Drug · FAERS side-effect profile with label screen
Albendazole side effects: what 1,886 FDA adverse event reports show
Who reports
1,886 reports · 86% serious · 310 with death outcome · 47% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Albendazole tablet is an anthelmintic drug indicated for: Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium . ( 1.1 ) Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus .
FDA label, Indications and Usage
What it is
Albendazole tablets, USP are an orally administered anthelmintic drug.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 2Labeled (related wording) 1Reporting / coding artifact 6Not in label — unassessed 31
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 81 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Impaired quality of life | 132 | 102.9 87.2–121.4ROR 110.6 · χ² 13,109 / p <1e-300 | 100.5 EB05 86.9 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 100.8 · ♀ 24% (drug 47%) · 91% clinician | no trial data cached |
| Tubulointerstitial nephritis | 132 | 78.9 66.9–93.1ROR 84.8 · χ² 10,012 / p <1e-300 | 77.5 EB05 67.0 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 52.7 · ♀ 23% (drug 47%) · 91% clinician | no trial data cached |
| Impaired work ability | 141 | 73.6 62.7–86.3ROR 79.4 · χ² 9,965 / p <1e-300 | 72.4 EB05 62.9 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 62.8 · ♀ 21% (drug 47%) · 92% clinician | no trial data cached |
| Frequent bowel movements | 153 | 63.6 54.6–74.0ROR 69.1 · χ² 9,320 / p <1e-300 | 62.7 EB05 54.8 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 65.0 · ♀ 20% (drug 47%) · 93% clinician | no trial data cached |
| Swollen tongue | 131 | 46.8 39.6–55.2ROR 50.2 · χ² 5,807 / p <1e-300 | 46.3 EB05 40.0 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 43.8 · ♀ 23% (drug 47%) · 92% clinician | no trial data cached |
| Systemic lupus erythematosus | 135 | 42.6 36.2–50.1ROR 45.8 · χ² 5,429 / p <1e-300 | 42.2 EB05 36.5 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 29.2 · ♀ 22% (drug 47%) · 92% clinician | no trial data cached |
| Nightmare | 132 | 42.4 35.9–50.0ROR 45.5 · χ² 5,280 / p <1e-300 | 42.0 EB05 36.3 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 48.1 · ♀ 22% (drug 47%) · 92% clinician | no trial data cached |
| Accidental overdose | 134 | 40.9 34.7–48.2ROR 44.0 · χ² 5,167 / p <1e-300 | 40.5 EB05 35.1 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 45.0 · ♀ 23% (drug 47%) · 91% clinician | no trial data cached |
| Rectal haemorrhage | 157 | 40.6 35.0–47.2ROR 44.2 · χ² 6,020 / p <1e-300 | 40.3 EB05 35.3 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 29.1 · ♀ 21% (drug 47%) · 93% clinician | no trial data cached |
| Colitis ulcerative | 157 | 39.3 33.8–45.6ROR 42.7 · χ² 5,809 / p <1e-300 | 39.0 EB05 34.1 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 28.2 · ♀ 19% (drug 47%) · 93% clinician | no trial data cached |
| Loss of personal independence in daily activities | 147 | 34.5 29.5–40.3ROR 37.3 · χ² 4,740 / p <1e-300 | 34.2 EB05 29.8 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 30.4 · ♀ 21% (drug 47%) · 92% clinician | no trial data cached |
| Haematochezia (blood in stool) | 164 | 33.2 28.7–38.4ROR 36.2 · χ² 5,085 / p <1e-300 | 33.0 EB05 29.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 24.4 · ♀ 20% (drug 47%) | no trial data cached |
| Tinnitus (ringing in the ears) | 135 | 32.7 27.8–38.5ROR 35.2 · χ² 4,115 / p <1e-300 | 32.5 EB05 28.1 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 33.7 · ♀ 24% (drug 47%) · 92% clinician | no trial data cached |
| Medication error | 151 | 30.3 26.0–35.3ROR 32.9 · χ² 4,253 / p <1e-300 | 30.1 EB05 26.3 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious PRR 32.9 · ♀ 21% (drug 47%) · 91% clinician | no trial data cached |
| Eczema | 134 | 29.7 25.2–35.0ROR 31.9 · χ² 3,686 / p <1e-300 | 29.5 EB05 25.5 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 57.8 · ♀ 22% (drug 47%) · 92% clinician | no trial data cached |
| Vertigo (spinning dizziness) | 150 | 27.4 23.5–32.0ROR 29.7 · χ² 3,793 / p <1e-300 | 27.3 EB05 23.8 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 24.8 · ♀ 23% (drug 47%) | no trial data cached |
