How to Read a Drug Label

Reading drug labels can help you ensure you are taking a medication correctly and inform you of possible side effects. Unfortunately, these labels can be challenging for the average person to understand.
If you find the information on your drug labels confusing, you are not alone.

In an interview with Drugwatch, Mireille Hobeika, who received her doctorate in pharmacy from the University of Saint Joseph in West Hartford, Connecticut, said, “Several studies have shown that patients often have difficulty in reading and understanding medication labels, which may lead to medication errors such as taking the wrong medication or the wrong dose.”

Understanding drug labels is particularly important for seniors and people with chronic illnesses. These groups typically have the greatest risk of medication errors or interactions because they tend to take multiple medications.

There are two kinds of drug labels:

• Over-the-counter drug labels: Also called Drug Facts, these labels include information like active ingredients, warnings and directions.
• Prescription drug labels: These may include many pages of safety information, such as pharmacy information sheets, medication guides and prescribing information.

Before you start taking a new medication, review the drug label with your doctor and pharmacist. Let them know about any health conditions you have and any medications and supplements you take.

Over-the-counter, or OTC, drugs are medications that don’t require a prescription. Manufacturers print drug labels called Drug Facts directly on OTC drug product packages.

The Food and Drug Administration classifies any product with a substance intended for diagnosis, cure, treatment, prevention or mitigation of a disease as a drug. This includes products like fluoride toothpaste and anti-dandruff shampoo.

If you are unsure whether a product is an OTC drug, check the packaging for a Drug Facts label.

Four out of five adults in the U.S. commonly take OTC drugs, according to an article published in the Pharmacy Times.

The most popular OTC drugs in 2016 included pain relievers, heartburn drugs like Prilosec and Nexium, upper respiratory drugs and toothpaste.

Information on OTC Drug Labels

In 1999, the FDA created a regulation to simplify and standardize the Drug Facts label. It required most OTC drugs to follow the new format and content requirements by May 2002.

These labels are short, simple and typically have six main parts. Some labels include a seventh section with a phone number to call if you have questions or comments.

Prescription drug labels are more complicated than OTC drug labels. According to Consumer Reports, more than half a million Americans misinterpret prescription drug labels each year.

The FDA doesn’t regulate pharmacy labels. Warning information printed or placed on the bottle as stickers may vary by pharmacy.

For example, Consumer Reports staffers filled prescriptions for Warfarin at different pharmacies. They found that packaging from Target, Walgreens, CVS, Costco and Walmart included different numbers of warnings for the same prescription. Walmart didn’t include any warnings on the first attempt to fill the prescription.

In an interview with Drugwatch, Rachel Brummert, a patient advocate and FDA special employee, stated “Labeling can be confusing, vague, misleading, hidden in medical jargon or missing altogether.” “If prescription labeling were consistent, we could avoid many of the problems caused by inconsistent labeling.”

Pharmacy Information Sheets

The drug label printed on prescription drug packaging doesn’t tell you all the safety information for the drug, so pharmacies will give you a pharmacy information sheet. On this sheet, look for warnings or cautions, drug uses, how to use the drug, side effects, precautions, drug interactions, overdose information and how to store the drug.

However, Dr. Michael Carome, director of Public Citizen’s Health Research Group, said in an interview with Drugwatch that the pharmacy information sheet might be incomplete.

“Lots of [prescription] drugs have pharmacy information sheets, and often … those information sheets have not been reviewed by the FDA,” Carome said. “And the information may not be as accurate in terms of things to watch out for.”

When Consumer Reports filled prescriptions for Warfarin, it found “incomplete or hard-to-read package inserts — and in four of five cases, a dangerous omission that violated an FDA regulation.”

Carome recommends finding the official FDA-approved prescribing information on the drug manufacturer’s website or on DailyMed, a site administered by the National Institutes of Health.

Prescribing Information

According to the FDA, the approved prescribing information — also called the package insert or professional labeling — is the actual prescription drug label. This information is several pages long and may contain about 17 sections. It’s intended to help providers properly prescribe the medication, and the FDA updates it regularly on DailyMed.

Prescribing information can be more complicated to read, but it includes more detailed safety information than the pharmacy drug label or information sheet. Plus, the FDA has reviewed it for accuracy, unlike information provided to you by the pharmacy.

