Andrographis herb

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15. Safety

Key points

• Anaphylaxis: 287 TGA reports to 31/12/2025 and one death; 71% after first or earlier uneventful use, 74% within 30 minutes.
• The TGA removed andrographis from the Permissible Ingredients Determination on 17/09/2026. Sponsor recalls of listed products began on 01/10/2026, and 33 products were on the TGA recall list by 23/10/2026, including MediHerb Andrographis Complex.
• Taste loss and taste disturbance are among the most common reports.
• Avoid in pregnancy and lactation, and after any previous reaction to andrographis or an Acanthaceae plant.
• Signs of anaphylaxis need emergency care at once: call 000.

15.1 Adverse effects in trials

• In the 33-trial review of acute respiratory infection, 23 trials reported on adverse events or safety. None reported acute toxicity, 11 found no adverse event in either arm, no serious adverse event was seen, and minor events were mainly gastrointestinal. The authors still advise caution until fuller safety data exist [27].
• In ulcerative colitis, adverse-event rates were the same as placebo (60% and 53% vs 60%) [54]. Mild diarrhoea at 180 mg andrographolide daily in COVID-19, with no liver or kidney toxicity over 5 days [51]; across the COVID-19 trials raised liver enzymes were the most common adverse event, and in one trial mild hepatitis occurred in 24.6% of patients taking the extract with favipiravir, all resolving within 28 days [31]. The review found no difference in adverse events from the comparator groups and notes that SARS-CoV-2 can itself raise liver enzymes [31].
• Isolated andrographolide at 5 then 10 mg/kg three times a day (far above usual doses) gave headache, fatigue, itch or rash, metallic or reduced taste and diarrhoea, and one anaphylactic reaction; the trial was interrupted at 6 weeks [3,67].
• Large doses may cause gastric discomfort, vomiting and loss of appetite [2,3]. Andrographolide 2 g daily for 4 days raised ALT transiently in volunteers (Chinese report cited by Mills and Bone) [3].
• Trials were small and short; none could detect a reaction as rare as anaphylaxis (TGA review) [19].

15.2 Anaphylaxis and severe allergic reactions (Australian and international reports)

Causality: the TGA considers the association established; its Advisory Committee on the Safety of Medicines advised in 2014 that there was sufficient information to confirm it [64].

No preparation type, extract ratio (14:1 to 200:1 were implicated), solvent (ethanol, methanol, water), plant part, maker or andrographolide dose per unit was free of reports in the TGA’s analysis of the 20 most-supplied products [19]. The TGA also received one report from a traditional herbal liquid extract [19].

The mechanism is unknown; cell and in-silico work suggests some constituents could release allergic mediators [19]. The TGA’s expert adviser listed cofactors that raise the chance or severity of allergic reactions: viral infection, NSAIDs such as ibuprofen, alcohol and exercise around the time of the dose [6,19].

Highest-risk setting. Andrographis is usually taken during a viral infection, often with an NSAID, which is the setting of highest risk.

Injectable andrographolide derivatives (China, overseas products not supplied in Australia) had adverse-reaction incidences of 3.7-5.5% in pooled studies. In the 152 patients of the case reports, 55 had life-threatening anaphylactic shock and 3 died of anaphylaxis; 2 more, older patients with serious heart and lung disease, died after a fall in platelet count, so 5 died in all [67]. WHO warns that crude extracts must not be injected [2]. Oral herbal preparations had mainly mild gastrointestinal and skin reactions in the same review [67].

15.3 Taste disturbance

Ageusia (325 reports) and dysgeusia (236) were the first and third most common reaction terms among the 1368 Australian reports [65]. Listed products have had to carry a taste-disturbance warning [19]. The herb’s bitterness does not explain loss of taste; duration and reversibility are not reported in the sources we read.

