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1

Lebwohl, Mark, Andrea Murina, George Han, and Abby Jacobson. "Brodalumab: 4-Year US Pharmacovigilance Report." SKIN The Journal of Cutaneous Medicine 7, no. 2 (2023): s132. http://dx.doi.org/10.25251/skin.7.supp.132.

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Garcia‐Doval, I., E. Segovia, H. Hunter, J. Frew, and L. Naldi. "The value of case reports in pharmacovigilance." British Journal of Dermatology 183, no. 5 (2020): 795–96. http://dx.doi.org/10.1111/bjd.19504.

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Schmutz, J. L. "Alitrétinoïne (Toctino®) : données récentes de pharmacovigilance." Annales de Dermatologie et de Vénéréologie 147, no. 4 (2020): 329–30. http://dx.doi.org/10.1016/j.annder.2020.01.002.

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Bettuzzi, Thomas, Aaron Drucker, Delphine Staumont-Sallé, Kevin Bihan, Bénédicte Lebrun-Vignes, and Emilie Sbidian. "34927 Adverse events associated with dupilumab in the WHO pharmacovigilance." Journal of the American Academy of Dermatology 87, no. 3 (2022): AB136. http://dx.doi.org/10.1016/j.jaad.2022.06.578.

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Khopkar, Uday. "Reporting of drug eruptions: The national pharmacovigilance program." Indian Journal of Dermatology, Venereology and Leprology 71, no. 1 (2005): 1. http://dx.doi.org/10.4103/0378-6323.13776.

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6

International, Journal of Medical Science and Advanced Clinical Research (IJMACR). "Evaluation of Adverse Drug Reactions in Outpatients and Inpatients in Department of Dermatology at Tertiary Care Hospital." International Journal of Medical Science and Advanced Clinical Research (IJMACR) 8, no. 2 (2025): 20–28. https://doi.org/10.5281/zenodo.15239868.

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<strong>Abstract</strong> <strong>Objective: </strong>The study aims to evaluate the clinical spectrum, morphology, and causative drugs responsible for CADRs in inpatients and outpatients attending the dermatology department of a tertiary care center. It also emphasizes the necessity of an effective pharmacovigilance system to improve drug safety and minimize CADR-related morbidity and mortality. <strong>Methods</strong>: A cross-sectional observational study was conducted at a tertiary care center in Jamnagar, Gujarat, from January 2023 to June 2024. A total of 150 patients presenting with CA
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7

Paul, C. "Science, marketing et pharmacovigilance : l’exemple des inhibiteurs topiques de la calcineurine." Annales de Dermatologie et de Vénéréologie 134, no. 11 (2007): 817–21. http://dx.doi.org/10.1016/s0151-9638(07)92823-9.

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CASTRO, Clarisse F., Cesar A. TEIXEIRA, Nurimar C. FERNANDES, and Guacira C. MATOS. "Severe cutaneous adverse reactions to drugs: a case series study." Revista Brasileira de Farmácia Hospitalar e Serviços de Saúde 11, no. 3 (2020): 471. http://dx.doi.org/10.30968/rbfhss.2020.113.0471.

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Objective: to describe five cases of severe cutaneous adverse reactions to drugs (SCARD) that led to hospitalization and were investigated and diagnosed by the dermatology service of a university hospital. Methods: this is a descriptive observational study of the case series type in which were included patients aged 18 years old or older from both sexes, hospitalized between January 2015 and July 2019, in a university hospital in Rio de Janeiro, Brazil and whose reason for hospitalization was SCARD diagnosed by the dermatology service. For SCARD causality assessments, two internationally adopt
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9

Pelet del Toro, Natalia, Andrew Strunk, Jashin Wu, et al. "Topical Clindamycin For Acne Vulgaris: Pharmacovigilance Safety Review and Retrospective Analysis of Gastrointestinal Events." SKIN The Journal of Cutaneous Medicine 8, no. 1 (2024): s341. http://dx.doi.org/10.25251/skin.8.supp.341.

