Safety information for PROVIGIL






Side effects you may experience

The most common side effects of PROVIGIL are headache, nausea, nervousness, stuffy nose, diarrhea, back pain, anxiety, trouble sleeping, dizziness, and upset stomach.

PROVIGIL may cause you to have a serious rash or serious allergic reaction. Stop taking PROVIGIL and call your doctor right away or get emergency treatment by calling 911 if you have any of the following:

  • Skin rash, hives, sores in your mouth, or your skin blisters or peels
  • Swelling in your face, eyes, lips, tongue, or throat
  • Trouble swallowing or breathing
  • Hoarse voice

PROVIGIL is not approved for use in children.

You should also stop taking PROVIGIL and call your doctor or get emergency help if you have any of the following:

  • Mental (psychiatric) symptoms. Symptoms include depression, anxiety, hallucinations, mania, thoughts of suicide, aggression, or other mental problems
  • Heart problems including chest pain

Some effects of PROVIGIL on the brain are the same as other medicines called "stimulants." These effects may lead to abuse or dependence on PROVIGIL. Before starting PROVIGIL, tell your doctor if you have ever abused drugs, including other stimulant medicines.

These are not all of the possible side effects of PROVIGIL. For more information, ask your doctor or pharmacist. Tell your doctor if you get any side effect that bothers you or that does not go away while taking PROVIGIL.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.