What adverse events were reported in garaherb human studies and at what frequency?
Executive summary
No publicly available sources in the provided reporting name or describe “garaherb” specifically, so direct, product-level adverse-event counts for garaherb cannot be reported from these documents; instead, published analyses of herbal‑medicine human adverse‑event reports show common reaction types (allergic/immune, hepatic, renal, nervous system) and a highly variable reporting frequency with a pooled median reporting rate around 1.42% (IQR 1.12%–1.71%), while single databases and spontaneous reports cannot establish causation or complete incidence estimates [1] [2] [3].
1. The immediate data gap: garaherb is not documented in the queried sources
A search of the supplied sources yields no entry or case series that explicitly references “garaherb,” so there is no direct evidence in these documents to list adverse events and frequencies tied to that name; therefore any product‑specific claim would be beyond what the reporting supports [3] [4].
2. What herbal‑medicine human studies commonly report as adverse events
Large compilations and pharmacovigilance analyses of herbal medicines identify immune‑system events (commonly allergic reactions), nervous‑system complaints such as dizziness and syncope, and organ‑specific toxicities including hepatotoxicity and renal failure among the adverse events described in human reports of herbal products [5] [1].
3. How often adverse events are reported in herbal pharmacovigilance datasets
A systematic review and meta‑analysis of pharmacovigilance studies found that reporting rates for adverse events associated with herbal medicines ranged from 0.03% to 29.84%, with a pooled median reporting rate of 1.42% (IQR 1.12%–1.72%); the studies contributing to that estimate exhibited extreme heterogeneity (I2 ≈ 99.96%), reflecting wide variation by dataset, reporter source, and methodology [1] [2].
4. Representative counts from a national herbal ADR system (Taiwan) and what they show
An analysis of Taiwan’s herbal medicine adverse‑reaction database (1998–2016) reported 1,028 cases: immune system diseases comprised 158 events (14.9%) and nervous system disorders 123 events (11.6%), with the remaining system‑organ classes each occurring at lower frequencies in that dataset, illustrating that allergic and neurologic presentations are prominent among reported herbal adverse reactions [5].
5. Why these numbers must be interpreted cautiously — limits of spontaneous reporting
Regulatory and methodological guidance cautions that spontaneous databases like FAERS and other pharmacovigilance systems, and similar voluntary schemes for herbal or dietary products, are subject to under‑reporting, inconsistent clinical detail, and inability to prove causation; FDA materials and audits emphasize that a report indicates a suspected association, not confirmed causality, and that limited clinical information from manufacturers and consumers can hamper signal assessment [3] [6] [7] [4].
6. Practical implication for assessing garaherb’s safety and next steps for definitive answers
Because the provided sources do not document garaherb specifically, the best available inference is that any herbal product can generate allergic, neurological, hepatic, or renal adverse reports and that reported frequencies in surveillance systems cluster around a low pooled median (~1.4%) but vary widely by context; resolving garaherb‑specific safety requires either (a) identifying adverse‑event reports that explicitly name garaherb in FAERS or national herbal ADR registries, or (b) controlled clinical studies or well‑documented case series that specify event types, severity, and denominators — none of which are present in the supplied materials [1] [5] [3] [7].