Rhodiola root

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15. Safety

15.1 Adverse effects

From controlled trials. Olsson reported no adverse event in either arm over 28 days [4]. Darbinyan 2007 reported no serious side effect in any of three arms over six weeks [4]. Shevtsov reported one case of hypersalivation, in the placebo group, and none in either verum group [4]. Spasov 2000a reported none [4] — and that is the assessment report’s label for a separate 660 mg study in 60 students, which the assessor set aside for want of any preparation detail and which is therefore not one of the fifteen trials in 13.2; the 100 mg trial in that table (Spasov 2000, trial 6) has no adverse-event line in the assessment report at all, so none is claimed for it here. De Bock reported one headache in a placebo subject in phase I and, in phase II, one moderate headache and one case of insomnia on active treatment against one minor headache on placebo [4]. Mao reported nervousness in two and dizziness in two of the twenty in the rhodiola arm, with nervousness also in two on placebo and two on sertraline; 30.0 per cent of the rhodiola arm reported any adverse event against 16.7 per cent on placebo and 63.2 per cent on sertraline (p = 0.012), and nobody stopped rhodiola or placebo for an adverse event [32]. Cropley reported one treatment-emergent event each in four of forty randomised to treatment, two of which were symptoms of the condition under study and two related to a concurrent unrelated condition [4]. Ishaque’s review of eleven studies and 446 subjects found five adverse events mentioned in three studies: a minor and a serious headache in two subjects on 200 mg/day for four weeks, and three on placebo (a minor headache, insomnia and hypersalivation) [45]. Ishaque contradicts itself on the insomnia case. Its adverse-effects paragraph puts it on placebo, while its own account of the De Bock trial puts "a minor headache and another had insomnia during long term supplementation of R. rosea" [45], which agrees with the assessment report’s De Bock line above [4]. This monograph follows the trial account for De Bock and does not settle Ishaque’s count of five. Braun and Cohen read the same review as two events on active treatment, not considered serious because headache occurred on placebo as well [5]. The five athlete trials (13.2, rows 16–20) add little: Dai and colleagues did not record adverse events systematically and say so [70]; Dou and colleagues report no serious supplement-related event in 96 players [71] and no adverse event at all in 24 [72], without describing how events were collected; Wang J and colleagues do not mention adverse events [75]; Marcos-Frutos and colleagues report no side effects in either condition [76]. Four gave 2.4 g/day of one maker’s rhodiola (Beijing Tong Ren Tang) for four weeks to healthy young men, which may not be one product, since Wang J 2025 names only the maker and states a salidroside content that differs from the capsule label in Dai 2026 (13.2); the fifth gave 1,200 mg/day of an extract for four days at a time. A combination trial reported in October 2026 (13.1) is the only blinded study here to stop anyone for a possible product effect: of 29 adults randomised to a morning capsule of ashwagandha 600 mg with R. rosea extract 300 mg, two men withdrew, one with mild diarrhoea after three days and one with moderate dizziness and mild muscle weakness after two; both resolved within 48 hours of stopping, neither needed medical care, and no such event occurred in the 29 who took the same morning capsule with an evening product [79]. With two herbs in the capsule the events cannot be assigned to rhodiola; dizziness is already on the rhodiola list above.

From open-label studies, where the rates are much higher and uncontrolled. Edwards: 54 events in 36 of 101 subjects (35.6 per cent), most often nervous-system (17 patients, 18 events) and gastrointestinal (10 patients, 10 events); no serious event; two withdrew (dizziness; abdominal distension), both assessed as unlikely related [4]. Kasper and Dienel: 145 events in 70 of 118 (59.3 per cent), 40.7 per cent mild, 46.9 per cent moderate, 12.4 per cent severe; most common nervous-system 27.1 per cent, infections 27.1 per cent, gastrointestinal 12.7 per cent, skin 4.2 per cent; a causal relationship rated "possible" in 10.9 per cent: head pressure, light-headedness, nausea, feeling irritated, eye swelling; four withdrew for adverse events [4]. Lekomtseva: 44 events in 41 of 101 (40.6 per cent), largest groups nervous-system (9), gastrointestinal (8) and infections (7); 32 of 44 assessed as unrelated and the remaining 12 as unlikely related; none withdrew [4]. An uncontrolled event rate is not an attributable rate, and the EMA assessor’s reading is that most of these were not drug-related.

