As women navigate midlife and menopause, many explore botanical options like ashwagandha (Withania somnifera) to support their well-being. Understanding the safety profile, particularly for longer-term use, is a common and important consideration.
This article provides an evidence-based overview of what current research suggests regarding the long-term safety of ashwagandha, drawing from available studies to help inform your understanding.
Understanding Ashwagandha and Its Traditional Use
Ashwagandha is an herb with a long history of use in traditional systems, often referred to as an ‘adaptogen.’ This means it is traditionally understood to help the body adapt to various stressors. Its potential benefits are a subject of ongoing scientific investigation, with research exploring its effects on areas such as stress, anxiety, and sleep [1][2].
The plant’s root is primarily used, and extracts are standardized to contain specific compounds, such as withanolides, which are thought to be responsible for many of its observed effects. While much attention is given to its potential benefits, an equally important aspect for those considering its use is its safety profile, especially when considering consistent or prolonged intake.
General Safety Profile from Preclinical Studies
Preclinical studies, often conducted in animal models, provide initial insights into the safety of substances. Several studies have investigated the acute and sub-chronic toxicity of ashwagandha root extracts.
For instance, acute and sub-chronic oral toxicity studies in Sprague Dawley rats have been conducted, suggesting a generally favorable safety profile at certain doses [3][4]. Another safety assessment of a Withania somnifera extract standardized for Withaferin A also reported on acute and sub-acute toxicity in animal models, indicating it was well-tolerated at tested doses [5]. These studies are important for understanding basic toxicological parameters but may not directly translate to human experience or long-term human use.
Human Clinical Trials and Reported Adverse Effects
When considering human safety, clinical trials are crucial. A systematic review and meta-analysis on the effect of ashwagandha on sleep, for example, noted that adverse events reported in the included studies were generally mild and infrequent, with no serious adverse events reported [2]. Similarly, a systematic review and meta-analysis on ashwagandha’s effects on stress and anxiety also indicated that it was generally well-tolerated, with mild adverse effects such as gastrointestinal upset being occasionally reported [1].
Another review highlighting ashwagandha’s healthcare claims, safety, and toxicity aspects also concluded that it appears safe for human consumption with minor adverse effects [6]. However, it’s important to note that many human studies on ashwagandha have been of shorter duration, typically ranging from a few weeks to a few months. Therefore, data specifically addressing very long-term (e.g., several years) consistent use in humans is still developing.
A review on the safety and clinical effectiveness of Withania Somnifera root in human ailments also concluded that the root is generally safe for consumption, with mild side effects in some individuals [7]. These mild side effects often include gastrointestinal discomfort, drowsiness, or changes in appetite. The endocrine system is an area of interest for ashwagandha’s potential effects, and a review of this topic also discussed its general safety profile, noting that while it shows promise for endocrine support, careful consideration of individual responses is warranted [8].
Specific Safety Concerns: Liver Injury
While generally considered safe, there have been isolated reports of ashwagandha-induced liver injury. A case series from Iceland and the US Drug-Induced Liver Injury Network identified several cases of liver injury associated with ashwagandha use [9]. These cases highlight that, like many dietary supplements and even conventional medications, ashwagandha carries a rare but potential risk for idiosyncratic adverse reactions in susceptible individuals.
It’s important to understand that ‘idiosyncratic’ means these reactions are unpredictable and not dose-dependent, making them difficult to foresee. The number of reported cases is relatively small compared to the widespread use of ashwagandha, suggesting that severe liver injury is an uncommon event. However, it underscores the importance of individual monitoring and discussing supplement use with a healthcare provider, especially for those with pre-existing liver conditions or who are taking other medications.
Considerations for Women in Midlife and Menopause
For women navigating midlife and menopause, factors such as hormonal shifts and potential concurrent health conditions or medications are important considerations. While current research suggests a generally favorable safety profile for ashwagandha in the short to medium term, specific long-term data tailored to this demographic, especially regarding interactions with hormone therapies or other common midlife medications, is not extensively documented.
The potential for ashwagandha to influence the endocrine system [8] means that individuals with hormone-sensitive conditions or those undergoing hormone therapy should exercise particular caution and discuss ashwagandha use with their healthcare provider. While some animal studies explore interactions with metabolic conditions, such as diabetes [10], direct long-term human data for women in midlife with various health profiles is still emerging. As with any botanical, individual responses can vary significantly.
References
- Effects of Ashwagandha (Withania Somnifera) on stress and anxiety: A systematic review and meta-analysis. Explore (New York, N.Y.), 2024
- Effect of Ashwagandha (Withania somnifera) extract on sleep: A systematic review and meta-analysis. PloS one, 2021
- Acute and sub-chronic oral GLP toxicity of Withania somnifera root extract in Sprague Dawley rats. Drug metabolism and personalized therapy, 2024
- Acute and sub-chronic oral GLP toxicity of Withania somnifera root extract in Sprague Dawley rats. Drug metabolism and personalized therapy, 2025
- Safety assessment of Withania somnifera extract standardized for Withaferin A: Acute and sub-acute toxicity study. Journal of Ayurveda and integrative medicine, 2016
- Pharmacological evaluation of Ashwagandha highlighting its healthcare claims, safety, and toxicity aspects. Journal of dietary supplements, 2021
- Safety and clinical effectiveness of Withania Somnifera (Linn.) Dunal root in human ailments. Journal of ethnopharmacology, 2020
- Can Ashwagandha Benefit the Endocrine System?-A Review. International journal of molecular sciences, 2023
- Ashwagandha-induced liver injury: A case series from Iceland and the US Drug-Induced Liver Injury Network. Liver international : official journal of the International Association for the Study of the Liver, 2020
- Effects of Berberis asiatica, Withania somnifera, and Their Combination on Body Weight in Streptozotocin-Nicotinamide-Induced Type 2 Diabetes in Wistar Rats. Cureus, 2024
These statements have not been evaluated by the Food and Drug Administration. This information is not intended to diagnose, treat, cure, or prevent any disease. Content is for informational purposes only and is not medical advice; consult a qualified healthcare provider before starting any supplement. As an Amazon Associate we earn from qualifying purchases.
