In this guide
What is Andrographis?
Andrographis paniculata is a very bitter herb used in South and Southeast Asian medical traditions. Oral supplements commonly contain leaf or aerial-part powder, extracts standardized to andrographolides, or multi-ingredient respiratory products. Andrographolide is a marker compound, but its percentage does not make unlike extracts clinically equivalent.
Most human research concerns short-term symptoms of acute respiratory tract infections. This evidence does not establish that Andrographis prevents infection, treats pneumonia, replaces diagnostic testing, or substitutes for antiviral or antibiotic care when indicated. The strongest current practical boundary is safety: serious allergic reactions can be sudden and unpredictable. [1]
Typical Andrographis Protocols
| Source and context | Material | Amount | Frequency | Duration | Observed result |
|---|---|---|---|---|---|
| Raj 2023 · uncomplicated upper respiratory viral infection | AP-Bio (KalmCold) standardized leaf extract | 200 or 400 mg/day total | Not reported in the PubMed abstract | 7 days | WURSS-21 favored both doses at day 3, but not at days 5 or 7 300 randomized equally to two active groups or placebo. The abstract does not report andrographolide percentage or administrations per day. |
| Saxena 2010 · uncomplicated upper respiratory tract infection | KalmCold extract | 200 mg/day total | Not reported in the PubMed abstract | 5-day assessment period | Symptom scores were similar at day 3 and favored extract at day 5 except earache 223 randomized. Product standardization and amount per administration cannot be reconstructed from the abstract. |
There is no RDA, AI or tolerable upper intake level for Andrographis. A label’s extract milligrams, whole-herb equivalent and andrographolide percentage answer different questions. Do not convert between them without the manufacturer’s extraction ratio and assay.
- Titration
- No evidence-based self-titration schedule applies across Andrographis products, and gradual exposure does not prevent anaphylaxis.
- Timing
- The recent trial measured a transient difference at day 3; that time point cannot be presented as a full-course benefit.
- Duration
- The cited trials lasted 5 to 7 days. They do not establish long-term daily safety.
- Stopping
- Stop immediately and obtain urgent help for breathing difficulty, tongue or throat swelling, wheeze, collapse or rapidly spreading hives.
Three checks before comparison
Keep formulation, time point and evidence source together.
Leaf extract, mixed product and injectable derivative differ.
A day-3 signal did not persist through days 5 or 7.
Spontaneous reports reveal signals, not incidence.
What is Andrographis commonly used for?
People most often use Andrographis for colds, sore throat, cough and broad “immune support.” Trials primarily measured symptom scores during already established acute respiratory illness. They do not prove prevention, reduced transmission, fewer complications or benefit for an undiagnosed illness.
Research also exists in inflammatory bowel disease, arthritis and other conditions, but products, endpoints and doses differ. Those studies do not support treating a chronic inflammatory or autoimmune condition without clinical supervision.
Which form and label details matter?
Record the Latin species, plant part, extraction ratio, extract mass per serving, andrographolide standardization, number of administrations and every co-ingredient. “Andrographis 400 mg” might mean plant powder, a concentrated extract or an herbal equivalent. A blend containing echinacea cannot isolate which ingredient caused benefit or allergy.
Oral plant extracts should not be treated as equivalent to injectable andrographolide derivatives used in some countries. Injection safety reports and dosing cannot be converted into an oral supplement protocol.
What does the human evidence show?
Raj 2023 randomized 300 adults equally to AP-Bio 200 mg/day, 400 mg/day or placebo for seven days. Both active groups had lower WURSS-21 global symptom scores than placebo at day 3 after multiplicity adjustment. Objective measures such as nasal mucus weight and interleukin-8 did not significantly differ. The symptom difference was absent at days 5 and 7, so the trial supports at most an early, formulation-specific signal. The abstract does not disclose dosing frequency or andrographolide content. [2]
Saxena 2010 randomized 223 people to KalmCold 200 mg/day or placebo. Symptom scores were similar at day 3 and favored the extract at day 5 for most listed symptoms. The PubMed abstract does not report frequency, standardization or enough methodological detail to map the regimen to another product. [5]
Hu 2017 pooled 33 randomized trials with 7,175 participants and reported favorable effects for cough, sore throat and overall acute respiratory symptoms. Interpretation is limited because the review combined Andrographis alone, herbal mixtures and adjunctive use, while diagnoses, comparators and preparations varied. Manufacturing or quality-control details were seldom reported, and overall methodological quality was poor. [3]
The 2018 correction added a missing disclosure that one author’s PhD fellowship received an educational stipend from Pukka Herbs. It did not report changes to the numerical outcomes, but readers should see that funding context when weighing the review. [4]
How might Andrographis work?
