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Journal articles on the topic 'WHO-UMC causality assessment'

Author: Grafiati

Published: 4 June 2025

Last updated: 1 August 2025

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1

Sharma, Sushil, Ajay Kumar Gupta, and G. Jyothi Reddy. "Inter-rater and intra-rater agreement in causality assessment of adverse drug reactions: a comparative study of WHO-UMC versus Naranjo scale." International Journal of Research in Medical Sciences 5, no. 10 (2017): 4389. http://dx.doi.org/10.18203/2320-6012.ijrms20174564.

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Background: The causality assessment system proposed by the WHO collaborating centre for international drug monitoring, the Uppsala monitoring centre (WHO-UMC) and the Naranjo probability scale are the generally accepted and most widely used methods for causality assessment. Both these scales are structured, transparent, consistent, and easy to apply with distinct advantages. The PvPI recommends use of WHO-UMC scale while many clinicians prefer Naranjo scale for its simplicity. As both these scales are used very widely in practise, it is important to study the level of agreement among them, to

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Misra, Saurav, Manmeet Kaur, Tirthankar Deb, et al. "Agreement and correlation between WHO-UMC Causality scale and the Naranjo algorithm for causality assessment of adverse drug reactions at tertiary care center in Northern India." Journal of Family Medicine and Primary Care 14, no. 4 (2025): 1252–58. https://doi.org/10.4103/jfmpc.jfmpc_1148_24.

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Abstract Background: To develop a structured and harmonized causality assessment method has been a holy grail in pharmacovigilance. The Pharmacovigilance Programme of India (PvPI) recommends the use of the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale, whereas many clinicians prefer the Naranjo algorithm for its simplicity. There is no universally accepted method for the causality grading of ADRs. In the present study, we assessed agreement and correlation between the two widely used causality assessment scales, that is, the WHO-UMC criteria and the Naranjo algorithm. Mat

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Rehan, H. S., Deepti Chopra, and Ashish Kumar Kakkar. "Causality assessment of spontaneously reported adverse drug events: Comparison of WHO-UMC criteria and Naranjo probability scale." International Journal of Risk & Safety in Medicine 19, no. 4 (2007): 223–27. https://doi.org/10.3233/jrs-2007-420.

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ADRs usually do not present with unique clinical and laboratory findings making it difficult to demarcate them from the concurrent illness. For the estimation of the probability that a drug caused an adverse event several methods have been developed namely, the WHO-UMC criteria, the Naranjo probability scale, the Kramer scale and the Karch and Lasagna scale. But none of the available assessment methods have been shown to produce a precise and reliable quantitative estimation of relationship likelihood. The present study was planned to compare the WHO-UMC causality assessment criteria and the N

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Kamdi, Amit S., Pankaj N. Bohra, and Suvarna M. Kalambe. "Ofloxacin-induced maculopapular rash in the infant." International Journal of Basic & Clinical Pharmacology 7, no. 11 (2018): 2261. http://dx.doi.org/10.18203/2319-2003.ijbcp20184185.

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Adverse drug reactions (ADRs) are a major cause of morbidity and mortality in countries having limited healthcare resources. The ofloxacin is an antimicrobial used for treating several bacterial infections. The ofloxacin, belonging to quinolone group of drugs, is bactericidal and acts by inhibition of bacterial DNA gyrase. Among the adverse drug reaction of ofloxacin, skin rashes are rare. An ofloxacin-induced maculopapular rash is the unique rare condition in the infant. The present case report was assessing the causality in ofloxacin induced maculopapular rash in the infant. Naranjo Adverse

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Misra, Saurav, AjayK Shukla, Ratinder Jhaj, ShahN Ahmed, Malaya Nanda, and Deepa Chaudhary. "Agreement between WHO-UMC causality scale and the Naranjo algorithm for causality assessment of adverse drug reactions." Journal of Family Medicine and Primary Care 10, no. 9 (2021): 3303. http://dx.doi.org/10.4103/jfmpc.jfmpc_831_21.

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Misra, Saurav, AjayK Shukla, Ratinder Jhaj, ShahN Ahmed, Malaya Nanda, and Deepa Chaudhary. "Agreement between WHO-UMC causality scale and the Naranjo algorithm for causality assessment of adverse drug reactions." Journal of Family Medicine and Primary Care 10, no. 9 (2021): 3303. http://dx.doi.org/10.4103/jfmpc.jfmpc_831_21.

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Kedia, Pulkit R., Netravathi Angadi, and Vikram P. Thondaebhavi. "Adverse drug reaction due to combination of gabapentin and nortriptyline along with its causality assessment." International Journal of Basic & Clinical Pharmacology 11, no. 5 (2022): 494. http://dx.doi.org/10.18203/2319-2003.ijbcp20222150.

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The combination of gabapentin and nortriptyline is used as the first line drug treatment for management of neuropathic pain; however adverse drug reactions (ADRs) are one of the main causes for discontinuation of the therapy. This is a case study of erythematous maculopapular rash induced by combination of gabapentin and nortriptyline along with its causality assessment. A 55-year-old female came with complaint of back pain for 1 month. She was diagnosed as a case of L1 acute osteoporotic disc compression fracture. The patient was then administered combination tablet of gabapentin and nortript

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Jeenalben, M. Patel, S. Patel Dishaben, R. Acharya Chetankumar, and R. Darji Bhargav. "Study of Adverse Drug Reactions in Inpatients of Medicine Department in a Tertiary Care Hospital: A Cross - Sectional Study." International Journal of Pharmaceutical and Clinical Research 14, no. 5 (2022): 641–55. https://doi.org/10.5281/zenodo.13829262.