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Background: Clindamycin, a lincosamide antibiotic, was the 125th most prescribed medicine in the US in 2020. Topical formulations that combine clindamycin with benzoyl peroxide or a retinoid are commonly used for acne vulgaris (AV) treatment. While oral and topical clindamycin carry warnings/contraindications regarding the development of gastrointestinal (GI) adverse events (AEs), the real-world incidence of these AEs with topical clindamycin is unknown. The objective is to provide an overview of safety data for topical clindamycin when used for AV treatment.&#x0D; Methods: Safety data from pu
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10

Pelet del Toro, Natalia, Andrew Strunk, Jashin Wu, et al. "Topical Clindamycin For Acne Vulgaris: Pharmacovigilance Safety Review and Retrospective Analysis of Gastrointestinal Events." SKIN The Journal of Cutaneous Medicine 8, no. 1 (2024): s356. http://dx.doi.org/10.25251/skin.8.supp.356.

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Background: Clindamycin, a lincosamide antibiotic, was the 125th most prescribed medicine in the US in 2020. Topical formulations that combine clindamycin with benzoyl peroxide or a retinoid are commonly used for acne vulgaris (AV) treatment. While oral and topical clindamycin carry warnings/contraindications regarding the development of gastrointestinal (GI) adverse events (AEs), the real-world incidence of these AEs with topical clindamycin is unknown. The objective is to provide an overview of safety data for topical clindamycin when used for AV treatment.&#x0D; Methods: Safety data from pu
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11

Bettuzzi, Thomas, Aaron Drucker, Delphine Staumont-Sallé, Kevin Bihan, Bénédicte Lebrun-Vignes, and Emilie Sbidian. "Adverse events associated with dupilumab in the World Health Organization pharmacovigilance database." Journal of the American Academy of Dermatology 86, no. 2 (2022): 431–33. http://dx.doi.org/10.1016/j.jaad.2021.09.050.

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12

Ganeva, Maria, Tanya Gancheva, Ivan Baldaranov, Jeni Troeva, and Evgenya Hristakieva. "Treatment of adverse drug reactions in a dermatology department." Open Medicine 6, no. 1 (2011): 37–44. http://dx.doi.org/10.2478/s11536-010-0057-y.

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AbstractThe aim of the study was to evaluate the pattern of utilization of systemic drugs used in the management of adverse drug reactions (ADRs) leading to hospitalization. A prospective pharmacovigilance study was carried out among patients admitted to the Clinic of Dermatology and Venereology in Stara Zagora (July 1999–June 2009). ADRs were classified by type, severity and causality. Casecausality was scored according to Naranjo et al. (1981). Drug utilization was measured in defined daily doses (DDDs) per 100 hospital bed days. A total of 144 cutaneous ADRs, predominantly “type B” were the
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13

Saxena, Kirti, Chaitali Tailor, Chaitali Mehta, Paresh Gajera, and S. K. Srivastava. "A retrospective analysis of adverse drug reaction reported in a tertiary care hospital." International Journal of Basic & Clinical Pharmacology 6, no. 5 (2017): 1146. http://dx.doi.org/10.18203/2319-2003.ijbcp20171667.

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Background: The adverse drug reactions (ADRs) reported to pharmacovigilance centre in tertiary care hospital was analysed to find out the incidence and causality.Methods: This was a retrospective study to analyse the ADR reported at pharmacovigilance centre after ethical clearance from Institutional Ethic Committee (IEC). ADR data were analysed and ADRs were categorized as department-wise, system affected and causative drug. The causality of each ADR was assessed by WHO-UMC scale.Results: The majority of patients who had suffered from ADRs were between 19-64 years of age (94.2%) and male patie
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14

Chaby, G., B. Lebrun-Vignes, C. Haddad, et al. "Déclaration des cas nationaux de Lyell/Stevens–Johnson à la pharmacovigilance : proportion et déterminants." Annales de Dermatologie et de Vénéréologie 145, no. 12 (2018): S247. http://dx.doi.org/10.1016/j.annder.2018.09.380.

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15

Remy, C., A. Barbaud, B. Lebrun-Vignes, et al. "Toxicité cutanée liée à la Percutalgine® : analyse de la base nationale de pharmacovigilance." Annales de Dermatologie et de Vénéréologie 139, no. 5 (2012): 350–54. http://dx.doi.org/10.1016/j.annder.2012.03.002.

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16

Hoisnard, Lea, Pr Sébastien Maury, Pr Matthieu Mahévas, et al. "32696 Adverse events associated with JAK inhibitors in 126,815 reports from the WHO pharmacovigilance database." Journal of the American Academy of Dermatology 87, no. 3 (2022): AB137. http://dx.doi.org/10.1016/j.jaad.2022.06.579.

