Bengal Physician Journal
Volume 9 | Issue 3 | Year 2022

Gastrointestinal System Adverse Drug Reactions in Geriatric Patients in Odisha

Satyabrata Sahoo1, Suhasini Dehury2, Dhirendra Nath Maharana3, Shambo Samrat Samajdar4

1,4Department of Clinical and Experimental Pharmacology, Calcutta School of Tropical Medicine, Kolkata, West Bengal, India

2Department of Pharmacology, SCB Medical College and Hospital, Cuttack, Odisha, India

3Department of Geriatric Medicine, SCB Medical College and Hospital, Cuttack, Odisha, India

Corresponding Author: Satyabrata Sahoo, Department of Clinical and Experimental Pharmacology, Calcutta School of Tropical Medicine, Kolkata, West Bengal, India, Phone: +91 9778297447, e-mail: drsatyabrata23@gmail.com

How to cite this article: Sahoo S, Dehury S, Maharana DN, et al. Gastrointestinal System Adverse Drug Reactions in Geriatric Patients in Odisha. Bengal Physician Journal 2022;9(3):60–63.

Source of support: Nil

Conflict of interest: Dr. Shambo Samrat Samajdar is associated as the Associate Editor of this journal and this manuscript was subjected to this journal’s standard review procedures, with this peer review handled independently of the Editor-in-Chief and his research group.

Received on: 18 October 2022; Accepted on: 13 November 2022; Published on: 06 January 2023


Aim and objective: Geriatrics is a specialty that deals with the care of the aged. The term “geriatric population” refers to those over 60 years. In India, the elderly make up 8.14% of the population. The pharmacokinetic and pharmacodynamic aspects of the delivered medications are affected by their complicated physiological and pathological profiles. Polypharmacy can lead to various drug–drug interactions and adverse drug reactions (ADRs) in elderly. Gastrointestinal (GI) system ADRs are mostly found in hospitalized elderly. Gastrointestinal ADRs include upper gastrointestinal bleeding (UGI) bleed, diarrhea, etc.; these are the frequent causes of seriousness and hospitalization in geriatric patients. These ADRs are difficult to manage. To prevent ADRs, we need to understand the risk of potential inappropriate prescribing. Deprescribing in appropriate time can prevent medication-related atrocities. Clinical pharmacological reconciliation and review would help us understand anticholinergic burden associated with polypharmacy. Gastrointestinal system ADRs in geriatric patients have been the subject of a small number of research in India, but none have been undertaken in Odisha. Therefore, the aim of this study is to evaluate the GI ADRs that geriatric patients in Odisha experience.

Materials and methods: This prospective, hospital-based observational study was carried out by the SCB Medical College and Hospital’s Department of Pharmacology and Geriatric Medicine. From August 2016 to July 2018, all elderly patients (aged ≥60 years) with ADR diagnoses were included. The Suspected Adverse Drug Reaction Reporting Form of Indian Pharmacopoeia Commission Version 1.3 was filled out with the ADRs and their features. The prevalence and profile of GI system ADRs were observed. The WHO-UMC System rated their causation, the Hartwig’s Severity Scale evaluated their severity, and the Schumock and Thornton Preventability Scale evaluated their preventability.

Results: In 2 years, 236 geriatric ADRs were documented, 11% of which involved the GI system. Out of the GI system ADRs, 85% ADRs were found to be in possible category, 92.3% were found to be of moderate in intensity, and 84.6% were found to be probably preventable. The most frequent GI system ADR identified was UGI bleeding caused by nonsteroidal anti-inflammatory drugs (NSAIDs) (61.5%).

Conclusion: Most of the ADRs were found to be of moderate intensity according to Hartwig’s Severity Scale and probably preventable according to Schumock and Thornton Preventability scale. NSAID-induced UGI bleeding is the major type of GI system ADR found in this study.

Keywords: Adverse drug reaction, Antidiabetic agents, Central nervous system, Elderly, Gastrointestinal, Hospitalized, Upper gastrointestinal bleeding.



This study was carried out to study GI ADRs with the following objectives:


Inclusion Criteria

  • Geriatric patients (≥60 years) of both sexes presenting in the Department of Geriatric Medicine with all types of suspected ADRs were included in the study.

  • The detailed information of the GI system ADRs was evaluated.

Exclusion Criteria

  • Patients who refused to give consent, those with substance abuse, and those with intentional or accidental intoxication were excluded from the study.

Statistical Analysis

Correct data collection after all patient consent. Data disaggregated by age-groups (60–69, 70–79, and ≥80 years) and gender-wise, and evaluated statistically in Excel. Most data are expressed as percentages.