From pharmacovigilance. The Swedish Medical Products Agency received, for Rhodiola over 2007–2015, one serious report (asthenia, dizziness, fatigue, headache, learning disorder, memory impairment, nausea) and four non-serious (anxiety, pruritus, tremor, headache, nausea, malaise) [4]. EudraVigilance, accessed 13/07/2021, held 26 reports related to R. rosea, of which six concerned Rhodiola products alone with no concomitant medication; the events were primarily nervous-system (headache, nervousness, insomnia, dizziness) and gastrointestinal (nausea, vomiting); no new safety issue was identified [4]. TGA Database of Adverse Event Notifications (DAEN) – medicines, searched by Medicine in September 2026. The medicine dimension of DAEN was filtered on "Rhodiola". Rhodiola rosea appears in DAEN only as one active ingredient among many in multi-ingredient listed complementary medicines, never as a single-ingredient medicine. The products returned included 123Diet Drops (AUST L 371892, twelve actives), Blackmores Alive Women’s Multivitamin (over fifty actives), Endorfix (not on the ARTG), Energy & Skin Radiance (AUST L 414384), Ethical Nutrients Mega Magnesium Energy & Stress (AUST L 380938), Happy Calm (AUST L 374581) and Happy Mammoth Hormone Harmony (AUST L 387339, 446811 and 521386). The consequence matters more than any count: not one report in DAEN can be attributed to rhodiola rather than to the other ingredients of the product, because no reported product contains rhodiola alone. The per-product case counts were not retrievable from this workstation – the DAEN search is now an embedded Power BI report and the per-medicine selection did not complete in a headless session – so no case number is quoted here, and that residual gap stays on the list in section 20. For scale, the whole database held 678,905 reports at the date of search. No TGA safety alert, safety advisory or recall for Rhodiola rosea was found on 23/09/2026 or on 27/09/2026. A further attempt on 28/09/2026 at the Medicine review did not get through: the regulator’s site search was behind an automated-traffic challenge that day and returned no result set, so the September 2026 check is the last one actually completed and the position is reported as at that date. 06/10/2026: the site search was again behind the challenge. A web search restricted to the regulator’s domain returned no safety alert, advisory or recall for rhodiola; what it did return were ARTG cancellations that the TGA files under cancellations by sponsors (section 30(1)(c) of the Therapeutic Goods Act 1989), among them three earlier MediHerb Rhodiola and Ginseng entries (ARTG 283709 and 226470, June 2020; ARTG 351314, 18/08/2025), sponsor Integria Healthcare Australia Pty Ltd. None of the three is an entry this monograph cites as current (12). A sponsor’s own cancellation is a commercial or regulatory step and carries no safety finding. 07/10/2026, at the fourth Medicine review: the site search was behind the same challenge; a domain-restricted web search again returned no safety alert, advisory or recall for rhodiola, only sponsor cancellation notices and the regulator’s general alert and recall pages. 16/10/2026, at the seventh Medicine review: the same challenge, and the same result from the domain-restricted search: ARTG entries and a sponsor cancellation, and no safety alert, advisory or recall.

The undesirable effects in the EU monograph, which is the regulatory consensus statement: nervous system disorders, headache; gastrointestinal disorders, nausea, abdominal pain, diarrhoea; skin and subcutaneous tissue disorders, skin rash, itching. Frequency not known in every case [3]. The assessment report’s own recommended wording adds nervousness, insomnia, dizziness and vomiting [4].

At high doses. Braun and Cohen record that increased irritability and insomnia have been reported within several days in some people taking 1,500–2,000 mg standardised to 2 per cent rosavin [5].

