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Pattern of Adverse Drug Reactions in Children Attending the Department of Pediatrics in a Tertiary Care Center: A
Kishour Kumar Digra1, Aakash Pandita1, G S Saini1
1Department of Pediatrics, SMGS hospital, Jammu, India.
Insights
Adverse drug reactions (ADRs) are common in children, with anticonvulsants and antibiotics being frequent causes. This study highlights the need for improved pediatric drug safety monitoring to prevent adverse events.
Area of Science:
- Pediatric Pharmacology
- Clinical Toxicology
- Drug Safety Surveillance
Background:
- Adverse drug reactions (ADRs) pose a significant risk in pediatric populations.
- Understanding the patterns of ADRs is crucial for enhancing drug safety in children.
Purpose of the Study:
- To investigate the incidence and characteristics of ADRs in pediatric patients at SMGS Hospital, Jammu.
- To identify the most common drug classes and clinical manifestations associated with ADRs in children.
Main Methods:
- A prospective study was conducted over one year involving pediatric patients.
- Data on ADRs were collected using a structured format and analyzed for probability (Naranjo scale) and severity (Hartwig scale).
- ADRs were classified according to the Adverse Drug Reaction Monitoring Center guidelines.
Main Results:
- 104 pediatric patients experienced acute drug reactions, with Type B reactions being most prevalent (83.6%).
- Anticonvulsants (25.96%) and antibiotics (22.11%) were the leading causes of ADRs.
- Dermatological manifestations (67.30%) were the most common, followed by central nervous system involvement (11.53%). Moderate severity ADRs were observed in 64.4% of patients.
Conclusions:
- ADRs are frequent in children aged 1-5 years (71%).
- Rash is the most common presentation (55.76%) of ADRs.
- There is a critical need for rigorous adverse drug monitoring in pediatric care to ensure therapeutic safety.
Aim:
To study the pattern of various adverse drug reactions (ADRs) occurring in children attending the Department of Pediatrics, SMGS Hospital, Jammu over 1 year.
Subjects And Methods:
This was a prospective study, with study population of patients attending Department of Pediatrics over a period of 1 year. A structured format was used to enroll the participants. A pilot study was conducted to test the suitability of the format and feasibility of the study. The study was carried out to review various pattern of ADRs by using the Naranjo probability scale, and severity was assessed by using the Hartwig severity scale. ADRs were classified according to the classification used by the Adverse Drug Reaction Monitoring Center, Central Drugs Standard Control Organization, New Delhi, India.
Results:
In the present study, 104 patients were found to have developed acute drug reactions. Among these, 83.6% were type B, 14.42% type A, and 1.92% were type U. Furthermore, 25.96% ADRs were due to anticonvulsants, followed by antibiotics (22.11%), antipyretics (11.53%), vaccination (8.65%), steroids (6.73%), decongestants (5.67%), snake antivenom and antiemetics (3.84%), and fluids, insulin, and antacids (1.92%). The patients' dermatological system was involved in 67.30%, followed by the central nervous system (CNS) in 11.53% patients. Renal system was involved in 6.73% patients. Cardiac, musculoskeletal, metabolic, and other systems were involved in 4.80%, 3.84%, 2.88%, and 0.96%, respectively. According to the Hartwig severity scale of ADRs, 64.4% patients had moderate ADRs, 29.8% patients had severe ADRs, and 5.76% had mild ADRs. In the present study, 64.4% patients expressed moderate severity, whereas 29.8% expressed high severity and 5.76% expressed mild ADRs.
Conclusion:
ADRs were seen in 71% of the patients between 1 and 5 years of age, 26% in the age group of 5-10 years, and 3% were more than 10 years old. Anticonvulsants (25.96%) and antibiotics (22.11%) were responsible for majority of ADRs. Rash (55.76%) was the most common presentation of ADR. Owing to the high number of ADRs, the present study points to the need for rigid adverse drug monitoring among pediatric patients to ensure the safety of drug therapy.
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