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<strong>Introduction:</strong> Adverse Drug Reactions (ADRs) cause considerable morbidity and mortality worldwide. Early detection, evaluation and monitoring of ADRs are essential to reduce harm to patients and thus improve public health. Spontaneous reporting system (SRS) by health care professionals is common method for reporting suspected ADRs. Chances of ADRs in medicine department are high due to various factors. ADR monitoring and evaluation are the key components of effective drug regulation systems, clinical practice and public health programmes. <strong>Aim:</strong> To

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Kishore Babu, A. V., and A. Srinivasa Rao. "A Pharmacovigilance Study on Causality and Severity Assessment of Adverse Drug Reactions in a Teaching Hospital." Journal of Drug Delivery and Therapeutics 9, no. 6-s (2019): 44–52. http://dx.doi.org/10.22270/jddt.v9i6-s.3746.

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Objectives: The main purpose of the study is to assess the causality, severity, preventability of ADRs and factors associated with ADRs in chronic disease patients of tertiary care teaching hospital. Study setting and Design: A Prospective observational longitudinal study was conducted in a tertiary care teaching hospital at Hyderabad, India, for 3 years. Materials and Methods: Patients of age group > 18 years were included in the study. All the patients were distributed according to their gender, age, number medications used, disease condition, and socioeconomic state. The repo

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Gawai, Pushpraj Prafulla. "Overview of important methods used for Causality Assessment of adverse drug events in Pharmacovigilance." journal 1, no. 2 (2020): 6–11. https://doi.org/10.5281/zenodo.4905241.

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<strong>Abstract</strong> The method of assessing causality between adverse events and suspect drugs is the most challenging task in pharmacovigilance. It requires attentive consideration of both the adverse events and suspect drugs, patient-related factors, and co-suspect drugs and other medical conditions of the patient. Though different methods were developed to assess causality, no single method has been proved to produce an accurate or authentic ascertainable evaluation of the causal relationship. Hence, causality assessment has become an important step in evaluating drug safety. Due to a

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Chetan, Sharma, K. Badyal Dinesh, Mittal Neeru, and Gulrez Gaurav. "Adverse Drug Reaction Pattern of First-Line Anti-tubercular Drugs in a Tertiary Care Hospital of Northern India." International Journal of Pharmaceutical and Clinical Research 15, no. 2 (2023): 63–71. https://doi.org/10.5281/zenodo.12797052.

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<strong>Background:</strong> Adverse drug reactions add directly or indirectly to health care burden in form of hospitalization or mortality. ADRs (adverse drug reactions) of antitubercular drugs are rarely reported but are important cause of morbidity and mortality. <strong>Methods and Material:</strong> Patients were called on the days fixed for evaluation. All the information regarding the observed ADRs was noted down in the suspected ADR reporting form version 1.3 issued by Indian pharmacopoeia commission ministry of health and family welfare, Government of India and was als

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Mala, Ravi D., D. M. Ravichand, B. V. Patil, B. S. Payghan, and Anurag Yadav. "An observational study of adverse drug reactions reported in a rural tertiary care hospital." International Journal of Basic & Clinical Pharmacology 8, no. 11 (2019): 2367. http://dx.doi.org/10.18203/2319-2003.ijbcp20194638.

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Background: Adverse drug reactions (ADRs) are noxious and unintended effects of a drug that occurs at doses normally used in humans. ADRs may also result in diminished quality of life, increased physician visits, hospitalizations, and even death. The objectives of this study are to analyze and assess the causality and severity of reported ADRs.Methods: A cross sectional study of ADRs reported to Pharmacovigilance cell of MNR Medical College and Hospital Sangareddy in a year. The details of the various ADRs were statistically analyzed to find out pattern of ADRs. The WHO-UMC causality category

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Lakhani, Preet, Divya Singh, Shireen Barua, et al. "An observational study to analyze predisposing factors, causality, severity and preventability of adverse drug reactions among multidrug resistant tuberculosis patients treated under RNTCP program in Northern India." International Journal of Research in Medical Sciences 7, no. 3 (2019): 687. http://dx.doi.org/10.18203/2320-6012.ijrms20190918.

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Background: There were 4.1% of all new cases and 19% of previously treated patients were diagnosed with either multidrug resistant or rifampicin resistant tuberculosis in 2016. In the state of Uttar Pradesh, there were 2.16 new cases and 44,531 previously treated cases. The objectives of the study were to assess the predisposing factors, causality assessment, severity grading and avoidability of the adverse drug reactions (ADRs) of the antitubercular drugs in MDR-TB patients in a tertiary care hospital of northern India.Methods: This prospective observational study was conducted for 12 months

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Kumar, Pankaj, Saajid Hameed, Manish Kumar, Lalit Mohan, and Harihar Dikshit. "Evaluation of suspected adverse drug reactions of oral anti-diabetic drugs in a tertiary care hospital of Bihar, India: An observational study." Panacea Journal of Medical Sciences 12, no. 1 (2022): 172–76. http://dx.doi.org/10.18231/j.pjms.2022.032.

