Skip to content
2000
Volume 21, Issue 5
  • ISSN: 1573-398X
  • E-ISSN: 1875-6387

Abstract

Introduction

Adverse drug reactions (ADRs) to antitubercular therapy (ATT) pose a major challenge in tuberculosis (TB) management, especially in patients with comorbidities. This study evaluated the prevalence, patterns, and risk factors for ADRs among TB patients with and without comorbidities receiving first-line ATT in India.

Methods

A prospective observational study was conducted at Erode Tertiary Care Hospital from July 2023 to January 2024. A total of 300 TB patients (207 without comorbidities, 93 with comorbidities such as diabetes mellitus, HIV, hypertension, and COPD) were enrolled. ADRs were assessed through clinical monitoring, lab investigations, and structured interviews using the WHO causality and Modified Hartwig and Siegel severity scales.

Results

The prevalence of ADR was 49.33%, which was significantly higher in patients with comorbidities (55.91%) than those without (46.37%, = 0.048; RR = 1.20, 95% CI: 0.96-1.52). Diabetes mellitus had the highest ADR rate (60.53%, = 0.032). ADRs were more frequent in comorbid patients during the intensive phase (59.32% 41.61%, = 0.018) and in pulmonary TB. Gastrointestinal ADRs were most common, with nausea/vomiting, gastritis, and diarrhea significantly more frequent in comorbid groups. Comorbid patients also had more multiple ADRs (40.38% 33.33%, = 0.027) and required more medication changes (17.31% 7.29%, = 0.013). Discussion: Higher ADR frequency in patients with comorbidities may reflect the impact of disease. The increased burden during the intensive phase and in pulmonary TB underscores the importance of tailored pharmacovigilance.

Conclusion

TB patients with comorbidities, particularly diabetes, face significantly higher ADR risks. Enhanced pharmacovigilance is essential. Age-related physiological vulnerability may independently increase ADR risk in elderly patients without comorbidities.

© 2025 Bentham Science Publishers
Loading

Article metrics loading...

/content/journals/crmr/10.2174/011573398X422511250828173106
2025-09-02
2025-12-28

  • From This Site

    /content/journals/crmr/10.2174/011573398X422511250828173106
    dcterms_title,dcterms_subject,pub_keyword
    -contentType:Contributor -contentType:Concept -contentType:Institution
    10
    5
Loading full text...

Full text loading...

