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Ruxolitinib Topical Side Effects

Medically reviewed by Drugs.com. Last updated on Feb 13, 2025.

Applies to ruxolitinib topical: topical application cream.

Important warnings This medicine can cause some serious health issues

Topical application route (cream)

Warning: Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis. Serious Infections. Patients treated with oral Janus kinase inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalizations or death.Reported infections include: active tuberculosis, which may present with pulmonary or extrapulmonary disease; invasive fungal infections, including cryptococcosis, and pneumocystosis; and bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.Avoid use of ruxolitinib in patients with an active, serious infection, including localized infections.

If a serious infection develops, interrupt ruxolitinib until the infection is controlled.The risks and benefits of treatment with ruxolitinib should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ruxolitinib.Mortality. In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing an oral JAK inhibitor to tumor necrosis factor (TNF) blocker treatment, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor.Malignancies. Malignancies were reported in patients treated with ruxolitinib.

Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions.

In RA patients treated with an oral JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers.

Patients who are current or past smokers are at additional increased risk.Major Adverse Cardiovascular Events (MACE)In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE)(defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers.

Patients who are current or past smokers are at additional increased risk.

Discontinue ruxolitinib in patients who have experienced a myocardial infarction or stroke.Thrombosis. Thromboembolic events were observed in trials with ruxolitinib.

Thrombosis, including pulmonary embolism (PE), deep venous thrombosis (DVT), and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions.

Many of these adverse reactions were serious and some resulted in death.

In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers.

Avoid ruxolitinib in patients at risk.

If symptoms of thrombosis occur, discontinue ruxolitinib and treat appropriately.

Common side effects of ruxolitinib topical

Some side effects of ruxolitinib topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

  • blemishes, itching, flushing, redness at the application site

Less common side effects

  • burning, itching, and pain in the hairy areas, pus at the root of hair
  • change in hearing
  • chest tightness
  • cough producing mucus
  • diarrhea
  • earache
  • ear drainage
  • headache
  • hives, itching, skin rash
  • stuffy or runny nose

Rare side effects

  • burning, dry, or itching eyes
  • discharge, excessive tearing
  • itching ears
  • redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

Serious side effects of ruxolitinib topical

Along with its needed effects, ruxolitinib topical may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ruxolitinib topical:

Less common side effects

  • black, tarry stools
  • bladder pain
  • bloody or cloudy urine
  • chest pain
  • chills
  • cough
  • difficult, burning, or painful urination
  • fever
  • frequent urge to urinate
  • lower back or side pain
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • trouble breathing
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Rare side effects

  • painful blisters on the trunk of the body
  • pale skin

Incidence not known

  • anxiety
  • bleeding gums
  • blood in the urine or stools
  • chest discomfort
  • coughing or spitting up blood
  • dizziness or lightheadedness
  • fainting
  • general feeling of illness
  • muscle aches
  • nausea
  • night sweats
  • pain, redness, or swelling in the arm or leg
  • pain or discomfort in the arms, jaw, back, or neck
  • pains in the chest, groin, or legs, especially calves of the legs
  • persistent non-healing sore
  • pink growth
  • pinpoint red spots on the skin
  • reddish patch or irritated area
  • severe headaches of sudden onset
  • shiny bump
  • sudden loss of coordination
  • sudden onset of slurred speech
  • sudden vision changes
  • sweating
  • vomiting
  • weight loss
  • white, yellow or waxy scar-like area
  • yellow skin and eyes

Further information

Ruxolitinib topical side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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