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17

Sharma, Shweta, Dhanya Jayakumar, and DhanyaS Palappalli. "Pharmacovigilance of cutaneous adverse drug reactions among patients attending dermatology department at a Tertiary Care Hospital." Indian Dermatology Online Journal 10, no. 5 (2019): 547. http://dx.doi.org/10.4103/idoj.idoj_419_18.

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18

Abs, D., N. Petitpain, P. Gillet, J. L. Schmutz, and A. C. Bursztejn. "Hyperhidrose et biothérapies : analyse de 2 cas et des données de la base nationale de pharmacovigilance." Annales de Dermatologie et de Vénéréologie 147, no. 12 (2020): A329—A330. http://dx.doi.org/10.1016/j.annder.2020.09.505.

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19

Yaldizli, Ö., P. Baumberger, and N. Putzki. "Natalizumab et nævus atypiques : commentaires sur la note de pharmacovigilance de J.-L. Schmutz et al." Annales de Dermatologie et de Vénéréologie 136, no. 5 (2009): 450–51. http://dx.doi.org/10.1016/j.annder.2009.03.018.

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20

Bag, Ranit, and Debajyoti Saha. "Pharmacovigilance of cutaneous adverse drug reactions-a focused research in times of COVID pandemic." International Journal of Basic & Clinical Pharmacology 12, no. 1 (2022): 111. http://dx.doi.org/10.18203/2319-2003.ijbcp20223364.

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Severe cutaneous adverse drug reactions are limiting, ranging from 5 cases per million including acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia systemic symptoms (DRESS) to 1 case per million of toxic epidermal necrolysis. Cutaneous adverse drug reactions following drug therapy of COVID-19 are not uncommon. Viral infection and drug interactions predisposes to the development of cutaneous adverse drug reactions, as already documented with Epstein-Barr virus, cytomegalovirus, human herpesvirus 6, and HIV. The Adverse drug reaction monitoring center of CNMCH
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21

Purushothama, Reddy K* Dr. Rajesh Asija Dr. M. Purushothaman Dr. S. Arshiya Banu. "A STUDY ON EVALUATION OF DERMATOLOGICAL ADVERSE DRUG REACTIONS CAUSALITY, SEVERITY AND PREVENTABILITY." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 08 (2018): 7357–63. https://doi.org/10.5281/zenodo.1341954.

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<strong><em>Background: </em></strong><em>The burden of dermatological Adverse Drug Reactions (ADR&rsquo;s) is resulting in switching or discontinuation of the drug as well as medication non-adherence. Active research is essential for evaluating, managing, reporting ADR&rsquo;s and strengthening the activity of pharmacovigilance of the country. The purpose of the study was to evaluate causality, severity, and preventability of Dermatological ADR&rsquo;s. </em> <strong><em>Method: </em></strong><em>A prospective observational study was carried out over a period of 1 year at the Department of De
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22

Boudghene Stambouli, O., N. Benosman, and A. Belbachir. "CA10 - Dermatite atopique compliquée d’un retard de croissance dermocortico-induit. La pharmacovigilance ne doit pas se relâcher." Annales de Dermatologie et de Vénéréologie 134, no. 1 (2007): 68. http://dx.doi.org/10.1016/s0151-9638(07)89108-3.

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23

Ganeva, Maria G., Tanya T. Gancheva, Ivan D. Baldaranov, Nataliya J. Kiriyak, and Evgeniya H. Hristakieva. "Risks of Oral Methotrexate Administration in Outpatients." Journal of Biomedical and Clinical Research 7, no. 1 (2014): 59–64. http://dx.doi.org/10.1515/jbcr-2015-0128.

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Abstract Methotrexate (MTX) is a cytostatic agent used in oncology. Because of its immunosuppressive properties, MTX is also used in autoimmune disorders. Low-dose MTX regimens in the treatment of rheumatoid arthritis and severe psoriasis are considered to be safe. However, pharmacovigilance centers warn of serious and even fatal incidents due to errors in oral MTX administration. The aim of this case series presentation was to identify the specific factors related to the development of adverse drug reactions (ADRs) induced by MTX. A prospective pharmacovigilance study was conducted at the Cli
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24

Bettuzzi, T., B. Lebrun-Vignes, L. Le Cleach, et al. "Caractérisation des principaux biais des associations médicament–nécrolyse épidermique : étude de pharmacovigilance à partir des données de Vigibase." Annales de Dermatologie et de Vénéréologie 147, no. 12 (2020): A162—A163. http://dx.doi.org/10.1016/j.annder.2020.09.167.