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Diabetic patients generally require life-long treatment and continuous follow up. In spite of their benefit of achieving glycemic control, there are many safety concerns with antidiabetic drugs such as gastrointestinal side effects, metabolic complications, central nervous system (CNS) symptoms, musculo-skeletal problems, genito-urinary disorders like UTI, development of peripheral oedema, weight gain etc. To highlight pattern of Adverse Drug Reactions with use of oral anti-diabetic drugs.All suspected Adverse Drug Reaction Reporting Form having any anti-diabetic drug as suspected cause of ADR

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Shah, R. C., S. Karki, S. B. Parajuli, P. Bhattarai, and P. K. Chowdhary. "Pharmacovigilance by World Health Organisation Uppsala Monitoring Center Causality Assessment Algorithm in Medicine Ward of Tertiary Care Hospital of New Delhi." Birat Journal of Health Sciences 1, no. 1 (2017): 61–64. http://dx.doi.org/10.3126/bjhs.v1i1.17102.

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Introduction Pharmacovigilance is not new to India and has in fact been going on since 1998. Adverse drugs reaction (ADRs) are important causes of morbidity and mortality all over the world. They account for approximately 10-20% of all hospitalized patients. The overall incidence of serious ADRs is 6.7% and that of fatal is 0.32%.Objective The objectives of the study was to find the pattern of adverse drug reactions in patients attending medicine ward of a tertiary care center of New Delhi.Methodology A prospective study was conducted from March 2013 to December 2013. On the basis of WHO-UMC c

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Prashant, Kumar, Srivastava Bhavana, Bhardwaj Reena, Kumar Pant Nirdosh, Rajdan Neeraj, and Gaur Jalaj. "Prescribing Pattern and Safety Profile of Anticancer Drugs in Carcinoma Lung in Tertiary Care Teaching Hospital, Haldwani." International Journal of Toxicological and Pharmacological Research 13, no. 5 (2023): 165–72. https://doi.org/10.5281/zenodo.11212582.

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<strong>Introduction:</strong> Cancer is most common cause of morbidity and mortality in world, Lung carcinoma second most commonly diagnosed cancer in men. It is multifactorial, most common cause is smoking. <strong>Objective</strong><strong>:</strong> This study was conducted to evaluate prescription pattern and adverse drug reactions (ADR) of Anti cancer drugs in Carcinoma Lung patients. <strong>Material and Methods:</strong> An observational, prospective, open label hospital based study of 114 patients, from January 2021 to September 2022. All cases of diagnosed lu

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., Chandrabhan, Pushpawati Jain, and Shipra Jain. "Adverse drug reaction monitoring study in hospitalized patients: support for pharmacovigilance at a tertiary care hospital." International Journal of Basic & Clinical Pharmacology 10, no. 3 (2021): 261. http://dx.doi.org/10.18203/2319-2003.ijbcp20210554.

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Background: Adverse drug reaction (ADR) reporting is an integral component of pharmacovigilance. However, under-reporting of ADR is commonly observed. The present study has been planned with aim to assess the pattern of reported ADRs in terms of its frequency, causality and severity so as to reinforce pharmacovigilance activities.Methods: This prospective observational study was conducted with the aim to evaluate suspected ADRs in hospitalized patients in departments of Medicine, Surgery and Orthopaedics of a tertiary care hospital in North India for a period of 6 months. The ADRs were assesse

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Sidhu, Harpreet Singh, and Akshay Sadhotra. "Evaluation the pattern of adverse drug reactions by non-steroidal anti-inflammatory drugs at the outpatient orthopedics department of a university teaching hospital in north India." International Journal of Basic & Clinical Pharmacology 7, no. 10 (2018): 1974. http://dx.doi.org/10.18203/2319-2003.ijbcp20183933.

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Background: The study was conducted with an aim to evaluate the pattern of occurrence of adverse drug reactions (ADRs) of Non-steroidal anti-inflammatory drugs (NSAIDs) in orthopedic patients in a tertiary care teaching hospital of North India.Methods: An observational study was carried out in the orthopedic outpatient department at the tertiary care hospital for the period of six months. All patients diagnosed with acute pain and receiving NSAIDs were included. The documented ADRs were assessed for causality, severity and preventability using Naranjo’s algorithm and WHO-UMC scale, modified Ha

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Begum, Shaik Haseena, Venugopal Reddy M., Christina Sahayaraj, Sharon Sonia S., and Vijayabhaskara Reddy Y. "Taxanes induced hypersensitivity reactions in cancer chemotherapy patients reported at adverse drug reaction monitoring centre at a tertiary care hospital." International Journal of Basic & Clinical Pharmacology 12, no. 1 (2022): 29. http://dx.doi.org/10.18203/2319-2003.ijbcp20223350.

