Background: Why Are People Talking About Ashwagandha and the Liver?
Ashwagandha (Withania somnifera) is one of the world's most popular adaptogens, and its use has surged in recent years. At the same time, questions about its safety have emerged, particularly regarding case reports of liver injury.
This article provides a balanced overview of the available evidence and regulatory developments.
Case Reports and Regulatory Warnings
What Happened?
Björnsson et al. (2020) published a review of rare liver injury case reports associated with ashwagandha consumption. These were individual cases, not large-scale studies, but they attracted regulatory attention.
Nordic Country Warnings (2023)
Iceland and Denmark issued warnings about ashwagandha supplements in 2023:
- Iceland: Warned consumers about potential liver injury risk
- Denmark: Recommended caution and consultation with a doctor
- Norway and Sweden: Monitored the situation but did not impose bans
These warnings were based primarily on case reports rather than controlled clinical trials.
EFSA Assessment
EFSA (European Food Safety Authority) has initiated a safety assessment of ashwagandha, but a final opinion has not yet been published. This is a standard process for food supplements when new safety data emerges.
What Do Clinical Trials Show?
It is important to view the case reports in a broader context:
Over 1,000 participants have been enrolled in randomised controlled trials (RCTs):
| Study | Participants | Dose | Duration | Serious Adverse Events |
|---|---|---|---|---|
| Chandrasekhar et al. 2012 | 64 | 600 mg/day | 60 days | None reported |
| Lopresti et al. 2019 | 60 | 240 mg/day | 60 days | None reported |
| Salve et al. 2019 | 150 | 600 mg/day | 8 weeks | None reported |
| Langade et al. 2021 | 80 | 600 mg/day | 8 weeks | None reported |
| Raut et al. 2012 | 18 | Up to 1,250 mg/day | 30 days | None reported |
In these controlled settings, ashwagandha has shown generally good tolerability, with no serious liver injuries recorded.
Risk Factors: Who Should Be Cautious?
Analysis of the case reports suggests several possible risk factors:
1. High doses — some case reports involved doses above recommended levels
2. Pre-existing liver conditions — prior liver disease may increase risk
3. Drug interactions — ashwagandha may affect liver cytochrome P450 enzymes
4. Contaminated products — low-quality products may contain adulterants
5. Long-term use — most studies lasted 8–12 weeks
How to Supplement Safely
If you are considering ashwagandha, following these guidelines is sensible:
Recommendations:
- Follow the dosage indicated on the product label
- Choose standardised extracts (KSM-66, Sensoril) from reputable manufacturers
- Consult your doctor, especially if you have liver issues
- Consult your doctor if you take medications
- Do not take ashwagandha if you have active liver disease
- Monitor how you feel and discontinue if symptoms arise
Warning signs of liver injury that warrant medical attention:
- Yellowing of the skin or eyes
- Unusual fatigue
- Dark urine
- Abdominal pain (especially upper right side)
- Nausea without an obvious cause
Perspective: How Real Is the Risk?
Millions of people worldwide take ashwagandha daily. The number of case reports is extremely small in comparison. This does not mean the risk is zero — every supplement carries some risk — but it suggests that serious adverse effects are rare.
Controlled clinical trials involving over 1,000 participants have not identified serious liver injuries. Nevertheless, individual case reports cannot be dismissed, particularly for at-risk groups.
Summary
Ashwagandha has shown generally good tolerability in clinical trials. However, isolated case reports of liver injury have prompted some regulators to issue warnings. The EFSA assessment is ongoing.
In practical terms this means: follow recommended dosages, choose quality products, and consult a healthcare professional, especially if you have health conditions.
References
- Björnsson, H. K., Björnsson, E. S., Avula, B., Khan, I. A., Jonasson, J. G., Ghabril, M., Chalasani, N., et al. (2020). Ashwagandha-induced liver injury: A case series from Iceland and the US Drug-Induced Liver Injury Network. Liver International, 40(4), 825–829.
- Chandrasekhar, K., Kapoor, J., & Anishetty, S. (2012). A prospective, randomized double-blind, placebo-controlled study of safety and efficacy of a high-concentration full-spectrum extract of ashwagandha root in reducing stress and anxiety in adults. Indian Journal of Psychological Medicine, 34(3), 255–262.
- Lopresti, A. L., Smith, S. J., Malvi, H., & Kodgule, R. (2019). An investigation into the stress-relieving and pharmacological actions of an ashwagandha (Withania somnifera) extract. Medicine, 98(37), e17186.
- Salve, J., Pate, S., Debnath, K., & Langade, D. (2019). Adaptogenic and anxiolytic effects of ashwagandha root extract in healthy adults: A double-blind, randomized, placebo-controlled clinical study. Cureus, 11(12), e6466.
- Langade, D., Thakare, V., Kanchi, S., & Kelgane, S. (2021). Clinical evaluation of the pharmacological impact of ashwagandha root extract on sleep in healthy volunteers and insomnia patients. Journal of Ethnopharmacology, 264, 113276.
- Raut, A. A., Rege, N. N., Tadvi, F. M., Solanki, P. V., Kene, K. R., Shirolkar, S. G., Vaidya, A. B., et al. (2012). Exploratory study to evaluate tolerability, safety, and activity of Ashwagandha (Withania somnifera) in healthy volunteers. Journal of Ayurveda and Integrative Medicine, 3(3), 111–114.
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Disclaimer
Dietary supplements are not a substitute for a varied, balanced diet and healthy lifestyle. This article is not medical advice. Consult a healthcare professional.
