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eravacycline Side Effects

Also known as: Xerava

Analysis of 205 adverse event reports submitted to the FDA from 2019 to 2025.

Total Reports

205

Death-Related

33

16.1% of reports

Hospitalizations

57

27.8% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

OFF LABEL USE
62
DRUG INEFFECTIVE
24
BLOOD FIBRINOGEN DECREASED
16
NAUSEA
15
THROMBOCYTOPENIA
14
MULTIPLE ORGAN DYSFUNCTION SYNDROME
13
PRODUCT USE IN UNAPPROVED INDICATION
13
LACTIC ACIDOSIS
11
HYPERTRANSAMINASAEMIA
10
DIARRHOEA
9
PANCREATITIS
8
ACUTE RESPIRATORY DISTRESS SYNDROME
6
CONDITION AGGRAVATED
6
DRUG INTOLERANCE
6
ENTEROCOCCAL INFECTION
6
PROTHROMBIN TIME PROLONGED
6
SEPSIS
6
BLOOD BILIRUBIN INCREASED
5
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION
5
GASTROINTESTINAL HAEMORRHAGE
5

Who Reports Side Effects

Gender Distribution

Female 51 (35%)
Male 95 (65%)

Age Distribution

0-17 6 (5%)
18-44 36 (29%)
45-64 45 (36%)
65-74 26 (21%)
75+ 11 (9%)

Reporting Trend by Year

19
20
21
22
23
24
25

Reactions in Death Reports

Top reactions reported in 33 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME 13
DRUG INEFFECTIVE 10
OFF LABEL USE 9
ACUTE RESPIRATORY DISTRESS SYNDROME 6
THROMBOCYTOPENIA 5
BLOOD FIBRINOGEN DECREASED 4
HYPERTRANSAMINASAEMIA 4
LACTIC ACIDOSIS 4
SHOCK 4
BLASTOMYCOSIS 3
CONDITION AGGRAVATED 3
DRUG INTOLERANCE 3
ENTEROCOCCAL INFECTION 3
MYCOBACTERIUM ABSCESSUS INFECTION 3
PNEUMONITIS 3
SEPSIS 3
SEPTIC SHOCK 3
DISSEMINATED BLASTOMYCOSIS 2
PULMONARY BLASTOMYCOSIS 2
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED 1

Reactions in Hospitalization Reports

Top reactions in 57 reports where hospitalization was an outcome.

Reaction Reports
OFF LABEL USE 19
DRUG INEFFECTIVE 11
BLOOD FIBRINOGEN DECREASED 9
HYPERTRANSAMINASAEMIA 8
LACTIC ACIDOSIS 8
THROMBOCYTOPENIA 8
ACUTE RESPIRATORY DISTRESS SYNDROME 6
MULTIPLE ORGAN DYSFUNCTION SYNDROME 6
BLASTOMYCOSIS 3
BLOOD BILIRUBIN INCREASED 3
DRUG INTOLERANCE 3
ENTEROCOCCAL INFECTION 3
NAUSEA 3
PNEUMONITIS 3
PROTHROMBIN TIME PROLONGED 3
SEPSIS 3
BILIRUBIN CONJUGATED INCREASED 2
COAGULOPATHY 2
CONDITION AGGRAVATED 2
DIARRHOEA 2

Nearby — Related Medications

Compare eravacycline vs amikacin →

What the FAERS Data Reveals About eravacycline Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 205 voluntary reports linked to eravacycline and its brand equivalents (Xerava), spanning 2019 through 2025. Of those, 33 (16.1%) listed death as an outcome and 57 (27.8%) 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, 35% were female and 65% male; age distribution skews toward 45-64, with 45 reports in that bracket. The single most reported reaction is off label use with 62 submissions, followed by drug ineffective and blood fibrinogen decreased.

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.