TGA issues second liver-injury warning for ashwagandha supplements

What just happened

The Therapeutic Goods Administration has issued its second safety alert about herbal products containing Withania somnifera — better known as ashwagandha. Four new adverse event reports involving possible liver injury have been received since the initial TGA advisory in 2024, bringing the total Australian case count to 11.

All 11 cases resolved when the supplement was discontinued. None required hospitalisation. In two of the cases, other ingredients in the products may have contributed to the reactions.

The TGA is not banning ashwagandha. It is reissuing a warning that the hepatotoxicity signal is real, that it has continued to accumulate since the first alert, and that the risk profile warrants specific precautions — particularly for anyone with existing liver disease.

This matters because ashwagandha is one of the most aggressively marketed supplements in the perimenopause and stress-management space right now. It is sold at pharmacies, health food shops, and online, often positioned as an “adaptogen” for fatigue, cortisol modulation, anxiety, and hormonal balance. Its target audience overlaps significantly with the readership here.

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The both-and

The hepatotoxicity signal is real but rare

Eleven cases over several years, in a market where ashwagandha supplements are sold in the tens of thousands of units annually, represents a very low absolute incidence. The WHO Programme for International Drug Monitoring has received similar reports from other countries, and the TGA characterises the risk as “very rare.” That characterisation is accurate.

The complication is that the outcome — liver injury — is not trivial, and it is not easily predictable in advance. There is no known genetic marker that identifies who will react. The mechanism is thought to involve idiosyncratic hepatotoxicity: a reaction that is dose-independent, unpredictable, and immunologically mediated rather than a straight dose-response toxicity. This is the same mechanism behind rare liver injuries from some prescribed medicines, and it means that “I’ve been taking it for months without trouble” is not a guarantee of future safety.

The TGA’s specific guidance that people with current or previous liver disease should avoid ashwagandha products entirely is the clearest risk reduction measure available. It is not a cure-all precaution — most of the 11 cases would not have had known prior liver disease — but it reduces exposure in the highest-vulnerability group.

The evidence for the claimed benefits is limited

The marketing claims for ashwagandha span a wide range: cortisol reduction, sleep improvement, anxiety relief, fatigue management, testosterone support, and perimenopause symptom relief. The evidence base for these claims is uneven.

Some randomised controlled trials do show modest benefits for stress-related outcomes and sleep quality, primarily in small study samples over short durations. The effect sizes are generally modest. The TGA’s adverse event documentation does not speak to efficacy, but the clinical picture is one where limited demonstrated benefit is being balanced against a rare but real hepatotoxicity signal. That is a different risk-benefit calculation than many patients assume when purchasing a supplement from a pharmacy shelf.

The framing common in marketing — that “natural” or “plant-based” products are inherently safer than pharmaceutical medicines — is not supported by the pharmacology. Withania somnifera is a bioactive compound. Bioactive compounds have biological effects, including on the liver.

What the TGA is and isn’t saying

The TGA is asking for three things: that people with liver disease avoid these products, that users know the hepatotoxicity symptoms and stop the supplement if they develop them, and that health professionals are aware of the signal so they can take a supplement history in patients presenting with unexplained liver abnormalities.

The TGA is not withdrawing ashwagandha products from the market and is not recommending that all users stop. It is asking for informed use and active symptom monitoring.

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My two cents

The woman navigating perimenopause in 2026 is swimming in supplement advice. Every wellness platform, every Instagram account aimed at women over 40, has an ashwagandha recommendation. The pitch is consistent: cortisol is high, oestrogen is dropping, and this adaptogen will smooth out the rough edges. That pitch resonates because the underlying problem it addresses — a body that feels like it’s running on fumes, with anxiety that spikes at night and energy that crashes by 3pm — is real.

I’m not in the business of dismissing symptoms. I’m in the business of being honest about what the evidence says, and what the risks are.

The evidence for ashwagandha at this point is: limited clinical trial data, modest effect sizes in small studies, a biological plausibility story around HPA axis modulation, and a TGA-confirmed rare but real hepatotoxicity signal that has now generated a second national safety alert in two years. That’s not nothing — but it’s not a clean risk-benefit profile either.

The conversation worth having in a general practice consultation is not “stop taking it immediately.” It is: what problem are you trying to solve? Is there clinical evidence that ashwagandha addresses that specific problem in your situation? And given the liver signal, what do you do if your body starts flagging something — jaundice, dark urine, fatigue that’s different in quality?

Those aren’t complicated questions. But they need to be asked before the first capsule, not after the third month.

Verdict: yes — active TGA safety alert, directly relevant to the supplement use patterns of this readership.

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Sources cited

1. TGA makes second safety alert on ashwagandha and liver injury. Medical Republic, 23 July 2026. https://www.medicalrepublic.com.au/tga-makes-second-safety-alert-on-ashwagandha-and-liver-injury/127554
2. TGA safety alerts. https://www.tga.gov.au/news-and-resources/safety-alerts