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What the label lists and what reports show

Telavancin side effects

Telavancin's FDA label: “Most common adverse reaction (≥10% of patients treated with VIBATIV) in the HABP/VABP trials is diarrhea; in the cSSSI trials, the most common adverse reactions (≥10% of patients treated with VIBATIV) include: taste disturbance, nausea, vomiting, and foamy …” FAERS holds 118 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 renal failure acute (15 reports).

  • No generic listed
  • Boxed warning

Check it at the source: the telavancin FDA label on DailyMed (effective December 19, 2025, Cumberland Pharmaceuticals Inc.); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of VIBATIV?

VIBATIV may cause serious side effects, including: See “ What is the most important information I should know about VIBATIV? ” Serious allergic reactions. Allergic reactions can happen in people who receive VIBATIV, even after only 1 dose. Stop receiving VIBATIV and get emergency medical help right away if you get any of the following symptoms of a severe allergic reaction: hives trouble breathing or swallowing swelling of the lips, tongue, face throat tightness, hoarseness rapid heartbeat faint Infusion-related reactions. People who receive VIBATIV too quickly can have a certain type of skin reaction called “Redman Syndrome”. Signs and symptoms of Red-man Syndrome can include: red color (flushing) rash itching Problems with the electrical system of your heart (QTc prolongation). […]

Source: FDA drug label, NDA022110 (Apotex), as published by Cumberland Pharmaceuticals Inc., effective December 19, 2025 (SPL set 5359b759-db7c-4672-9e8a-59c93869bd91), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

Most common adverse reaction (≥10% of patients treated with VIBATIV) in the HABP/VABP trials is diarrhea; in the cSSSI trials, the most common adverse reactions (≥10% of patients treated with VIBATIV) include: taste disturbance, nausea, vomiting, and foamy urine.

Table 4: Incidence of Treatment-Emergent Adverse Drug Reactions Reported in ≥2% of Patients Treated in cSSSI Trial 1 and Trial 2

ReactionVIBATIV (N=929)Vancomycin (N=938)
Rigors4%2%
Nausea27%15%
Vomiting14%7%
Diarrhea7%8%
Decreased appetite3%2%
Taste disturbance33%7%
Foamy urine13%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, continued

The following serious adverse reactions are also discussed elsewhere in the labeling: Nephrotoxicity [ see Warnings and Precautions ( 5.3 ) ] Infusion-related reactions [ see Warnings and Precautions ( 5.7 ) ] Clostridium difficile -associated diarrhea [ see Warnings and Precautions ( 5.8 ) ] 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. Most common adverse reaction (≥10% of patients treated with VIBATIV) in the HABP/VABP trials is diarrhea; in the cSSSI trials, the most common adverse reactions (≥10% of patients treated with VIBATIV) include: taste disturbance, nausea, vomiting, and foamy urine. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cumberland Pharmaceuticals Inc. at 1-877-683-6110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Complicated Skin and Skin Structure Infections The two Phase 3 cSSSI clinical trials (Trial 1 and Trial 2) for VIBATIV included 929 adult patients treated with VIBATIV at 10 mg/kg IV once daily. The mean age of patients treated with VIBATIV was 49 years (range 18-96). …

Source: FDA drug label, NDA022110 (Apotex), as published by Cumberland Pharmaceuticals Inc., effective December 19, 2025 (SPL set 5359b759-db7c-4672-9e8a-59c93869bd91), via openFDA; the full label on DailyMed

What do FAERS reports show?

118 reports list telavancin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 11 are coded as a death and 27 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 22 reactions below, 8 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

  • Off Label Use (a use or a product term, not a reaction)19
  • Renal Failure Acute (named in the label)15
  • Blood Creatinine Increased12
  • Nausea (named in the label)12
  • Chills9
  • Thrombocytopenia7
  • Diarrhoea (named in the label)6
  • Dyspnoea6
  • Leukopenia6
  • Renal Failure (named in the label)6
  • Vomiting (named in the label)6
  • Rash (named in the label)5
  • Renal Impairment (named in the label)5
  • Tubulointerstitial Nephritis5
  • Alanine Aminotransferase Increased4
  • Anaemia4
  • Aspartate Aminotransferase Increased4
  • Diabetes Mellitus Inadequate Control4
  • Disease Progression (a use or a product term, not a reaction)4
  • Dysgeusia4
  • Infusion Related Reaction (named in the label)4
  • Lip Swelling4
  • Neutropenia4
  • Pancytopenia4
  • Pneumonia (a use or a product term, not a reaction)4

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Telavancin: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions