Drug · FAERS side-effect profile with label screen
Ivermectin side effects: what 6,297 FDA adverse event reports show
Drug class
Antiparasitic, Pediculicide
FDA label (Established Pharmacologic Class)
Who reports
6,297 reports · 58% serious · 565 with death outcome · 53% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Ivermectin is indicated for the treatment of the following infections: Strongyloidiasis of the intestinal tract Ivermectin is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis .
FDA label, Indications and Usage
What it is
DESCRIPTION Ivermectin is a semisynthetic, anthelmintic agent for oral administration. Ivermectin is derived from the avermectins, a class of highly active broad-spectrum, anti-parasitic agents isolated from the fermentation products of Streptomyces avermitilis .
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 9Labeled (related wording) 5Reporting / coding artifact 3Not in label — unassessed 23
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. 249 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 |
|---|---|---|---|---|---|---|
| Encephalopathy | 140 | 19.1 16.2–22.6ROR 19.5 · χ² 2,377 / p <1e-300 | 19.0 EB05 16.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 18.7 · ♀ 30% (drug 53%) · 99% clinician | no trial data cached |
| Ocular hyperaemia | 257 | 18.4 16.3–20.8ROR 19.2 · χ² 4,200 / p <1e-300 | 18.3 EB05 16.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 50.6 · ♀ 28% (drug 53%) · 94% clinician | no trial data cached |
| Coma | 246 | 17.3 15.3–19.5ROR 17.9 · χ² 3,742 / p <1e-300 | 17.2 EB05 15.4 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.0 · ♀ 22% (drug 53%) · 98% clinician | no trial data cached |
| Urinary incontinence | 136 | 15.4 13.0–18.1ROR 15.7 · χ² 1,805 / p <1e-300 | 15.2 EB05 13.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 19.9 · ♀ 21% (drug 53%) · 94% clinician | no trial data cached |
| Hepatic cytolysis | 49 | 13.4 10.1–17.7ROR 13.5 · χ² 548 / p 2e-121 | 13.1 EB05 10.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 13.2 · 100% clinician | no trial data cached |
| Vertigo (spinning dizziness) | 218 | 11.9 10.5–13.6ROR 12.3 · χ² 2,173 / p <1e-300 | 11.8 EB05 10.6 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.8 · 92% clinician | no trial data cached |
| Anorexia | 41 | 10.5 7.7–14.2ROR 10.5 · χ² 341 / p 2e-76 | 10.0 EB05 7.5 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.5 · ♀ 32% (drug 53%) · 98% clinician | no trial data cached |
| Depressed level of consciousness | 123 | 10.4 8.7–12.4ROR 10.6 · χ² 1,035 / p 3e-227 | 10.2 EB05 8.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 · 98% clinician | no trial data cached |
| Dermatitis contact | 34 | 10.0 7.1–14.0ROR 10.0 · χ² 266 / p 5e-60 | 9.4 EB05 6.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=5 · ♀ 73% (drug 53%) | no trial data cached |
| Eosinophilia | 50 | 9.6 7.2–12.6ROR 9.6 · χ² 374 / p 2e-83 | 9.1 EB05 7.1 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.8 · 96% clinician | no trial data cached |
| Product prescribing issue | 58 | 9.5 7.4–12.3ROR 9.6 · χ² 433 / p 2e-96 | 9.1 EB05 7.2 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 9.3 | no trial data cached |
| Rash papular | 61 | 9.1 7.1–11.6ROR 9.1 · χ² 429 / p 1e-95 | 8.7 EB05 7.0 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.7 · ♀ 84% (drug 53%) | no trial data cached |
| Eyelid oedema | 29 | 8.3 5.7–11.9ROR 8.3 · χ² 178 / p 8e-41 | 7.5 EB05 5.4 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.9 | no trial data cached |
| Dermatitis allergic | 30 | 8.0 5.6–11.5ROR 8.1 · χ² 177 / p 9e-41 | 7.3 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.0 · ♀ 88% (drug 53%) | no trial data cached |
| Hepatocellular injury | 34 | 8.0 5.7–11.2ROR 8.0 · χ² 200 / p 9e-46 | 7.4 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · 97% clinician | no trial data cached |
