At a glance
- The EMA accepts rhodiola extract for relief of stress symptoms solely on the basis of long-standing traditional use and states that clinical evidence is insufficient. [2]
- EFSA (2012) concluded that a cause-and-effect relationship had not been established for the claim of reduction of mental fatigue. [3]
- A 60-person RCT reported a favorable result in burnout-related fatigue; superiority over placebo was not shown in the 57-person trial in depression. [4] [5]
- About one in five products on the market did not contain rosavin. [7]
- This guide does not determine personal doses.
What is rhodiola?
Rhodiola rosea L. is a plant of the Crassulaceae family; its root and rhizome are known as “golden root” or “arctic root.” [7] The EMA defines arctic root as the underground stem (rhizome) and root of the plant; preparations are dry extracts obtained with ethanol. [2] There are also various Rhodiola species used in traditional Chinese medicine, and of these, Rhodiola crenulata is considered a common adulterant in the R. rosea supply chain. [7]
The word “adaptogen” does not appear in the indication in the EMA monograph; the indication is written as “relief of symptoms of stress such as fatigue and exhaustion.” [1]
What does rosavin and salidroside standardization mean?
The extract examined by EFSA in 2012 was a dry powder extract standardized to its rosavin and salidroside content, and the Panel found this extract “sufficiently characterized.” [3] The EMA monograph, in turn, defines the preparation as a dry extract obtained with ethanol (67–70% V/V) with a herbal substance-to-extract ratio of 1.5–5:1. [1]
According to Booker and colleagues, rosavin is the main marker used to distinguish R. rosea from related species; salidroside, however, is also found in other Rhodiola species. That is, a product containing only salidroside does not show that it is R. rosea. [7] This distinction was also important in EFSA’s assessment (below).
What do the EMA and EFSA say about rhodiola?
EMA (HMPC). The European Union herbal monograph (Revision 1, date of last revision 20 March 2024) defines rhodiola extract as a traditional herbal medicinal product “for relief of symptoms of stress such as fatigue and exhaustion” and states that the product’s indications rest only on long-standing use. In the EMA’s 2014 public summary based on the first monograph, the wording is “temporary relief of symptoms of stress, for example feeling of fatigue and weakness.” [2] The monograph applies to adults and older people; it states that a doctor or qualified health care professional should be consulted if symptoms last more than two weeks; it does not recommend use under 18 years. [1]
The EMA’s public summary explains “traditional use” as follows: there is insufficient evidence from clinical trials, but there is evidence that the effect is plausible and that the product has been used safely for at least 30 years (at least 15 years of it within the EU). The HMPC also evaluated small placebo-controlled clinical trials in adults with stress and fatigue; a possible effect toward temporary relief was observed, but various shortcomings were identified in these trials and the results were therefore based on long-standing use. [2]
EFSA (2012). Under an application (Article 13(5)), the claim “stimulation of mental functions in stress situations after first intake” was handled, in the applicant’s explanation, as “reduction of fatigue and exhaustion in stress situations.” The applicant presented two published human studies; EFSA stated that these studies were conducted with an extract standardized only for salidroside content and not standardized for rosavins, that they were not conducted with the extract subject to the claim, and reported that no conclusion could be drawn from these studies. The Panel’s conclusion: a cause-and-effect relationship has not been established between consumption of rhodiola extract and reduction of mental fatigue. [3]
Does rhodiola help fatigue?
