin N=976 (%) | Vancomycin N=983 (%) |
|---|---|---|
| Diarrhea | 36 (3.7) | 32 (3.4) |
| Nausea | 97 (9.9) | 103 (10.5) |
| Vomiting | 45 (4.6) | 46 (4.7) |
| Dizziness | 26 (2.7) | 26 (2.6) |
| Headache | 69 (7.1) | 66 (6.7) |
| Infusion site phlebitis | 24 (2.5) | 15 (1.5) |
| Infusion site reaction | 19 (1.9) | 34 (3.5) |
| Abscess (limb and subcutaneous) | 37 (3.8) | 23 (2.3) |
| Alanine aminotransferase increased | 27 (2.8) | 15 (1.5) |
| Aspartate aminotransferase increased | 18 (1.8) | 15 (1.5) |
| Tachycardia | 24 (2.5) | 11 (1.1) |
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 adverse reactions are also discussed in the Warnings and Precautions section of labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Infusion Related Reactions [see Warnings and Precautions (5.3) ] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions (5.4) ] Osteomyelitis [see Warnings and Precautions (5.6) ] The most common adverse reactions (≥3%) in patients treated with oritavancin products were headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea. The adverse reactions occurring in ≥2 patients receiving KIMYRSA were hypersensitivity, pruritus, chills and pyrexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Melinta Therapeutics at 1-844-633-6568 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 oritavancin products cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of KIMYRSA has been established from adequate and well-controlled trials of another oritavancin product, ORBACTIV (hereinafter referred to as oritavancin), in patients with ABSSSI, and a study of KIMYRSA in patients with ABSSSI.
Source: FDA drug label, Melinta Therapeutics, LLC, effective December 18, 2025 (SPL set 5e755c40-6e73-4572-b474-4d8a131693d1), via openFDA; the full label on DailyMed
What do FAERS reports show?
297 reports list oritavancin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 5 are coded as a death and 30 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 24 reactions below, 15 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?
- Oritavancin: 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