Symptom experience of adverse drug reaction among male and female patients with newly diagnosed pulmonary tuberculosis in Thailand

Apichaya Thontham, Rapin Polsook



Background: Patients with newly diagnosed pulmonary tuberculosis often suffer from adverse drug reaction symptoms, which leads to the automatic discontinuation of anti-tuberculosis drugs. Thus, understanding symptom experience of adverse drug reactions is necessary.

Objective: This study aimed to examine differences in symptoms experienced in four dimensions: presence, frequency, severity, and distress of adverse drug reactions, between male and female patients.

Methods: This was a quantitative survey with a cross-sectional design, with data collected between January and April 2020. A total of 394 patients with newly diagnosed pulmonary tuberculosis was selected through a purposive sampling technique. The symptom experiences of adverse drug reactions were measured using a validated instrument. Data were analyzed using mean, standard deviation, and independent t-test.

Results: The most commonly reported symptom was itchiness (24.1% in males and 34.9% in females). Vomiting occurred as the most frequent symptom among males (x̅ ± SD = 2.73 ± .88), and fatigue was found to be the most severe and distressing symptom across male patients (x̅ ± SD = 2.50 ± 1.61 and 2.06 ± 1.30, respectively). In contrast, yellowing of the eyes and skin was most frequent and severe among females (x̅ ± SD = 3.17 ± .75 and 3.83 ± 1.47, respectively). In addition, flu-like symptoms were evaluated as the most distressing symptom for female patients (x̅ ± SD = 2.80 ± 1.09). The symptom burdens of the females ranged significantly and reached higher than those of the male patients at a p-value of .05 (t = 3.33).

Conclusion: Females taking anti-tuberculosis drugs should be carefully monitored to deal with adverse drug reaction symptoms. This finding would help to decrease the severity of disease and improve their quality of life.

Funding: This study received funding from the Ratchadaphiseksomphot Endowment Fund, Chulalongkorn University, Bangkok, Thailand (GCUGR1125633058M).


adverse drug reaction; pulmonary tuberculosis; symptom experiences; quality of life; drug-related side effects; nursing; Thailand

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Almutary, Hayfa, Bonner, Ann, & Douglas, Clint. (2015). Arabic translation, adaptation and modification of the dialysis symptom index for chronic kidney disease stages four and five. BMC Nephrology, 16(1), 1-8.

Armstrong, Terri S. (2003). Symptoms experience: A concept analysis. Oncology Nursing Forum, 30(4), 601-612.

Dodd, Marylin, Janson, Susan, Facione, Noreen, Faucett, Julia, Froelicher, Erika S., Humphreys, Janice, . . . Rankin, Sally. (2001). Advancing the science of symptom management. Journal of Advanced Nursing, 33(5), 668-676.

Fang, Yong, Xiao, Heping, Tang, Shenjie, Liang, Li, Sha, Wei, & Fang, Yuanyuan. (2016). Clinical features and treatment of drug fever caused by anti‐tuberculosis drugs. The Clinical Respiratory Journal, 10(4), 449-454.

Fei, Cheah Meng, Zainal, Hadzliana, & Ali, Irfhan Ali Hyder. (2018). Evaluation of adverse reactions Induced by anti-tuberculosis drugs in Hospital Pulau Pinang. The Malaysian Journal of Medical Sciences: MJMS, 25(5), 103-114.

Grove, S. K., & Gray, J. . (2018). Understanding nursing research: Building an evidence‐based practice. St. Louis, Missouri: Elsevier.

Health Data Center. (2020). Report of age and gender of Thais new tuberculosis. Retrieved from

Imam, Faisal, Sharma, Manju, Khayyam, Khalid Umer, Al-Harbi, Naif O., Rashid, Mohd Khan, Ali, Mohammad Daud, . . . Qamar, Wajhul. (2020). Adverse drug reaction prevalence and mechanisms of action of first-line anti-tubercular drugs. Saudi Pharmaceutical Journal, 28(3), 316-324.

Iranpour, Abedin, & Nakhaee, Nouzar. (2019). A review of alcohol-related harms: A recent update. Addiction & Health, 11(2), 129-137.

Lin, Wei-Quan, Jing, Meng-Juan, Tang, Jie, Wang, Jia-Ji, Zhang, Hui-Shan, Yuan, Le-Xin, & Wang, Pei-Xi. (2015). Factors associated with fatigue among men aged 45 and older: A cross-sectional study. International Journal of Environmental Research and Public Health, 12(9), 10897-10909.

