TGA flags liver injury risk from ashwagandha supplements

What just happened

The Therapeutic Goods Administration issued a safety alert this week on herbal preparations containing Withania somnifera — better known as ashwagandha — following ongoing reports of liver injury in Australia and internationally.

Ashwagandha is an Ayurvedic herb that has become one of the most-purchased supplements in Australian pharmacies and health food stores over the past five years. It is marketed for stress, sleep, energy, libido, and hormonal balance — all concerns that resonate in perimenopause. The supplement is typically framed as “natural,” “adaptogenic,” and implicitly safe compared to pharmaceutical alternatives.

The TGA has positioned it differently. The alert identifies that drug-induced liver injury linked to ashwagandha has been documented in the scientific literature, by regulators in other countries, and in adverse event reports in the Australian database. The injury appears to be dose-related. Symptoms can emerge weeks after starting the supplement. In most cases, they resolve after stopping — but not in all.

The TGA has regulated a number of listed complementary medicines containing ashwagandha. The alert applies broadly to products containing the ingredient, not to a single brand.

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The both-and

The “natural” framing is not a safety claim

The word “natural” does not mean safe, tested, or free of organ toxicity. Paracetamol is synthesised in a laboratory. Aristolochic acid — which causes irreversible renal failure — comes from a plant. The distinction between “natural remedy” and “pharmaceutical drug” is a marketing category, not a pharmacological one.

Under Australian law, ashwagandha products fall under the TGA’s listed complementary medicines pathway. An AUST L number on the packaging means the product has met quality standards for the listed ingredients. It does not mean the product has been assessed for efficacy, nor that its adverse effect profile has been fully characterised in a randomised controlled trial. The evidence standard for listed complementary medicines is meaningfully different to the standard applied to prescription medicines before they reach Australian shelves.

That regulatory distinction is not a failure of the system — it is a deliberate calibration for a lower-risk category. The problem is when consumers interpret “TGA listed” as equivalent to “TGA approved for this condition” or “TGA assessed as safe for long-term use.” Those are different things.

The hepatotoxicity signal is not new — and it is now confirmed in Australia

Case reports of liver injury associated with ashwagandha have appeared in international medical literature since at least 2021. Iceland’s Icelandic Medicines Agency issued an alert in 2023. Ireland’s Health Products Regulatory Authority flagged the signal. The United States FDA has received multiple case reports through its MedWatch system.

What the TGA’s alert adds is confirmation that the signal has now been identified in the Australian adverse event database, and that Australian regulators regard it as sufficiently established to warrant a public safety communication. That is the appropriate response to an emerging hepatotoxicity signal — it does not mean the risk is catastrophic or ubiquitous, but it does mean it has met the threshold for being named.

The pattern of injury described in international case reports is typically cholestatic or mixed — affecting the liver’s ability to process and excrete bile as well as causing cellular damage. Most cases are dose-related, resolve with cessation of the supplement, and do not lead to permanent liver damage. Some cases have required specialist hepatology review. The rarer, more severe end of the spectrum has included acute liver failure.

Why this matters particularly for women in midlife

Two things converge for a 45-year-old woman in 2026. First, ashwagandha is specifically marketed at the perimenopause demographic. Supplement brands use language about cortisol, adrenal fatigue, hormonal rebalancing, thyroid support, and fatigue management — all framings that are common in the midlife wellness space. The marketing directly targets people most likely to be using the supplement without disclosing it to their GP.

Second, many women in this cohort are managing other conditions and taking other regular medications: antidepressants, antihypertensives, thyroid replacement, or hormonal therapy. Drug-induced liver injury risk is not additive in a simple linear way, but hepatic metabolism is shared across many of these medicines through cytochrome P450 enzyme pathways. A supplement that affects hepatic function is not an inert addition to a polypharmacy list.

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2 cents

If you are taking ashwagandha — or any supplement you have not mentioned to your GP — now is a practical moment to raise it.

The specific question worth asking at your next general practice appointment: given the TGA alert, does your GP recommend a baseline liver function test? This is a standard panel available through routine blood work. It is inexpensive. It gives you a reference point. If you have been taking ashwagandha for more than a few weeks, having that baseline on file is a reasonable and low-effort precaution.

The symptoms of liver injury from supplements are non-specific: fatigue, nausea, loss of appetite, right upper abdominal discomfort, dark urine. These are easy to attribute to other things — particularly in perimenopause, when fatigue and nausea are common companions. The ambiguity is part of why supplement-related liver injury gets identified late. Telling your GP what you are taking is the simplest way to make sure the dots can be connected if they need to be.

If you have existing liver disease, take regular medications that are hepatically metabolised, or are pregnant, the question is not whether to discuss this — it is how soon.

Verdict: yes — a TGA safety alert on a widely used supplement, directly relevant to this audience, with a documented and now Australian-confirmed liver injury risk.

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Sources cited

1. Therapeutic Goods Administration — Safety alerts and recalls. https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts
2. TGA — How we regulate complementary medicines. https://www.tga.gov.au/how-we-regulate/medicines/complementary-medicines
3. TGA — News and articles. https://www.tga.gov.au/news/news-articles