FDA Adverse Event Reporting System (FAERS) Statin Review

Introduction to FAERS Statin Drug Reviews

by Philip Blair, MD

There's been increasing awareness and concern about adverse effects of statin drugs. However, the evidence for this is limited, contradictory and highly debated.

In an effort to seek more objective evidence, we have focused on the adverse event reporting system by the US Food and Drug Administration (FDA) to provide additional information about the incidence of statin related adverse events.

We realize by the very nature of adverse reporting that these reports cannot provide a causal relationship. Nevertheless, it's hoped that the sheer numbers of reports will be helpful in suggesting additional monitoring, research and consideration for previous unestablished relationships.

All of the information provided in these studies is public sector data available from the FDA. 


 FAERS Statin Review of Associated Conditions as of 2014 Q1

FDA Adverse Event Reporting System (FAERS) Statin Review


FAERS Statin Review

15 December 2014

2014 Q1 showed substantial increases in total Adverse Events (AE) (29%) as well as the proportion of statin related events. Statin reports rose 22% alone in the previous year (19k vs 11k). Diabetes-Statin reports surged over 10x the quarterly average of 300 to 3703.

These numbers were verified in careful review using the same previous search methodology. Muscle conditions followed diabetes then cardiac and renal disorders in frequency of reports.

New findings for diabetes and diabetic complications: Terms of reactions overlap extensively in FAERS. For example, “diabetes mellitus” is part of six separate reaction terms. “Diabetes complicating pregnancy” is one more.

“Diabetic…” is part of 41 reaction terms. Furthermore, “diabetes mellitus” is not always listed with the “diabetic…” terms. Searching both terms either/or revealed 5105 reports for 2014 Q1 and 74,352 for all 37 quarters. This is considerably more AE than reflected in today’s spreadsheet report.

In addition, there is significant overlap with other conditions like “nephropathy” that has not been previously reported in FAERS Statin Reviews. For this category 7871 statin related AE were reported and 281 for 2014 Q1.

Red Yeast Rice (RYR): 729 AE were reported for this supplement for all Quarters and 47 AE for 14Q1. RYR has been included in the statin drug list because it contains an HMG-CoA inhibitor similar to lovastatin. A sample of these reports revealed about half of the individuals using RYR also reported using standard statin medication.

Procedure: Data from FAERS quarterly files from 2004 was downloaded from the FDA server, converted from text (csv) into a Filemaker database and processed into a relational configuration. All statin class drugs or their combinations were marked. Each case was marked in which a statin class drug was listed as a probable or possible cause of the observed adverse effect (AE).

Searches were performed for each AE to find the number of cases that were marked for the use of statin drug. A quarterly and cumulative report is generated with each FAERS quarterly data release. More information is available from the FDA about their data and how it is updated. Strengths and weaknesses of FAERS data are listed in the two references provided.

Statin class drugs: 27 search names were used that included statin drugs, generic names, statin combinations or herbal statin products and Red Yeast Rice (added 12/4/14) in the FAERS files. Lipitor, ATORVASTATIN, Crestor, ROSUVASTATIN, Zocor, SIMVASTATIN, Simcor, Vytorin, Caduet, Advicor, LOVASTATIN, Lipex, Pravachol, PRAVASTATIN, Selektine, Lipostat, Livalo, PITAVASTATIN, ITAVASTATIN, Pitava, Lescol, FLUVASTATIN, Torvast, Baycol, CERIVASTATIN, LIPTRUZET, Red Yeast Rice.

Adverse Reactions: Number 60. This list is reviewed quarterly for higher prevalence events in statin drug reports and grouped by general topic. The terms commonly used in reports change over time.

Reaction terms have been grouped in most cases to provide a better picture of body systems being impacted. Spelling variations require special care. Some overlap occurs so that any single report may list more than one AE in one or more condition groups.


The data indicate a substantial number of adverse events associated with statin drug use. Understandably, many of these patients are severely ill with a wide variety of physical conditions.

Many of the events are not unexpected, for example myocardial infarction. And other conditions represent known complications of statin drugs, for example renal failure and diabetes.

Estimating that the number of reports of adverse effects represents approximately 1% of the actual incidents suggests a very high rate of occurrence for some problems.

It appears that further investigation is warranted for myofascial disorders, renal disorders, neuropathy, memory impairment and behavioral symptoms including depression and suicide.

Philip W. Blair, MD,

Joshua J. Gagne, PharmD, ScD ; Finding Meaningful Patterns in Adverse Drug Event Reports; JAMA Internal Medicine Published online October 20, 2014

Toshiyuki Sakaeda; Data Mining of the Public Version of the FDA Adverse Event Reporting System; Int J Med Sci 2013; 10(7):796­803. doi:10.7150/ijms.6048

 August 2015


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