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Table 3 Hypersensitivity reactions with critical term among patients using andrographis product

From: Characterization of hypersensitivity reactions reported among Andrographis paniculata users in Thailand using Health Product Vigilance Center (HPVC) database

Case no. Product Adverse event/symptom Outcome
Drug Typea Dosage Adverse event Details Onset Seriousness Causality assessment
1 andrographis (325 mg/cap) S 5 cap PO, OD anaphylactic shock Angioedema, urticaria, BP 90/60 30 min serious (hospitalization or prolongation of hospitalization) Certain Complete recovery without lesion
2 andrographis (352 mg/cap) S 3 cap 1 time used anaphylactic shock Urticaria, BP 87/73 1 day serious (hospitalization or prolongation of hospitalization) Probable Complete recovery without lesion
  paracetamol (500 mg) O 1 tab PO, OD      
  chlorpheniramine (4 mg) O 1 tab PO, TID      
3 andrographis S 2 cap 1 time used anaphylactic shock Urticaria, BP 90/70 30 min serious (hospitalization or prolongation of hospitalization) Probable Complete recovery without lesion
  paracetamol (500 mg) O 2 tab PO, prn      
4 andrographis S 2 cap 1 time used anaphylactic shock Oedema, uticaria, chest pain, BP 130/70 1 day serious (hospitalization or prolongation of hospitalization) Probable Complete recovery without lesion
5 andrographis (352 mg/cap) S 1 cap PO, TID anaphylactic shock Puffy eyelid, lung wheezing, drowsiness, BP 80/50 1 day serious (life threatening) Certain Complete recovery without lesion
6 andrographis S 1750 mg 1 time used anaphylactic reaction Urticaria, sweat increased, nausea, BP 96/59 10 min serious (hospitalization or prolongation of hospitalization) Probable Complete recovery without lesion
7 andrographis S 350 mg PO, 1 time used anaphylactic reaction anaphylactic reaction, BP 120/80 45 min serious (life threatening) Probable Complete recovery without lesion
8 andrographis S 400 mg 2 time used anaphylactic reaction Oedema eyelid, wheezing, rash, BP 153/101 16 hr serious (hospitalization or prolongation of hospitalization) Probable Complete recovery without lesion
9 andrographis S 2 cap PO, 1 time used anaphylactic reaction Urticaria, rash, chest tightness, , tachycardia 5 min serious (hospitalization or prolongation of hospitalization) Probable Complete recovery without lesion
10 andrographis S 4 cap PO, TID angioedema Angioedema, urticaria 1 day Non-serious Certain Complete recovery without lesion
11 andrographis S 3 cap PO, TID angioedema - 1 day Non-serious Possible Complete recovery without lesion
  guaifenesin (100 mg) O 1 tab PO, TID       
  Salbutamol (4 mg) O 1 tab PO, TID       
12 andrographis S N/A angioedema - N/A Non-serious Possible Complete recovery without lesion
  ranitidine O N/A       
  hydrochlorothiazide O N/A       
  Curcuma longa Linn. O N/A       
13 andrographis S N/A angioedema - 1 day Non-serious Probable Still has some symptom
  1. aS = Suspected product, O = Other product.
  2. Abbreviations: PO Per oral, OD once a day, TID three times a day, QID Quater In Die (four times a day), prn Pro Re Nata (as needed), N/A not available, min minute (s), hr hour (s).