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Andrographis paniculata

Plant immunomodulator, supplement. In EU – traditional herbal medicinal product (EMA HMPC monograph 2013)

ATC code: A11JA-ANDROGRAPHIS

Brand names – supplements: Now Andrographis, Solgar Andrographis, Paradise Herbs Andrographis, Kan Jang (Swedish Herbal Institute)Supplements are not tested in clinical trials and are not registered as medications.

Updated · Methodology

Indications

C

Acute viral bronchitis

Adjunct

Andrographis has been studied in acute viral bronchitis as symptomatic therapy. The Saxena 2010 RCT with KalmCold extract 200 mg/day × 5 days in 223 patients with uncomplicated upper-respiratory URI with cough showed significant cough intensity and sore throat reduction by day 3–5 vs placebo. The Hu 2017 systematic review confirmed cough effect in a subgroup. HMPC 2013 lists traditional use for «cough associated with cold». Acute viral bronchitis (>90% of cases) per AAFP and SEIMC is managed symptomatically (dextromethorphan, guaifenesin for dry cough, acetylcysteine); antibiotics are not indicated. Andrographis may be considered as adjunct to symptomatic therapy in adults without red flags (febrile fever >38.5 °C >3 days, purulent sputum, bronchospasm).

Sources

  1. Phytomedicine: A randomised, double blind, placebo controlled clinical evaluation of extract of Andrographis paniculata (KalmCold) in patients with uncomplicated upper respiratory tract infection (2010)
  2. PLoS One: Andrographis paniculata (Chuan Xin Lian) for symptomatic relief of acute respiratory tract infections in adults and children: systematic review and meta-analysis (2017)

ICD-10: J20 · ICD-11: CA42

C

Common cold

Adjunct

Andrographis is one of the adaptogens with relatively more convincing evidence in the common cold. The Hu 2017 systematic review of 33 RCTs in 7175 participants showed moderate reduction in cold symptom duration and severity (cough, sore throat, nasal congestion) with andrographis extracts 1200–6000 mg/day for 5–7 days. The Cáceres 1999 RCT in 152 cold patients showed significant symptom reduction by day 4–5 with SHA-10 vs placebo. The Saxena 2010 RCT in 223 patients with KalmCold showed symptom reduction by day 2-3. Evidence quality is limited by product heterogeneity, varied andrographolide standardisation and potential publication bias. HMPC 2013 recognises «traditional use». AAFP 2019 and SEIMC 2020 for the common cold list symptomatic therapy first-line; andrographis is in the «evidence limited» category.

Sources

  1. Phytomedicine: Use of visual analogue scale measurements to assess the effectiveness of standardised Andrographis paniculata extract SHA-10 in reducing the symptoms of common cold: randomised double-blind placebo controlled study (1999)
  2. Phytomedicine: A randomised, double blind, placebo controlled clinical evaluation of extract of Andrographis paniculata (KalmCold) in patients with uncomplicated upper respiratory tract infection (2010)
  3. PLoS One: Andrographis paniculata (Chuan Xin Lian) for symptomatic relief of acute respiratory tract infections in adults and children: systematic review and meta-analysis (2017)
  4. Explore (NY): Andrographis paniculata for the treatment of upper respiratory tract infection: a systematic review (2006)

ICD-10: J00 · ICD-11: CA00

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

D

Immune support and respiratory infection care

Not recommended

Andrographis is sold as «immunity boosting and URI prophylaxis». The Hu 2017 systematic review in a prophylaxis subgroup showed moderate cold frequency reduction with long-term (3-month) intake in adults, but the number and quality of these trials are limited. HMPC 2013 recognises «short-term traditional use for common cold», not long-term prophylaxis. approved no «immunity» health claim for andrographis. For URI prevention international guidelines list hand hygiene, influenza and pneumococcal vaccination in risk groups; herbal supplements are not in recommendations. Long-term andrographis intake (>8 weeks) is associated with hepatotoxicity and allergic reaction risk.

Sources

  1. PLoS One: Andrographis paniculata (Chuan Xin Lian) for symptomatic relief of acute respiratory tract infections in adults and children: systematic review and meta-analysis (2017)
D

Influenza

Not recommended

Andrographis is sold as a «natural flu remedy» promising symptom severity reduction. Evidence in lab-confirmed influenza is limited: most RCTs studied mixed URIs without PCR or serology confirmation. The Hu 2017 systematic review in a flu-like symptom subgroup recorded moderate severity reduction, but fever duration and complications were not assessed. 2018 in confirmed influenza in patients with risk factors (age ≥65, pregnancy, immunosuppression, COPD, diabetes, obesity, children under 5) lists oseltamivir within 48 hours of symptom onset first-line. If andrographis was recommended as an oseltamivir substitute in a high-risk patient, consider seeking a second opinion.

