Introduction: Statins cause adverse drug reactions (ADRs) in patients on chronic use of medications. No specific tool available for patients to report these ADRs. Most of previous studies based on the doctors’ reports.

Aim: development specific tool for reporting of satins-ADRs for cardiac outpatients, and to determine the incidences and correlations among these ADRs.

Method: the questionnaire based on the commonly reported ADRs of statins, researchers' agreements and the consistent understanding of the questions by cardiac clinic outpatients. Also a comparison conducted between current study and literatures depending on type of reporting

Statistical analysis: SPSS version 18.0 used for the analysis of results collected in this study. For preparation of specific questionnaire, factor analysis used to determine the ADRs correlated to statin depending on the statistical value of terms (must be equal or more than 0.4), as well as, Cronbach's alpha and Spearman-Brown tests used to approve the reliability of the questionnaire (must be more than 0.7).

Results: factor analysis showed six classes of ADRs found (musculoskeletal, neurological, reparatory, urological, gastrointestinal and others) identified with acceptable statistical values ranging from 0.406 to 0.737. The reliability of the questionnaire for both Cronbach's alpha and Equal-length Spearman-Brown coefficient were 0.853 and 0.890 respectively. The incidence of multiple ADRs significantly increased with the increased number of groups. The musculoskeletal and neurological group showed highest significant incidence (91%).

Conclusion: validity and reliability of the questionnaire and its terms within acceptable range to approve for clinical studies, therefore it considered as a suitable tool for cardiac outpatients in reporting the ADRs of statins. Besides, this simple approach to determine ADRs from outpatients on chronic therapy. Patients' self-reporting is more reliable than doctors reporting type.