Ruxolitinib Topical Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 15, 2024.

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.

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

This medicine should not be used together with azathioprine or cyclosporine.

If your condition does not improve within 8 weeks for atopic dermatitis or 24 weeks for nonsegmental vitiligo, or if it become worse, check with your doctor.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections (eg, herpes, tuberculosis, hepatitis B or C, fungal infection) more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may increase your risk of cancer (eg, lymphoma, non-melanoma skin cancer). Tell your doctor right away if you have black, tarry stools, general feeling of illness, swollen glands, weight loss, yellow skin and eyes, persistent non-healing sore, reddish patch or irritated area, shiny bump, pink growth, or white, yellow or waxy scar-like area on the skin.

This medicine may increase your risk of serious heart or blood vessel problems, including heart attack or stroke, especially in patients with rheumatoid arthritis who are 50 years of age and older and with a heart or blood vessel disease. Call your doctor right away if you have chest pain or discomfort, confusion, difficulty in speaking, double vision, headache, inability to move arms, legs, or facial muscles, nausea, pain or discomfort in the arms, jaw, back, or neck, sweating, trouble breathing, or vomiting.

This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

This medicine may increase your risk of developing blood clots (eg, arterial thrombosis, deep vein thrombosis, pulmonary embolism), especially in patients with rheumatoid arthritis who are 50 years of age and older and with a heart or blood vessel disease. Check with your doctor right away if you have anxiety, chest pain, cough, dizziness, lightheadedness, or fainting, fast heartbeat, pain, redness, or swelling in the arm or leg, pains in the chest, groin, or legs, especially calves of the legs, severe headaches, sudden loss of coordination, sudden onset of slurred speech, sudden vision changes, or trouble breathing.

This medicine may increase the level of cholesterol and fat in your blood. Talk to your doctor if you have concerns.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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.

Medical Disclaimer

Drug Status

Availability Prescription only Rx

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

User Reviews & Ratings

5 Reviews

Images

Pill medicine is Opzelura 1.5% cream — Opzelura (ruxolitinib) 1.5% cream

Ruxolitinib Topical Side Effects

Important warnings This medicine can cause some serious health issues

Common side effects of ruxolitinib topical

More common side effects

Less common side effects

Rare side effects

Serious side effects of ruxolitinib topical

Less common side effects

Rare side effects

Incidence not known

See also:

Opzelura

Eucrisa

Adbry

Cibinqo

Dupixent

Temovate

Lidex

Clobex

Olux

Oxsoralen

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