Sources

  1. PLoS One: Andrographis paniculata (Chuan Xin Lian) for symptomatic relief of acute respiratory tract infections in adults and children: systematic review and meta-analysis (2017)
  2. IDSA: Clinical practice guidelines by the Infectious Diseases Society of America: 2018 update on diagnosis, treatment, chemoprophylaxis and institutional outbreak management of seasonal influenza (2018)

ICD-10: J10-J11 · ICD-11: 1E32

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Andrographis leaves contain diterpene lactones – andrographolide, neoandrographolide, deoxyandrographolide, deoxydidehydroandrographolide. In vitro and animal models show andrographolide suppresses NF-κB activation, reduces pro-inflammatory cytokine synthesis (TNF-α, IL-6, IL-1β) and inhibits influenza and rhinovirus replication. The human mechanism is not clinically characterised; oral andrographolide bioavailability is moderate with peak concentration at 1–2 hours. HMPC 2013 recognised the aerial parts of andrographis as a traditional herbal medicinal product for cold symptoms based on 30 years of traditional use in Ayurvedic, traditional Chinese and Thai medicine. Standardisation is by andrographolide content – typically 4–6% or 10–30 mg per capsule.

Safety

Contraindications

  • Pregnancy and lactation (abortifacient effect in animal models)
  • Pregnancy planning (antifertility effect)
  • Children under 12 (EMA HMPC – insufficient data)
  • Autoimmune disease (SLE, MS, RA) – immune response activation risk
  • Immunosuppressant therapy (ciclosporin, tacrolimus, methotrexate, biologics)
  • Allergy to Acanthaceae family plants
  • Long-term intake >8 weeks without break

Serious adverse effects

  • Anaphylactic reactions (rare, up to anaphylactic shock)
  • Hepatotoxicity with long-term high-dose intake (ALT, AST, bilirubin elevation)
  • Acute urticaria and angio-oedema (Swedish and Finnish pharmacovigilance data)
  • Reduced fertility with long-term intake (experimental data)

Common adverse effects

  • Nausea, vomiting
  • Diarrhoea
  • Reduced appetite
  • Bitter taste
  • Allergic reactions (urticaria, skin rash)
  • Headache

Pregnancy: can you take Andrographis paniculata?

No RCT data in pregnancy. EMA HMPC 2013 lists pregnancy as contraindication. Andrographis showed abortifacient and antifertility effects in experimental animal models. Avoid in pregnancy and women trying to conceive.

Breastfeeding: can you take Andrographis paniculata?

No data on andrographolide milk transfer. EMA HMPC 2013 lists lactation as contraindication. Lactating women should avoid.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

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Frequently asked

What is Andrographis paniculata used for?

Andrographis paniculata is evaluated for the following indications with varying evidence strength: Common cold (evidence tier C), Acute viral bronchitis (evidence tier C), Influenza (evidence tier D). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Andrographis paniculata?

Common side effects of Andrographis paniculata (≥ 1 in 100): Nausea, vomiting, Diarrhoea, Reduced appetite, Bitter taste, Allergic reactions (urticaria, skin rash), Headache. See the Safety section for uncommon and serious reactions.

Is Andrographis paniculata safe during pregnancy?

No RCT data in pregnancy. EMA HMPC 2013 lists pregnancy as contraindication. Andrographis showed abortifacient and antifertility effects in experimental animal models. Avoid in pregnancy and women trying to conceive.

Is Andrographis paniculata compatible with breastfeeding?

No data on andrographolide milk transfer. EMA HMPC 2013 lists lactation as contraindication. Lactating women should avoid.

Who should not take Andrographis paniculata?

Andrographis paniculata is contraindicated in: Pregnancy and lactation (abortifacient effect in animal models); Pregnancy planning (antifertility effect); Children under 12 (EMA HMPC – insufficient data); Autoimmune disease (SLE, MS, RA) – immune response activation risk; Immunosuppressant therapy (ciclosporin, tacrolimus, methotrexate, biologics). Full list in the Safety section.

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