| Neurotoxicity | 41 | 7.9 5.8–10.7ROR 7.9 · χ² 239 / p 4e-54 | 7.4 EB05 5.6 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.8 · 95% clinician | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 35 | 7.7 5.6–10.8ROR 7.8 · χ² 198 / p 2e-45 | 7.2 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 | no trial data cached |
| Drug effective for unapproved indication | 66 | 7.5 5.9–9.6ROR 7.6 · χ² 367 / p 4e-82 | 7.2 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Multiple organ dysfunction syndrome | 60 | 7.2 5.6–9.2ROR 7.2 · χ² 312 / p 3e-70 | 6.8 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 · ♀ 10% (drug 53%) · 100% clinician | no trial data cached |
| Pain of skin | 57 | 7.0 5.4–9.1ROR 7.1 · χ² 289 / p 4e-65 | 6.7 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.8 · ♀ 86% (drug 53%) · 74% consumer | no trial data cached |
| Dermatitis | 42 | 6.8 5.0–9.1ROR 6.8 · χ² 200 / p 9e-46 | 6.3 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 50 | 6.5 4.9–8.6ROR 6.6 · χ² 228 / p 7e-52 | 6.2 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.4 · 94% clinician | no trial data cached |
| Product use in unapproved indication | 472 | 6.4 5.9–7.0ROR 6.9 · χ² 2,186 / p <1e-300 | 6.4 EB05 5.9 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.8 | no trial data cached |
| Abnormal behaviour | 76 | 6.4 5.1–7.9ROR 6.4 · χ² 338 / p 1e-75 | 6.1 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 · ♀ 25% (drug 53%) · 96% clinician | no trial data cached |
| Skin irritation | 84 | 6.1 4.9–7.5ROR 6.2 · χ² 353 / p 4e-79 | 5.9 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=3 · ♀ 88% (drug 53%) | no trial data cached |
| Aphasia (loss of speech) | 53 | 5.8 4.5–7.6ROR 5.9 · χ² 207 / p 2e-47 | 5.6 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Skin burning sensation | 123 | 5.8 4.8–6.9ROR 5.9 · χ² 480 / p 8e-107 | 5.6 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 · ♀ 83% (drug 53%) · 72% consumer | no trial data cached |
| Drug ineffective for unapproved indication | 95 | 5.7 4.7–6.9ROR 5.8 · χ² 362 / p 5e-81 | 5.5 EB05 4.7 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 5.9 | no trial data cached |
| Asthenia (weakness) | 590 | 5.2 4.8–5.6ROR 5.7 · χ² 2,048 / p <1e-300 | 5.2 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.1 · ♀ 32% (drug 53%) · 91% clinician | no trial data cached |
| Oral discomfort | 21 | 5.0 3.3–7.7ROR 5.0 · χ² 64 / p 7e-16 | 4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious n=18 · ♀ 100% (drug 53%) | no trial data cached |
| Scab | 17 | 5.0 3.1–8.0ROR 5.0 · χ² 50 / p 6e-13 | 4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Rash maculo-papular | 33 | 5.0 3.5–7.0ROR 5.0 · χ² 100 / p 6e-24 | 4.7 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · 100% clinician | no trial data cached |
| Altered state of consciousness | 32 | 4.9 3.5–7.0ROR 5.0 · χ² 97 / p 4e-23 | 4.6 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 97% clinician | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 33 | 4.9 3.5–6.9ROR 5.0 · χ² 100 / p 9e-24 | 4.6 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 | no trial data cached |
| Covid-19 pneumonia | 17 | 4.8 3.0–7.7ROR 4.8 · χ² 47 / p 4e-12 | 4.3 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Acute respiratory distress syndrome | 25 | 4.7 3.2–7.0ROR 4.7 · χ² 69 / p 4e-17 | 4.4 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · ♀ 25% (drug 53%) · 96% clinician | no trial data cached |
| Pyrexia (fever) | 485 | 4.7 4.3–5.1ROR 5.0 · χ² 1,416 / p <1e-300 | 4.6 EB05 4.3 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.6 · ♀ 31% (drug 53%) · 91% clinician | no trial data cached |
| Peripheral coldness | 19 | 4.6 2.9–7.2ROR 4.6 · χ² 50 / p 8e-13 | 4.2 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Musculoskeletal discomfort | 23 | 4.5 3.0–6.7ROR 4.5 · χ² 58 / p 1e-14 | 4.1 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · ♀ 100% (drug 53%) · 100% clinician | no trial data cached |
