How to read a Prescription Drug Package Insert
Package insert styles vary from
company to company but generally must include information under the section
headings at the left and in the order listed. This website includes a brief
description of each section's contents.
Within this section, you will find the following general information:
If appropriate, other important chemical or physical information is included in this section.
INDICATIONS AND USAGE
This section contains information about the diagnosis or diagnoses that the drug has been formally approved to treat. However, sometimes drugs can be prescribed for various reasons other than the FDA-approved indications and many drugs have well-established secondary "off-label" uses. Ask your doctor, pharmacist, or other healthcare professional if you have questions about why a particular drug has been prescribed for you.
Under this section heading, the labeling describes those situations in which the drug should not be used because the risk of use clearly outweighs any possible benefit. These situations include:
If no contraindications are known, this section of the labeling will state "None known."
This section describes serious adverse reactions and potential safety hazards, limitations in use of the drug imposed by them, and steps that should be taken if they occur. Check with your pharmacist or the drug's manufacturer to make sure you are looking at the most current version of the package insert (PI).
This section includes information about precautions for most individuals taking the drug, as well as specific groups such as pregnant women and nursing mothers and children.
The General precautions section includes information regarding any special care to be exercised by the healthcare practitioner for the safe and effective use of the drug.
The Information for Patients section contains information recommended to be given to patients by the doctor or other prescribing healthcare professionals to ensure safe and effective use of the drug. For example, this section may include precautions concerning driving when taking the medication, or the use of other substances (e.g., other drugs, food, alcohol) that may have harmful effects if taken while you are on this medication.
Within the Precautions section of the labeling, you will also find information about any laboratory tests that may be helpful in following patients' responses or in identifying possible adverse reactions to the drug, known interactions of the drug with other drugs or certain foods or ingredients, and known interference of the drug with laboratory tests. This section also includes information of interest if you are pregnant, thinking of becoming pregnant, or nursing.
If there is a specific pediatric indication (i.e., an indication for children
from birth to 16 years, different from those approved for adults) it will be
described under the Indications and Usage section, and appropriate pediatric
dosage information will appear in the Dosage and Administration section
An adverse reaction is an undesirable effect that may be associated with the use of the drug. Some adverse reactions are unexpected, may be serious, and are unpredictable. Causes of adverse reactions can include medication errors (e.g., overdosage), or interactions between different drugs or between drugs and certain foods.
This section of the labeling lists the adverse reactions that occur with the drug and with drugs in the same pharmacologically active and chemically related class (e.g., antibiotics, analgesics), if applicable.
DRUG ABUSE AND DEPENDENCE
Within this section of the package insert, information may appear if the drug is considered to have a potential for abuse, dependence, or withdrawal. Examples of drugs that may fall into this category are amphetamines and certain analgesics.
Under this section heading, the labeling describes the signs, symptoms, and laboratory findings associated with an overdosage of the drug, as well as complications that can occur with the drug (e.g. organ toxicity).
DOSAGE AND ADMINISTRATION
This section states the recommended usual dose, the usual dosage range, and, if appropriate, an upper limit beyond which safety and effectiveness have not been established. This section also includes information about the intervals recommended between doses, the usual duration of treatment, and any modification of dosage needed in special patient populations (e.g., children, senior citizens, and patients with renal or hepatic disease).
This section includes information on the available dosage forms to which the labeling applies and for which the manufacturer or distributor is responsible. This information generally includes:
The labeling may also contain the following additional section headlines if appropriate and in compliance with federal regulations:
In most cases, the labeling need not include this section. Significant animal data necessary for safe and effective use of the drug in humans will ordinarily be included in one or more of the other sections of the labeling, as appropriate.
CLINICAL STUDIES or REFERENCES
These sections may appear in labeling in the place of a detailed discussion of a subject that is of limited interest but nonetheless important. A reference to a specific important clinical study may appear in any section of the label if the study is essential to an understandable presentation of the available information.