Causality and grade for 15.1. The case and spontaneous reports above are assessed against the WHO–Uppsala Monitoring Centre categories [74], on what the source gives for each; none of the individual reports has been read in its original form. The Swedish serious report and the EudraVigilance reports: unassessable, because the assessment report gives no timing, dose, product or outcome for any single case [4]. The DAEN reports: unassessable for rhodiola, because every product named contains other actives. The headaches on active treatment in De Bock’s four-week phase: possible, because headache occurred on placebo in the same trial [4,45]. The high-dose irritability and insomnia: possible, with no case detail given [5]. Grade for 15.1: the profile rests on small, short controlled trials (blinded arms of about 6 to 40 participants, given anything from a single dose to 12 weeks of treatment), on uncontrolled studies, and on spontaneous reports in which rhodiola cannot be separated from co-ingredients. It supports the EU monograph’s frequency "not known" [3] and no estimate of a rate.

15.2 Toxicology

Much of the repeat-dose work is unpublished company data reported at second hand in the assessment report, and this monograph says so rather than presenting it as a literature finding. The consequence is on the record: because published genotoxicity data are missing, the HMPC could not support a European Union List Entry for this drug [4].

15.3 Contraindications

• Hypersensitivity to the active substance. The only contraindication in the EU monograph [3]. Grade: regulatory consensus.
• Bipolar states. Braun and Cohen: "While the administration of rhodiola may be beneficial in monopolar depression, use is not recommended for bipolar states" [5]. Grade: theoretical, on the stimulant and monoamine profile. AIP has found no case report.
• Children and adolescents under 18. Not recommended, because no safety data from clinical trials in that age group exist; the EU monograph says so explicitly, and the assessment report notes that although registered products are permitted in adolescents in some member states, the monograph could not cover them [3,4]. Barnes goes further: "Given the intended uses of R. rosea, it is not suitable for use in children" [6]. Grade: regulatory consensus, resting on the absence of data.

15.4 Herb–drug interactions

The EU monograph’s own interaction statement is "No clinically relevant interactions have been observed" [3]. That statement is a regulatory conclusion about a registered traditional product at 144–400 mg/day, reached after the assessor weighed everything above [4]. It is not a finding that no interaction exists, and this monograph does not present it as one.

15.5 Pregnancy and lactation

No data published. Safety in pregnancy and lactation has not been established, and in the absence of data the EU monograph does not recommend use during pregnancy or lactation [3,4]. No fertility data are available. There are no reproductive or developmental toxicity studies at all [4]. Braun and Cohen say the same [5]. MediHerb’s label says professional supervision is suggested in pregnancy and lactation [10]. The library copy of Mills, Dugoua and Perri, Herbal Medicines in Pregnancy and Lactation, contains no entry for this drug [checked in September 2026]. Ishaque and colleagues add that no dosage recommendation can be made for pregnant or lactating women until safety studies are done [45]. Practice runs ahead of the data here. Mills and Bone print a one-week postnatal-depression formula containing 20 mL of Rhodiola 2:1 (with Panax ginseng, St John’s wort, liquorice and Withania), without discussing breastfeeding [9, p. 300]; that is expert practice in a population that is often lactating, and it is not safety evidence. Grade for the whole of 15.5: no human data; regulatory consensus (do not recommend) and manufacturer’s caution (professional supervision). The honest position is that nobody knows, and the absence of reproductive toxicity data is itself the finding.

15.6 Children, older people, overdose, driving

Children and adolescents: not recommended under 18; no data [3,6]. Older people: the EU monograph’s posology covers adults and elderly at the same dose [3]; the only study weighted to older people is the uncontrolled combination trial in 120 adults aged 50–89 [5]. Overdose: no case of overdose has been reported [3,4]. Driving and machinery: no study has been performed [3]. Grade for 15.6: no human data in any of the four groups; the positions are the EU monograph’s regulatory consensus [3,4].

15.7 Referral

Nobody should self-prescribe this drug alongside an antidepressant, an anticoagulant or any medicine with a narrow therapeutic index on the strength of a retail label. Anyone considering rhodiola, and particularly anyone already taking prescribed medicines, should consult a degree-qualified herbalist with competencies and adequate training in pharmacognosy.