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history of alcoholism or drug addiction.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Provigil can make certain birth control less effective. Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment. Talk with your doctor about the best methods of birth control to use while taking Provigil.

It is not known whether modafinil passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Provigil is not approved for use by anyone younger than 17 years old.

Other drugs may interact with modafinil, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

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Get emergency medical help if you have signs of an allergic reaction to Provigil: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Provigil can cause skin reactions that may be severe enough to need treatment in a hospital. Stop taking this medicine and get emergency medical help if you have:

skin rash or hives, blisters or peeling;
mouth sores, trouble swallowing;
fever, shortness of breath;
swelling in your legs;
dark urine, jaundice (yellowing of the skin or eyes); or
swelling in your face, eyes, lips, tongue, or throat.

Stop using Provigil and call your doctor at once if you have:

depression, anxiety, suicidal thoughts or actions;
hallucinations, unusual thoughts or behavior, aggression, being more active or talkative than usual;
chest pain, trouble breathing, uneven heart beats; or
the first sign of any skin rash, no matter how minor you think it might be.

Common Provigil side effects may include:

headache, dizziness;
feeling nervous or anxious;
back pain;
nausea, diarrhea, upset stomach;
sleep problems (insomnia); or
stuffy nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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