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Table 2 Details of observational studies on ADRs in pediatric hospitalized patients (n = 10)

From: Pharmacovigilance and incidence of adverse drug reactions in hospitalized pediatric patients: a mini systematic review

Study/year (reference) Gender Age group Mean age of population Types of ADRs/causality assessment
(n, %)
Severity Most common drug class involved in ADRs Most common reported ADRs
Gallagher RM et al./2011 [22] Not reported Not reported Not reported Probable ADR (17, 63%) and definite/probable (10, 37%) Not reported Anti-neoplastic agents Neutropenia, vomiting, and diarrhea
Gallagher RM et al./2012 [23] Male = 52.8%
Females = 47.2%
Age not reported 3 years 1 month Definite (94/249, 37.8%) Severe 14 (5.6%) Cytotoxic drugs Neutropenia, thrombocytopenia and anemia.
Khan LM et al./2013 [16] Male = 48.7%
Female = 51.3%
0–15 years Not reported Possible ADRs (36, 47.3%), probable (34, 44.7%), and definite (6, 7.9%) Not reported Anti-microbials Skin-associated ADRs
Dash M et al./2015 [29] Male = 37.8 %
Females = 62.2 %
< 14 years Not reported Probable (101, 80%) and possible category (26, 20%) Mild 88 (69.3%), moderate 30 (23.6%), and severe 9 (7%) Anti-epileptic and anti-microbial drugs Skin-associated ADRs
Gholami K et al./201 5[24] Male = 59.2%
Females = 40.8%
≤ 18 years 40.6 ± 36 months Probable (23, 85.2%), possible (3, 11.1%), and definite (1, 3.7%). Not reported Anti-microbials and central nervous system agents Skin-associated ADRs, diarrhea, and vomiting
Rivas AB et.al/2016 [28] Male = 63%
Females = 37%
Age not reported 0.9 ± 2.9 days Probable ADRs (66, 57%), possible (37, 32%), and definite (13, 11%). Moderate (49, 42%), mild (47, 41%), and severe (20, 17.2%) Anti-microbials and caffeine citrate Feed intolerance, phlebitis, and tachycardia
Salas Rdl et al./2016 [30] Male = 50.9%
Females = 49.1%
< 6 years 20.8 ± 17.3 months Probable (153, 98.1%), possible (2, 1.3%), and definite/certain (1, 0.6%) Mild (103, 66.0%), moderate (53, 34 %), and no severe case Anti-microbials Diarrhea, vomiting, rash, and phlebitis
Kurian J et al./2016 [25] Male = 68.5%
Females = 31.5%
≤ 18 years Not reported Probable category (56, 87.5%) followed by possible (8, 12.5%). Mild (53, 82.8%), moderate (11, 17.2%), and no severe case Anti-microbials and anticonvulsants Diarrhea vomiting, rashes, and somnolence
Vázquez-Alvarez AO et al./2017 [27] Male = 57.6%
Females = 42.4%
1 day to 18 years 7.2 (± 5.9) years Probable (13, 68.4%), definite (4, 21%) and possible (2, 10.6%) Severe (8, 42%) Anti-microbials and anti-epileptic drugs Skin-associated ADRs and anxiety
Sindhu AR et al./2019 [26] Male = 53.3%
Females = 46.7%
0 to 12 years Not reported Probable (10. 66.6%), possible (4, 26.6%), and definite (1, 6.6%). Mild (9, 60%), moderate (6, 40%) and no severe case Anti-microbials and anti-convulsants Skin-associated ADRs, hypotension, and diarrhea