Echinacea purpurea root

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15. Safety

15.1 Adverse effects in trials

In Melchart’s trial 10 of 99 people on E. purpurea root extract reported adverse effects against 11 of 90 on placebo; none was serious (HMPC [5]; Mills and Bone give the same counts [2]). No adverse events were reported in the Bräunig trial [5]. In Barrett 2010 potential adverse effects were similar across the four groups; headache was the only possible exception, and open questions showed no pattern attributable to echinacea [5,16]. In the Cochrane review, drop-outs and adverse effects did not differ significantly from placebo, with a trend towards more drop-outs for adverse events in prevention trials [15]. The EU monograph lists skin hypersensitivity reactions, frequency not known [4]. The HMPC records no serious adverse events or deaths in the trials it reviewed [5].

15.2 Allergy

An Australian case of anaphylaxis in an atopic woman who took a commercial E. purpurea and E. angustifolia extract with other supplements, at twice the recommended amount, was published in 1998 (Mullins, as reported by Mills and Bone and Braun and Cohen [2,7]). A 2002 Australian analysis of 51 ADRAC reports found 26 reactions (urticaria, angio-oedema, asthma, anaphylaxis) judged IgE-mediated; more than half the patients had asthma, allergic rhinitis or atopic dermatitis; four were hospitalised and none died; 94 per cent reacted within 24 hours (Mullins and Heddle, as reported by the HMPC [5]). Braun and Cohen read the same series as 2 certain, 10 probable and 12 possible over 21 years [7]; 20 per cent of 100 atopic people who had never taken echinacea had positive skin-prick tests [2]. Mills and Bone judge root preparations less likely to cause allergy than aerial parts, which carry pollen, and note that it is unclear whether the implicated products contained root [2]. TGA safety advisory, 02/07/2024 (issued for Andrographis paniculata): more than 80 per cent of andrographis adverse-event reports involve multi-ingredient medicines that also contain Echinacea; the TGA states that echinacea has also been reported to cause allergic reactions, including anaphylaxis, and advises people with a past severe allergic reaction to any trigger to avoid medicines containing andrographis [21]. In the same advisory, under information for health professionals, the TGA advises that patients with a history of severe allergies, including anaphylaxis, should as a precaution avoid medicines containing andrographis and/or echinacea, and that anyone who has had an allergic reaction to a product containing either should avoid both in future [21]. TGA updated safety review, version 1.0, March 2026 (adverse event data to 31/12/2024): of 254 anaphylaxis reports for andrographis since 2005, 206 (81 per cent) involved medicines that also contained echinacea, which the TGA attributes mainly to supply volume. Over the same period the TGA received 10 anaphylaxis reports for echinacea-containing medicines without andrographis: 8 multi-ingredient and 2 with echinacea as the only active ingredient, species not specified. The TGA’s expert advice notes the allergenic potential of echinacea itself and that some reports may reflect the echinacea component or both herbs acting together [27, p. 4, 9, 12]. From 17/09/2026 the TGA removed Andrographis paniculata from the Permissible Ingredients Determination, so no new listed medicines containing andrographis can be included in the ARTG. Echinacea was not removed [28]. Existing echinacea-andrographis combinations may stay on sale for now; the TGA has said it will recommend voluntary cancellation or recall [28].

15.3 Contraindications and precautions (each with source and grade)

15.4 Herb-drug interactions

AIP comment: the Gorski data are the most specific human interaction data for this root, and they concern CYP3A and CYP1A2 substrates with narrow margins (for example midazolam, some cytotoxics, clozapine and theophylline by class). The HMPC’s "none reported" in the EU monograph [4] and its own discussion of Gorski [5] sit uneasily together. Medicine review (23/09/2026): the Gorski result is graded as one small open-label human pharmacokinetic study (12 healthy volunteers, low certainty), and it is enough to make CYP3A and CYP1A2 substrates with a narrow therapeutic margin a precaution (15.3, 15.8). The darunavir, etravirine and warfarin studies [18-20] found no clinically relevant change, so no dose change is indicated for those drugs. Monitoring is still sensible when the root is started or stopped in someone stabilised on a narrow-margin drug.