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Kaur, Manmeet, Tirthankar Deb, Jayant Kairi, and Ankit Arora. "A pharmacovigilance study of adverse drug reactions in a tertiary care hospital in Haryana." International Journal of Basic & Clinical Pharmacology 8, no. 10 (2019): 2184. http://dx.doi.org/10.18203/2319-2003.ijbcp20194149.

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Background: Adverse drug reaction (ADR) is an inevitable risk associated with all the prescribed medicines. They vary in severity &amp; duration in any population. Thus, ADRs are monitored and assessed on a large scale in our country by the Pharmacovigilance programme of India through adverse drug reaction monitoring centres. This study was taken to assess the pattern of ADR reported in a tertiary care hospital in Haryana.Methods: This study was conducted in the Kalpana Chawla Government Medical College, Karnal, Haryana from January 2018 to June 2019. ADRs were collected from different departm
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26

Le, T., I. Brown, M. Taylor, et al. "195 Cutaneous toxicities associated with immune checkpoint inhibitors: An observational, pharmacovigilance study." Journal of Investigative Dermatology 142, no. 8 (2022): S33. http://dx.doi.org/10.1016/j.jid.2022.05.202.

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Charvet, E., C. Cassius, P. Eftekhari, et al. "Lupus induit par les inhibiteurs de checkpoint immunitaire : expérience d’un centre Melbase et étude de la base nationale de pharmacovigilance." Annales de Dermatologie et de Vénéréologie 147, no. 12 (2020): A308—A309. http://dx.doi.org/10.1016/j.annder.2020.09.463.

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Dequidt, L., N. Franck, P. Sanchez‐Pena, et al. "Cutaneous lymphomas appearing during treatment with biologics: 44 cases from the French Study Group on Cutaneous Lymphomas and French Pharmacovigilance Database." British Journal of Dermatology 181, no. 3 (2019): 616–18. http://dx.doi.org/10.1111/bjd.17834.

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Boudghene Stambouli, O., B. Dahmani, and A. Belbachir. "CA3 Réactions cutanées aux médicaments : 90 cas de toxidermies observées de 1981 à 2004. La pharmacovigilance ne doit pas se relâcher." Annales de Dermatologie et de Vénéréologie 134, no. 1 (2007): 64. http://dx.doi.org/10.1016/s0151-9638(07)89101-0.

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Reolid, Alejandra, Ester Muñoz‐Aceituno, Pedro Rodríguez‐Jiménez, et al. "Bullous pemphigoid associated with dipeptidyl peptidase‐4 inhibitors. A case series and analysis of cases reported in the Spanish pharmacovigilance database." International Journal of Dermatology 59, no. 2 (2019): 197–206. http://dx.doi.org/10.1111/ijd.14658.

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Tedeschi, G., M. P. Amato, R. D’Alessandro, et al. "The pharmacovigilance program on natalizumab in Italy: 2 years of experience." Neurological Sciences 30, S2 (2009): 163–65. http://dx.doi.org/10.1007/s10072-009-0143-6.

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32

Prashanthi, B., Hepsibha Modi, and Dharmateja Kalagara. "Adverse Drug Reactions (ADR’S) monitoring at tertiary care Hospital." Journal of Drug Delivery and Therapeutics 9, no. 1 (2019): 195–98. http://dx.doi.org/10.22270/jddt.v9i1.2207.

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The observational and brief cross section study was conducted in the ADR monitoring centre, department of pharmacology, SVS MEDICAL HOSPITAL. The adverse drug reactions (ADR) reported by physician of dermatology department of SVSMH were collected and then causality, severity and preventability assessment was done. The results were presented as number and percentage. Total of 544 patients were observed with 15 suspected ADRs. The incidence of dermatological ADR was 3.78%. Maximum incidence of dermatological ADRs were observed with anti-inflammatory agents and immunosuppressive (33.30%) followed
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33

Lakshmi, G. N. S. Sangeetha, Chilkuri Priyanka, and Mortha Vineela. "Drug utilisation pattern in dermatology outpatient department at a tertiary care hospital." International Journal of Basic & Clinical Pharmacology 7, no. 11 (2018): 2101. http://dx.doi.org/10.18203/2319-2003.ijbcp20184197.

