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What is the most important information I should know about phenylpropanolamine?

Phenylpropanolamine has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Do not take phenylpropanolamine for longer than 7 days if your condition does not improve or if your symptoms are accompanied by a high fever.

Do not take more of this medication than is recommended on the package or by your doctor. Use caution when driving, operating machinery, or performing other hazardous activities. Phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

What is phenylpropanolamine?

Phenylpropanolamine is a decongestant. It works by constricting (shrinking) blood vessels (veins and arteries) in your body. Constriction of blood vessels in your sinuses, nose, and chest allows drainage of those areas, which decreases congestion.

Phenylpropanolamine is used to treat the congestion associated with allergies, hay fever, sinus irritation, and the common cold. Phenylpropanolamine also causes a decrease in appetite and is used in some over-the-counter diet aids.

Phenylpropanolamine has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

Who should not take phenylpropanolamine?

Do not take phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

• high blood pressure;

• any type of heart disease, hardening of the arteries, or irregular heartbeat;

• thyroid problems;

• diabetes;

• glaucoma or increased pressure in your eye;

• an enlarged prostate or difficulty urinating; or

• liver or kidney disease.

You may not be able to take phenylpropanolamine, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

It is not known whether phenylpropanolamine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. Infants are especially sensitive to the effects of phenylpropanolamine. Do not take this drug if you are breast-feeding a baby. If you are over 60 years of age, you may be more likely to experience side effects from phenylpropanolamine. You may require a lower dose of this medication. Using a short-acting formulation of phenylpropanolamine (not a long-acting or a controlled-release formulation) may be safer if you are over 60 years of age.