Something in this widely available plant could damage the liver
A plant revered for centuries as a restorative tonic has drawn the quiet attention of regulators on multiple continents, as rare but serious reports of liver injury remind us that the boundary between remedy and risk is rarely fixed. Australia's Therapeutic Goods Administration, following a 2024 safety alert, is now weighing whether ashwagandha — one of the country's most widely consumed herbal supplements — requires tighter controls after eleven possible liver injury cases emerged domestically and fatal outcomes were recorded abroad. The story is not one of a dangerous substance unmasked, but of a complex botanical whose risks, though uncommon, have outpaced the surveillance systems designed to catch them. It raises an older question: how much certainty do we owe the public before we act, and how much silence do we afford tradition?
- A single 2021 case report in Australia quietly set in motion a regulatory investigation that would surface eleven possible liver injury cases and reshape how a beloved herbal remedy is monitored.
- Three deaths in India and hospitalizations across Australia and the Netherlands have given urgency to what regulators once treated as a low-risk, minimally supervised ingredient.
- The herb remains freely available with no dose restrictions, creating tension between its enormous popularity and a safety signal that is rare but real enough to have prompted a formal public warning.
- A critical gap in the data — most adverse event reports come from consumers, not clinicians — is leaving regulators without the detailed medical evidence needed to determine whether stricter controls are warranted.
- Regulators are now calling on health professionals to report suspected cases, framing better surveillance as the essential next step before any definitive regulatory action can be taken.
In 2021, a single report of serious liver damage linked to an ashwagandha-containing medicine reached Australian health regulators — and set off an investigation that would eventually prompt a formal public warning about one of the country's most widely used herbal supplements.
Withania somnifera, sold in teas, tablets, powders, and syrups across Australia, had long been a permitted ingredient in listed medicines with no restrictions on dose or preparation. Its bioactive compounds, called withanolides, vary depending on whether manufacturers use root or leaf extract and how they process it. A pregnancy warning appeared on labels, but otherwise the herb operated with minimal oversight.
By 2024, the Therapeutic Goods Administration issued a safety alert after tracking a rise in adverse event reports. Most patients recovered after stopping the product, but four required hospitalization, and some experienced sudden gastrointestinal symptoms. The international picture was more alarming: Indian researchers identified eight liver injury cases from single-ingredient ashwagandha preparations, three of them fatal. The Netherlands documented twelve cases with onset ranging from six weeks to nearly two years after starting the herb.
Within Australia, eleven possible liver injury cases have now been recorded. In six, no other ingredient appeared responsible; two of those required hospitalization. All resolved after discontinuation. The TGA is also aware of additional cases reported to the WHO's global drug monitoring program.
The regulatory response has been inconsistent. India's Ministry of Ayush concluded in 2024 that ashwagandha root extract is safe, attributing reported injuries to rare individual reactions — yet India itself banned the use of ashwagandha leaves while permitting roots under prescribed limits. The TGA is now examining whether different plant parts carry different risks.
A deeper problem complicates the picture: most adverse event reports come from consumers, not clinicians. Only five of Australia's eleven cases were reported by health professionals, limiting the quality of available data. The TGA is urging doctors, nurses, and pharmacists to report suspected cases, framing their participation as essential to detecting safety signals before they widen.
Ashwagandha remains on the Australian market. Whether the rare but serious risk of liver injury will ultimately justify label changes, dose restrictions, or removal from the permitted ingredients list depends on the evidence regulators can gather — and on whether the reporting systems designed to protect the public can keep pace with the remedies millions of Australians are already taking.
In 2021, Australian health regulators received a report of serious liver damage tied to a medicine containing Withania somnifera, a common herbal ingredient sold across the country in teas, tablets, powders, and syrups. The case prompted an investigation that would eventually reshape how the Therapeutic Goods Administration monitors one of Australia's most widely used botanical remedies.
Withania somnifera—also known as ashwagandha—has been a permitted ingredient in Australian listed medicines for years, with no specific restrictions on dose, concentration, or how it's prepared. The herb contains bioactive compounds called withanolides, which vary in type and strength depending on whether manufacturers extract from the root or leaf, and how they process it. Most Australian products use concentrated root extracts. A pregnancy warning is required on labels, but otherwise the ingredient has operated with minimal regulatory oversight.
