March20, 2023

Abstract Volume: 3 Issue: 1 ISSN:

Review on Adverse Drug Reactions of Chemotherapy

V M. Gokkul¹, R.Roshni¹, Sreya Suresh¹*, S. Naveen Prasanth¹, Dr. D. Jothieswari², Mrs. V. Hari³


1.Department of Medicine, Sri Venkateswara Pharmacy College, RVS Nagar, Chittoor, AP, India

2.Vice Principal, Department of Pharmaceutical Analysis, College Of Pharmacy, RVS Nagar, Chittoor, AP, India.

3.Assistant Professor, Department of Medicine, Sri Venkateswara, College Of Pharmacy, RVS Nagar, Chittoor, AP, India.

Corresponding Author: Sreya Suresh, Department of Medicine, Sri Venkateswara Pharmacy College, RVS Nagar, Chittoor, AP, India.

Received Date: June 01, 2021

Published date: July 01, 2021


One of the most common cancer treatments is chemotherapy. Drug reactions, however, have become a major public health problem in the world. More than half (54.5 percent) of cancer patients need hospitalization to continue treatment, in addition to the additional cost of treatment. ADRs are associated with the analysis of cancer clearance by chemistry in size and prevention. The result will create awareness among health care providers and prevent their recurrence.

Review on Adverse Drug Reactions of Chemotherapy


The development and use of drugs in various forms of disease has brought shock to the human race but has also posed new threats in the form of illicit drugs (ADRs). Drug reaction (ADR) is defined by the World Health Organization (WHO) as “Anywhere responding to a dangerous, unintentional and over-the-counter medication used by a man for prophylaxis, diagnosis or treatment.” ADR has become a major concern for the general public, the medical profession, the pharmaceutical industry, and regulatory authorities around the world. [1]

The effect of the drug response given to the treatment varies from mild severity to permanent paralysis and death. Due to health effects, it has become one of the major causes of illness associated with high hospital admissions and adverse treatment outcomes. Approximately 6.5-10.9% of admissions are included in ADR worldwide. Globally, ADRs account for 10% of hospital admissions and 6% of hospital patients suffer from ADRs. With the introduction of pharmacovigilance in recent times, other ADRs have been reported and recorded in various parts of the world. [2,3]

Chemical cancer treatment is one of the best ways to treat cancer patients and this ensures improved quality of life, especially with the development of new drugs to treat various plants. However, this has also resulted in a variety of adverse events that are often overlooked by physicians for therapeutic purposes.

The literature for ADRs associated with chemotherapy cancer chemically appropriately evaluates its severity and safety. The result will create awareness among health care providers and prevent their recurrence in subsequent chemotherapeutic cycles; hence the purpose of this test. [3]

Cancer is a group of diseases characterized by the growth and spread of uncontrolled cells. A variety of treatments, including chemotherapy, radiotherapy, surgery, hormonal, immuno- logical and biological therapy, are available for cancer. One of the most common treatments is chemotherapy, which is very helpful in treating cancer. As a result, it controls the spread of cancer cells, eliminates tumor-related symptoms, improves quality of life, and prolongs patient survival. [4]

Although there are treatments for cancer, patients are at risk for ADR for a variety of reasons, including adverse drug reactions and clinical conditions. In many earlier cases of death, such as lymphomas and leukaemias, chemotherapy is curative. Although antiretroviral drugs (ARVs) are well-studied and are very beneficial in achieving better treatment outcomes, compared with other prescription drugs, they are associated with a wide range of drug responses (ADRs). In Jordan, anti-neoplastic drugs (37.6%) followed by immune modulators (14.1%), antibiotics (10.3%) and analgesics (6.6%) were the most common categories of drugs involved in ADR. [47]

This is because antiretroviral drugs have a lower medical window and a more toxic environment; as a result, cells such as bone marrow, gastric and hair follicles are damaged. They therefore produce various forms of ADR, such as bone marrow suppression, hair loss, nausea and vomiting oral mucositis, hepatotoxicity, and protoxicity. [5,6]

