Understanding Prescription Drug Labels

The Food and Drug Administration requires drug companies to inform consumers of risks associated with their products, but it can be difficult to understand prescription drug labels and warnings if you don't know where to look. You’ll find most information about your prescription drug in the package insert or in a Boxed Warning.

The Food and Drug Administration (FDA) requires that prescription drug manufacturers tell consumers about risks associated with their products. However, drug labels often contain unfamiliar medical language that can make it difficult or overwhelming to read them. It doesn’t have to be, as long as you know where to look. You’ll find most information about your prescription drug in one of two places: in the package insert or in the Boxed Warning.

Package Insert

The package insert is also referred to as the product label, product information, or prescribing information. It’s the small pamphlet that comes either with your prescription or inside its box. The insert contains instructions for taking your medication, as well as information about the risks and side effects associated with the drug. Sections to pay close attention to are:

  • Warnings and Precautions
  • Adverse Reactions
  • Contraindications

The Warnings and Precautions section provides a list of known side effects that are serious or clinically significant, meaning that they caused noticeable changes to patients’ health in a clinical trial. This section will include side effects associated with a drug, and give details about side effects listed in the Boxed Warning. The Warnings and Precautions section will also list any available tests that can predict or identify possible side effects.

The Adverse Reactions section will include more detail about a medication’s side effects. Here you will find risk factors that increase the chances of being hurt by a drug, and estimates of the likelihood of an adverse reaction actually happening. It’s important to note that side effects are listed in the order of their relative significance, and that drug companies are required to list all side effects observed in a clinical trial. In other words, the most severe side effects will be listed first and some of the side effects listed may be very rare.

Contraindications refer to specific situations in which a drug should not be used. A medication is contraindicated if data proves that the potential risks associated with a drug definitively outweigh its benefits for a certain group of users. Age, gender, existing conditions or use of other medications might put you at risk for using a drug. If there are contraindications listed, read them carefully to make sure you do not fall into any of the contraindicated user categories. Contact your doctor immediately if you believe that you fall into one of these groups. If there are no known contraindications, this section will read “none.”

All prescription drugs have a package insert, but Boxed Warnings drug labels are used only when a drug is known to cause very serious side effects or reactions in some users.

Boxed Warning

The Boxed Warning, more commonly referred to as a “black box” warning, contains information about a drug’s most serious known side effects. A boxed warning is a drug label which looks similar to the “drug facts” box on nonprescription drugs. Black box warnings are recognizable by their black border and bold print text. Prescription medications will have a Boxed Warning if the drug meets one or more of these conditions:

  • The drug can cause life-threatening health conditions, fatalities, or permanent disability in users.
  • The drug can cause serious preventable or reducible side effects if used inappropriately or without monitoring.
  • The drug has been approved by the FDA, but only with restricted access and distribution to ensure that it is used safely.

Boxed Warning drug labels indicate that the potential risks associated with a drug may outweigh its benefits. Medications with black box warnings can still prove beneficial to some patients, while others may experience complications. Be sure to talk to your doctor if you have concerns about being prescribed a medication with a Boxed Warning.

Terms to Know from the FDA

The following terms often appear in drug labels:

Adverse Reaction — Any negative side effects associated with a drug’s use.

Adverse Event — Any negative occurrence associated with a drug, even if it is unclear whether it was caused by the drug.

Benefit — A health improvement caused by the use of a drug.

Interaction — Drugs sometimes respond to the presence of certain foods, beverages, supplements or other drugs in your body. This is called an interaction. Not all interactions are negative. Contact your doctor if you believe your medication is causing an adverse interaction.

Serious Adverse Reaction — An adverse reaction or event which causes death, hospitalization, a life-threatening health condition or event, loss of quality of life, birth defects or a congenital anomaly.
Different people may respond differently to the same medication — that’s why it is so important to be aware of possible side effects and complications before you start a new medication.

Always Be Informed

At the end of the day, there’s no way to know exactly how your body will react to a drug, even if it has been prescribed by your doctor. You should always talk to your doctor before taking a new drug, and notify your doctor immediately if you have concerns about your prescription or begin experiencing unexpected side effects.