Background Case reports have suggested that the use of statins may be associated with an increase in the risk of interstitial lung disease (ILD).

Methods Within a large cohort of users of respiratory medications identified in the Quebec health administrative databases during 1990–2005, we carried out a nested case–control analysis of the relationship between statins and the risk of ILD as defined by specialist visits or hospitalisations.

Results The cohort included over 1.4 million patients, of which 6665 possible or probable cases of ILD were identified during follow-up. These were compared with 26 660 controls matched for age, gender and calendar time. After adjustment for confounders and comorbid conditions, there was no association between current use of statins and risk of ILD (adjusted OR 0.99, 95% CI 0.91 to 1.08). The results were similar when any use of statins within the previous 1 or 2 years was considered or when the analysis was limited to more definite cases.

Conclusions This large cohort study did not find an association between statin use and the incidence of ILD.