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Drug side effects

oritavancin Side Effects

The reactions most often reported to the FDA for oritavancin (also sold as Orbactiv), with demographics, serious outcomes, and reporting trends.

Data updated 2026-05-15

896
FAERS reports

Data from the FDA Adverse Event Reporting System (FAERS), 2014 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.

The most commonly reported side effects of oritavancin come from 896 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.

This page analyzes 896 reports to the FDA Adverse Event Reporting System (FAERS) for oritavancin (Orbactiv): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.

Total Reports

896

Reports Mentioning Death

30

3.3% of reports — not proof the medicine caused the death

Hospitalizations

161

18.0% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

PRURITUS
162
URTICARIA
105
RASH
84
CHILLS
83
BACK PAIN
81
DYSPNOEA
74
NAUSEA
67
INFUSION RELATED REACTION
60
ERYTHEMA
58
CHEST PAIN
54
FLUSHING
41
VOMITING
41
HEADACHE
39
RED MAN SYNDROME
38
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
CARDIAC ARREST 5
BACK PAIN 4
DYSPNOEA 4
NAUSEA 4
BLISTER 3
CHILLS 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
NAUSEA 19
BACK PAIN 16
CHEST PAIN 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 pruritus with 162 submissions, followed by urticaria and rash.

How to read these numbers

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.

Drugs With a Similar FAERS Report Volume

Other medications with a total FDA adverse-event report count closest to oritavancin's 896.