Andrographolide and related diterpene lactones affect inflammatory signaling, immune-cell responses and viral processes in laboratory systems. Oral exposure also depends on extraction and metabolism.
These experiments can generate hypotheses. They do not show that an oral supplement clears a respiratory virus or improves a clinical outcome. Human symptom trials and pharmacovigilance remain more relevant for decisions.
What are the risks and interactions?
Allergy is the leading concern. The TGA’s 2026 review counted 287 reports of anaphylaxis linked to Andrographis-containing medicines through December 31, 2025, including one fatal case reported in 2024. Many reports involved multi-ingredient products, so ingredient attribution is imperfect, and spontaneous reporting cannot calculate incidence. The repeated, serious signal still drove removal from Australia’s low-risk listed-medicine pathway. [1]
Reactions can occur on first use or after prior tolerance, often within 30 minutes. Stop at the first allergic symptom. Call emergency services immediately for difficult or noisy breathing, tongue or throat swelling, wheeze, persistent cough, hoarse voice, dizziness or collapse. Do not retry the product to test causality. [1]
Other reported effects include nausea, diarrhea, abdominal discomfort, rash, headache and taste disturbance. Interaction evidence is limited. Review use with anticoagulants or antiplatelet drugs, blood-pressure or glucose-lowering medicines, immunosuppressants and medicines with a narrow therapeutic range. Laboratory interaction signals are not precise enough to self-adjust prescriptions.
Avoid unsupervised use during pregnancy or breastfeeding because reproductive and infant safety data are inadequate. Seek pediatric guidance rather than scaling an adult product by body weight.
Legal status in the United States and Canada
In the United States, Andrographis may be sold as a dietary supplement, but products are not preapproved as treatments for respiratory infection.
In Canada, licensed natural health products carry an NPN tied to their exact formulation and claims. Check the product licence and warning label; a foreign formulation is not automatically equivalent.
In Australia, Andrographis was removed from ingredients allowed in new listed medicines from September 17, 2026 because severe-allergy risk could not be adequately managed in that low-risk pathway. Sponsors recalled affected products in October 2026. [6], [7]
What should be monitored?
Record product and lot, plant part, extraction ratio, andrographolide percentage, amount per administration, frequency, first dose, symptom onset, test result, temperature, breathing, hydration, rash, swelling and all concurrent medicines. Keep each study-style symptom score at a consistent time.
What happens after stopping?
No withdrawal syndrome or taper is established. Stop immediately after a suspected allergy and seek advice even if symptoms settle, because a severe reaction may recur. Respiratory illness can worsen independently after a supplement is stopped.
How should Andrographis be stored?
Keep it sealed, dry and away from children. Retain the label, lot and expiry so a suspected reaction can be reported accurately.
Community experience
Online reports often mix tinctures, plant powder, branded extracts and combination cold products. They can surface bitterness, nausea, taste changes or allergy timing, but cannot establish infection clearance, incidence or which ingredient caused an effect.
How does Andrographis compare with other approaches?
Andrographis does not replace vaccination, diagnostic testing, hydration, symptom-directed care or prescription treatment when indicated. Echinacea, elderberry and pelargonium have different preparations and evidence bases; none can be substituted milligram for milligram.
Common questions
Did the recent trial show a benefit?
Only at day 3. The two AP-Bio groups had lower WURSS-21 scores then, but differences were absent at days 5 and 7. [2]
Does the meta-analysis prove that every product works?
