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albendazole Side Effects

Also known as: Albenza

Analysis of 1,829 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

1,829

Death-Related

302

16.5% of reports

Hospitalizations

658

36.0% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DRUG INEFFECTIVE
365
OFF LABEL USE
284
PYREXIA
236
PRODUCT USE IN UNAPPROVED INDICATION
224
HEADACHE
222
CONDITION AGGRAVATED
213
FATIGUE
167
WEIGHT DECREASED
166
RASH
165
PAIN
164
SOMNOLENCE
159
HAEMATOCHEZIA
157
RECTAL HAEMORRHAGE
149
COLITIS ULCERATIVE
148
STRESS
148
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION
147
INTENTIONAL PRODUCT USE ISSUE
147
STEROID DEPENDENCE
147
BRONCHIECTASIS
146
DEEP VEIN THROMBOSIS
146

Who Reports Side Effects

Gender Distribution

Female 758 (47%)
Male 860 (53%)
Unknown 4

Age Distribution

0-17 226 (16%)
18-44 466 (33%)
45-64 518 (36%)
65-74 143 (10%)
75+ 68 (5%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 302 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DRUG INEFFECTIVE 69
DEATH 64
STRONGYLOIDIASIS 44
PYREXIA 33
SEPSIS 28
RESPIRATORY FAILURE 26
SEPTIC SHOCK 25
DIARRHOEA 24
OFF LABEL USE 24
VOMITING 20
ANAEMIA 17
CONDITION AGGRAVATED 17
DIZZINESS 15
DYSPNOEA 14
HEADACHE 14
ACUTE KIDNEY INJURY 13
ASTHENIA 13
DISSEMINATED STRONGYLOIDIASIS 13
PNEUMONIA 13
ABDOMINAL PAIN 12

Reactions in Hospitalization Reports

Top reactions in 658 reports where hospitalization was an outcome.

Reaction Reports
DRUG INEFFECTIVE 92
PYREXIA 90
VOMITING 75
HEADACHE 62
ASTHENIA 60
OFF LABEL USE 58
STRONGYLOIDIASIS 54
CONDITION AGGRAVATED 52
DIARRHOEA 47
SOMNOLENCE 33
ABDOMINAL PAIN 31
DEHYDRATION 29
FATIGUE 29
NAUSEA 29
RASH 27
ANAEMIA 26
SEPSIS 26
PAIN 25
DYSPNOEA 24
GASTRITIS 24

Nearby — Related Medications

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What the FAERS Data Reveals About albendazole Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 1,829 voluntary reports linked to albendazole and its brand equivalents (Albenza), spanning 2004 through 2025. Of those, 302 (16.5%) listed death as an outcome and 658 (36.0%) 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, 47% were female and 53% male; age distribution skews toward 45-64, with 518 reports in that bracket. The single most reported reaction is drug ineffective with 365 submissions, followed by off label use and pyrexia.

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.