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oritavancin Side Effects

Also known as: Orbactiv

Analysis of 896 adverse event reports submitted to the FDA from 2014 to 2025.

Total Reports

896

Death-Related

30

3.3% of reports

Hospitalizations

161

18.0% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

OFF LABEL USE
173
PRURITUS
162
URTICARIA
105
RASH
84
CHILLS
83
BACK PAIN
81
DYSPNOEA
74
NAUSEA
67
INFUSION RELATED REACTION
60
ERYTHEMA
58
CHEST PAIN
54
DRUG INEFFECTIVE
48
FLUSHING
41
VOMITING
41
HEADACHE
39
RED MAN SYNDROME
38
NO ADVERSE EVENT
37
TREMOR
35
HYPERSENSITIVITY
33
PYREXIA
28

Who Reports Side Effects

Gender Distribution

Female 336 (52%)
Male 313 (48%)

Age Distribution

0-17 10 (2%)
18-44 130 (27%)
45-64 180 (38%)
65-74 66 (14%)
75+ 89 (19%)

Reporting Trend by Year

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

Reactions in Death Reports

Top reactions reported in 30 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 7
OFF LABEL USE 6
CARDIAC ARREST 5
BACK PAIN 4
DYSPNOEA 4
NAUSEA 4
BLISTER 3
CHILLS 3
DRUG INEFFECTIVE 3
DRUG RESISTANCE 3
ACUTE KIDNEY INJURY 2
CARDIAC FAILURE CONGESTIVE 2
INFUSION RELATED REACTION 2
PRURITUS 2
SEPSIS 2
URTICARIA 2
VOMITING 2
ABDOMINAL PAIN 1
ACUTE MYELOID LEUKAEMIA 1
ACUTE MYOCARDIAL INFARCTION 1

Reactions in Hospitalization Reports

Top reactions in 161 reports where hospitalization was an outcome.

Reaction Reports
CHILLS 31
DYSPNOEA 29
OFF LABEL USE 29
NAUSEA 19
BACK PAIN 16
CHEST PAIN 15
DRUG INEFFECTIVE 15
PYREXIA 14
VOMITING 14
INFUSION RELATED REACTION 13
AGRANULOCYTOSIS 12
TACHYCARDIA 12
PRURITUS 10
URTICARIA 10
ERYTHEMA 9
TREMOR 9
HYPOTENSION 8
MULTIPLE USE OF SINGLE-USE PRODUCT 8
RASH 8
DIZZINESS 7

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What the FAERS Data Reveals About oritavancin Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 896 voluntary reports linked to oritavancin and its brand equivalents (Orbactiv), spanning 2014 through 2025. Of those, 30 (3.3%) listed death as an outcome and 161 (18.0%) 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, 52% were female and 48% male; age distribution skews toward 45-64, with 180 reports in that bracket. The single most reported reaction is off label use with 173 submissions, followed by pruritus and urticaria.

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.