Although ADR can be affected by a variety of factors, some of the reported causes of adverse drug reactions were gender, age, multiple medications, new drugs, medication type, race, alcohol consumption, cirrhosis, liver and kidney status, anxiety and vision of patients. Studies have also shown that, due to developmental changes affecting the pharmacokinetics of many drugs used in Pediatrics. Pediatric patients undergoing chemotherapy are among those at high risk for ADR. [7,8]

The World Health Organization (WHO), aware of the burden of the problem, has developed a pharmacovigilance program to detect, diagnose, and prevent adverse drug reactions. The 35 African countries, including Ethiopia, have increasingly collected nearly 103,499 ADR cases in the global pharmacovigilance database in the system up to 2015, representing only 0.88% of global ADRs.[7] The discovery of ADR- related chemotherapy and risk factors for pediatric cancer patients in Ethiopia, where self-medication and adherence to treatment is high, is not well studied. This study, therefore, examined the magnitude of ADR associated with chemotherapy and chemotherapy in pediatric cancer patients in the hospital, which is critical to understanding the extent of the problem. [9]


Classification Of Adverse Drug Reactions:

Drug reactions can be classified by immunologic and nonimmunologic Etiologies. The majority (75 to 80 percent) of drug reactions are the result of predictable, non-pharmacological side effects.1 The remaining 20 to 25 percent of adverse drug reactions are due to side effects that may or may not be inhibited by the immune system. Immune-induced responses account for 5 to 10 percent of all drug reactions and are highly drug-resistant, with IgE-mediated drug allergies fall into this category.[36]

Immunologic and Nonimmunologic Drug Reactions

Immunologic Drug Reaction’s:

Table 1

Non-immunologic Drug Reaction’s:


Table 2


Table 3

Table 4



Drug reactions caused by the immune system and dysfunction are a major cause of illness and death worldwide. It is the most common iatrogenic disease, affecting 5 to 15 percent of medical studies. In the United States, over 100,000 people die each year as a result of side effects of drugs. Three to six percent of all hospital admissions are due to drug reactions, and 6 to 15 percent of hospital patients (2.2 million people in the United States in 1994) experience adverse drug reactions.

Epidemiologic data supports the presence of certain factors that increase the risk of common drug resistance, such as female genital mutilation, or infection with the human immunodeficiency virus (HIV), or herpes. Factors associated with an increased risk of drug reaction are asthma, systemic lupus erythematosus, or use of beta blockers. Although atopic patients do not have a high level of drug sensitivity, they are at high risk for an overdose. [36]

Clinical Disclosure:

Excessive drug reactions to hypersensitivity are major components of the disease and can manifest itself in the involvement of any organ system, including systemic reactions such as anaphylaxis. Drug reactions are often manifested by skin symptoms caused by the immune system and the skin's immune system. The most common manifestation of dermatologic drug reaction is morbilliform rash. Usually, erythematous, maculopapular rashes appear within one to three weeks after exposure to the drug, from the trunk, and eventually spreading to the legs. Urticaria is usually a sign of a real allergen, of the I-type reaction, but may also be manifested by type III or pseudo allergic reaction as well. The strong nonallergic, hypersensitivity reactions (i.e., erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) represent serious skin diseases that need immediate attention due to their association with significant illness and death. Eczematous rashes are often associated with therapeutic drugs and often represent contact dermatitis, which is classified as a type IV response to drug exposure.[36]


After the ADRs were collected and analyzed, we found that people aged 48.71 ± 15.94 were significantly more likely to develop ADRs during chemical cancer. [10.11] The incidence of ADRs was higher for male participants (61.43%) compared to female participants (38.57%) which can be explained by the high incidence of lung cancer (22.86%) seen in our condition as reported in western and eastern India. However, studies from other parts of India and Bangladesh have shown a high prevalence of ADR in cases affecting female patients. [12,13]

In our study, anti-cancer drugs that cause ADRs are vincristine, doxorubicin and cyclophosphamide; but in reported studies from Mexico, cisplatin based, cyclophosphamide, 5-Fluorouracil and paclitaxel chemotherapeutic agents contributed to the occurrence of ADRs. of ADRs compared with other study reports. [15,16,18]