No. It pooled different preparations, mixtures, diagnoses and comparators, and judged overall trial quality poor. [3]
How common is anaphylaxis?
The TGA reports establish a serious signal but cannot calculate incidence because the number of all exposed users and completeness of reporting are unknown. [1]
Is prior tolerance reassuring?
It does not eliminate risk. Reactions occurred after previous uneventful use as well as on first exposure. [1]
Is 400 mg always a stronger equivalent dose?
No. Milligrams cannot be compared without plant part, extraction ratio and standardization.
Can it replace antibiotics or antivirals?
No. Testing and clinical indications determine treatment; symptom trials do not establish treatment of bacterial infection, influenza complications or pneumonia.
Is long-term daily use established?
No. The featured trials lasted only 5 to 7 days.
Glossary
Terms used in this guide.
- Andrographolide
- A diterpene lactone used as a chemical marker in some Andrographis extracts.
- WURSS-21
- A 21-item questionnaire measuring the impact of upper respiratory symptoms.
- Anaphylaxis
- A rapidly developing, potentially fatal allergic reaction requiring emergency treatment.
- Pharmacovigilance
- Monitoring and evaluation of suspected adverse reactions after products are used in practice.
- Standardization
- Specification of one or more marker compounds in an extract; it does not guarantee clinical equivalence.
- Titration
- Planned dose adjustment; it is not a method for preventing anaphylaxis.
How this guide was researched
This draft prioritized the Australian TGA’s 2026 safety review, the 2023 phase III trial, a full-text systematic review, its correction notice and a named older randomized trial. Evidence was refreshed October 9, 2026.
How this guide was made
The ledger preserves branded formulation, total daily amount, unreported frequency, assessment day, heterogeneity, correction status and the limitations of spontaneous safety reports.
Research method and gaps
Four PubMed records were checked against live NCBI efetch XML for title, authors, journal, identifiers and CommentsCorrections. Full PMC text was read for Hu 2017, and full Europe PMC XML was read for its 2018 correction. Raj 2023 and Saxena 2010 protocol details are limited to their PubMed abstracts.
Gaps include independent replication of the recent extract, absolute allergy incidence, long-term safety, pregnancy and breastfeeding, pediatric equivalence, interaction magnitude and reliable comparisons across products.
Sources
Search the official safety review, randomized trials, systematic review and correction.
Showing 7 sources
- 01
Andrographis paniculata (Andrographis) and anaphylaxis — updated safety review and supplementary report ↗
Official pharmacovigilance and regulatory review
Reports 287 linked anaphylaxis cases through 2025 and explains the unpredictable reaction pattern.
- 02
Efficacy and safety of AP-Bio®(KalmCold®) in participants with uncomplicated upper respiratory tract viral infection (common cold) - A phase III, double-blind, parallel group, randomized placebo-controlled trial. ↗
Randomized phase III placebo-controlled trial
300 participants; day-3 symptom difference did not persist at days 5 or 7.
- 03
Andrographis paniculata (Chuān Xīn Lián) for symptomatic relief of acute respiratory tract infections in adults and children: A systematic review and meta-analysis. ↗
Systematic review and meta-analysis
33 trials; pooled findings were favorable but methods were poor and preparations heterogeneous.
- 04
Correction: Andrographis paniculata (Chuān Xīn Lián) for symptomatic relief of acute respiratory tract infections in adults and children: A systematic review and meta-analysis. ↗
Published correction
Adds an omitted Pukka Herbs educational-stipend disclosure; no outcome correction reported.
- 05
A randomized double blind placebo controlled clinical evaluation of extract of Andrographis paniculata (KalmCold) in patients with uncomplicated upper respiratory tract infection. ↗
Randomized double-blind placebo-controlled trial
223 participants; favorable day-5 symptom scores, with formulation and frequency incompletely reported in the abstract.
- 06
Andrographis removed from listed medicines framework because of allergy risk ↗
Official regulatory decision
Confirms removal from ingredients permitted in new listed medicines from September 17, 2026.
- 07
Andrographis recalls: Concerns over allergy risk ↗
Official recall notice
Lists recalls arising from the risk of severe allergic reactions.
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