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fondaparinux Side Effects

Also known as: Arixtra

Analysis of 7,980 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

7,980

Death-Related

1,436

18.0% of reports

Hospitalizations

4,235

53.1% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

ANAEMIA
610
HAEMATOMA
558
PULMONARY EMBOLISM
441
OFF LABEL USE
365
HAEMORRHAGE
348
HAEMOGLOBIN DECREASED
335
DEATH
296
DEEP VEIN THROMBOSIS
293
DYSPNOEA
269
THROMBOCYTOPENIA
260
DRUG INEFFECTIVE
258
PYREXIA
240
NAUSEA
234
THROMBOSIS
233
VOMITING
230
DRUG INTERACTION
228
MUSCLE HAEMORRHAGE
215
DIARRHOEA
214
CEREBRAL HAEMORRHAGE
208
ABDOMINAL PAIN
206

Who Reports Side Effects

Gender Distribution

Female 4,133 (56%)
Male 3,157 (43%)
Unknown 47

Age Distribution

0-17 65 (1%)
18-44 668 (13%)
45-64 1,615 (30%)
65-74 1,289 (24%)
75+ 1,683 (32%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 1,436 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 294
CEREBRAL HAEMORRHAGE 124
PULMONARY EMBOLISM 117
ANAEMIA 84
HAEMORRHAGE 78
SHOCK HAEMORRHAGIC 76
HAEMATOMA 69
SEPSIS 69
OFF LABEL USE 63
COMA 62
THROMBOCYTOPENIA 61
GENERAL PHYSICAL HEALTH DETERIORATION 57
CARDIAC ARREST 53
RENAL FAILURE 49
HYPOTENSION 48
MALIGNANT NEOPLASM PROGRESSION 48
DYSPNOEA 46
GASTROINTESTINAL HAEMORRHAGE 45
FALL 43
PNEUMONIA 43

Reactions in Hospitalization Reports

Top reactions in 4,235 reports where hospitalization was an outcome.

Reaction Reports
ANAEMIA 476
HAEMATOMA 429
PULMONARY EMBOLISM 270
HAEMOGLOBIN DECREASED 221
OFF LABEL USE 221
DYSPNOEA 191
DEEP VEIN THROMBOSIS 190
ABDOMINAL PAIN 177
MUSCLE HAEMORRHAGE 172
THROMBOCYTOPENIA 169
HAEMORRHAGE 165
VOMITING 163
PYREXIA 162
INCORRECT DRUG ADMINISTRATION DURATION 159
DIARRHOEA 158
NAUSEA 149
HYPOTENSION 147
THROMBOSIS 142
PAIN IN EXTREMITY 139
DRUG INEFFECTIVE 135

Nearby — Related Medications

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What the FAERS Data Reveals About fondaparinux Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 7,980 voluntary reports linked to fondaparinux and its brand equivalents (Arixtra), spanning 2004 through 2025. Of those, 1,436 (18.0%) listed death as an outcome and 4,235 (53.1%) 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, 56% were female and 43% male; age distribution skews toward 75+, with 1,683 reports in that bracket. The single most reported reaction is anaemia with 610 submissions, followed by haematoma and pulmonary embolism.

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.