The most affected program in ADR was the Gut Spinal cord (GIT), a feature similar to other studies reported by Goo and colleagues and Chopra and colleagues. A total of 15.09% cases of nausea and vomiting, including vomiting (within 24 hours) and pre-cleaning cases, were reported in our very low case compared to 31.5% and 48.1% reported in two other studies. The low incidence of this allergic reaction in our patients is due to the rapid initiation of antiemetic drugs such as granisetron and the intensive administration of ranitidine, pantoprazole, dexamethasone and aprepitant. [7,20,21,22]

The most common method of nausea and chemotherapy is to use a chemoreceptor trigger zone (CTZ). The management plan in our multi-response program was the administration of high-dose granisetron in line with the findings of other studies in which patients received high doses of antiemetic drugs for the treatment of nausea and vomiting.

  • There is documentary evidence of the onset of constipation with anticancer drugs containing vincristine and cisplatin. Constipation was detected in our 12.26% patients which was higher than other reported studies. Concomitant administration of pre- prescription drugs such as pheniramine maleate with low emetogenic drugs may be one of the causes of constipation. It is noteworthy that the presentation of constipation observed in our patients was a Grade 1 type and was treated with medication and appropriate dietary modification. However, three of our patients were subjected to persistent grade 2 constipation when exposed to regular laxatives. [30,32,33]

Schumock and Thornton scale blockade tests have shown that only 45.3% of ADRs are likely to be prevented in patients with symptoms of vomiting, general weakness, constipation and hiccough where appropriate medication is administered and confirmed proper dietary advice before starting chemotherapy. All of the ADR cases reported in our study were treated fairly and all of these patients have fully recovered without recurrence. [35,36] Our study examined three different ADR parameters, namely the cause of severity, severity and security due to the various cancer-accepted management programs, management costs, and patient- related factors, thus providing basic information about the safety profile of anti- cancer drugs. The WHO status test showed that 70% of responses were "possible," similar to other onco-pharmacovigilance studies. Since anti-cancer drugs usually include many drugs and a description, we suggest that other drugs on the list may contribute to the visual response. In addition, it is undeniable that the symptoms and  signs of this disease can sometimes mimic ADR in these terminally ill patients. In addition, information about drug withdrawal next to the negative response is lacking as ADRs are quite common in those drugs and withdrawal is often uncommon in such cases. On the scale of difficulty, most responses were low levels that did not allow the drug to be stopped or modified. Preventive measures showed that most ADRs were protected. As it was a retrospective study, there is the potential for lower reporting and incomplete data for ADRs data, especially from the first few reports. We expect that in the near future, the reporting of ADRs will continue to improve following the increase in departmental intelligence. [25,28,30]



The ADR analysis associated with cancer chemotherapy at the hospital setup provides insight into the severity, severity and prevention of the identified ADRs. It can also create awareness among clinicians who can prevent the recurrence of similar ADRs in the same patient. Pharmacovigilance is very important to ensure that the drugs are safe and effective, especially in enjoyable health care services. Proper testing of ADRs helps to prevent their recurrence in subsequent chemotherapeutic cycles. Our study highlighted the common ADR of anti-cancer drugs and their severity, severity and safety. The analysis of ADRs associated with the cancer chemotherapy in a hospital setup gives an insight regarding the causality, severity and preventability of the identified ADRs. It may also create awareness among the treating physicians that can prevent further occurrence of similar ADRs in the same patient.

The intensive surveillance from our end has led to early detection of some common but important ADRs and to some extent contributed towards achieving the goal of pharmacovigilance in this part of the country. Proper evaluation of ADRs helps in preventing their recurrence in subsequent chemotherapeutic cycles. We may conclude that an Monitoring and reporting system (onco-pharmacovigilance) will be the most effective tool for better management of chemotherapy-related ADRs. Practices such as an early detection, timely intervention, avoiding agents with overlapping toxicity, or changing the offending agent and substituting it with an alternative agent are few suggestions. Onco-pharmacovigilance will increase the bulk of data on frequency, severity, outcome, etc., associated with anticancer drug use, particularly in the Indian population.