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Background: Cancer chemotherapy involves highly complex regimens using antineoplastic agents like taxanes (paclitaxel, docetaxel) etc. Taxanes cause hypersensitivity reactions (HSRs) like redness, rashes, dyspnoea, severe anaphylaxis and death. In this study, adverse drug reactions (ADRs) associated with taxanes are described & analysed on their severity and preventability. The present study aims to analyse and determine the prevalence of ADRs, especially HSRs in patients treated with taxanes.Methods: After getting IEC approval, the present study is done retrospectively by assessing the HS

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Raghute, Latesh B., Sujata Dudhgaonkar, Kavita M. Jaiswal, Akhilesh Singh Parihar, Swapna M. Bhalerao, and Sagrika R. Jumle. "Angioedema caused by over the counter use of dicyclomine hydrochloride and paracetamol fixed dose combination in a child: a case report." International Journal of Basic & Clinical Pharmacology 7, no. 8 (2018): 1659. http://dx.doi.org/10.18203/2319-2003.ijbcp20183040.

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Authors describe a case of angioedema in a male child due to over-the-counter (OTC) use of fixed dose combination (FDC) of Tab. dicyclomine hydrochloride (20mg) and paracetamol (500mg) for abdominal pain. Use of OTC drugs in children without a doctor’s suggestion can lead to unnecessary medication use and is not free of risks. Here, there is a probable causal relationship between the suspected drug and angioedema according to WHO-UMC criteria for Causality Assessment. This case was also reported to the Pharmacovigilance Programme of India (PvPI) through PvPI ADR android application.

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Udhiyati, Aida, and Fita Rahmawati. "Identification of Adverse Drug Reactions of Antidiabetic Drugs Among Hospitalized Elderly Patient with Diabetes." Majalah Farmaseutik 20, no. 3 (2024): 292. http://dx.doi.org/10.22146/farmaseutik.v20i3.80221.

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The pharmacologic management of many acute and chronic conditions and the aging population have contributed to increasing medication use among elderly patients, this situation may lead to drug-related problems (DRPs) especially adverse drug reactions (ADR). This study aims to identify ADR of antidiabetic drugs among hospitalized elderly patient with diabetes. This descriptive observational study with a cross sectional design involved 98 geriatric patients at UGM Academic Hospital that admission between January to December 2021. The inclusion criteria were patients aged above 60 years, has comp

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Nevo, Ofir Noah, Lois La Grenade, Ida-Lina Diak, and Robert Levin. "Acute Generalized Exanthematous Pustulosis in Association with Hydroxyzine and Cetirizine." SKIN The Journal of Cutaneous Medicine 1, no. 3 (2017): 112–16. http://dx.doi.org/10.25251/skin.1.3.1.

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Purpose: Describe our review of the occurrence of acute generalized exanthematous pustulosis (AGEP) with hydroxyzine, and its active metabolites, cetirizine, and levocetirizine.Methods: The Division of Pharmacovigilance of the Food and Drug Administration (FDA) searched the FDA Adverse Event Reporting System (FAERS) and the medical literature for cases of AGEP reported in association with use of hydroxyzine, cetirizine, and levocetirizine. Causality was assessed using a modified World Health Organization Uppsala Monitoring Centre (WHO-UMC) causality assessment tool.Results: The FDA identified

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Nazir, Tauseef, Sameena Farhat, Mohd Adil, and Zuryat Asraf. "Adverse drug reactions associated with first line anti-tubercular drugs, their prevalence and causality assessment in patients on Directly Observed Treatment Short-course (DOTS) in a tertiary care hospital." International Journal of Basic & Clinical Pharmacology 8, no. 1 (2018): 147. http://dx.doi.org/10.18203/2319-2003.ijbcp20185174.

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Background: Treatment of tuberculosis involves giving multiple drugs to the patient which is done to prevent development of resistance besides targeting all bacterial sub-populations. The objective of the present study was to find out the adverse drug reactions (ADRs) of the first line anti-tubercular drugs and to calculate prevalence and causality of these drugs.Methods: The study was conducted by the Department of Pharmacology, Government Medical College, Srinagar in association with the department of Chest medicine. All patients of tuberculosis on directly observed treatment-short course (D

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Munshi, RenukaP, MaheshN Belhekar, and SantoshR Taur. "A study of agreement between the Naranjo algorithm and WHO-UMC criteria for causality assessment of adverse drug reactions." Indian Journal of Pharmacology 46, no. 1 (2014): 117. http://dx.doi.org/10.4103/0253-7613.125192.

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Rasool, Shaheena, Masarat Nazeer, and Mehwish Majeed. "Assessment of causality and severity of various reported adverse drug reactions by different classes of anti-cancer drugs." International Journal of Basic & Clinical Pharmacology 7, no. 3 (2018): 503. http://dx.doi.org/10.18203/2319-2003.ijbcp20180665.

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Background: Chemotherapy involves highly complex regimens and hence accounts to high susceptibility towards Adverse Drug Reactions. All antineoplastic drugs have potential to cause one or more Adverse Drug Reactions which may vary from mild to severe form. So the aim of this study was to determine the prevalence of Adverse Drug Reactions in patients treated with chemotherapy.Methods: After getting approval from the Institutional Ethical Committee, the prospective observational study was conducted in the Department of Pharmacology in association with Department of Radiation Oncology and Departm

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Bansal, Alka, Ashish Agrawal, Lokendra Sharma, and Smita Jain. "A comparative study of active and passive adverse drug reaction reporting systems in terms of false reporting rate." Scripta Medica 51, no. 4 (2020): 223–30. http://dx.doi.org/10.5937/scriptamed51-29065.

