July 24, 2016
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Orfadin Patient Information including How Should I Take

What should I discuss with my health care provider before taking nitisinone (Orfadin)?

Before taking nitisinone, tell your doctor if you have eye pain, redness, or swelling, or if your eyes are more sensitive to light than usual. You may need to have an eye examination.

While you are taking nitisinone, your doctor may recommend regular visits to check your liver with blood tests and ultrasounds or CT scans.

Some side effects may result from not properly following your diet plan and consuming restricted foods or beverages. Call your doctor if you develop eye redness, pain, burning, or sensitivity to light; painful overgrowth of skin on the palms of your hands or the soles of your feet; changes in behavior; or delayed developmental milestones in a baby such as walking, talking, sitting up, or rolling over.

Nitisinone is in the FDA pregnancy category C. This means that it is not known whether nitisinone will be harmful to an unborn baby. Although it is unlikely that a child taking nitisinone would become pregnant, the medicine may also be used in women of child-bearing age. Do not take nitisinone without telling your doctor if you are pregnant.

It is not known whether nitisinone passes into breast milk. Do not use nitisinone without telling your doctor if you are breast-feeding a baby.

How should I take nitisinone (Orfadin)?

Take your dose of nitisinone on an empty stomach, at least one hour before a meal.

To make it easier to swallow the medicine, you may open a capsule and sprinkle the contents into a small amount of water, infant formula, or applesauce. Use this mixture right away and do not keep it for later use.

Store this medication in the refrigerator and do not allow it to freeze.

Side Effects Centers

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Women's Health

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