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Ashwagandha root extract is well-tolerated and safe in adults with stress and anxietyAshwagandha extract proves safe for stress and anxiety

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Key Takeaway
Note that 600 mg/day of Ashwagandha Root Extract is well-tolerated and safe in adults with stress and anxiety over 8 weeks.

This multi-center, multinational randomized controlled trial evaluated the safety of Ashwagandha Root Extract (ARE) in 1002 healthy adults reporting stress and anxiety. Participants received either 600 mg/day of ARE (two divided doses) or a placebo over an 8-week period.

The primary outcome was the safety profile assessed via laboratory parameters and adverse events. Total adverse events were reported at 7.4% overall, with 28 in the ARE group and 46 in the placebo group. Specific events included nausea (3.2% in placebo vs. 2.0% in ARE), dry mouth (1.4% in both groups), and headache (2.2% in placebo vs. 0.2% in ARE).

Laboratory evaluations for liver, renal, and hematological parameters showed no significant changes between the ARE and placebo groups; all values remained within normal ranges. Tolerability ratings on a 7-point Likert scale showed no statistically significant difference between groups (p = 0.487), with most participants rating the treatment as Good or Excellent.

A primary limitation of this study is the short follow-up duration of 8 weeks, meaning long-term effects are not yet explored. However, the findings suggest ARE is a well-tolerated non-pharmacological intervention for managing stress and anxiety.

How this fits prior evidence

How this fits prior evidence: This finding addresses a gap in non-pharmacological management for conditions related to the factors previously discussed. While previous coverage identified that stress and anxiety are linked to worse urinary incontinence, this study provides specific safety data for Ashwagandha as a potential intervention for those underlying symptoms of stress and anxiety.

If you're one of the millions of adults dealing with everyday stress or anxiety, you might have wondered about natural supplements like ashwagandha. A new study brings reassuring news: a daily dose of ashwagandha root extract appears to be safe and easy to tolerate.

Researchers gave 1,002 healthy adults with stress and anxiety either 600 mg of ashwagandha root extract per day (split into two doses) or a placebo pill. Over 8 weeks, they tracked side effects and how well people tolerated the supplement.

The results were encouraging. Overall, about 7.4% of participants reported side effects, but they were more common in the placebo group (9.2%) than in the ashwagandha group (5.6%). Specifically, nausea occurred in 3.2% of placebo users versus 2.0% of ashwagandha users, and headache was reported by 2.2% of placebo users versus just 0.2% of ashwagandha users. Dry mouth was the same in both groups at 1.4%. No serious side effects were reported.

Blood tests checking liver, kidney, and blood health showed no significant changes between the groups, and all values stayed within normal ranges. When asked to rate how well they tolerated the treatment, most people in both groups said "Good" or "Excellent," with no meaningful difference between them.

It's important to note that this study only lasted 8 weeks, so we don't know about long-term safety. But for short-term use, ashwagandha seems to be a gentle option for stress and anxiety relief.

What this means for you:
Ashwagandha is safe and well-tolerated for 8 weeks in adults with stress and anxiety.

Common questions

Is ashwagandha safe to take for stress and anxiety?

In this 8-week study, ashwagandha was safe. About 5.6% of people taking it reported side effects, compared to 9.2% on placebo. No serious side effects occurred, and blood tests for liver, kidney, and blood health stayed normal. However, long-term safety beyond 8 weeks isn't known yet.

What are the side effects of ashwagandha?

Common side effects in the study were nausea (2.0% in the ashwagandha group vs. 3.2% in placebo) and dry mouth (1.4% in both groups). Headache was rare, at 0.2% in the ashwagandha group. Overall, side effects were less common with ashwagandha than with placebo.

Who was included in the ashwagandha study?

The study included 1,002 healthy adults who reported stress and anxiety. They took either 600 mg of ashwagandha root extract per day (split into two doses) or a placebo for 8 weeks. The trial was multi-center and multinational, meaning it took place at several locations across different countries.

How does ashwagandha compare to placebo for tolerability?

People taking ashwagandha rated their tolerability just as well as those on placebo. There was no statistically significant difference between the groups (p=0.487), and most participants in both groups rated their experience as 'Good' or 'Excellent.' This suggests ashwagandha is easy to tolerate.

Study Details

Study typeRct
EvidenceLevel 2
PublishedAug 2026
View Original Abstract ↓
Ashwagandha ( Withania somnifera ) has been recognized for enhancing physical strength, mental well-being, and overall vitality. Despite its long-standing use across generations, some clinical reports have noted occasional adverse events. This study compared the safety and tolerability of Ashwagandha Root Extract (ARE) in healthy adults. This was a prospective, multicenter, multinational, randomized, double-blinded, placebo-controlled study (n = 1002; 18 to 65 years). Participants with reported stress and anxiety were randomly assigned to receive either 600 mg/day (two divided doses) of ARE (n = 498) or a placebo (PL, n = 504) orally for 8 weeks. The primary outcome was the safety profile assessed through laboratory parameters and adverse events (AEs), while tolerability was assessed by the participants on a 7-point Likert scale of Global Assessment of Tolerability to Therapy. Demographic and baseline characteristics were similar between groups. No serious adverse events were reported; a total of 74 AEs (7.4%) were documented, with 46 events (9.2%) in the PL group and 28 events (5.6%) in the ARE group. The most common AEs include nausea (3.2% in PL vs. 2.0% in ARE), dry mouth (1.4% in both groups), and headache (2.2% in PL vs. 0.2% in ARE). Laboratory evaluations showed no significant changes in liver function tests, renal function markers, or hematological parameters between the ARE and PL groups. Both groups maintained normal ranges for key biomarkers, including aspartate aminotransferase, alanine aminotransferase, creatinine, and hemoglobin levels throughout the study duration. Tolerability ratings showed no statistically significant difference between the groups (p = 0.487), and most of the participants rated the ARE therapy as "Good" or "Excellent." ARE is well-tolerated and safe in adults with stress and anxiety. These results support the use of Ashwagandha root extract as a viable non-pharmacological treatment, warranting further exploration of its long-term effects in diverse populations.
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