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Background: Skin is the part of integumentary system that constitutes the largest organ of human body and thus it is exposed to injury by various extrinsic and intrinsic factors. The skin disorders have serious detrimental effect on quality of life of the general population. The present study was planned to define the prescription pattern in terms of rationality, drug interactions and financial burden of disease to the individual. Also, in the identification of problems related to drug use such as poly-pharmacy and drug-drug interaction.Methods: The present study was conducted in the male and
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Agier, M. S., N. Boivin, A. Maruani, et al. "Risk assessment of drug-induced drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome: a disproportionality analysis using the French Pharmacovigilance Database." British Journal of Dermatology 175, no. 5 (2016): 1067–69. http://dx.doi.org/10.1111/bjd.14649.

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Babic, V., N. Petitpain, C. Guy, et al. "Ulcérations induites par le nicorandil : une étude observationnelle de tous les cas rapportés à la Banque nationale de pharmacovigilance pendant 10 ans." Annales de Dermatologie et de Vénéréologie 144, no. 12 (2017): S237. http://dx.doi.org/10.1016/j.annder.2017.09.381.

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36

Bettuzzi, T., B. Lebrun-Vignes, C. Chinchilla Portillo, et al. "Évolution du spectre des médicaments associés à la nécrolyse épidermique au cours du temps : étude de pharmacovigilance à partir des données de Vigibase." Annales de Dermatologie et de Vénéréologie 147, no. 12 (2020): A83. http://dx.doi.org/10.1016/j.annder.2020.09.024.

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Mavoori, Archana, Sudha Bala, Sneha Pamar, Karunasree Podila, and Deepthi Sriram. "Clinical profile and causality of cutaneous adverse drug reactions among patients attending tertiary care teaching hospital in South India." International Journal of Research in Dermatology 6, no. 3 (2020): 318. http://dx.doi.org/10.18203/issn.2455-4529.intjresdermatol20201020.

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&lt;p class="abstract"&gt;&lt;strong&gt;Background:&lt;/strong&gt; Any undesirable change in the structure or function of the skin and its appendages related to drug eruption regardless of the aetiology is called the cutaneous adverse drug reaction (CADR). Manifestations are varied with diverse morphological pattern ranging from trivial urticarial to severe form of vasculitis which are fatal. Identifying the culprit drug in this new era with advanced development of multi drugs is a challenging task and can help in prevention of further complications and provide safer drugs. Objective of the st
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M. Bruijn, T. V., A. O. Gérard, M. Labat, et al. "Immune checkpoint inhibitor-induced eosinophilic fasciitis: an international retrospective and pharmacovigilance analysis by the EADV “Dermatology for Cancer patients” Task Force." EJC Skin Cancer 3 (2025): 100561. https://doi.org/10.1016/j.ejcskn.2025.100561.

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39

Melcy, Mary Philip, Kesavan P. Kala, and Prakash Jai. "Toxic epidermal necrolysis associated with combination therapy of spironolactone and torsemide." Journal of Pharmacovigilance and Drug Research 1, no. 1 (2020): 19–21. https://doi.org/10.5281/zenodo.4905501.

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<strong>Abstarct</strong> Dytor plus tablet is a fixed-dose combination of torsemide and spironolactone used for generalized edema. TEN is a serious, potentially life-threatening dermatological disorder. Here we present a case report of a 47-year-old female who was on Dytor Plus (5/50 mg)therapy once daily for generalized edema; presented to dermatology outpatient department with chief complaints of multiple erosions over oral cavity, swelling of lips with scaling, redness and burning sensation in both eyes, multiple well defined mostly erythematous rashes over the entire body since 2 days .on
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40

Mishra, P., P. Subish, S. Gupta, et al. "Pattern and economic impact of cutaneous adverse drug reactions: initial experiences from the regional pharmacovigilance center, Western Nepal." International Journal of Risk & Safety in Medicine 18, no. 3 (2006): 163–71. https://doi.org/10.3233/jrs-2006-379.