If you have trouble understanding prescribing information, your doctor or pharmacist might be able to help clarify anything you find confusing.

In 2006, the FDA issued a final rule that changed the format of product labels to make it easier for health care professionals.

“The label is now divided into highlights of prescribing information, contents of the full prescribing information (FPI) and the FPI,” Hobeika said. “The highlights section is a half-page summary of the information that health care practitioners most commonly refer to and consider as most important.”

Highlights of Prescribing Information

Full Prescribing Information

The full prescribing information elaborates on the overview provided in the highlights section. This part of the prescribing information is the most complicated because manufacturers typically write it for health care providers, scientists and researchers —, not patients.

In addition to the highlights, the full prescribing information contains details on how the drug works, how long it lasts in the body and how the body gets rid of the drug. It even talks about animal studies, which might provide information about whether or not the drug causes cancer or infertility.

The manufacturers also share results of clinical trials, data showing how well the drug works and the side effects seen in those clinical trials.

In an interview with Drugwatch, Diana Zuckerman, president of the National Center for Health Research, recommended patients consider the following questions and tips when reading clinical trial data on drug labels:

• Were patients in the study like you in terms of age, sex, race and other characteristics? Look for at least 30 patients similar to you in the study. Otherwise, it might not provide you with the most relevant data if people in the study are different from you.
• Were patients in the study like you in terms of medical diagnosis? For example, if it’s a cancer drug, did the study involve people with your type of cancer? The same goes for drugs that treat other diseases. Data might be less relevant to you if you are not represented by patients in the study.
• Is the drug tested in people who failed at other treatments? The FDA approves some higher-risk drugs for people with no other treatment options.

Medication Guides

If a drug has an FDA-approved medication guide, pharmacists are supposed to give it to patients with their prescription. Unfortunately, this doesn’t always happen. Plus, not all drugs have these guides.

The FDA requires manufacturers to write medication guides in easy-to-understand language for patients. You can find these medication guides on the drug manufacturer’s website or on DailyMed.

As an example, the blood thinner Coumadin, also known under the generic name Warfarin, has a medication guide. Similar to the Drug Facts on an OTC label, the medication guide tells patients the most important prescription drug information in simple language. For example, this is the medication guide for the blood thinner Coumadin, also known under the generic name Warfarin.

Information in a Medication Guide

In 2024, the FDA announced it is proposing new “Patient Medication Information” to replace existing drug labels for outpatient prescriptions, including blood products. This would be a simple, one-page document with clear information to help patients safely use medications. You’ll be able to choose paper or electronic versions.

Elements of FDA’s Proposed New Medication Guide

• Clear, concise information
• Essential information highlighted
• FDA-approved
• Single-page format
• Paper or electronic option

Side effect information on drug labels usually comes from clinical trial data collected before a manufacturer sells the drug. Sometimes, the label will get an update based on side effect reports the FDA receives after the drug has been on the market for a while. This information is called postmarketing data.

“If side effects are known, they should always be included on the label, but some side effects aren’t known until years after a product goes on the market,” Zuckerman said.

Drug manufacturers may face lawsuits if they know about a side effect but fail to warn consumers and doctors.

“Back when I took Levaquin in 2006, there were no black box warnings on fluoroquinolones,” said Brummert, who suffered multiple ruptured tendons after taking the antibiotic. “The first warning came in 2008 for tendon ruptures, and that black box only stated that people over 60 were at risk. Adverse reactions I have suffered that are still not included in the warnings are autonomic and central nervous system dysfunction and neurodegenerative disorders.”

Brummert said she discovered the FDA had admitted to these side effects in a hidden document obtained through a Freedom of Information Act request.

If you have tried reading a drug label and don’t understand it, consider asking for help. Your health care providers, including doctors and pharmacists, are there to assist you.

“Before leaving the doctors’ office, patients should make sure they are well informed about the name of the drug and why they are taking it, the medical conditions this drug treats, how many times per day should they take it, how long will it take this drug to work, when should they stop taking it, are there any side effects that they should know about and any situations where they should not be taking the drug,” Hobeika said.

If you leave your health care provider’s office without the information you need to take your medicine safely and effectively, the pharmacy where you pick up your medication can help. Your pharmacist can answer questions about OTC and prescription medications.