Important Safety Information
What important information should I know about PROVIGIL?
- PROVIGIL may cause serious side effects including a serious rash or a serious
allergic reaction that may affect parts of your body such as your liver or blood
cells. Any of these may need to be treated in a hospital and may be life-threatening.
If you develop a skin rash, hives, sores in your mouth, blisters, peeling, or yellowing
of your skin or eyes, trouble swallowing or breathing, dark urine, or fever, stop
taking PROVIGIL and call your doctor right away or get emergency help.
- Provigil is not approved for children for any condition. It is
not known if PROVIGIL is safe or if it works in children under the age of 17.
- You should not take PROVIGIL if you have had a rash or allergic reaction to PROVIGIL
or NUVIGIL® (armodafinil) Tablets [C-IV], or are allergic to any of the
following ingredients: modafinil, armodafinil, lactose monohydrate, microcrystalline
cellulose, pregelatinized starch, croscarmellose sodium, povidone, and magnesium
What are possible side effects of PROVIGIL?
Stop taking PROVIGIL and call your doctor right away or get emergency help if you
get any of the following serious side effects:
- Mental (psychiatric) symptoms, including: depression, feeling anxious, sensing things
that are not really there, increase in activity (mania), thoughts of suicide, aggression,
other mental problems.
- Symptoms of a heart problem, including: chest pain, abnormal heart beats, and trouble
Common side effects of PROVIGIL are headache, nausea, feeling nervous, stuffy nose,
diarrhea, back pain, feeling anxious, trouble sleeping, dizziness, and upset stomach.
These are not all the side effects of PROVIGIL.
Tell your doctor if you get any side effect that bothers you or that does not go
away. Talk to your doctor for medical advice about side effects.
What should I avoid while taking PROVIGIL?
- Do not drive or do other dangerous activities until you and your doctor know how
PROVIGIL affects you.
- Avoid drinking alcohol.
What should I tell my doctor before starting PROVIGIL?
- Tell your doctor about all of your health conditions including if you have: history
of mental health problems (including psychosis), heart problems or had a heart attack,
high blood pressure, liver or kidney problems, a history of drug or alcohol abuse
or addiction, or are pregnant, planning to become pregnant, or breastfeeding.
- Tell your doctor about all of the medicines you take. Women who use hormonal birth
control may have a higher chance of getting pregnant, while taking and for one month
after stopping PROVIGIL. Talk to your doctor about other birth control methods while
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, or by fax at 1-800-FDA-0178.
For more information, ask your doctor or call 1-800-896-5855.
This information does not take the place of talking with your doctor for medical
advice about your condition or treatment.
Please read the Medication Guide for patients in the Full Prescribing Information for PROVIGIL.
There is a registry for women who become pregnant during treatment with PROVIGIL.
The purpose of this registry is to collect information about the safety of PROVIGIL
during pregnancy. You or your doctor can get information and enroll you in the registry
by calling 1-866-404-4106 or by visiting www.PROVIGILpregnancyregistry.com.