By 2024, the TGA issued a formal safety alert. The warning came after reviewing scientific literature and tracking a rise in adverse event reports linking the herb to liver injury—cases described as very rare but serious enough to warrant public notice. Most patients recovered once they stopped taking the product, but some needed medical care. Four cases required hospitalization. The alert also flagged sudden, potentially severe gastrointestinal symptoms in some users.
The international picture was darker. In 2023, Indian researchers examined hospital records and identified eight cases of liver injury from single-ingredient Withania somnifera preparations in various forms—powdered root, syrups, tablets, herbal teas. Three of those patients died. The Netherlands Pharmacovigilance Centre documented twelve cases of liver injury by June 2025, with onset ranging from six weeks to twenty-two months after starting the herb. Most recovered after stopping use, though the pattern was clear: something in this widely available plant could, in rare instances, damage the liver.
Within Australia, regulators have now received eleven possible liver injury cases linked to Withania somnifera medicines. In six of those cases, no other ingredients appeared to contribute to the injury. Four of those six involved products registered on the Australian Register of Therapeutic Goods, and two required hospitalization. All cases resolved when patients discontinued the product. The TGA is aware of additional possible cases reported to the World Health Organization's international drug monitoring program.
The regulatory response has been uneven globally. India's Ministry of Ayush published a safety dossier in 2024 concluding that Withania somnifera root extract is safe for human consumption, finding no evidence of inherent liver toxicity and suggesting reported injuries may stem from other causes or rare individual reactions requiring further study. Yet India itself banned the use of Withania somnifera leaves while permitting roots under prescribed limits—a distinction the TGA is now examining as it weighs whether different plant parts carry different risks.
The challenge facing regulators is fundamental: most adverse event reports for herbal medicines come from consumers, not health professionals. Of the eleven cases Australia has documented, only five were reported by doctors or other medical practitioners. This gap matters because health professionals can provide detailed clinical information, connect symptoms to timing, and help distinguish between the herb itself and other contributing factors. The TGA is now urging doctors, nurses, and pharmacists to report any suspected adverse events involving herbal medicines, framing such reports as essential to detecting emerging safety signals before they spread further.
For now, Withania somnifera remains on the market in Australia. The TGA says it will continue assessing evidence and determining whether regulatory action—such as label warnings, dose restrictions, or removal from the permitted list—becomes necessary. The herb's popularity means millions of Australians may be using it. The question is whether the very rare risk of serious liver injury warrants tighter controls, and whether regulators will have the reporting data they need to answer that question with confidence.
Citas Notables
Most patients recovered after discontinuing the product, though some required medical treatment and 4 cases required hospitalisation— TGA 2024 safety alert
The available evidence indicates that while the risk appears to be very rare, there is a potential for liver injury associated with the use of this herbal ingredient— TGA regulatory assessment
La Conversación del Hearth Otra perspectiva de la historia
Why did it take until 2024 for a safety alert, if the first case came in 2021?
The TGA needed to see a pattern. One case could be coincidence. By 2024, they had multiple reports from Australia plus evidence from international regulators and published research showing the same injury appearing across different countries. That's when it became a signal worth warning about.
The Indian government says the herb is safe. Are they wrong?
They're not necessarily wrong about the herb itself. They're saying the liver injuries might be due to other causes or rare individual sensitivities. But the fact remains: people took this herb and developed liver damage. Whether it's the herb's fault or an interaction or an idiosyncratic reaction, the outcome was the same for those patients.
Why does it matter whether it's the root or the leaf?
The chemical composition changes depending on which part of the plant you use. If liver injury is linked to one part but not the other, regulators could allow one while restricting the other. India banned the leaves but allows roots. Australia is trying to figure out if that distinction matters here.
Most cases resolved after people stopped taking it. Doesn't that suggest it's not that dangerous?
It suggests the injury is reversible in most cases, which is good news. But reversibility doesn't mean it's safe. Four Australians still needed hospitalization. Three people in India died. For a very rare risk, those are significant numbers when you're talking about a product millions of people use.
Why aren't more doctors reporting these cases?
Doctors may not connect the dots. A patient comes in with liver problems; the doctor treats it without asking about herbal supplements. Or the patient doesn't mention it. The TGA can only act on what it knows about. Right now, half the reports they're getting come from consumers, not clinicians. That's a blind spot.