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Guide to Safe Use of Prescription Drugs: Ask About Side Effects

Ask your doctor, pharmacist or other healthcare professional about any side effects associated with the medication and any specific recommendations about how and when to take it.

side effect is a reaction or consequence of medication or therapyVirtually any drug will occasionally cause an unwanted reaction. A side effect is a reaction or consequence of medication or therapy that is additional to the desired effect of the medicine. Some side effects are predictable. For example, some antihistamines can cause drowsiness and many cancer therapies can cause hair loss. Side effects are listed in the U.S. Food and Drug Administration (FDA) (This link will take you to a web site to which this Privacy Policy does not apply. You are solely responsible for your interactions with such web sites.) approved labeling for the drug.

Some adverse reactions are unexpected, may be serious, and are unpredictable. Serious adverse reactions are also, in general, rare. The causes of such reactions include medication errors (e.g., overdose), or interactions between different drugs or between drugs and certain foods. Call your doctor, pharmacist, or other healthcare professional immediately if you think you’ve experienced an adverse drug reaction to your medication.

Do not be afraid to ask your doctor, pharmacist or other healthcare professionals any questions or concerns you have about your medications. They can help you anticipate and understand your medicine’s side effects and help you deal with them.

Pharmaceutical companies track adverse events and they must notify the FDA when they learn of side effects. Many pharmaceutical companies offer toll-free numbers you can call if you have questions about your medicine.

Most companies also provide information via web sites on the Internet. The types and amount of information will vary by company.

There are other sources of information you can access to get more information about your medication and possible side effects.

Package Inserts

The Package Insert (also referred to as ‘Labeling,’ ‘Prescribing Information’, or ‘PI’) is prepared by your medicine’s manufacturer for healthcare professionals who prescribe or dispense prescription medicines. PIs ordinarily follow a particular format mandated by the Food and Drug Administration. Your pharmacy should have a current package insert for any drug dispensed. If it does not, ask your pharmacist to get one for you.

Package inserts are not the same as the abbreviated safety information printouts that many pharmacies now offer with your prescription. They may also vary from the labeling information that accompanies most advertisements for prescription medicines (these are called “brief summaries”). The brief summary contains a portion of the full prescribing information. It contains information relating to side effects, warnings, precautions, and contraindications (circumstances under which your medicine should not be used) of the drug, and sometimes is written using more easily understood language.

For several prescription medicines, such as oral contraceptives and other hormone-based products, the FDA requires that manufacturers provide special materials (patient package inserts) written for consumers. The FDA has reviewed these materials. If you receive a prescription for one of these products, the patient package insert should be included. If it is not, ask your doctor, pharmacist or healthcare professional for this information.

Many package inserts can also be found in the Physician’s Desk Reference ® (often referred to as the PDR). For over 50 years, this publication has served as an annual compendium of FDA-approved labeling for many prescription drugs. Keep in mind, however, that the PDR is published only once a year, so any revisions to the package insert occurring in the interim may not appear in the version you are looking at (Note: two supplements to the PDR are published every year). Check at the very end of the package insert or the PDR entry to see when it was last updated. If you’re not sure you have the latest version, ask your doctor, pharmacist, or other healthcare professional, or contact the company.

The PDR ® Family Guide to Prescription Drugs ® is another good resource. In addition to listing each medication under its familiar brand name, as well as its generic name, the publication includes important information about side effects specifically attributed to the drug by the manufacturer. It also provides full information on standard dosage recommendations and provides advice on what to do when you miss a dose of your medication, while alerting you to the warning signs of overdose.

Check your local library or bookstore to see if they have a current version of these books. Both are also available on the Internet.

Other Sources

The Internet offers a number of sources of information about approved drugs.

While you may find a wealth of data on the Net, however, keep in mind that these sites generally do not cover all possible uses, actions, precautions, side effects, or interactions of these medicines, nor are they intended as medical advice for individual problems or for making an evaluation as to the risks and benefits of taking a particular drug. It is still best to discuss this information with your doctor, pharmacist, or other healthcare professional to find out how any medicine applies to you and your particular situation.

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