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Background: World Health Organisation Uppsala Monitoring Centre (WHO-UMC) was set up in 1968 to collect Adverse Drug Reactions (ADRs) periodically for all drugs across the globe. It identifies two main approaches to pharmacovigilance: active (intensive) and passive (spontaneous). However, very few studies are available to compare these two methods of adverse drug reaction reporting. Methods: A prospective observational study was done on 303 newly diagnosed patients with tuberculosis receiving directly observed therapy short-course (DOTS) in the Sawai Man Singh (SMS) Hospital, Jaipur between 1

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Prasad, Raja Vikram, M. A. Mushtaq Pasha, Afsar Fatima, and C. Deepalatha. "A demographic study on gender related differences in adverse drug reactions of a tertiary care teaching hospital." International Journal Of Community Medicine And Public Health 4, no. 7 (2017): 2344. http://dx.doi.org/10.18203/2394-6040.ijcmph20172821.

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Background: As a part of pharmacovigilance program of India (PvPI) adverse drug reactions (ADRs) are cause of mortality and morbidity in patients unnoticed, which is a part of WHO program for International Drug Safety Monitoring across world. ADRs are considered to be among top 10 causes for mortality. The reason for sex difference in medication response is multi factorial with wide range of aspects like steroid hormones, organ physiology to psychology and socio-cultural factors. The aim was to study on gender related differences in adverse drug reactions in patients attending tertiary care te

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Baijayanti, Rath, Ranjan Naik Manas, Rath Bhabagrahi, Bhoi Renuka, and Prakash Jai. "Cutaneous Adverse Drug Reactions in a Tertiary Care Hospital: An Observational Study." Journal of Pharmacovigilance and Drug Research 1, no. 1 (2020): 1–4. https://doi.org/10.5281/zenodo.4905379.

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Abstract: Cutaneous adverse drug reactions (CADRs) are one of the most common ADRs caused by drugs causing a lot of morbidity and mortality. The overall incidence of CADRs in developed countries is 1-3 %, while that in the developing countries is reported to be higher between 2 % and 5 %. Changes in drug metabolism drug interactions, oxidative stress, and various cytokines are the various factors that cause cutaneous adverse drug reactions. This study aims to evaluate the patterns of CADRs, the causative drugs along with causality and severity assessment. A total of 50 Patients with cutaneous

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Arunabha, Ray, Mukherjee Shoma, Ahmad Shamran, Kiran Sharma Kajal, and Prakash Jai. "Evaluation of Suspected Adverse Drug Reactions and their Causal Associations: Experience of an Adverse Drug Reaction Monitoring Centre of A Tertiary Health Care Unit." International Journal of Toxicological and Pharmacological Research 13, no. 2 (2023): 87–97. https://doi.org/10.5281/zenodo.11281579.

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<strong>Objective:</strong> The objective of this study was to evaluate the profile and causality of adverse drug reactions reported from various departments of a tertiary care teaching hospital in North India. <strong>Methods:</strong> This was an observational study which was conducted in a 510 bedded tertiary care teaching hospital in New Delhi for a period of 2 years. A retrospective analysis of ICSRs from the Adverse Drug Reaction Monitoring Centre (AMC) was done from the records in the department and the reports submitted by VigiFlow. Patients of all age and either sex wer

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Baijayanti Rath, Manas Ranjan Naik, Bhabagrahi Rath, Renuka Bhoi, and Jai Prakash. "Cutaneous adverse drug reactions in a tertiary care hospital: An observational study." Journal of Pharmacovigilance and Drug Research 1, no. 1 (2020): 6–9. http://dx.doi.org/10.53411/jpadr.2020.1.1.2.

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Introduction: Cutaneous adverse drug reactions (CADRs) are one of the most common ADRs caused by drugs causing a lot of morbidity and mortality. The overall incidence of CADRs in developed countries is 1-3 %, while that in the developing countries is reported to be higher between 2 % and 5 %. Changes in drug metabolism drug interactions, oxidative stress, and various cytokines are the various factors that cause cutaneous adverse drug reactions. Aim and objective: This study aims to evaluate the patterns of CADRs, the causative drugs along with causality and severity assessment. Met

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CHAVI, JAIN, SRIVASTAVA BHAVANA, and KUMAR AGARWAL RAJAT. "SAFETY PROFILE OF ANTIDEPRESSANT DRUGS IN TERTIARY CARE TEACHING HOSPITAL, HALDWANI." International Journal of Toxicological and Pharmacological Research 13, no. 7 (2023): 208–2013. https://doi.org/10.5281/zenodo.8254343.

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<strong>ABSTRACT </strong> <strong>Objective:</strong> This prospective observational study was carried out to identify the safety profile of antidepressant drugs in a tertiary care teaching hospital. <strong>Materials and Methods:</strong> New patients aged above 18 years prescribed with at least one antidepressant reporting to outpatient and inpatient unit of Department of Psychiatry of Dr. Susheela Tiwari Government Hospital, Haldwani, meeting the inclusion criteria and consenting to participate in the study were recruited. <strong>Results:</strong> Of the 205 patients who received antidepr

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Bharani, Kalpana R., Nitibhushansingh R. Chandel, and Chhaya A. Goyal. "Dermatological adverse drug reactions in tertiary care hospital: an analysis of causality and severity." International Journal of Basic & Clinical Pharmacology 7, no. 8 (2018): 1620. http://dx.doi.org/10.18203/2319-2003.ijbcp20183033.

