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
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
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
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.
Read our methodology — how this data is sourced, computed, and verified.