The study by Olsson and colleagues is a randomized, double-blind, placebo-controlled, parallel-group phase III trial. 60 people aged 20–55 who met the Swedish National Board of Health and Welfare’s criteria for fatigue syndrome received 576 mg daily of a standardized R. rosea extract (n = 30) or placebo (n = 30) for 28 days. The Pines burnout scale, SF-36, a depression scale (MADRS), an attention test (CCPT II) and the awakening cortisol response were measured. Improvement in some measures was seen in both groups (placebo effect); when the groups were compared, rhodiola showed a significant difference over placebo on the burnout scale and some indicators of the attention test; the awakening cortisol response was also different in the treatment group. No serious side effects were reported. [4] One of the authors, A. Panossian, is cited in the 2015 article by Mao and colleagues as an employee of the Swedish Herbal Institute, which supplies the same extract. [5]
Limits: a single trial, 60 people, 28 days, a single extract. This trial appears in the references of EFSA’s 2012 opinion; the Panel reported that no conclusion could be drawn from the two human studies in the application. The EMA also noted shortcomings in small clinical trials. This trial should therefore be read not as proof that rhodiola reduces fatigue but as a first sign. [3] [2]
Detailed guideRhodiola benefits: which claims are supported?Does rhodiola help depression?
Mao and colleagues randomized 57 people with mild–moderate major depression to receive standardized R. rosea extract (n = 20), sertraline (n = 19) or placebo (n = 18) for 12 weeks. Modest, statistically non-significant decreases were seen in all three groups on the HAM-D, BDI and CGI/C scores; there was no significant difference among the groups. The HAM-D decrease was −8.2 with sertraline, −5.1 with rhodiola and −4.6 with placebo. The proportion of people with side effects was 63.2% with sertraline, 30.0% with rhodiola and 16.7% with placebo. [5]
The probability of overall improvement relative to placebo (odds ratio) was 1.39 (95% CI 0.38–5.04) for rhodiola and 1.90 (0.44–8.20) for sertraline; that is, sertraline also did not separate significantly from placebo. The trial was designed with the power to detect relatively large differences, not small ones. [5] As a result, the trial did not show rhodiola to be superior to placebo; the authors’ own interpretation is also that rhodiola appeared less effective than sertraline. The trial is a “proof of concept” study, not an evidence-building one, and is small. The study was funded in the US by NIH’s center for complementary and alternative medicine (NCCAM, today NCCIH) and a research fund at the University of Pennsylvania; the extract was supplied by the Swedish Herbal Institute, and the Institute was reported to have had no role in the study’s design, conduct or reporting. [5] There is no evidence that rhodiola replaces treatment in those receiving depression treatment.
Does rhodiola improve exercise performance?
The systematic review by Sanz-Barrio and colleagues covered 13 RCTs (263 participants; 198 men, 65 women; aged 18–65) in healthy participants with no other supplement used. Results were heterogeneous: 11 studies reported some favorable effects, and 2 studies showed no effect on variables such as perceived exertion, heart rate, antioxidant capacity, blood lactate, creatine kinase and CRP. The authors reported that acute use had a favorable effect on endurance performance and perceived exertion and that chronic use had a favorable effect on anaerobic exercise performance but not on endurance performance; the risk of bias was unclear or high in most studies and the supplement and exercise protocols differed from one another. [6]
More detailed exercise studies are covered on the benefits page.
Is rhodiola safe?
According to the EMA monograph, the contraindication is hypersensitivity to the active substance; safety in pregnancy and breastfeeding has not been established and use is not recommended because of insufficient data; there are no fertility data. The reported undesirable effects are headache, nausea, abdominal pain, diarrhea, rash and itching (frequency not known). No clinically significant interaction has been observed; no case of overdose has been reported. [1]
In the Mao trial, six of 20 people in the rhodiola group reported side effects (three of 18 with placebo); side effects seen in more than one person included dizziness (2 people in the rhodiola group) and tension (2 people in each of the three groups). [5] As to the liver, in the Björnsson series, in one of five cases rhodiola together with ashwagandha was also considered a possible cause; it is a single case and the two were being used together. [8] The duration in controlled trials is short (28 days, 12 weeks); the safety of long-term use has not been measured.
Do rhodiola products contain what is on the label?
Booker and colleagues examined about 40 products (granulated powder and extract) from the European market with HPTLC, mass spectrometry and 1H NMR. About one in five of the products claiming to be R. rosea did not contain rosavin; some also lacked salidroside. In about 80% of the rest, the rosavin content was lower than in products registered under traditional herbal medicine legislation, and the products appeared to be adulterated with other Rhodiola species. The authors described the variability among products as “a major cause for concern.” [7] One of the authors worked at a German company producing herbal medicines and two at a Swiss company producing analytical instruments. The finding is limited to products on the European market.
