Statin-associated ocular disorders: the FDA and ADRAC data

Int J Clin Pharm. 2015 Oct;37(5):844-50. doi: 10.1007/s11096-015-0128-x. Epub 2015 May 5.


Background: Statins are a class of medication indicated for atherosclerotic diseases and dyslipidemia. Since their appearance, many adverse events have been associated with their use. Ocular disorders are rare but serious adverse events of statins.

Objective: To report the association between statins and ocular adverse events (blurred vision, visual impairment, visual field defect, reduced visual acuity, myopia, hypermetropia, presbyopia, and astigmatism) which might be associated with muscle or liver problems by examining the frequency of ocular adverse events among the reported adverse drug reactions from the Food and Drug Administration (FDA) and Adverse Drug Reactions Advisory Committee (ADRAC) data. Setting The FDA USA and ADRAC Australia databases.

Methods: We conducted a retrospective study of statin-associated ocular adverse events reported to FDA between 1988 and 2013 and ADRAC between 1988 and 2011. The recoded data included: patient's age, gender, suspected drug and dosage, concomitant drug, adverse events, duration of therapy, dechallenge and rechallenge therapy. The differences in the adverse events profiles between each of the statins and atorvastatin were performed using Chi square and multivariate (logistic regression) statistical tests.

Main outcome measure: Percentages of subjects correlated with each Ocular adverse events.

Results: Among 131,755 cases of patients taking statins in the FDA, there were 2325 cases reported ocular adverse events after using statins (1.8%). The Chi square statistic showed that the proportions of ocular adverse events varied significantly (p < 0.0001) across the different statin drugs. The most highly reported ocular adverse events associated with statins were blurred vision (48.4%) and visual impairment (25.7%). Results from logistic regression indicated that the ocular problems formed a greater proportion of the adverse events for subjects taking atorvastatin (2.1%). Of the 1.8%, ocular adverse events mostly occurred alone (60.9%), followed by 30.3% where muscle adverse events also were involved. The ADRAC data held 136 cases of statins associated ocular adverse events (47 patients reported blurred vision and 64 reported vision impairment).

Conclusion: All statins were associated with ocular side effects, with atorvastatin showed a higher incidence of ocular side effects in conjunction with muscle and liver problems.

Keywords: Adverse event; Blurred vision; Liver; Muscle; Statins; Visual impairment.

MeSH terms

  • Adverse Drug Reaction Reporting Systems*
  • Australia / epidemiology
  • Chemical and Drug Induced Liver Injury / epidemiology
  • Databases, Factual
  • Eye Diseases / chemically induced*
  • Eye Diseases / epidemiology*
  • Female
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / adverse effects*
  • Male
  • Middle Aged
  • Muscular Diseases / chemically induced
  • Muscular Diseases / epidemiology
  • Retrospective Studies
  • United States / epidemiology
  • United States Food and Drug Administration*


  • Hydroxymethylglutaryl-CoA Reductase Inhibitors