Table 3. Hypersensitivity reactions with critical term among patients using andrographis product
Case
No.
Age
1
42
Patient
History of drug
allergy
female
no
2
32
female
3
18
female
Product
Date
stop
Aug 17,
2008
3 cap 1 time
used
Sep 26,
2011
Sep 26,
2011
O
1 tab PO, OD
Cont’
O
1 tab PO, TID
S
2 cap 1 time
used
Sep 26,
2011
Sep 26,
2011
Aug 13,
2009
paracetamol
(500 mg)
andrographis
O
2 tab PO, prn
S
2 cap 1 time
used
Aug 13,
2009
May 7,
2011
Aug 13,
2009
May 7,
2011
Type a
Dosage
andrographis
(325 mg/cap)
S
5 cap PO, OD
andrographis
(352 mg/cap)
S
no
paracetamol
(500 mg)
chlorphenira
mine (4 mg)
andrographis
no
Adverse event/symptom
Date
begin
Aug 17,
2008
Drug
Gender
Adverse event
Details
Onset
anaphylactic shock
Angioedema,
urticaria, BP
90/60
30 min
anaphylactic shock
Urticaria, BP
87/73
1 day
anaphylactic shock
Urticaria, BP
90/70
30 min
anaphylactic shock
Oedema, uticaria,
chest pain, BP
130/70
1 day
Puffy eyelid, lung
wheezing,
drowsiness, BP
80/50
Urticaria, sweat
increased,
nausea, BP 96/59
1 day
anaphylactic
reaction, BP
120/80
Oedema eyelid,
wheezing, rash,
BP 153/101
45 min
Urticaria, rash,
chest tightness, ,
tachycardia
5 min
Seriousness
serious
(hospitalization or
prolongation of
hospitalization)
serious
(hospitalization or
prolongation of
hospitalization)
Causality
assessment
Certain
Outcome
Complete recovery
without lesion
Probable
Complete recovery
without lesion
serious
(hospitalization or
prolongation of
hospitalization)
Probable
Complete recovery
without lesion
serious
(hospitalization or
prolongation of
hospitalization)
serious (life
threatening)
Probable
Complete recovery
without lesion
Certain
Complete recovery
without lesion
serious
(hospitalization or
prolongation of
hospitalization)
serious (life
threatening)
Probable
Complete recovery
without lesion
Probable
Complete recovery
without lesion
serious
(hospitalization or
prolongation of
hospitalization)
serious
(hospitalization or
prolongation of
Probable
Complete recovery
without lesion
Probable
Complete recovery
without lesion
Cont’
Aug 13,
2009
4
13
female
no
5
49
female
no
andrographis
(352 mg/cap)
S
1 cap PO, TID
Mar 7,
2011
Mar 7,
2011
anaphylactic shock
6
63
male
no
andrographis
S
1750 mg 1
time used
Dec 14,
2010
Dec 14,
2010
anaphylactic reaction
7
44
female
no
andrographis
S
350 mg PO,
QID
Jan 20,
2011
Jan 20,
2011
anaphylactic reaction
8
51
female
no
andrographis
S
400 mg 2
time used
Mar 29,
2010
Mar 30,
2010
anaphylactic reaction
9
23
female
no
andrographis
S
2 cap PO, TID
Oct 9,
2012
Oct 9,
2012
anaphylactic reaction
10 min
16 hr
Patient
History of drug
Gender
allergy
Case
No.
Age
10
13
male
11
32
female
12
13
75
51
female
male
yes
(Tetracycline)
yes
(Ibruprofen)
no
no
Product
Drug
Type a
Dosage
andrographis
S
4 cap PO, TID
andrographis
S
3 cap PO, TID
guaifenesin
(100 mg)
Salbutamol (4
mg)
andrographis
O
1 tab PO, TID
O
1 tab PO, TID
S
N/A
ranitidine
O
N/A
hydrochlorot
hiazide
Curcuma
longa Linn.
andrographis
O
N/A
O
N/A
S
N/A
Adverse event/symptom
Date
begin
Date
stop
Aug 3,
2010
Jul 2,
2012
Jul 2,
2012
Jul 2,
2012
N/A
Aug 3,
2010
Jul 2,
2012
Jul 2,
2012
Jul 2,
2012
Jun 14,
2008
Jun 14,
2008
Jun 14,
2008
Jun 14,
2008
Jan 22,
2011
Apr 1,
2008
Apr 1,
2008
Apr 1,
2008
Jan 21,
2011
Adverse event
Details
Onset
Seriousness
Causality
assessment
Outcome
1 day
hospitalization)
Non-serious
Certain
angioedema
Angioedema,
urticaria
-
1 day
Non-serious
Possible
angioedema
-
N/A
Non-serious
Possible
Complete recovery
without lesion
angioedema
-
1 day
Non-serious
Probable
Still has some
symptom
angioedema
a Product type: S = suspected product, O = other product, I = product interaction
BP = blood pressure, cap = capsule, cont’ = continue, hr = hour, min = minute, mg = milligram, PO = per oral, prn = as necessary, OD = once a day, TID = three time a day, QID = four time a day, tab = tablet, NA = not applicable.
Complete recovery
without lesion
Complete recovery
without lesion