15.4 Contraindications (each with source and grade)

15.5 Herb-drug interactions

15.6 Pregnancy, lactation and fertility

• Pregnancy. WHO: should not be used in pregnancy [2]. Mills and Bone: Australian category B3, best avoided in early pregnancy [3]. MediHerb: avoid in early pregnancy; professional supervision in mid to late pregnancy [5]. Braun and Cohen: insufficient reliable evidence [11]. Animal data conflict: a whole-plant decoction given by injection prevented implantation and ended pregnancy in mice and rabbits; oral extract below 2 g/kg in the first 9 days of gestation did not interrupt pregnancy in rats; oral extract at 200-2000 mg/kg for the first 19 days of pregnancy did not change progesterone in rats [2,3]. AIP position: avoid throughout pregnancy.
• Lactation. No human data on transfer into breast milk or effects on the infant were found in the sources read [2,3,5]. WHO: should not be used in lactation [2]. MediHerb: professional supervision suggested [5]. AIP position: avoid.
• Male fertility. Early studies of leaf powder and of andrographolide in rats reported testicular damage [3]. Later rat studies of an extract at 20, 200 and 1000 mg/kg a day for 60-65 days found no change in testicular histology, testosterone, or sperm count, motility and form, and andrographolide at 50 mg/kg a day for 2-8 weeks had no significant effect; the authors of one study put the difference from the early work down to the plant material used [3]. A phase I study of Kan Jang at three times the usual dose in healthy men found a slightly positive effect on sperm count, sperm activity and other fertility indices [3].

15.7 Children and older people

No adverse events were reported in a 3-month prevention trial in healthy children (extract 200 mg a day) or in a 10-day trial of Kan Jang in children aged 4-11 (both as reported by Mills and Bone) [3]; these trials were far too small to detect anaphylaxis. WHO advises against use in children without supervision [2]. Older people: no specific data; interactions (section 15.5) are more likely with more medicines.

15.8 Toxicology and overdose

Acute toxicity is low: oral LD50 of an alcohol extract in mice above 15 g/kg; andrographolide above 40 g/kg [3]. A methanolic extract showed no significant genotoxicity in three in vitro tests, and female rats given 5 g/kg of a methanolic extract by mouth for 14 days showed no adverse effects [3]. A nitrosated ethanol extract was mutagenic in Salmonella (1989 conference abstract cited by Mills and Bone) [3]. No overdose case found; high doses cause gastric upset, anorexia and vomiting [3].

15.9 Australian regulatory action

• 2014-2015: ACSOM confirmed the association with allergic reactions; the TGA published a safety review and alert [64].
• 2019-2020: a mandatory label warning ("Andrographis may cause allergic reactions in some people. If you have a severe reaction (such as anaphylaxis) stop use and seek immediate medical attention") for all listed medicines released from 02/05/2020 [64]. A taste-disturbance warning is also required [19].
• June-July 2024: a fatal anaphylactic reaction was reported to the TGA in June 2024, and the TGA published an updated safety advisory on 02/07/2024 [19,85].
• 08/04/2026: updated safety review and supplementary report published; targeted consultation 08/04/2026 to 08/05/2026 [6,19].
• 17/09/2026: andrographis removed from the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2026 by an amendment under section 26BC of the Therapeutic Goods Act 1989, on the ground that the anaphylaxis risk "is not adequately mitigable within the listed medicines framework" [6]. New listed medicines can no longer contain it. Existing listings are not cancelled automatically; the TGA will recommend voluntary cancellation or recall and may compel it [6]. Access remains possible through the registered-medicines pathway [6].
• 01/10/2026 onward: the TGA published a recall notice for listed andrographis medicines on 01/10/2026 and has added to it as sponsors act; it was last updated 23/10/2026 and re-read in full that day [90]. It then listed 33 ARTG-listed products from 22 sponsors under 22 recall records, each recalled for all unexpired batches (table below). The first version, of 01/10/2026 to 06/10/2026, named only the four Arrotex and PBA Wholesale products; the version of 20/10/2026 listed 24 products from 18 sponsors, and the update of 23/10/2026 added nine, from Integria Healthcare (MediHerb and Eagle), Metagenics (including Ethical Nutrients), Nuchev Practitioner (BioPractica) and Homart Wellness (Thompson’s). People holding any listed product are told not to use it and to return it to the place of purchase or the sponsor. The notice repeats that a reaction can follow a first dose or earlier uneventful use, and that anyone who may be having anaphylaxis should call 000 [90]. Listed andrographis products not on the list stay on the ARTG until their sponsors cancel or recall them. The TGA page lists the recalls to date, so check it for later additions.

Products on the TGA andrographis recall list, as updated 23/10/2026 (read in October 2026) [90]. All unexpired batches.