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The high mortality, morbidity and cost associated with adverse drug reactions (ADRs) represent an important public health concern. Cutaneous ADRs, the most common ADRs constitute of 15 to 30% of the total ADRs. The economic impact of cutaneous ADRs is not known. The present study analyzed the cutaneous ADRs reported to the Regional Pharmacovigilance Center, Manipal Teaching Hospital, Western Nepal and established their causality, severity, preventability and calculated the cost of drug therapy in managing them. The filled ADR reporting forms received by the center from September 2004 till Augu
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41

Philip, Melcy Mary, Kala Kesavan P, and Jai Prakash. "Toxic epidermal necrolysis associated with combination therapy of spironolactone and torsemide." Journal of Pharmacovigilance and Drug Research 1, no. 1 (2020): 19–21. http://dx.doi.org/10.53411/jpadr.2020.1.1.5.

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Introduction: Dytor plus tablet is a fixed-dose combination of torsemide and spironolactone used for generalized edema. TEN is a serious, potentially life-threatening dermatological disorder.&#x0D; Methods: Here we present a case report of a 47-year-old female who was on Dytor Plus (5/50 mg)therapy once daily for generalized edema; presented to dermatology outpatient department with chief complaints of multiple erosions over oral cavity, swelling of lips with scaling, redness and burning sensation in both eyes, multiple well defined mostly erythematous rashes over the entire body since 2 days.
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42

Chavda, Dinesh A., Satish D. Suthar, Shradhanand Singh, Jayesh D. Balat, Sailesh P. Parmar, and Suresh D. Mistry. "A study of cutaneous adverse drug reactions in the outpatient department of Dermatology at a tertiary care center in Gujarat, India." International Journal of Basic & Clinical Pharmacology 6, no. 5 (2017): 1115. http://dx.doi.org/10.18203/2319-2003.ijbcp20171661.

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Background: The data for adverse cutaneous drug reactions (ACDRs) is limited in Gujarat. The ACDRs are one of the frequent ADRs and cause of significant morbidity and mortality in patients of all areas of healthcare today. They are responsible for significant number of hospital admissions. Thus, the present study emphasises on the need and importance of an effective pharmacovigilance programme.Methods: A prospective study was undertaken in a 183 cases tertiary care teaching hospital of India. Male to female ratio, most common class of drug, individual drug causing ACDR, common types of ACDRs P
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Davidson, Linda, Juul M. P. A. Van den Reek, Florence Van Hunsel, Elke M. G. J. De Jong, and Bart Jan Kullberg. "Global Risk of Bacterial Skin Infections and Herpesviridae Infections with Ustekinumab, Secukinumab, and Tumour Necrosis Factor-alpha Inhibitors: Spontaneous Reports of Adverse Drug Reactions from the World Health Organization Pharmacovigilance Center." Acta Dermato-Venereologica 102 (February 11, 2022): adv00648. http://dx.doi.org/10.2340/actadv.v102.175.

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Genetic defects in interleukin-12/23/17 immunity are associated with an increased risk of Staphylococcus aureus and herpesvirus skin infections. This study analysed spontaneous safety reports from the WHO Pharmacovigilance Center of bacterial skin or herpesvirus infections associated with secukinumab, ustekinumab and tumour necrosis factor-α inhibitors. Associations found in disproportionality analyses were expressed as reporting odds ratios (ROR). For bacterial skin infections, ustekinumab showed the strongest association (ROR 6.09; 95% confidence interval (95% CI) 5.44–6.81), and, among the
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Kanagasanthosh, K., C. Sujeetha, K.S. Saravanan, and C.K. Elandevan. "Analysis of Reporting Pharmacovigilance in a Rural Tertiary Care Hospital in South India: A Retrospective Study of Two Years Survey." International Journal of Toxicological and Pharmacological Research 13, no. 10 (2023): 82–89. https://doi.org/10.5281/zenodo.11059178.

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<strong>Introduction:&nbsp;</strong>In India the Adverse Drug Reaction (ADR) reporting have to enhanced in the tertiary care teaching institute and corporate hospital. Majority of the drug fate will be revealed if there is documental evidence of ADR reporting. In many countries ADR ranks among the top ten leading cause of morbidity and mortality. Objective of the Present study was planned to evaluate and analyses the incidence and pattern of various ADR reported from both the outpatient and inpatient department in a tertiary care teaching hospital. The study objective is with special emphasize
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Patel, Jeet J., Megha K. Shah, Prakruti P. Patel, A. M. Gandhi, and Mira K. Desai. "Knowledge, attitude and practice among consumers about adverse drug reaction reporting." International Journal of Basic & Clinical Pharmacology 8, no. 8 (2019): 1776. http://dx.doi.org/10.18203/2319-2003.ijbcp20193177.