What is its status in Türkiye?
In the TİTCK (Turkish Medicines and Medical Devices Agency) Medicinal Plant List under the Ministry of Health, there is a monograph dated 24/03/2025 for Rhodiola rosea L. (Turkish name Rodiyola). The monograph was prepared to be referenced in traditional herbal medicinal product license applications and is based on the EMA monograph as well as Canadian and Egyptian monographs. Among the safety warnings are the following: it should not be used in hypersensitivity to the active substance and in bipolar disorder or bipolar spectrum disorder; use in pregnancy and breastfeeding is not recommended because of insufficient data, and use under 18 years has not been established; use before bedtime is not recommended and use should be stopped if insomnia occurs; the product should be used under the supervision of a physician and pharmacist trained in herbal treatment. [9] This guide does not recommend a product or place of supply.
The food supplement side is a separate path. In the Ministry of Agriculture and Forestry Plant List (update 16/07/2026), the root of Rhodiola rosea appears as positive (P). [11] The Restricted Substances List (21/09/2026), in turn, limits two marker compounds from Rhodiola rosea root extract for ages 11 and over: salidroside 5.8 mg/day (27/06/2016) and rosavin 18 mg/day (19/12/2016). [10] These limits are component amounts, not extract amounts; they cannot be compared in the same unit with the 576 mg/day extract dose in the Olsson trial.
There is a separate guide for ashwagandha, another herbal stress supplement: ashwagandha.
Who should be careful with rhodiola?
- Pregnant and breastfeeding women: According to the EMA monograph, safety has not been established and use is not recommended because of insufficient data. [1]
- Under 18: The EMA does not recommend use; there are insufficient data. [1]
- Those hypersensitive to the active substance: This is the EMA’s only contraindication. [1]
- People with bipolar disorder: The TİTCK monograph states it should not be used; the EMA monograph does not have this warning. [9]
- People with depression: Rhodiola was not found superior to placebo in the phase II trial; it therefore cannot be said to replace depression treatment. [5]
- Those using it together with ashwagandha: In one liver injury case, rhodiola together with ashwagandha was cited as a possible cause; a liver signal specific to rhodiola has not been measured. [8]
How reliable is the overall evidence on rhodiola?
The fatigue and depression results rest on single trials of 60 and 57 people. [4] [5] In the exercise reviews, the risk of bias was unclear or high in most studies. [6] On the regulatory side, the EMA’s acceptance rests on traditional use and EFSA’s conclusion on the fact that the studies in the application were not conducted with the extract subject to the claim. [2] [3] Individual, defined extracts were used in the trials; the content of products on the market is variable, so the result of one trial cannot be carried over to another product whose label looks the same. [7]
This guide does not recommend personal doses.
What does the evidence say?
What it does and does not affectLimited or insufficient evidence
- CStress-related fatigue (burnout)In a single RCT (60 people, 28 days), improvement over placebo on the burnout scale and attention measures; the placebo group also improved.
- CExercise performance — inconsistentIn a 13-RCT review, 11 studies reported a favorable effect; the evidence is heterogeneous and the risk of bias is unclear or high in most studies.
- DStress symptoms (traditional use)EMA: use rests not on clinical evidence but on long-standing traditional use; shortcomings were identified in small clinical trials.
- DMental fatigue (EU health claim) — insufficient evidenceInsufficient evidence: EFSA (2012) could not draw a conclusion because the two studies in the application were not conducted with the extract subject to the claim; a cause-and-effect relationship was not established.
- DSafetyEMA: headache, nausea, abdominal pain, diarrhea and rash were reported, frequency unknown; safety in pregnancy and breastfeeding has not been established.
What do the A–E grades mean?