Medical, radio, and surgical oncologists, clinical pharmacologists, and other health- care providers involved in the care of cancer patients must all be involved in the onco- pharmacovigilance program to enhance the quality of data generated by exchanging and updating each other with constructive information. In addition, they should also ensure effective communication and education concerning the appropriate use of drugs in cancer patients. In addition, the patient population should also be encouraged to report whenever they feel anything that in their opinion is not normal. Moreover, to strengthen ADR detection and reporting at grass-root level, the public at large may play an important role if they are well informed in their own language about proper use and safety of drugs through various means, i.e., TV, radio, print media, social media or public awareness lecture, etc. The motivation for voluntary reporting of ADRs for preventing the morbidity and mortality in this vulnerable population could be of immense importance.



1.Signature VK, Sewal RK, Ahmad Y, Medhi B. “Expected research study of non-cancer drugs used in cancer treatment at a tertiary care hospital”. Indian J Pharm Sci 2015; 77: 687-93. [Full text]

2.Angiji A “Adverse drug reactions related to            mortality and  morbidity: drug-drug interactions and overdoses”. Xendo. 2010. Available from http://wwwxendocom/images/pdf/ADRs-by- Majorsystems-II-Final-Reportpdf. Accessed October 22, 2020.

3.Parande F, Anand A, Khaparde M, Pawar S.  Chemotherapy-induced adverse drug reactions in pediatric oncology. J Young Pharm. 2018;10(3):340. doi:10.5530/jyp.2018.10.75

4.Joseph SG, Badyal DK. “Spontaneous adverse drug reaction monitoring in a tertiary care hospital in Northern India”. JK Science. 2016;18(2):103.

5.Chabner BA. “General principles of chemical cancer. In: Brunton L, Chabner B, Knollman B, editors. Goodman and Gilman are Pharmacological Basis of Therapeutics” 12th day. New York: McGraw-Hill Inc.; 2011. page. 1667-75.

6.Alsbou M, Abdeen G, Batarseh A, Bawaresh N, Jaber J, Qawasmi G. “Analysis of the National Pharmacovigilance Database in Jordan (2010–2014)”. Biomed Pharmacol J.2017;10(1):319–328. doi:10.13005/bpj/1112

7.Rabbur RS, Emmerton L. “Introduction to a malicious program to report drug reactions in different countries”. Int J Pharm Prac 2005; 13: 91-100.

8.Turgay AS, Khorshid L, Eser I. “Results of the first chemotherapy study on the quality of life of cancer patients in Turkey”. Cancer Nurse 2008; 31: E19-23.

9.Ma L, Wang SP, Chung J. “Research on associated symptoms and their impact on the quality of life in breast cancer patients”. Chin J Evid Founded in Med 2007; 7: 169-74.

10.The ADR form is PvPI. Available from: [Last available on 2017 Mar 06].

11.Skrbo A, Begovi? B, Skrbo S. “Classification of drugs using the ATC system (Anatomic, therapeutic, chemical classization) and the latest changes”. IMed Arh 2004; 58: 138-41.

12.Zaki SA. “Negative drug reactions and contraindication scales”. Lung India 2011; 28: 152-3.[PUBMED] [Full text]

13.Hartwig SC, Siegel J, Schneider PJ. “Prevention and severity testing in reporting adverse drug reactions”. I am J J Hosp Pharm 1992; 49: 2229-32.

14.Schumock GT, Seeger JD, Kong SX. “Control charts for monitoring drug response rates”. Hosp Pharm 1995; 30:1088, 1091-2, 1095-6.

15.Balmer CM, Valley AW, Iannucci A. “Cancer treatment and chemotherapy. In: Pharmacotherapy: Pathophysiologic Method”. Date 6. USA: McGraw-Hill Companies; 2005. page. 2279.

16.Sisay EA, Engidawork E, Yesuf T, Ketema E. “Drug related problems in chemotherapy of cancer patients”. J Cancer Sci Ther. 2015;7 (2):55–59.

17.Kshirsagar NA, Karande SC, Potkar CN. “Drug resistance in India”. J Assoc Doctors in India 1993; 41: 374-6.

