Supplementary Table 1.
Adverse drug effects meeting the criteria for reporting
Pulmonary ADE | Benazepril | Captopril | Enalapril | Fosinopril | Lisinopril | Perindopril | Quinapril | Ramipril | Candesartan | Irbesartan | Losartan | Olmesartan | Telmisartan | Valsartan |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
PULMONARY EDEMA | 0 | 3 | 1 | 0 | 1 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 2 |
PLEURAL EFFUSION | 0 | 3 | 2 | 3 | 1 | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
OROPHARYNGEAL PAIN | 0 | 0 | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 0 | 2 | 2 | 1 | 1 |
DYSPNEA | 1 | 3 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 2 |
DYSPHONIA | 0 | 0 | 1 | 0 | 1 | 3 | 0 | 0 | 3 | 0 | 3 | 1 | 0 | 1 |
COUGH | 1 | 3 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 2 | 1 | 1 | 1 |
SINUSITIS | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 3 | 3 | 1 | 1 | 0 | 0 | 1 |
PNEUMONIA | 1 | 3 | 2 | 0 | 1 | 3 | 1 | 1 | 1 | 1 | 2 | 1 | 1 | 2 |
NASOPHARYNGITIS | 0 | 0 | 1 | 0 | 1 | 3 | 0 | 1 | 1 | 3 | 1 | 1 | 1 | 1 |
BRONCHITIS | 0 | 3 | 1 | 0 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 1 | 3 | 1 |
PNEUMONIA ASPIRATION | 0 | 3 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 2 |
EMPHYSEMA | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
PLEURISY | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 3 |
Note: Numbers in the table indicate how many of the following criteriaa are met: (1) at least 3 incidences, (2) a proportional reporting ratio greater than 2, and (3) a proportional reporting ratio that is more than the lower 95% CI boundary with the lower CI being greater than 1.
Source: U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. Guidance for Industry Good Pharmacovigilance Assessment Guidance for Industry Practices and Pharmacoepidemiologic Assessment. Available at: http://www.fda.gov/cber/guidelines.htm. Accessed April 14, 2020.