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Background: Dermatological adverse drug reactions (ADRs) are easily detected by patients and that precludes further usage of drugs. So, decided to study the pattern, causative drugs, severity of adverse drug reactions and their causality in tertiary care hospital.Methods: It was prospective non inventional cross sectional study. Patients attending OPD or admitted to IPD of all age group and both gender with suspected dermatological ADRs following drug intake were included and the ADRS were recorded on CDSCO’s Pharmacovigilance form. Collected data was analyzed for assessment of causality using

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A. Acharya, Tejas, D. Trivedi, Krupal J. Joshi, Sunita B. Chhaiya, and Dimple S. Mehta. "A Study of Agreement between WHO-UMC Causality Assessment System and the Naranjo Algorithm for Causality Assessment of Adverse Drug Reactions Observed in Medical ICU of a Tertiary Care Teaching Hospital." Biomedical and Pharmacology Journal 13, no. 1 (2020): 79–83. http://dx.doi.org/10.13005/bpj/1863.

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Scholz, I., S. Banholzer, and M. Haschke. "P90 Neuropsychiatric disorder and Montelukast: a case report and VigiBase® analysis." Archives of Disease in Childhood 104, no. 6 (2019): e54.2-e55. http://dx.doi.org/10.1136/archdischild-2019-esdppp.128.

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Learning objectiveRecognize neuropsychiatric symptoms as possible adverse drug reactions (ADR) associated with the leukotriene receptor antagonist Montelukast in childrenClinical CaseAn 11-year-old boy suffering from asthma presented to his pediatrician with an acute onset of nervousness, restlessness and irritability. The teacher noticed a decline in school performance with a reduced attention span. The patient had been treated with Salbutamol (Ventolin®) and Salmeterol/Fluticasone (Seretide®) for the last few years. A treatment with Montelukast chewable tablets was started four months ago. T

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Prajapati, Himani, Neetu Bala, and Dinesh Kansal. "Nevirapine induced Stevens Johnson syndrome." Journal of Pharmacovigilance and Drug Research 1, no. 2 (2020): 35–38. http://dx.doi.org/10.53411/jpadr.2020.1.2.6.

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Introduction: Severe and life-threatening SJS is more common with nevirapine than with other NNRTIs Case presentation: A 56-year-old male patient presented with a complaint of lesions all over the body with a burning sensation for 4 days. He was on an ART regimen, containing zidovudine, lamivudine, and efavirenz combination for 4 years. But patient accidentally started nevirapine and after 10 days he developed maculopapular lesions which were diagnosed as SJS syndrome. There was a history of rash with nevirapine when ART was started initially in 2012. This incident of an adverse event co

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Prajapati, Himani, Neetu Bala, and Dinesh Kansal. "Nevirapine induced Stevens Johnson Syndrome." Journal of Pharmacovigilance and Drug Research 1, no. 2 (2020): 33–35. https://doi.org/10.5281/zenodo.4905249.

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Abstract A 56-year-old male patient presented with a complaint of lesions all over the body with a burning sensation for 4 days. He was on an ART regimen, containing zidovudine, lamivudine, and efavirenz combination for 4 years. But patient accidentally started nevirapine and after 10 days he developed maculopapular lesions which were diagnosed as SJS syndrome. There was a history of rash with nevirapine when ART was started initially in 2012. This incident of an adverse event could be assigned a term "probable" according to the WHO-UMC scale for causality assessment as the re-challe

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Swain, Trupti Rekha, Lorika Sahu, and Jyotishree Mallik. "An unusual and interesting case of sequential serious adverse event." Indian Journal of Pharmacology 57, no. 1 (2025): 52–54. https://doi.org/10.4103/ijp.ijp_675_22.

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Abstract Hydrocortisone and pheniramine are frequently administered drugs for the management of severe allergic or anaphylactic reactions. However, there is hardly any literature that shows the association between the use of these drugs for the management of anaphylactic reactions that can induce serious adverse effect. We present a peculiar case of loss of consciousness following concurrent administration of intravenous pheniramine (Avil) and hydrocortisone (primacort) for the management of another drug-induced adverse reaction characterized by urticaria and pruritis that erupted succeeding i

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Shaifali, Iram, Suruchi Prakash, Shalini Chandra, and Jagdamba Saran. "A comparative evaluation of diclofenac and tramadol as post-operative analgesics along with causality and severity assessment of ADRs." International Journal of Basic & Clinical Pharmacology 8, no. 4 (2019): 725. http://dx.doi.org/10.18203/2319-2003.ijbcp20191107.

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Background: Diclofenac and Tramadol are well established analgesics for post-operative pain management, yet some adverse effects are associated with their use which govern their tolerability. The objective of the study was to evaluate the comparative efficacy of the two drugs and to assess the causality and severity of documented Adverse Drug Reactions (ADRs).Methods: An open labelled, prospective, interventional, simple randomized clinical study to compare efficacy and safety of diclofenac and tramadol was conducted by the Department of Pharmacology in collaboration with the Department of Sur

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Bhavana, Srivastava, Rajdan Neeraj, Sharma Kunal, Virak Bhawna, and Joshi Kalpana. "Hypersensitivity Reaction Induced by Lignocaine Hydrochloride: A Case Series." International Journal of Toxicological and Pharmacological Research 13, no. 7 (2023): 288–90. https://doi.org/10.5281/zenodo.11115638.