The letter describes the strength of evidence for a specific claim, not the size of the benefit or a usage recommendation. E does not mean ineffectiveness has been proven.
- AStrong
- Established physiology (e.g. correcting a deficiency) or strong, consistent, direct human studies
- BModerate
- Supportive human evidence; small effect or some limitations
- CLimited
- A single randomised trial, mixed results or low-certainty human findings
- DInsufficient
- Small, uncontrolled or indirect evidence; not enough to judge
- ENo benefit shown / not studied in humans
- No benefit shown for the claim, or only animal or cell data exist
These grades are Half-Life Journal’s editorial evidence summary; they are not a formal GRADE rating or independent medical approval.
The letter shows evidence strength; it is not a score for positive effect or a usage recommendation.
Frequently asked questions
What is rhodiola and what is it used for?
The extract obtained from the root and rhizome of Rhodiola rosea is accepted in the EU as a traditional herbal product for relief of stress symptoms; this acceptance rests not on clinical evidence but on long-standing use. Clinical trials are small and their results are not consistent.
Does rhodiola help depression?
In a single 57-person phase II trial, there was no significant difference among the rhodiola, sertraline and placebo groups in mild–moderate depression; sertraline also did not separate from placebo, meaning the trial was too small to detect small differences. Rhodiola has not been shown to be effective in depression.
Do rhodiola supplements really contain rhodiola?
In an analysis of about 40 products from the European market, about one in five did not contain rosavin, the marker compound that distinguishes R. rosea; in about 80% of the rest, rosavin was lower than in registered products and these products appeared to be adulterated with other Rhodiola species.
Can rhodiola be used in pregnancy?
According to the EMA monograph, safety in pregnancy and breastfeeding has not been established and use is not recommended because of insufficient data. Use under 18 years is also not recommended.
Sources
- Institution EMA/HMPC — European Union herbal monograph on Rhodiola rosea L., rhizoma et radix (Revision 1, EMA/HMPC/24177/2023) (2024)Back to text ↑
- Institution EMA — Rhodiolae roseae rhizoma et radix (arctic root): herbal medicinal product, kamuya özet (2014)Back to text ↑
- Institution EFSA NDA Panel — Scientific Opinion on the substantiation of a health claim related to Rhodiola rosea L. extract and reduction of mental fatigue pursuant to Article 13(5) of Regulation (EC) No 1924/2006 (2012)Back to text ↑
- RCT A randomised, double-blind, placebo-controlled, parallel-group study of the standardised extract shr-5 of the roots of Rhodiola rosea in the treatment of subjects with stress-related fatigue. (2009)Back to text ↑
- RCT Mao et al. — Rhodiola rosea versus sertraline for major depressive disorder: A randomized placebo-controlled trial (2015)Back to text ↑
- Rhodiola rosea supplementation on sports performance: A systematic review of randomized controlled trials. (2023)Back to text ↑
- Source The authenticity and quality of Rhodiola rosea products. (2016)Back to text ↑
- Human study Ashwagandha-induced liver injury: A case series from Iceland and the US Drug-Induced Liver Injury Network. (2020)Back to text ↑
- Institution T.C. Sağlık Bakanlığı, TİTCK — Tıbbi Bitki Listesi: Rhodiola rosea L. (Rodiyola) monografı, TBM063a2 (24/03/2025) (2025)Back to text ↑
- Institution T.C. Tarım ve Orman Bakanlığı — Takviye Edici Gıdalar Kısıtlı Maddeler Listesi (son güncelleme 21/09/2026) (2026)Back to text ↑
- Institution T.C. Tarım ve Orman Bakanlığı — Bitki Listesi (güncelleme tarihi 16/07/2026) (2026)Back to text ↑
Method: Institutional clinical guidance and relevant studies were compared. Each finding is presented with its population, outcome, sources and limitations. Independent medical review has not yet been completed.
Updated
This content is for information only and is not medical advice. It does not recommend doses, products or vendors. Talk to your clinician before making any health decision.