The list takes in practitioner-channel brands (MediHerb, Eagle, Metagenics, BioPractica, BioCeuticals, Designs for Health, Phytologic) and a Chinese-medicine tablet named for the herb (Chuan Xin Lian), as well as supermarket and pharmacy cold and flu products. MediHerb Andrographis Complex, the tablet in the section 12 table, is now recalled. The MediHerb Andrographis 1:2 liquid was not on the list as read in October 2026, and its ARTG status was not checked (AIP comment).

• Practitioner supply. The TGA’s review states that implications for traditional practitioners were outside its scope [19]. In the consultation the TGA rejected practitioner-only supply as a mitigation, noting that the product with the most anaphylaxis reports was already restricted to practitioner access by its sponsor [74]. How the decision affects practitioner-dispensed liquids and extemporaneous preparations (including any exemption under the Therapeutic Goods Regulations 1990) has not been checked by us; Legal is asked to advise. MediHerb’s 2015 guide lists the 1:2 liquid [5]; its current ARTG status was not checked.
• Overseas (not applicable in Australia): the EMA could not establish an EU herbal monograph (2013) [7]; New Zealand’s Medsafe (2017) and Health Canada (2020) issued allergy communications, as cited by the TGA [19,64].

Poisons Standard. We found no entry for Andrographis paniculata or andrographolide in a web search in September 2026, and the TGA review lists no restriction on the ingredient other than the two label warnings [19]. The instrument in force from 01/10/2026 was searched in full in October 2026 and has no entry for andrographis, Andrographis paniculata or andrographolide [84].

TGA safety alerts (read in full by Medicine on tga.gov.au, October 2026; the 2024 advisory and the recall notice re-read in October 2026). Four pages are relevant: three safety alerts and the 2026 recall notice.

• "Safety review of Andrographis paniculata and anaphylactic/allergic reactions" (published 08/10/2015) [87]. It links the 2015 safety review and records that ACSOM considered the issue on 11/07/2014.
• "Products containing Andrographis paniculata: safety advisory – risk of allergic reactions" (published 08/10/2015) [86]. It reports 43 anaphylaxis reports and 78 other allergic-type reactions received between December 2002 and April 2014, and states that no label warnings were required at that time.
• "Medicines containing Andrographis paniculata safety advisory" (published 02/07/2024) [85]. Its main points:
  • about 100 ARTG-listed medicines contained andrographis;
  • more than 300 anaphylaxis or hypersensitivity reports had been received since 2005, more than 200 of them since 2019;
  • a fatal anaphylactic reaction was reported in June 2024;
  • more than 80% of reports involve products that also contain Echinacea;
  • severe reactions have followed earlier uneventful use;
  • anyone with symptoms of a severe allergic reaction should call 000, and anyone who has had any allergic reaction to an andrographis medicine should avoid all of them.
• "Andrographis recalls: Concerns over allergy risk" (published 01/10/2026, last updated 23/10/2026, re-read in full by Medicine October 2026). It lists the 33 recalled products in the table above [90].

These pages [85-87,90] agree with the later TGA documents cited above [6,19,64,65].

TGA Database of Adverse Event Notifications (DAEN). Searched by Medicine in October 2026 (search term "andrographis", all dates, data to September 2026). The search matched 91 medicines by trade name or active ingredient, nearly all of them multi-ingredient listed products. Results:

• 1472 cases in total;
• 1435 cases in which the andrographis product was the single suspected medicine;
• 1 case with a reported death.

The most frequent reaction terms:

How to read the DAEN figures:

• DAEN cases are reports. They do not establish that the medicine caused the event, and one case can carry several reaction terms.
• The counts run to a later date than the TGA’s case-reviewed analyses above (287 anaphylaxis reports to 31/12/2025 [65]), so the two sets of figures do not match exactly. They agree in pattern: taste loss and anaphylaxis lead, and one death.

Referral. Anyone who is pregnant, has had any allergic reaction to andrographis or an Acanthaceae plant, takes anticoagulant, antiplatelet, immunosuppressant or antihypertensive medicines, or is considering andrographis during an infection, should consult a degree-qualified herbalist with competencies and adequate training in pharmacognosy before use. Anyone with signs of anaphylaxis (difficult or noisy breathing, swelling of the tongue or throat, wheeze, persistent dizziness or collapse) needs emergency care at once: call 000 [6].