What the label lists and what reports show
Dalbavancin side effects
Dalbavancin's FDA label: “The most common adverse reactions occurring in >4% of adult patients treated with DALVANCE were nausea, headache, and diarrhea.” FAERS holds 1,183 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 rash (100 reports).
- Generic listed
Check it at the source: the dalbavancin FDA label on DailyMed (effective January 13, 2025, Allergan, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions occurring in >4% of adult patients treated with DALVANCE were nausea, headache, and diarrhea.
Table 2. Selected Adverse Reactions Occurring in ≥ 2% of Patients Receiving DALVANCE in…
| Adverse Reactions | DALVANCE (N = 1 , 778) | Comparator* (N = 1 , 224) |
|---|---|---|
| Nausea | 98 (5.5) | 78 (6.4) |
| Diarrhea | 79 (4.4) | 72 (5.9) |
| Headache | 83 (4.7) | 59 (4.8) |
| Vomiting | 50 (2.8) | 37 (3) |
| Rash | 48 (2.7) | 30 (2.4) |
| Pruritus | 38 (2.1) | 41 (3.3) |
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 also discussed elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Infusion Related Reactions [see Warnings and Precautions ( 5.2 )] Hepatic Effects [see Warnings and Precautions ( 5.3 )] Clostridioides difficile -associated Diarrhea [see Warnings and Precautions ( 5.4 )] The most common adverse reactions occurring in >4% of adult patients treated with DALVANCE were nausea, headache, and diarrhea. The most common adverse reaction that occurred in >1% of pediatric patients was pyrexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-678-1605 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 clinical trials of DALVANCE cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice. Clinical Trials Experience in Adult Patients Adverse reactions were evaluated for 2,473 patients treated with DALVANCE: 1,778 patients were treated with DALVANCE in seven Phase 2/3 trials comparing DALVANCE to comparator antibacterial drugs and 695 patients were treated with DALVANCE in one Phase 3 trial comparing DALVANCE single and two-dose regimens. …
Source: FDA drug label, NDA021883 (Abbvie), as published by Allergan, Inc., effective January 13, 2025 (SPL set 4b4674d8-4d1e-4728-8465-d42ada33fa5c), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,183 reports list dalbavancin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 36 are coded as a death and 322 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 23 reactions below, 12 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?
- Dalbavancin: 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