PlainMeds provides educational information only. This is not medical advice. Always consult your doctor or pharmacist.

dalbavancin Side Effects

Also known as: Dalvance

Analysis of 911 adverse event reports submitted to the FDA from 2014 to 2025.

Total Reports

911

Death-Related

20

2.2% of reports

Hospitalizations

207

22.7% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

OFF LABEL USE
138
RASH
93
BACK PAIN
55
PRURITUS
55
DYSPNOEA
53
DRUG INEFFECTIVE
51
NAUSEA
49
HYPERSENSITIVITY
45
ERYTHEMA
42
VOMITING
42
URTICARIA
37
CHEST DISCOMFORT
28
INFUSION RELATED REACTION
28
DIARRHOEA
26
PYREXIA
25
ANAPHYLACTIC REACTION
24
CHEST PAIN
22
CHILLS
22
PRODUCT PREPARATION ERROR
22
INFUSION SITE EXTRAVASATION
21

Who Reports Side Effects

Gender Distribution

Female 331 (48%)
Male 352 (51%)
Unknown 1

Age Distribution

0-17 24 (5%)
18-44 105 (22%)
45-64 164 (35%)
65-74 85 (18%)
75+ 95 (20%)

Reporting Trend by Year

14
15
16
17
18
19
20
21
22
23
24
25

Reactions in Death Reports

Top reactions reported in 20 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 14
OFF LABEL USE 3
TREATMENT FAILURE 3
PYREXIA 2
CEREBROVASCULAR ACCIDENT 1
CHILLS 1
DRUG DOSE OMISSION 1
DRUG INEFFECTIVE 1
EMBOLISM 1
HAEMORRHAGE 1
MULTIPLE ORGAN DYSFUNCTION SYNDROME 1
NAUSEA 1
PERIPHERAL SWELLING 1
RASH 1
SEPSIS 1
SUDDEN DEATH 1

Reactions in Hospitalization Reports

Top reactions in 207 reports where hospitalization was an outcome.

Reaction Reports
DRUG INEFFECTIVE 25
OFF LABEL USE 25
DYSPNOEA 18
PYREXIA 15
NAUSEA 14
HYPERSENSITIVITY 13
ACUTE KIDNEY INJURY 12
RASH 12
ANAPHYLACTIC REACTION 11
INFUSION RELATED REACTION 11
VOMITING 11
PAIN 9
PRURITUS 9
ERYTHEMA 8
CELLULITIS 7
CHILLS 7
HYPOTENSION 7
MUSCLE SPASMS 7
PERIPHERAL SWELLING 7
SEPSIS 7

Nearby — Related Medications

Compare dalbavancin vs amikacin →

What the FAERS Data Reveals About dalbavancin Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 911 voluntary reports linked to dalbavancin and its brand equivalents (Dalvance), spanning 2014 through 2025. Of those, 20 (2.2%) listed death as an outcome and 207 (22.7%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 48% were female and 51% male; age distribution skews toward 45-64, with 164 reports in that bracket. The single most reported reaction is off label use with 138 submissions, followed by rash and back pain.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.