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

Table 1 Characteristics of patients and adverse event reports among andrographis products users

Characteristics	No. (%) [n = 106]^a
Patients
Sex
Female	76 (71.7)
Male	30 (28.3)
Age [y], mean (SD) [min – max]	38.5 (18.4) [8 – 80]
<15	11 (10.4)
15-30	26 (24.5)
31-60	49 (46.2)
>60	11 (10.4)
N/A	9 (8.5)
History of drug allergy
No	93 (87.7)
Yes	12 (11.3)
N/A	1 (1.0)
Adverse event reports
Source of reports
Spontaneous	95 (89.6)
Intensive	11 (10.4)
Seriousness
Serious	18 (17.0)
Hospitalization or prolongation of hospitalization	16
Life threatening	2
Non-serious	88 (83.0)
Causality assessment^b
Certain	8 (7.5)
Probable	61 (57.6)
Possible	33 (31.1)
Unlikely	0 (0.0)
N/A	4 (3.8)
No. of concomitant drug, mean (SD) [min – max]	0.4 (0.8) [0 – 4]
None	82 (77.4)
1item	13 (12.3)
2items	7 (6.6)
3items	3 (2.8)
≥4items	1 (0.9)
Time of exposure (day), mean (SD) [min – max]	1.2 (3.4) [0 – 30]
1 day	51 (48.1)
2 days	20 (18.9)
3 days	14 (13.2)
≥4 days	8 (7.6)
N/A^c	13 (12.2)
Time to onset (day), mean (SD) [min – max]	0.8 (1.6) [0 – 8]
First day of use	61 (57.6)
2daysof use	24 (22.6)
3 days of use	15 (14.2)
≥4 days of use	5 (4.7)
N/A	1 (0.9)

^aAll 106 reports contained hypersensitivity reactions and an andrographis product was considered as the sole suspected drug.
^bAs per reported from health professional.
^cSome reports had no information on starting date, stopping date, or both.
N/A = not available.

ISSN: 2662-7671