References

  1. World Health Organization. Global Tuberculosis Report 2023. Geneva: World Health Organization2023Available from: https://www.who.int/publications/i/item/9789240083851
  2. CentralT.B. Division India TB Report 2023New DelhiMinistry of Health and Family Welfare, Government of India2023
     [Google Scholar]
  3. World Health Organization. WHO consolidated guidelines on tuberculosis: Module 4. Treatment – Drug-susceptible tuberculosis treatment. Geneva: World Health Organization2022Available from: https://www.who.int/publications/i/item/9789240048126
  4. CentralT.B. Division Training Modules (1-4) for Programme Managers and Medical OfficersNew DelhiMinistry of Health and Family Welfare, Government of India2020
     [Google Scholar]
  5. BhushanB. ChanderR. KajalN.C. RangaV. GuptaA. BhartiH. Profile of adverse drug reactions in drug resistant tuberculosis from Punjab.Indian J Tuberc201461431832425675695
     [Google Scholar]
  6. SinghA. PrasadR. BalasubramanianV. GuptaN. GuptaP. Prevalence of adverse drug reaction with first-line drugs among patients treated for pulmonary tuberculosis.Clin Epidemiol Glob Health201531S80S9010.1016/j.cegh.2015.10.005
     [Google Scholar]
  7. PrasadR. SinghA. GuptaN. Adverse drug reactions in tuberculosis and management.Indian J Tuberc201966452053210.1016/j.ijtb.2019.11.00531813444
     [Google Scholar]
  8. Pérez-GuzmánC. VargasM.H. Torres-CruzA. Villarreal-VelardeH. Does aging modify pulmonary tuberculosis?: A meta-analytical review.Chest1999116496196710.1378/chest.116.4.96110531160
     [Google Scholar]
  9. JayapriyaB, Antony LJ, Balamurugan PV, Raja AD. Pattern of adverse drug reactions of antitubercular drugs in tuberculosis patients with comorbidities and risk factors in South Indian government health-care facilities.Natl J Physiol Pharm Pharmacol20211108920-92410.5455/njppp.2021.11.07220202105072021
     [Google Scholar]
  10. MarzukiO.A. FauziA.R. AyoubS. ImranK.M. Prevalence and risk factors of anti-tuberculosis drug-induced hepatitis in Malaysia.Singapore Med J200849968869318830542
     [Google Scholar]
  11. Sant´AnnaF.M. Araújo-PereiraM. SchmaltzC.A.S. ArriagaM.B. AndradeB.B. RollaV.C. Impact of adverse drug reactions on the outcomes of tuberculosis treatment.PLoS One2023182e026976510.1371/journal.pone.026976536749743
     [Google Scholar]
  12. DostalekM. AkhlaghiF. PuzanovovaM. Effect of diabetes mellitus on pharmacokinetic and pharmacodynamic properties of drugs.Clin Pharmacokinet201251848149910.1007/BF0326192622668340
     [Google Scholar]
  13. SeifertS.M. Castillo-MancillaJ.R. ErlandsonK.M. AndersonP.L. Inflammation and pharmacokinetics: Potential implications for HIV-infection.Expert Opin Drug Metab Toxicol201713664165010.1080/17425255.2017.131132328335648
     [Google Scholar]
  14. ThompsonK. KulkarniJ. SergejewA.A. Reliability and validity of a new Medication Adherence Rating Scale (MARS) for the psychoses.Schizophr Res200042324124710.1016/S0920‑9964(99)00130‑910785582
     [Google Scholar]
  15. Safety Monitoring of Medicinal Products: Guidelines for Setting Up and Running a Pharmacovigilance Centre2000Available from: https://who-umc.org/media/1703/24747.pdf
  16. HartwigS.C. SiegelJ. SchneiderP.J. Preventability and severity assessment in reporting adverse drug reactions.Am J Health Syst Pharm19924992229223210.1093/ajhp/49.9.22291524068
     [Google Scholar]
  17. AlfarisiO. MaveV. GaikwadS. SahasrabudheT. RamachandranG. KumarH. GupteN. KulkarniV. DeshmukhS. AtreS. RaskarS. LokhandeR. BarthwalM. KakraniA. ChonS. GuptaA. GolubJ.E. DooleyK.E. Effect of diabetes mellitus on the pharmacokinetics and pharmacodynamics of tuberculosis treatment.Antimicrob Agents Chemother20186211e01383-1810.1128/AAC.01383‑1830126955
     [Google Scholar]
  18. GwiltP.R. NahhasR.R. TracewellW.G. The effects of diabetes mellitus on pharmacokinetics and pharmacodynamics in humans.Clin Pharmacokinet199120647749010.2165/00003088‑199120060‑000042044331
     [Google Scholar]
  19. SemvuaH.H. KibikiG.S. KisangaE.R. BoereeM.J. BurgerD.M. AarnoutseR. Pharmacological interactions between rifampicin and antiretroviral drugs: challenges and research priorities for resource-limited settings.Ther Drug Monit2015371223210.1097/FTD.000000000000010824943062