| Deep vein thrombosis (leg blood clot) | 154 | 26.3 22.6–30.6ROR 28.5 · χ² 3,722 / p <1e-300 | 26.1 EB05 22.9 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 17.9 · ♀ 19% (drug 47%) · 93% clinician | no trial data cached |
| Stress | 155 | 24.0 20.6–27.9ROR 26.1 · χ² 3,399 / p <1e-300 | 23.9 EB05 20.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 26.5 · ♀ 20% (drug 47%) · 93% clinician | no trial data cached |
| Dysgeusia (altered taste) | 134 | 20.0 17.0–23.5ROR 21.4 · χ² 2,402 / p <1e-300 | 19.9 EB05 17.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 37.4 · ♀ 22% (drug 47%) · 92% clinician | no trial data cached |
| Intentional product use issue | 154 | 19.5 16.8–22.7ROR 21.1 · χ² 2,691 / p <1e-300 | 19.4 EB05 17.0 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 19.1 · ♀ 21% (drug 47%) · 92% clinician | no trial data cached |
| Arthritis | 137 | 19.4 16.5–22.8ROR 20.8 · χ² 2,372 / p <1e-300 | 19.3 EB05 16.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 20.0 · ♀ 24% (drug 47%) · 90% clinician | no trial data cached |
| Adverse drug reaction | 133 | 16.6 14.0–19.5ROR 17.7 · χ² 1,933 / p <1e-300 | 16.5 EB05 14.3 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 32.0 · ♀ 26% (drug 47%) | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 22 | 16.2 10.7–24.6ROR 16.4 · χ² 299 / p 2e-67 | 15.8 EB05 10.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 | no trial data cached |
| Gastroenteritis | 21 | 16.0 10.5–24.6ROR 16.2 · χ² 281 / p 2e-63 | 15.6 EB05 10.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.5 | no trial data cached |
| Migraine | 135 | 15.8 13.5–18.6ROR 17.0 · χ² 1,868 / p <1e-300 | 15.8 EB05 13.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 20.5 · ♀ 23% (drug 47%) · 91% clinician | no trial data cached |
| Pulmonary embolism (lung blood clot) | 133 | 15.5 13.2–18.3ROR 16.6 · χ² 1,797 / p <1e-300 | 15.4 EB05 13.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 · ♀ 23% (drug 47%) · 92% clinician | no trial data cached |
| Transaminases increased | 30 | 15.0 10.5–21.4ROR 15.3 · χ² 379 / p 1e-84 | 14.7 EB05 10.6 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.4 · ♀ 11% (drug 47%) | no trial data cached |
| Palpitations (pounding heartbeat) | 147 | 14.0 12.0–16.3ROR 15.1 · χ² 1,767 / p <1e-300 | 13.9 EB05 12.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 14.4 · ♀ 26% (drug 47%) · 90% clinician | no trial data cached |
| Septic shock | 53 | 13.6 10.5–17.8ROR 14.0 · χ² 609 / p 8e-135 | 13.5 EB05 10.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 · 96% clinician | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 27 | 13.5 9.3–19.6ROR 13.7 · χ² 300 / p 2e-67 | 13.0 EB05 9.1 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.1 | no trial data cached |
| Encephalopathy | 29 | 13.2 9.2–18.9ROR 13.4 · χ² 314 / p 1e-70 | 12.7 EB05 9.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 · ♀ 19% (drug 47%) | no trial data cached |
| Gastritis | 31 | 13.1 9.3–18.6ROR 13.3 · χ² 335 / p 4e-75 | 12.7 EB05 9.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 · 90% clinician | no trial data cached |
| Drug ineffective for unapproved indication | 63 | 12.6 9.9–16.0ROR 13.0 · χ² 661 / p 5e-146 | 12.4 EB05 9.9 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 8.7 | no trial data cached |
| Deformity | 10 | 11.9 6.4–22.0ROR 11.9 · χ² 89 / p 2e-21 | 9.8 EB05 5.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Abortion induced | 10 | 11.8 6.4–21.9ROR 11.9 · χ² 88 / p 3e-21 | 9.7 EB05 5.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Generalised oedema | 13 | 11.7 6.8–20.2ROR 11.8 · χ² 117 / p 1e-27 | 10.2 EB05 5.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Eosinophilia | 18 | 11.5 7.2–18.2ROR 11.6 · χ² 162 / p 3e-37 | 10.4 EB05 6.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Brain oedema | 13 | 11.5 6.7–19.7ROR 11.5 · χ² 114 / p 7e-27 | 9.9 EB05 5.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Emphysema | 10 | 11.0 5.9–20.4ROR 11.0 · χ² 81 / p 1e-19 | 8.9 EB05 4.6 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Product use in unapproved indication | 234 | 10.7 9.5–12.0ROR 12.0 · χ² 2,061 / p <1e-300 | 10.6 EB05 9.5 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 12.6 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Pyrexia (fever) | 243 | 7.8 6.9–8.8ROR 8.8 · χ² 1,459 / p <1e-300 | 7.7 EB05 6.9 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.5 | no trial data cached |
