warnings

What is the most important information I should know about Olumiant (Baricitinib)?

Taking baricitinib can increase your risk of life-threatening medical problems including serious infections, a hole or tear in your digestive tract, a heart attack or stroke, blood clots, or cancer. Tell your doctor if you've had:

a weak immune system or chronic infection (such as tuberculosis, shingles, HIV, or hepatitis);
any type of cancer;
kidney disease;
diverticulitis, an ulcer in your stomach or intestines;
heart problems;
a heart attack, stroke, or blood clot;
high cholesterol; or
if you've ever smoked.

Tell your doctor if you've been sick with signs of infection, such as fever, chills, muscle aches, cough, trouble breathing, skin sores, diarrhea, or painful urination.

Tell your doctor if you've had or been exposed to tuberculosis, or if you recently traveled. Some infections are more common in certain parts of the world, and you may have been exposed during travel.

Also tell your doctor if you have ever had:

liver disease (especially hepatitis B or C);
chronic lung disease;
diabetes; or
if you are scheduled to receive any vaccine.

Using baricitinib may increase your risk of developing certain cancers, such as lymphoma or lung cancer. Ask your doctor about this risk.

Tell your doctor if you are pregnant or plan to become pregnant.

Do not breastfeed.

Not approved for use by anyone younger than 18 years old.

Side Effects

What are the side effects of Olumiant (Baricitinib)?

Stop taking baricitinib and get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people taking baricitinib have developed heart attacks, strokes, or serious blood clots. Stop taking baricitinib and seek emergency medical attention if you have:

sudden shortness of breath;
chest pain or pressure that may spread to your jaw, shoulder, arms, or back;
nausea, vomiting, cold sweat;
a light-headed feeling, like you might pass out;
weakness on one side of your body;
slurred speech, drooping on one side of your mouth; or
pain, swelling, or redness in an arm or a leg.

Call your doctor at once if you have:

fever, chills, night sweats, constant tiredness;
wheezing, trouble breathing, severe or worsening cough;
increased urination, pain or burning when you urinate;
unexplained weight loss;
lumps in your neck, armpits, or groin;
signs of shingles--flu-like symptoms, tingly or painful blistering rash on one side of your body;
a hole (perforation) in your digestive tract--fever, severe stomach pain, diarrhea or changes in bowel habits; or
signs of hepatitis--loss of appetite, vomiting, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

cold sores, shingles;
nausea; or
cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Dosage Guidelines & Tips

How to take Olumiant (Baricitinib)?

Use Olumiant (Baricitinib) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Talk to your doctor if you cannot swallow whole tablets. You may use this medicine in a different administration route if you are not able to swallow the tablets.

Your doctor may perform tests to make sure you do not have tuberculosis or other infections.

You may take baricitinib with or without food.

You may get infections more easily, even serious or fatal infections. You will need frequent medical tests.

If you've ever had shingles (herpes zoster), using baricitinib can cause these viruses to become active or get worse.

You must remain under the care of a doctor while you are using baricitinib for COVID-19. Use this medicine for the full prescribed length of time (usually for 14 days or until you leave the hospital, whichever comes first).

Store at room temperature away from moisture and heat.

What should I do if I missed a dose of Olumiant (Baricitinib)?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.