     [Google Scholar]
  20. NiemiM. KivistöK.T. BackmanJ.T. NeuvonenP.J. Effect of rifampicin on the pharmacokinetics and pharmacodynamics of glimepiride.Br J Clin Pharmacol200050659159510.1046/j.1365‑2125.2000.00295.x11136298
     [Google Scholar]
  21. ParkJ. KimK.A. ParkP.W. ParkC.W. ShinJ.G. Effect of rifampin on the pharmacokinetics and pharmacodynamics of gliclazide.Clin Pharmacol Ther200374433434010.1016/S0009‑9236(03)00221‑214534520
     [Google Scholar]
  22. NiemiM. BackmanJ.T. FrommM.F. NeuvonenP.J. KivistöK.T. Pharmacokinetic interactions with rifampicin : Clinical relevance.Clin Pharmacokinet200342981985010.2165/00003088‑200342090‑0000312882588
     [Google Scholar]
  23. DestaZ. SoukhovaN.V. FlockhartD.A. Inhibition of cytochrome P450 (CYP450) isoforms by isoniazid: Potent inhibition of CYP2C19 and CYP3A.Antimicrob Agents Chemother200145238239210.1128/AAC.45.2.382‑392.200111158730
     [Google Scholar]
  24. ShahH. YasobantS. PatelJ. BhavsarP. SahaS. PatelY. SaxenaD. SinhaA. Characteristics and contributing factors of adverse drug reactions: an analytical study of patients with tuberculosis receiving treatment under the National TB Program of India.F1000 Res202211138810.12688/f1000research.125815.239935535
     [Google Scholar]
  25. KumarR.N.H. RaoC.R. MaradiR. UmakanthS. SanjuS.V.C. BaluP.S. Incidence of adverse drug reactions among tuberculosis patients initiated on daily drug regimen in a southern district of Karnataka.Perspect Clin Res2025161313710.4103/picr.picr_20_2439867528
     [Google Scholar]
  26. MalekiD. LockeG.R. CamilleriM. ZinsmeisterA.R. YawnB.P. LeibsonC. MeltonL.J. Gastrointestinal tract symptoms among persons with diabetes mellitus in the community.Arch Intern Med2000160182808281610.1001/archinte.160.18.280811025791
     [Google Scholar]
  27. PhamA.Q. DoanA. AndersenM. Pyrazinamide-induced hyperuricemia.PT2014391069571525336865
     [Google Scholar]
  28. SsentongoP. Prevalence and incidence of new-onset seizures and epilepsy in patients with human immunodeficiency virus (HIV): Systematic review and meta-analysis.Epilepsy Behav201993495510.1016/j.yebeh.2019.01.03330831402
     [Google Scholar]
  29. AsrilI. SoetiknoV. AscobatP. Associations between the adverse drug reactions and the tuberculosis treatment dropout rates at the CempakaPutih Islamic Hospital in Jakarta, Indonesia.J Nat Sci Biol Med2019103S29S3310.4103/jnsbm.JNSBM_31_19
     [Google Scholar]
  30. NoorS. IsmailM. KhanF. Drug safety in hospitalized patients with tuberculosis: Drug interactions and adverse drug effects.Clin Respir J20211519710810.1111/crj.1327632949069
     [Google Scholar]
  31. AbdallahY.E.H. ChahalS. JamaliF. MahmoudS.H. Drug-disease interaction: Clinical consequences of inflammation on drugs action and disposition.J Pharm Pharm Sci2023261113710.3389/jpps.2023.1113736942294
     [Google Scholar]
  32. McNeillR.P. ZhangM. EptonM.J. DoogueM.P. Drug metabolism in severe chronic obstructive pulmonary disease: A phenotyping cocktail study.Br J Clin Pharmacol202187114397440710.1111/bcp.1486233855722
     [Google Scholar]
  33. HöchtC. BerteraF.M. MayerM.A. TairaC.A. Issues in drug metabolism of major antihypertensive drugs: β-blockers, calcium channel antagonists and angiotensin receptor blockers.Expert Opin Drug Metab Toxicol20106219921110.1517/1742525090339738120095790
     [Google Scholar]
/content/journals/crmr/10.2174/011573398X422511250828173106
Loading
Comorbidity-Associated Adverse Drug Reactions During Tuberculosis Treatment: A Prospective Study
Curr. Respir. Med. Rev. 21, 507 (2025); https://doi.org/10.2174/011573398X422511250828173106
/content/journals/crmr/10.2174/011573398X422511250828173106
/content/journals/crmr/10.2174/011573398X422511250828173106
Loading

Data & Media loading...


  • Article Type:     Research Article
Keyword(s): adverse drug reactions (ADRs); comorbidities; diabetes mellitus; HIV; hypertension; pharmacovigilance; prevalence; Tuberculosis (TB)

Most Cited Most Cited RSS feed

This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error
Please enter a valid_number test