Summary Introduction Patient information leaflet contains specific information regarding the medical conditions, medications as well as the lifestyle modifications required to be followed by the patients. The information collected for the leaflet should be in the simplest form possible so that it can be easily interpreted by the targeted population. Objective The present study aims to develop and validate patient information leaflet for cancer patients. Materials and methods The information for the leaflet was gathered from various primary, secondary and tertiary resources. The content of the leaflet was validated by 10 members including general physicians, medical oncologists, academic pharmacists and clinical pharmacists. Readability of the patient information leaflets was assessed using Flesch Reading Ease test, Flesch-Kincaid Grade Level test and user readability method. User opinion on the content, layout and design was also obtained from the enrolled patients. Results and discussion The FRE and FK-GL scores of English version of patient information leaflet were 61.2 and 7.9 respectively. The overall user readability score of English, Kannada and Malayalam versions of PIL improved significantly from a pre-test score of 41.80 ± 23.18 to a post-test score of 70.40 ± 23.03. Ninety percent of the total patients enrolled in the study recorded good opinion about the leaflet in terms of its content, layout and design. Conclusion Patient information leaflet based education had a significant impact in improving the knowledge level of cancer patients.