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FDALabel — Full-Text Search of Drug Label Database

Overview of FDALabel Database
What are Drug Labels?
Database Features
FDA Drug Labels and Adverse Drug Reactions (ADRs)
Potential Users
Updates and Statistics
Launch FDALabel Database
References
Contact Information
 

FDA over LABEL in blue on a grey background with five pills of various colors and sizes in upper right corner
 

Overview of FDALabel Database

The FDALabel Database is a free web-based application that can be used to query a database of about 30,000 drug labels. The primary goal of FDALabel is to provide a user-friendly interface with customizable searches against the entire text of drug labels. It is implemented as a secure three-tier platform with an Oracle database. The source of FDALabel’s data is the Structured Product Labeling (SPL)1 archive of DailyMed2 that is maintained by the National Library of Medicine (NLM).

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What are Drug Labels?

The FDA-approved drug label is the official description of a drug product and includes what the drug is used for, who should take it, side effects, instructions for use, and safety information for the patient. Labels are often found inside drug product packaging.  More details about labels can be found here: http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm.

The FDALabel database only contains U.S. drug labels. Categories include:

  • Human Over-The-Counter Labels
  • Homeopathic Labels
  • Animal Labels
  • Remainder Labels (Bulk Ingredients, Vaccines, and some Medical Devices)2

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Database Features

The simple search options in FDALabel include full-text search as well as searches within only the product or generic name. The advanced search options allow querying text:

  • within specific sections (e.g., indication and usage, clinical pharmacology, boxed warning, adverse drug reactions, drug interaction)
  • specification of dosage forms
  • SPL identifiers
  • document types
  • routes of administration
  • marketing categories
  • market status
  • market start/end date

Importantly, query results can be saved in a spreadsheet format in your local computer.  The internal FDA version of the software allows some additional features, including the ability to save searches for future use and to tag specific drug labels with annotations for organization and quick retrieval.

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FDA Drug Labels and Adverse Drug Reactions (ADRs)

FDA-approved drug labels contain a wealth of information about ADRs from clinical trials and post-marketing surveillance. The information included in the labels is agreed upon by regulatory, industry, and consulting experts who have incorporated their contributions over decades, reflecting the best thinking at the time. Thus, the drug labeling implicitly balances the information of causality, incidence, and severity based on 1) data from controlled trials, 2) published literature reports, and 3) spontaneous reports to AERS (adverse event reporting systems)3,4.

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Potential Users

The wealth of information in the FDALabel Database can be a resource to physicians for quick access to drug indications and warnings, to pharmaceutical companies for drug development and repositioning, to researchers studying drug safety, to FDA medical officers for drug review, etc. For example, a recent publication demonstrated how a systematic classification scheme using FDA-approved drug labels had been developed to assess each drug’s potential for drug-induced liver injury, thus illustrating the utility of the FDALabel Database4.

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Updates and Statistics

The database is updated weekly. Statistics are posted on the main database page showing the total number of labels and the number of newly added, updated, and removed labels.
*Note: Currently, the updated database is only available inside the FDA firewall; non-FDA users are not allowed to access most current data. We are working to provide the updated version to non-FDA users.

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Launch FDALabel Database

FDA Version:
Launch FDALabel Database

Non-FDA Version:
Launch FDALabel Database for non-FDA user

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References

1. http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
2. http://dailymed.nlm.nih.gov/dailymed/downloadLabels.cfm
3. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=201.57
4. Chen, M.J., Vijay, V., Shi, Q., Liu, Z.C., Fang, H., and Tong, W.D. "FDA-Approved Drug Labeling for the Study of Drug-Induced Liver Injury," Drug Discovery Today, 16(15-16):697-703, 2011. Abstract disclaimer icon 

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Contact Information

 Questions or Suggestions: Dr. Weida Tong (870-543-7142 or weida.tong@fda.hhs.gov)
 Dr. Hong Fang (870-543-7538 or hong.fang@fda.hhs.gov)
 Report Technical Problems or get Assistance:  NCTRBioinformaticsSupport@fda.hhs.gov

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