Table 1 shows the number of ADRs that affected various body systems. The most commonly affected body system was skin system, i.e., 100 (42.3%) ADRs, followed by metabolic system, i.e., 68 (28.8 %) ADRs followed by GI system, i.e., 26(11%), central nervous system (CNS) system, i.e.,12 (5%), and respiratory system, i.e., 10 (4.2%).

Table 1: ADRs in different body system
System involved No. of ADR (n = 236) % of ADR
Skin 100 42.3
Metabolic 68 28.8
GI 26 11
CNS 12 5
Respiratory 10 4.2
Blood 10 4.2
Musculoskeletal 6 2.5
Renal 4 1.6

The total ADRs in geriatric patients are 236, out of which GI system ADRs are 26. Table 2 depicts the demographic profile of GI system ADRs in geriatric patients. Maximum 80.8% GI system ADRs found in males followed by females (19.2%).

Table 2: Demographic profile of GI system ADRs in geriatric patients
Gender No. (%ADRs)
Male 21 (80.8%)
Female 5 (19.2%)

The total ADRs in geriatric patients are 236, out of which GI system ADRs are 26. Table 3 above shows number and percentage of GI system ADRs in different age-groups. Maximum 76.9% of GI system ADRs found in group (60–69 years). Least ADRs (7.7%) found in very old age-group (≥80 years).

Table 3: Number and percentage of GI system ADRs in different age-groups
Age-groups No. and % of ADRs
60–69 years 20 (76.9%)
70–79 years 4 (15.4%)
≥80 years 2 (7.7%)

Table 4 depicts type and percentage of GI system ADRs due to different drugs. Maximum GI system ADRs are NSAID-induced UGI bleed (61.5%) found in our study due to diclofenac and aceclofenac followed by antibiotic-induced diarrhea (30.8%) due to amoxyclav and penclav.

Table 4: Type and percentage of GI system ADRs due to different drugs
Type of GI system ADRs Number of ADRs with % Drugs causing ADRs
NSAID-induced UGI bleed 16 (61.5%) Aceclofenac and diclofenac
Antibiotic-induced diarrhea 8 (30.8%) Amoxyclav and penclav
Immunosuppressant-induced mouth ulcer 2 (7.7%) Methotrexate

Table 5 depicts NSAID-induced UGI bleed (61.5%) most common GI system ADRs found in our study followed by antibiotic-induced diarrhea (30.8%) followed by immunosuppressant-induced mouth ulcer (7.7%).

Table 5: Percentage of different GI system ADRs
NSAID-induced UGI bleed 16 (61.5%)
Antibiotic-induced diarrhea 8 (30.8%)
Immunosuppressant-induced mouth ulcer 2 (7.7%)

Table 6 shows the percentage of ADRs attributed to various categories of both WHO-UMC and Naranjo scales. WHO-UMC scale shows that 22 (85%) ADRs in possible category, 4(15%) in probable category. Naranjo Probability scale shows that 22(85%) ADRs in possible category and 4 (15%) ADRs in probable category.

Table 6: Causality assessment by various scales
Causality category WHO-UMC scale Number of ADRs (%) Naranjo ADR probability scale–Number of ADRs (%)
Certain/definite 0 0
Probable 4(15%) 4(15%)
Possible 22(85%) 22(85%)
Unlikely 0 0
Conditional/unclassifiable 0 0
Total 26 (100%) 26 (100%)

Table 7 above shows Hartwig’s severity scale, according to this scale 24(92.3%) ADRs were found to be of moderate intensity and 2 (7.7%) ADRs were found to be of severe intensity.

Table 7: Severity assessed by Hartwig’s scale
Severity Level Number of ADRs Total (%)
Mild 1 0 0
  2 0  
Moderate 3 0 92.3%
  4 24  
Severe 5 2 7.7%
  6 0  
  7 0  

The total GI system ADRs in geriatric patient are 26. Table 8 above depicts preventability of ADRs by Schumock and Thornton preventability scale. According to this scale, 22 (84.6 %) ADRs were observed to be in probably preventable, 2 (7.7 %) were observed to be in definitely preventable, and 2 (7.7%) were observed to be in not preventable category.

Table 8: Preventability assessment by Schumock and Thornton scale
Preventability of ADRs
Definitely preventable 2 GI system ADRs
Probably preventable 22 GI system ADRs
Not preventable 2 GI system ADRs




The authors pray for Dr Sahoo’s family and thank Dr Sahoo’s family for their kind support and blessings.


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