| Product use in unapproved indication | 234 | 10.7 9.5–12.0ROR 12.0 · χ² 2,061 / p <1e-300 | 10.6 EB05 9.5 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 12.6 | no trial data cached |
| Condition aggravated | 223 | 8.2 7.3–9.3ROR 9.2 · χ² 1,426 / p <1e-300 | 8.1 EB05 7.3 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 8.2 | no trial data cached |
| Weight decreased (weight loss) | 174 | 6.9 6.0–8.0ROR 7.5 · χ² 889 / p 9e-196 | 6.8 EB05 6.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 · ♀ 19% (drug 47%) | no trial data cached |
| Somnolence (drowsiness) | 167 | 9.2 8.0–10.7ROR 10.0 · χ² 1,230 / p 9e-270 | 9.1 EB05 8.0 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.7 · ♀ 24% (drug 47%) · 90% clinician | no trial data cached |
| Haematochezia (blood in stool) | 164 | 33.2 28.7–38.4ROR 36.2 · χ² 5,085 / p <1e-300 | 33.0 EB05 29.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 24.4 · ♀ 20% (drug 47%) | no trial data cached |
| Colitis ulcerative | 157 | 39.3 33.8–45.6ROR 42.7 · χ² 5,809 / p <1e-300 | 39.0 EB05 34.1 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 28.2 · ♀ 19% (drug 47%) · 93% clinician | no trial data cached |
| Rectal haemorrhage | 157 | 40.6 35.0–47.2ROR 44.2 · χ² 6,020 / p <1e-300 | 40.3 EB05 35.3 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 29.1 · ♀ 21% (drug 47%) · 93% clinician | no trial data cached |
| Inappropriate schedule of product administration | 156 | 9.8 8.4–11.4ROR 10.6 · χ² 1,236 / p 5e-271 | 9.7 EB05 8.5 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 16.2 · ♀ 21% (drug 47%) · 92% clinician | no trial data cached |
| Stress | 155 | 24.0 20.6–27.9ROR 26.1 · χ² 3,399 / p <1e-300 | 23.9 EB05 20.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 26.5 · ♀ 20% (drug 47%) · 93% clinician | no trial data cached |
| Intentional product use issue | 154 | 19.5 16.8–22.7ROR 21.1 · χ² 2,691 / p <1e-300 | 19.4 EB05 17.0 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 19.1 · ♀ 21% (drug 47%) · 92% clinician | no trial data cached |
| Deep vein thrombosis (leg blood clot) | 154 | 26.3 22.6–30.6ROR 28.5 · χ² 3,722 / p <1e-300 | 26.1 EB05 22.9 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 17.9 · ♀ 19% (drug 47%) · 93% clinician | no trial data cached |
| Frequent bowel movements | 153 | 63.6 54.6–74.0ROR 69.1 · χ² 9,320 / p <1e-300 | 62.7 EB05 54.8 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 65.0 · ♀ 20% (drug 47%) · 93% clinician | no trial data cached |
| Abdominal discomfort | 151 | 10.1 8.6–11.7ROR 10.8 · χ² 1,231 / p 7e-270 | 9.9 EB05 8.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 14.9 | no trial data cached |
| Medication error | 151 | 30.3 26.0–35.3ROR 32.9 · χ² 4,253 / p <1e-300 | 30.1 EB05 26.3 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious PRR 32.9 · ♀ 21% (drug 47%) · 91% clinician | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Impaired quality of life — n=132, PRR 102.9
- Tubulointerstitial nephritis — n=132, PRR 78.9
- Impaired work ability — n=141, PRR 73.6
- Frequent bowel movements — n=153, PRR 63.6
- Swollen tongue — n=131, PRR 46.8
- Systemic lupus erythematosus — n=135, PRR 42.6
- Nightmare — n=132, PRR 42.4
- Rectal haemorrhage — n=157, PRR 40.6
- Colitis ulcerative — n=157, PRR 39.3
- Loss of personal independence in daily activities — n=147, PRR 34.5
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Albendazole?
In FDA FAERS, the most frequently co-reported reaction terms for Albendazole are pyrexia, weight decreased, somnolence, haematochezia, colitis ulcerative, rectal haemorrhage. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Albendazole have an FDA boxed warning?
No. The FDA label retrieved for Albendazole has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Albendazole causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 594f7aab-b336-4d6d-b702-a33346c69645, effective 20200201; matched on
openfda.generic_name.exact:"ALBENDAZOLE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 121 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.