Fact check: What are the potential side effects of ivermectin according to FDA reports in 2025?

1. Why FAERS is a powerful alarm bell — and why it can mislead

FAERS is a large surveillance system containing millions of reports of adverse events, medication errors, and product-quality issues submitted to the FDA, and it is designed to detect signals that warrant further investigation rather than to provide definitive risk estimates ^[1]. FAERS data are subject to reporting bias, duplicate entries, variable report quality, and absence of denominator data, so a high number of reports for a drug does not equal proof that the drug causes those events; it instead indicates that regulators and researchers should study the signal with more robust methods ^[2]. Analysts must therefore combine FAERS signals with clinical trial data and epidemiologic studies before drawing firm safety conclusions ^{[1] [2]}.

2. What the FDA has publicly said about ivermectin’s risks as of 2025

The FDA has publicly warned that ivermectin is not approved to treat COVID-19 and cautioned the public about toxicity with improper use, using blunt messaging to discourage use of veterinary formulations; the agency framed the issue as a safety concern rather than an efficacy endorsement ^[3]. That public messaging reflects regulatory judgment about misuse risk and reported adverse events, but the materials supplied do not include a 2025 FDA technical safety bulletin enumerating specific side effects tied to ivermectin in FAERS; the available sources summarize the agency stance rather than provide exhaustive adverse-event lists ^{[3] [1]}.

3. Gaps in the supplied evidence — what’s missing to answer the original question

None of the documents provided include a direct extract of FAERS entries for ivermectin or a FDA 2025 formal adverse-event report listing specific side effects attributed to the drug; instead, the sources explain how FAERS works and recount the FDA’s public warnings and controversies around ivermectin’s use in COVID-19 ^{[1] [2] [3]}. Without direct FAERS query results or a FDA product-safety communication listing coded adverse events, we cannot enumerate specific side effects from these materials alone; producing a reliable list requires access to updated FAERS tables, FDA drug-safety communications, or peer-reviewed analyses that synthesize those reports ^{[1] [2]}.

4. Conflicting narratives, contested research, and the politics of ivermectin

The ivermectin debate has involved contested studies, misinterpreted abstracts, and demands to dismiss unfavorable reviews, illustrating how scientific uncertainty has been amplified by political and institutional disputes ^{[4] [5]}. Some researchers and advocates have pushed findings that others described as flawed or confounded, and those disputes affect how adverse-event reports are framed in public discourse; stakeholders may selectively cite FAERS counts or small flawed studies to promote agendas for or against ivermectin’s use in COVID-19 ^{[4] [5]}.

5. How investigators turn FAERS signals into actionable safety conclusions

Regulators and researchers use FAERS to generate hypotheses that must then be tested with controlled studies, pharmacoepidemiologic analyses, or active surveillance systems; FAERS alone cannot establish causality or rate estimates because it lacks exposure denominators and is vulnerable to reporting biases ^{[1] [2]}. Best practice is to combine spontaneous-report signals with clinical-trial safety data, electronic-health-record pharmacoepidemiology, and mechanistic toxicology so that regulators can decide whether to update labeling, issue warnings, or restrict use ^{[1] [2]}.

6. What a rigorous answer would require and recommended next steps for someone seeking specifics

To list FDA-reported ivermectin side effects for 2025 with confidence, one must query FAERS for ivermectin-associated Preferred Terms and Serious Outcome flags, review any FDA drug-safety communications or MedWatch alerts from 2025, and consult peer-reviewed pharmacoepidemiologic studies that analyze those reports; none of these detailed datasets are present in the supplied materials ^{[1] [2]}. Practical next steps are to access FAERS Public Dashboard or FOIA FDA safety communications for 2025 and to examine independent analyses in the literature that cross-check FAERS signals, which will produce a defensible, evidence-based list.

7. Bottom line: what can be stated confidently from the supplied sources

From the materials provided, it is certain that the FDA warned against ivermectin misuse and described the drug as potentially toxic when used off-label for COVID-19, and that FAERS exists as a large repository of adverse-event reports that requires careful interpretation ^{[3] [1] [2]}. What cannot be produced from these sources is a definitive, source-attributed list of specific ivermectin side effects reported to the FDA in 2025; compiling that list would require direct FAERS outputs or a dedicated FDA 2025 safety communication, neither of which are included here ^{[1] [2] [3]}.