15.5 Pregnancy and lactation

A prospective controlled cohort of 206 women who took echinacea in pregnancy (112 in the first trimester) found no difference in major malformations from 206 matched controls; species and plant part were not recorded, courses were typically 5-7 days, and the study could detect only common malformations (Gallo 2000, as reported by the HMPC and Mills and Bone [5,2]). Pregnant mice fed E. purpurea (probably root) had fewer viable fetuses (Chow 2006, as reported by Mills and Bone [2]). Norwegian and Italian surveys found echinacea among the herbs most used in pregnancy, without species or part [5]. The EU monograph does not recommend use in pregnancy and lactation for lack of data [4]; MediHerb suggests professional supervision [8]; Mills and Bone place it in category A and judge it compatible with breastfeeding, noting that about 0.5 per cent of the maternal alkylamide dose reached the infant in one breastfeeding woman [2]. No reproductive toxicity study of E. purpurea root preparations exists [4,5]. Barrett 2010 excluded pregnant women [16].

AIP comment: the human evidence is one small cohort that cannot be assigned to this root. Certainty is very low. Medicine review (23/09/2026): AIP does not recommend routine use in pregnancy or lactation. This follows the EU position [4] in preference to the Mills and Bone category A [2], because category A assumes consumption by a large number of women, and the only cohort (206 women) neither recorded species and plant part nor could detect uncommon malformations. The mouse finding [2] is unreplicated; AIP records it as a signal that needs testing.

15.6 Children and older people

No adequate data in children; the EU monograph does not recommend use under 12 [4]. Mills and Bone have no specific information for the root in children [2]. MediHerb suggests the glycetract for children at a suitable dose [8]. No specific data in older people.

15.7 Toxicology and overdose

Oral acute toxicity of an E. purpurea root extract exceeded 3000 mg/kg in mice (Bauer and Liersch, as reported by the HMPC and Mills and Bone [2,5]). Male rats given root extract at 50 mg/kg for 8 weeks showed reduced testicular mass and histological change (as reported by Mills and Bone [2]). Repeat-dose, reproductive, genotoxicity and carcinogenicity tests on the EU monograph preparations have not been done, so no EU list entry was made [4,5]. No overdose case is reported [4]. A Finnish case records chronic misuse of a high-ethanol echinacea extract as a source of alcohol [5]. Case reports attributed to echinacea (species and part usually unstated) include erythema nodosum, leukopenia, aggravation of autoimmunity, acute hepatitis and hypereosinophilia [2]; causality has not been assessed for any of them. The saturated pyrrolizidine alkaloids carry no hepatotoxic structure [2].

TGA checks. The 02/07/2024 andrographis advisory covers echinacea combination products and is summarised in 15.2 [21]. The TGA’s March 2026 updated safety review (15.2) reports its own adverse event database counts to 31/12/2024 [27]. A direct DAEN (medicines) pull for "Echinacea" was not made (the DAEN search needs an interactive browser session, and the automated attempt for AIP-HP 004 in September 2026 was blocked). It is outstanding before release. The TGA safety-alert search for echinacea in September 2026 (Medicine) found no alert specific to echinacea beyond refs 21, 27 and 28.

15.8 Referral

Anyone with a known daisy-family allergy, asthma or atopy, an autoimmune or progressive systemic disease, a transplant or immunosuppressant treatment, anyone taking a medicine cleared by CYP3A or CYP1A2 with a narrow margin, or anyone pregnant or breastfeeding, should consult a degree-qualified herbalist with competencies and adequate training in pharmacognosy before using Echinacea purpurea root. Anyone with a history of severe allergy or anaphylaxis to any trigger, or who has had any allergic reaction to an echinacea or andrographis product, should avoid medicines containing echinacea (TGA advice [21]). Throat or tongue swelling, wheeze, hives or faintness after a dose is an emergency: call 000.