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Lignocaine Hydrochloride is the preferred anaesthetic agent used in surgical procedures. Hypersensitivity reactions are exaggerated immunologic reaction occurring in response to exogenous and endogenous substances. Triple Response is an immediate type Hypersensitivity reaction having cutaneous response due to release of histamine which is a dibasic vasoactive amine located in skin and other body tissues Suspected ADRs due to Lignocaine Hydrochloride were reported from Obstetrics and Gynaecology Dept. The ADRs were filled in Suspected ADR reporting form and as per WHO-UMC causality assessment s

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Chavi, Jain, Srivastava Bhavana, and Kumar Agarwal Rajat. "Safety Profile of Antidepressant Drugs in Tertiary Care Teaching Hospital, Haldwani." International Journal of Toxicological and Pharmacological Research 13, no. 7 (2023): 208–13. https://doi.org/10.5281/zenodo.11115339.

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<strong>Objective:</strong> This prospective observational study was carried out to identify the safety profile of antidepressant drugs in a tertiary care teaching hospital. <strong>Materials and Methods:</strong> New patients aged above 18 years prescribed with at least one antidepressant reporting to outpatient and inpatient unit of Department of Psychiatry of Dr. Susheela Tiwari Government Hospital, Haldwani, meeting the inclusion criteria and consenting to participate in the study were recruited. <strong>Results:</strong> Of the 205 patients who received antidepres

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Laskar, Jahirul Islam, Pinaki Chakravarty, and Babul Dewan. "A study on incidence of adverse drug reactions with commonly prescribed drugs and causality assessment in Silchar Medical College and Hospital." International Journal of Basic & Clinical Pharmacology 6, no. 5 (2017): 1175. http://dx.doi.org/10.18203/2319-2003.ijbcp20171673.

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Background: Present study was carried out to assess the incidence of adverse drug reactions (ADRs) and assessment of causality, severity with reported suspected ADRs.Methods: A prospective observational study was conducted over a period of one year in inpatients and out patients hospitalization due to ADRs, at Silchar Medical College & Hospital, Silchar, Assam. WHO–UMC Probability scale was used for causality assessment. Reported ADRs were classified according to Wills and Brown classification and assessed for severity using scale developed by Hartwig et al. All data were calculated by ‘De

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Agarwal, Rahul, Ashok Goel, Jaswant Rai, and Nirmal Chand Kajal. "Pharmacovigilance of first line anti-tubercular therapy in category I patients of pulmonary tuberculosis." International Journal of Basic & Clinical Pharmacology 6, no. 3 (2017): 643. http://dx.doi.org/10.18203/2319-2003.ijbcp20170829.

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Background: Study was done to determine incidence of ADR’s in sputum positive, pulmonary TB patients, on DOTS category I and to determine the effect of ADR’s on sputum conversion.Methods: Open, prospective, observational, non-comparative study conducted in the Department of Pharmacology in collaboration with Department of Tuberculosis and Chest Diseases, Government Medical College, Amritsar for the duration of 18 months (March 2015 to September 2016). One hundred sputum positive patients of pulmonary tuberculosis on DOTS category I, of either sex, in age group of 14 years to 65 years, were rec

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S., Narendra Babu, Vinoth Kumar C., and Nandini R. "Comparative study of adverse drug reaction pattern of two anti-asthma groups of drugs in a tertiary care hospital." International Journal of Basic & Clinical Pharmacology 8, no. 4 (2019): 788. http://dx.doi.org/10.18203/2319-2003.ijbcp20191118.

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Background: Bronchial Asthma is one of the worldwide health problems associated with increased morbidity and also mortality. Bronchial Asthma is a disease of airways that is characterized by increased responsiveness of the trachea-bronchial tree. Anti asthmatic drugs are associated with adverse effects which can affect the compliance and course of treatment. Monitoring adverse drug reactions in asthma will play a vital role in alerting physicians about the possibility and circumstances of such events, thereby protecting the user population from avoidable harm.Methods: The study was conducted i

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James, Janet M., Eldho M. Paul, Dinu Varghese, et al. "Evaluation of adverse drug reactions in a tertiary care hospital in India." International Journal of Basic & Clinical Pharmacology 14, no. 2 (2025): 248–55. https://doi.org/10.18203/2319-2003.ijbcp20250485.

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Background: Adverse drug reaction (ADR) is a major concern in the healthcare system and has been a persistent issue in the health sector. This study aimed to evaluate and assess the ADRs reported, the system organ class (SOC) affected, seriousness, outcomes, causality. Methods: A retrospective observational study in a tertiary care hospital from April 2021 to May 2024. A descriptive analysis of reactions, causality of suspected drugs was carried out according to the setting analysed. Results: Out of 7,396 individual case safety report (ICSR) reported, the highest number of ADRS was reported in

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Rout, Anima, Rajendra K. Panda, Vedvyas Mishra, Prasant Parida, and Srikant Mohanty. "Pharmacovigilance in cancer chemotherapy in regional cancer center of Eastern India: prospective observational study." International Journal of Basic & Clinical Pharmacology 6, no. 8 (2017): 1910. http://dx.doi.org/10.18203/2319-2003.ijbcp20173148.

