Statins and interstitial lung disease: a systematic review of the literature and of food and drug administration adverse event reports

Chest. 2008 Oct;134(4):824-830. doi: 10.1378/chest.08-0943. Epub 2008 Aug 8.


Objective: To systematically review all published case reports and the US Food and Drug Administration adverse event reporting (FDA-AER) database to examine the relationship between statins and interstitial lung disease (ILD).

Data sources: PubMed (1987 to September 2007) and the FDA-AER database (as of June 2007) were searched for reports of ILD in which a statin was listed as a causative suspect.

Review methods: Two authors (one author for Pub Med cases and one for FDA-AER cases) independently abstracted patient data. Given the paucity of information, all case reports and case series in English and French were included. All adverse event reports from the FDA-AER database in which a statin was listed as causative suspect were included.

Results: The literature search using PubMed yielded eight articles describing a total of 14 case reports of ILD in association with statin use. The FDA-AER system database contained 162 cases of reported statin-induced ILD as of June 2007. For every 10,000 reports of a statin-associated adverse event, approximately 1 to 40 reports were for ILD.

Conclusions: Statin-induced ILD is a possible newly recognized side effect of statin therapy. The mechanism of lung injury is not defined. The current review provides novel information from the FDA-AER that supports a possible, although unusual, pulmonary class effect of statins.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review
  • Systematic Review

MeSH terms

  • Adverse Drug Reaction Reporting Systems*
  • Aged
  • Aged, 80 and over
  • Databases, Factual
  • Female
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / adverse effects*
  • Hyperlipidemias / complications
  • Hyperlipidemias / drug therapy
  • Hyperlipidemias / epidemiology
  • Lung Diseases, Interstitial / chemically induced*
  • Lung Diseases, Interstitial / diagnosis
  • Lung Diseases, Interstitial / epidemiology*
  • Male
  • Middle Aged
  • Risk Factors
  • United States / epidemiology
  • United States Food and Drug Administration


  • Hydroxymethylglutaryl-CoA Reductase Inhibitors