Marçôa, R., Ribeiro, A. I., Zão, I., & Duarte, R. (2018). Tuberculosis and gender-Factors influencing the risk of tuberculosis among men and women by age group. Pulmonology, 24(3), 199-202.

Mathew, Sowmya, & Joseph, Anoop. (2017). Adverse effects of antituberculosis drugs in patients under dots category – 1. Journal of Evidence Based Medicine and Healthcare, 4(8), 415-422.

Naser, Syed Mohammad, Nandy, Manab, Banu, Parvin, Banerjee, Arghya, Paul, Suhrita, Podder, Indrashis, & Mukherjee, Mayukh. (2016). Adverse drug reaction monitoring through active surveillance of antitubercular therapy in an urban tertiary care center. Community Acquired Infection, 3(2), 51-54.

Nazir, Tauseef, Farhat, Sameena, Adil, Mohd, & Asrafv, Zuryat. (2019). 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(1), 147.

Pal, Shanthi N., Duncombe, Chris, Falzon, Dennis, & Olsson, Sten. (2013). WHO strategy for collecting safety data in public health programmes: Complementing spontaneous reporting systems. Drug Safety, 36(2), 75-81.

Pongcharoen, Padcha, & Fleischer Jr, Alan B. (2016). Itch management: Systemic agents. Itch-Management in Clinical Practice, 50, 46-53.

Qureshi, D., & Kausar, H. (2013). Adverse effects of first line anti-tuberculosis drugs in patients on DOTS CAT1 under revised national tuberculosis control programme (RNTCP). IJBPAS, 2, 2267-2280.

Rademaker, Marius. (2001). Do women have more adverse drug reactions? American Journal of Clinical Dermatology, 2(6), 349-351.

Raftery, Ann, Tudor, Carrie, True, Lisa, & Navarro, Catalina. (2018). Nursing guide for managing side effects to drug-resistant TB treatment. Retrieved from

Ramappa, Vidyasagar, & Aithal, Guruprasad P. (2013). Hepatotoxicity related to anti-tuberculosis drugs: Mechanisms and management. Journal of Clinical and Experimental Hepatology, 3(1), 37-49.

Saputra, Muhammad Reza, Rakhmawati, Windy, Hendrawati, Sri, & Adistie, Fanny. (2020). Knowledge, attitude, and healthcare-seeking behavior among families of children with tuberculosis. Belitung Nursing Journal, 6(4), 127-135.

Singh, Abhijeet, Prasad, Rajendra, Balasubramanian, Viswesvaran, Gupta, Nikhil, & Gupta, Pawan. (2015). Prevalence of adverse drug reaction with first-line drugs among patients treated for pulmonary tuberculosis. Clinical Epidemiology and Global Health, 3, S80-S90.

Singh, Anita, Bhat, Tej K, & Sharma, Om P. (2011). Clinical biochemistry of hepatotoxicity. Journal of Clinical Toxicology, 4(1), 1-19.

Sinha, Kumarjit, Marak, Izora Trudy R., & Singh, W. Asoka. (2013). Adverse drug reactions in tuberculosis patients due to directly observed treatment strategy therapy: Experience at an outpatient clinic of a teaching hospital in the city of Imphal, Manipur, India. The Journal of Association of Chest Physicians, 1(2), 50-53.

Watson, Sarah, Caster, Ola, Rochon, Paula A., & den Ruijter, Hester. (2019). Reported adverse drug reactions in women and men: Aggregated evidence from globally collected individual case reports during half a century. EClinicalMedicine, 17, 100188.

WHO. (2019). Global tuberculosis report 2019. Geneva, Switzerland: World Health Organization.

World Health Organization. (2020). Global tuberculosis report 2020. Retrieved from

Yamane, Taro. (1973). Statistics: An introductory analysis. New York: Harper & Row.

Yee, Daphne, Valiquette, Chantal, Pelletier, Marthe, Parisien, Isabelle, Rocher, Isabelle, & Menzies, Dick. (2003). Incidence of serious side effects from first-line antituberculosis drugs among patients treated for active tuberculosis. American Journal of Respiratory and Critical Care Medicine, 167(11), 1472-1477.

Zucker, Irving, & Prendergast, Brian J. (2020). Sex differences in pharmacokinetics predict adverse drug reactions in women. Biology of Sex Differences, 11, 1-14.


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