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Background: Globally cancer is the leading cause of morbidity and mortality with annual death rate of 12%. According Indian Council of Medical Research, more than 1300 Indians die every day due to cancer. Chemotherapy is one of the multimodal approaches for treatment of cancer and regimens are much complex and cancer patients are more susceptible to adverse drug reaction with little tolerance due to diminished immunity. The present study was done to evaluate the prevalence of various adverse drug reactions with different cancer chemotherapy regimens, their nature and severity as well as their

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Barvaliya, Sandip, Jigar R. Panchal, Mira K. Desai, and Minakshi Parikh. "Pattern of adverse drug reactions into psychiatric patients." International Journal of Basic & Clinical Pharmacology 8, no. 5 (2019): 1059. http://dx.doi.org/10.18203/2319-2003.ijbcp20191601.

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Background: To analyse adverse drug reactions (ADRs) reported in patients prescribed psychiatric medications at tertiary care hospital.Methods: ADRs reported in psychiatric patients between January 2011 to June 2017 were analyzed for demographic details, causal drugs, system organ classification, causality assessment (WHO-UMC criteria and Naranjo’s scale), preventability (Modified Schumock and Thorton’s criteria) and severity (Hartwing scale).Results: A total 4368 ADRs were reported during study period, out of which 658 (15.06%) were in psychiatric patients. The mean age of patients was 38±13.

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Venkateswaran, M., M. Dhanasekaran, and S. Rajavelu. "Prescribing pattern and adverse drug effects monitoring of anti-rheumatoid drugs in rheumatoid arthritis patients in a tertiary care hospital." International Journal of Basic & Clinical Pharmacology 8, no. 3 (2019): 462. http://dx.doi.org/10.18203/2319-2003.ijbcp20190567.

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Background: Rheumatoid arthritis (RA) is a common disease that causes substantial morbidity in most patients and premature mortality in many. All the drugs used in the treatment of rheumatoid arthritis show significant toxicity and hence it is important to monitor the drugs for adverse drug reaction. This study will estimate the prescribing pattern and bring out the possible adverse drug reactions in patients with rheumatoid arthritis.Methods: This study included 200 patients with rheumatoid arthritis who fulfilled the study criteria were observed for three months. Their prescriptions were col

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Alugubelly, Nikhitha, Lokesh Bayyapu, Keerthi Priya Aregudem, and Jashwanthini Challapally. "Assessment of Potential Adverse Drug Reactions Associated with Cardiovascular Medicines." Journal of Advances in Bio- pharmaceutics and Pharmacovigilance 5, no. 2 (2023): 30–49. http://dx.doi.org/10.46610/jabp.2023.v05i02.004.

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Background: Every drug has the potential to cause ADRs. Cardiovascular medications are a major problem in drug therapy as they can result in several consequences, ranging from allergic reactions to permanent harm. We have undertaken a meta-analytic review of various types of studies performed in different hospital settings to understand the importance of ADRs in CVD patients and how ADRs might be better detected, evaluated, and avoided. Objectives: To study various factors and assess the incidence, causality, severity, and preventability of ADRs associated with cardiovascular drugs. Methods: M

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Divakar, Manasa, Ananth Ram, and Lalitha K. "Incidence of Adverse Drug Reactions (ADRs) and their Determinants among Sputum-Positive Pulmonary TB Patients in A Metropolitan Area, Bengaluru: A Prospective Study." National Journal of Community Medicine 14, no. 10 (2023): 628–34. http://dx.doi.org/10.55489/njcm.141020233057.

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Background: India accounts for 2.42 million new Tuberculosis cases in 2022. Treatment adherence is major challenge, ADRs being one of the main causes of poor adherence. Early identification and addressing of ADRs can improve adherence, reducing associated morbidity and drug resistance. With introduction of daily FDC regimen in India, we intend to study incidence of ADRs and their determinants among Pulmonary TB patients who are on FDC daily regimen. Methodology: Newly diagnosed drug-sensitive PTB patients aged 18 years and above were recruited. A pretested questionnaire was administered and pa

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Jindal, Amita, Raj Kumar, Sumir Kumar, Amandeep Kaur, Kiranjit, and Rakesh Tilak Raj. "Pattern of adverse drug reactions reported at the adverse drug reaction monitoring centre at tertiary care teaching hospital in North India." International Journal of Basic & Clinical Pharmacology 12, no. 3 (2023): 375–78. http://dx.doi.org/10.18203/2319-2003.ijbcp20231113.

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Background: The aim of the present study was to determine the pattern of adverse drug reactions (ADRs) reported at ADR monitoring centre (AMC) in Punjab. Methods: This observational retrospective study was done in department of Pharmacology, GGS Medical College and Hospital, Faridkot from September 2020 to August 2021. A total of 148 ADRs were reported during the study period. Each ADR was analyzed for demographic data and characteristics of ADR. Assessment of causality, severity and preventability was done according to WHO UMC scale, modified Hartwig and Siegel scale and Modified Schumock and

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