ICI’s Guide to the FDA-approved Drug Label

What is the Drug Label?

The FDA-approved “drug label” is a document written by the manufacturer of a particular pharmaceutical drug in collaboration with the U.S. Food and Drug Administration (FDA), and is intended to provide patients and practitioners with key information about one or more approved uses of the drug in the United States, its main chemical properties, some of its known risks, its interactions with other drugs and substances, and more. The official, complete FDA-approved drug label includes information about a drug that can be invaluable for understanding how the drug may be affecting you and for conducting the safest possible taper.

Drug labels in this and other countries may have other names such as the “drug product monograph”, and also sometimes go by the names of some of its component parts such as “Patient Package Insert”, “Medication Guide”, or “Full Prescribing Information”. Note that the documents ordinarily provided to consumers by pharmacists or found inside drug packages often include only a few pages of “highlights” from the full drug label or even unregulated, unapproved information. The full drug label, on the other hand, is mainly aimed at health professionals, and for psychiatric drugs can be 10-50 pages in length and sometimes longer. The drug label includes a great deal of important information; below, we explain how to get copies of drug labels, briefly summarize what is typically included in a drug label, and highlight those sections of a drug label that are of particular relevance when developing the safest possible tapering plan.

Sometimes, your physician has prescribed a drug to you for an “off-label” or “non FDA-approved” indication. That means, for example, that the manufacturer of the drug did not try or did not succeed to obtain FDA approval to market the drugs to people in your age group or who have the condition you’ve been diagnosed with. Thus the official drug label may not have information about possible drug effects on people such as yourself. Even in these situations, the complete FDA label of the drug you are taking will contain much vital information for understanding how the drug may be affecting you and for conducting the safest possible taper.

Where to Find Drug Labels

Some pharmacies will print out copies of a drug label upon request – be sure to get a copy of the complete drug label with the Full Prescribing Information and Medication Guide (where applicable) included, and not just 1-2 page summaries of the label in simplified language. These complete FDA-approved drug labels can also be viewed for free online. Some commercial sites provide access to altered versions of drug labels, but the most official, reliable and up-to-date labels are on the sites produced by the U.S. Federal government.

• U.S. National Library of Medicine “DailyMed” website
  This website provides access to past and present drug labels for both brand-name and generic versions of drugs. It also sometimes provides links to related information, such as links to U.S. registered clinical trials.
   
• U.S. Food and Drug Administration “Drugs@FDA” database
  This website provides access to “drug approval packages” for many drugs, which, along with drug labels, can also include historical documentation of medical reviews of clinical trials, statistical reviews, correspondence between the FDA and drug companies, and more. Note that only labels for brand-name drugs can be found here; no drug labels for generic drugs are available.

Search tips:

• Ask the pharmacist, or use a drug bottle, drug packet, and/or a copy of the drug product label that came with the drug to identify the drug’s official name. Note whether the name includes both a brand name and a generic name or just the generic name, and whether there are any supplements to the name such as acronyms or formulation descriptions (e.g. “Adderall XR” or “Depakote – Divalproex Sodium Delayed-release Tablets”). Use this complete name to conduct your search for the appropriate drug label.
   
• If a brand-name drug, search on the complete brand name (e.g. “Abilify (aripiprazole) tablet”).
   
• If a generic drug, when searching for the right drug label, match the name of the active ingredient or generic name for the drug and the packager and/or manufacturer’s name as well. However, if the drug label does not include all of the numbered sections described below, then it is likely an older label that has not been updated. It is advisable to then search to see if there is also a copy of a newer label for the same drug form and formulation from a different manufacturer.
   
• Always be sure that you are viewing the most recent version of the drug label. The date is usually found at the beginning or the end of the label, and sometimes in the margins. Also, different parts of the drug label may have different revision dates.

• If you find the above websites and drug labels overwhelming or difficult to navigate, another option is to search for your drug in the U.S. Food and Drug Administration "Medication Guides" database. These Medication Guides are shorter, more streamlined versions of the drug labels, specifically designed to be more understandable to consumers. (As of 2018, many drugs still do not have a Medication Guide. And notably, where Medication Guides do exist, they are usually already included in a supplemental section of the full drug label.)

What’s Included in the Drug Label?

Newer drug labels often begin with one to two pages of highlights followed by a table of contents for the more detailed information that follows. Despite the large amount of information they contain, drug labels are not considered to be comprehensive, but are simply selective summaries of some of the most important issues that have come to the FDA’s attention about that particular drug and that have been decided to be worthy enough to be mentioned. In addition, the standards and requirements for the drug labels have changed over the years, so the subheaders, order of information, and amount of detail can vary greatly depending on how long the drug has been in the U.S. market and when the label was last updated. For these reasons, if a particular issue is not mentioned in a drug label, that cannot be taken to mean that the issue isn’t of concern in relation to that particular drug. Where your safety is at stake, please do further research and consult well-informed pharmacists and prescribers. Below, we identify the main sections of newer drug labels, along with a selective list of some of the types of useful information that can often be found in those sections – with a particular emphasis on information that can be important for tapering. 

Typical Drug Label Contents