18.Lumpkin MM. “International pharmacovigilance: Developing partnerships to meet the challenges of the 21st century”. Pharmacol Toxicol 2000; 86 Suppl 1: 20-2.

19. Aggarwal M, Chawla S, Singh K, Rana P. “Evaluation of anticancer drug utilization and monitoring of adverse drug reaction in the indoor patients receiving cancer chemotherapy in a Tertiary Care Hospital in New Delhi”. J Basic Clin Pharmacol. 2018;9:2.

20. Dewan P, Singhal S, Harit D. “Management of chemotherapy-induced nausea and vomiting”. Indian Pediatr. 2010;47(2):149–155.

21.Surendiran A, Balamurugan N, Gunaseelan K, Akhtar S, Reddy KS, Adithan C, et al. “Profile of adverse drug response of cisplatin-based chemotherapy regimen at a hospital in India nursing: Experimental study”. Indian J Pharmacol 2010; 42: 40- 3.

22.Soldin OP, Chung SH, Matison DR. “Sexual differences in dealing with drugs”. J Biomed Biotechnol 2011; 2011: 187103.

23.Astolfi L, Ghiselli S, Guaran V, Chicca M, Simon E, Olivetto E, et al. “Combining the side effects of cisplatin administration in patients affected by severe abscesses: A retrospective study”. Oncol Rep 2013; 29: 1285-92.

24.Balmer CM, Valley AW, Iannucci A. “Cancer treatment and chemotherapy. In: Pharmacotherapy: A Pathophysiologic Approach”. 6th ed. USA: McGraw-Hill Companies;2005. p. 2279.

25.Grunberg SM. “Antiemetic activity of corticosteroids in patients receiving cancer chemotherapy: Measurement, efficacy, and tolerance analysis”. Ann Oncol 2007; 18: 233-40.

26.Hanlon JT, Ruby CM, Artz M. Geriatrics. To: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM, editors. Pharmacotherapy Pathophysiologic Method. Date 5. New York: McGraw-Hill Inc .; 2002. page. 79-89.

27.Manohar HD, Adiga S, Thomas J, Sharma A. “Profile of adverse drug reactions to microtubule antineoplastic: A pharmacovigilance study focused on India”. Indian J Pharmacol 2016; 48: 509-14.

28.Ma X, Yu H. “The global burden of cancer”. Yale J Biol Med 2006; 79: 85-94.

29.Mallik S, Palaian S, Ojha P, Mishra P. “A pattern of drug-induced adverse reactions to chemical cancer in a higher education hospital in Nepal”. Pak J Pharm Sci 2007; 20: 214-8

30.Lau PM, Stewart K, Dooley M. “The ten most common drug responses (ADRs) in oncology patients: Are they important to you?” Support Cancer Care 2004; 12: 626-33.

31.Wahlang JB, Laishram PD, Brahma DK, Sarkar C, Lahon J, Nongkynrih BS, et al. “Drug reactions due to chemical cancer in a tertiary care education hospital”. Ther Adv Drug Saf 2017; 8: 61-6.

32.Lihite RJ, Lahkar M, Das S, et al. “A study on drug reactions at Northeast India High School in India”. Alexandria J Med. 2017; 53 (2): 151-156. i-doi: 10.1016 / j.ajme.2016.05.007

33.Gaur S, Sinha A, Gunjita B, Bhardwaj R, Renu K, Srivastava B “Pattern of adverse drug reactions of various chemotherapeutic drugs in cancer patients in the Kumaun region”.

34.Schatz S, Weber R. “Different drug reactions”. Pharm Pract (Granada). 2015; 1: 1.

35.Sunny S, Thampi A, Johnkennedy NS, Babasahib SK, Chacko C. “Assessment of adverse effects of most commonly prescribed antic- ancer drugs in a Tertiary Care Teaching Hospital”. Int J Pharm Pract. 2017;10(4):271.

36.MARC A. RIEDL, M.D., and ADRIAN M. CASILLAS, M.D., “University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, California Am Fam Physician”. 2003 Nov 1;68(9):1781-1791.


Figure 1

Figure 2

Figure 3