| Septic shock | 57 | 4.4 3.4–5.7ROR 4.4 · χ² 146 / p 6e-34 | 4.2 EB05 3.4 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · ♀ 31% (drug 53%) · 96% clinician | 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 811 | 2.1 1.9–2.2ROR 2.2 · χ² 465 / p 2e-103 | 2.0 EB05 1.9 · IC025 +0.9 | Reporting / coding artifact | serious PRR 1.6 | no trial data cached |
| Headache | 647 | 3.4 3.2–3.7ROR 3.7 · χ² 1,152 / p 7e-253 | 3.4 EB05 3.2 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.5 | no trial data cached |
| Asthenia (weakness) | 590 | 5.2 4.8–5.6ROR 5.7 · χ² 2,048 / p <1e-300 | 5.2 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.1 · ♀ 32% (drug 53%) · 91% clinician | no trial data cached |
| Off label use (used outside approved label) | 500 | 1.9 1.8–2.1ROR 2.0 · χ² 228 / p 7e-52 | 1.9 EB05 1.8 · IC025 +0.8 | Reporting / coding artifact | serious PRR 2.1 | no trial data cached |
| Pyrexia (fever) | 485 | 4.7 4.3–5.1ROR 5.0 · χ² 1,416 / p <1e-300 | 4.6 EB05 4.3 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.6 · ♀ 31% (drug 53%) · 91% clinician | no trial data cached |
| Product use in unapproved indication | 472 | 6.4 5.9–7.0ROR 6.9 · χ² 2,186 / p <1e-300 | 6.4 EB05 5.9 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.8 | no trial data cached |
| Pruritus (itching) | 388 | 3.4 3.1–3.8ROR 3.6 · χ² 674 / p 8e-149 | 3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | no trial data cached |
| Ocular hyperaemia | 257 | 18.4 16.3–20.8ROR 19.2 · χ² 4,200 / p <1e-300 | 18.3 EB05 16.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 50.6 · ♀ 28% (drug 53%) · 94% clinician | no trial data cached |
| Coma | 246 | 17.3 15.3–19.5ROR 17.9 · χ² 3,742 / p <1e-300 | 17.2 EB05 15.4 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.0 · ♀ 22% (drug 53%) · 98% clinician | no trial data cached |
| Erythema (skin redness) | 239 | 3.9 3.4–4.4ROR 4.0 · χ² 512 / p 1e-113 | 3.8 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 1.3 · ♀ 79% (drug 53%) | no trial data cached |
| Back pain | 229 | 3.3 2.9–3.7ROR 3.4 · χ² 365 / p 1e-81 | 3.3 EB05 2.9 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · ♀ 30% (drug 53%) · 91% clinician | no trial data cached |
| Vertigo (spinning dizziness) | 218 | 11.9 10.5–13.6ROR 12.3 · χ² 2,173 / p <1e-300 | 11.8 EB05 10.6 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.8 · 92% clinician | no trial data cached |
| Arthralgia (joint pain) | 210 | 1.7 1.5–1.9ROR 1.7 · χ² 59 / p 7e-15 | 1.7 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 2.6 | no trial data cached |
| Rash | 205 | 1.6 1.4–1.8ROR 1.6 · χ² 43 / p 2e-11 | 1.6 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.5 | no trial data cached |
| Gait disturbance | 166 | 2.9 2.5–3.3ROR 2.9 · χ² 204 / p 2e-46 | 2.9 EB05 2.5 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · ♀ 28% (drug 53%) | 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.
- Encephalopathy — n=140, PRR 19.1
- Ocular hyperaemia — n=257, PRR 18.4
- Urinary incontinence — n=136, PRR 15.4
- Hepatic cytolysis — n=49, PRR 13.4
- Depressed level of consciousness — n=123, PRR 10.4
- Dermatitis contact — n=34, PRR 10.0
- Dermatitis allergic — n=30, PRR 8.0
- Hepatocellular injury — n=34, PRR 8.0
- Drug effective for unapproved indication — n=66, PRR 7.5
- Multiple organ dysfunction syndrome — n=60, PRR 7.2
✓ A hand-written Bradford Hill causality assessment exists for this drug: Ivermectin ↔ Neurotoxicity.
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 Ivermectin?
In FDA FAERS, the most frequently co-reported reaction terms for Ivermectin are headache, asthenia, pyrexia, pruritus, ocular hyperaemia, coma. 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 Ivermectin have an FDA boxed warning?
No. The FDA label retrieved for Ivermectin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ivermectin 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 104a5045-94b1-4022-bc49-719521f30f0d, effective 20260303; matched on
openfda.generic_name.exact:"IVERMECTIN") - 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, 289 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.