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Background: Background: Adverse Drug Reaction (ADR) reporting by consumers is quite low in India. Assessing knowledge and attitude of consumers regarding ADR reporting and observing practice of ADR reporting among them can help explore probable causes for underreporting of ADRs by consumers.Methods: This was a cross-sectional study conducted in a tertiary care teaching hospital using investigator-administered questionnaire and interviewing indoor patients of Surgery, Medicine, Obstetrics &amp; Gynaecology and Dermatology departments. The questionnaire was prepared to assess knowledge, attitude
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Memon, Rohail, Ryan C. Kelm, Maia K. Erickson, et al. "15156 Autoimmune cutaneous disorders associated with PD-1 and PD-L1 inhibitors: Pharmacovigilance analysis of the FDA Adverse Event Reporting System from the Research on Adverse Drug Events and Reports program." Journal of the American Academy of Dermatology 83, no. 6 (2020): AB142. http://dx.doi.org/10.1016/j.jaad.2020.06.658.

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Kahen, Negar, Yasmeen Ali, and Dennis P. West. "35128 Cerebrovascular accident events associated with IL-23 inhibition: Pharmacovigilance analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) from the RADAR (Research on Adverse Drug Events And Reports) Program." Journal of the American Academy of Dermatology 87, no. 3 (2022): AB27. http://dx.doi.org/10.1016/j.jaad.2022.06.141.

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Malhotra, SK, Baljit Kaur, and Inderpal Kaur. "A prospective study of clinical spectrum of cutaneous adverse drug reactions and their incidence in Indian population." IP Indian Journal of Clinical and Experimental Dermatology 7, no. 2 (2021): 143–47. http://dx.doi.org/10.18231/j.ijced.2021.027.

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Making the diagnosis of a drug-induced reaction requires familiarity with the clinical patterns as the current understanding of the disease processes is not enough to explain about apparently similar pathological mechanisms generating different clinical patterns. Therefore, it remains useful and relevant to overlay a pathological understanding with a clinical classification. This study concentrated on observing and documenting the clinical presentation of cutaneous adverse drug reactions (CADR) encountered in patients. The purpose of the study was to evaluate causality, severity and preventabi
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Misra, Debasish, Manika Bose, Sansita Parida, Smita Das, Swati Mishra, and Sudhansu Sekhar Mishra. "Adverse drug reaction reporting in a tertiary care teaching hospital in eastern India: a retrospective study." International Journal of Basic & Clinical Pharmacology 8, no. 10 (2019): 2322. http://dx.doi.org/10.18203/2319-2003.ijbcp20194280.

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Background: Adverse drug reactions (ADRs) are one of the prime causes of morbidity and mortality, increase in hospital stay and socioeconomic burden on the patients. Periodic monitoring aids in formulating methods for safe usage of medicines in hospitals. This study was undertaken to study the patterns, assessment of causality, severity, preventability, body systems affected from ADRs received by the Pharmacovigilance cell, Department of Pharmacology between April 2018 to June 2019.Methods: The present study is an observational, retrospective, non-interventional analysis of voluntarily reporte
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Phan, Duc Binh, Hugo Jourdain, Alicia González-Quesada, et al. "Drug survival and safety of biosimilars and originator adalimumab in the treatment of psoriasis: a multinational cohort study." BMJ Open 13, no. 7 (2023): e075197. http://dx.doi.org/10.1136/bmjopen-2023-075197.

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IntroductionPsoriasis is a chronic inflammatory skin disease. Adalimumab is an effective but previously expensive biological treatment for psoriasis. The introduction of biosimilars following the patent expiry of the originator adalimumab Humira has reduced the unit cost of treatment. However, the long-term effectiveness and safety of adalimumab biosimilars for treating psoriasis in real-world settings are uncertain and may be a barrier to widespread usage.Methods and analysisThis study aims to compare the drug survival and safety of adalimumab biosimilars to adalimumab originator for the trea
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