Ruxolitinib Side Effects

Some side effects of ruxolitinib may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to ruxolitinib: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking ruxolitinib: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may be similar to the symptoms of myelofibrosis. Call your doctor at once if you have a serious side effect such as:

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• fever, chills, body aches, flu symptoms, vomiting, sores in your mouth and throat;

• pain or burning when you urinate; or

• blisters or painful skin rash.

Less serious side effects of ruxolitinib may include:

• headache;

• dizziness;

• weight gain; or

• bloating gas.

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

For Healthcare Professionals

Applies to ruxolitinib: oral tablet

Dermatologic

Dermatologic side effects have included bruising (23.2%).

Gastrointestinal

Gastrointestinal side effects have included flatulence (5.2%).

Genitourinary

Genitourinary side effects have included urinary tract infections (9.0%).

Hematologic

Hematologic side effects have included anemia (96.1%), thrombocytopenia (69.7%), and neutropenia (18.7%).

Immunologic

Immunologic side effects have included herpes zoster (1.9%).

Metabolic

Metabolic side effects have included weight gain (7.1%).

Laboratory abnormalities have included alanine transaminase (ALT) abnormalities (25.2%), aspartate transaminase (AST) abnormalities (17.4%), and elevated cholesterol levels (16.8%).

Nervous system

Nervous system side effects have included dizziness (18.1%), and headache (14.8%).

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