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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).