Tacrolimus (Protopic) is a prescription non-steroid ointment used short-term on the skin to treat moderate-to-severe eczema (atopic dermatitis). It's a calcineurin inhibitor that helps lower the immune system’s response so it doesn’t cause inflammation and make eczema worse. Tacrolimus (Protopic) is approved for both adults and children ages 2 years and older who don't have a weakened immune system. It comes as both a brand-name and generic ointment that you apply to the affected area twice daily. Common side effects include stinging, itching, and a burning sensation at the application site.
Moderate-to-severe eczema in adults and children ages 2 years and older
Tacrolimus (Protopic) is a topical calcineurin inhibitor. It's not completely known how this medication works to treat eczema. But it's thought to block calcineurin, a protein in the body that helps activate the immune system. By blocking calcineurin, tacrolimus (Protopic) helps to reduce inflammation on the skin to treat eczema.
Source: DailyMed
Along with its needed effects, a medicine 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:
Incidence not known
Agitation
black, tarry stools
bloody urine
burning or stinging sensation of the face
change in size, shape, or color of an existing mole
coma
confusion
convulsions
decreased frequency or amount of urine
general feeling of illness
growth or bump on skin
hostility
increase in bone pain
increased blood pressure
increased thirst
irritability
lethargy
looks very ill
loss of appetite
loss of bladder control
lower back or side pain
mole that leaks fluid or bleeds
muscle spasm or jerking of all extremities
muscle twitching
new mole
rapid weight gain
red rash with watery, yellow-colored, or pus filled blisters
redness of the face
seizures
small, red skin lesion, growth, or bump usually on the face, ears, neck, hands, or arms
sore that will not heal
spider-like blood vessels on the face
stupor
sudden loss of consciousness
swelling of the face, ankles, lower legs, hands, or fingers
swollen glands
thick, yellow to honey-colored crusts
unusual tiredness or weakness
vomiting
yellow skin and eyes
Some side effects 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
general aches and pains
headache
itching skin—in children
loss of appetite
skin burning
skin flushing in areas of ointment application when drinking alcohol
weakness
Less common
Acid or sour stomach
back pain
belching
burning, itching, or pain in hairy areas
chills
cyst
flushing
increased sensitivity to sunlight
increased skin sensitivity
indigestion
itching eyes
joint pain
muscle aches or pain
pain in the eye
pain or tenderness around the eyes and cheekbones
pus at root of the hair
rash
redness in the eye
severe skin rash or hives
skin blisters—in children
skin tingling
stomach discomfort, upset, or pain
swelling of the eye, eyelid, or inner lining of the eyelid
swollen glands
tightness of the chest
troubled breathing or wheezing
watery eyes
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Non-steroid option for treating eczema
Usually starts to work as early as 1 week
Can be used in both adults and children
Can be applied to the face, neck, groin, around the eyes, or in skin folds
Not a first-choice medication for treating eczema
Typically only used short term
Can cause burning and stinging where you apply it
Unknown if safe during pregnancy or while breastfeeding
Before using tacrolimus (Protopic), let your prescriber know if you have areas of skin cancer or precancerous conditions. This medication has been linked to cancer but isn't known to cause it.
Apply the smallest amount of tacrolimus (Protopic) needed to cover the affected area with a thin layer. Wash your hands with soap after applying the ointment, unless your hands are being treated.
Tacrolimus (Protopic) might make your skin more sensitive to the sun. Limit your amount of time in the sun during treatment. If you need to be outdoors, wear clothing that protects the treated area from the sun and apply sunscreen.
Let your prescriber know if you have burning, stinging, itching, or any other skin irritation that's bothersome or doesn't go away during the first few days after applying tacrolimus (Protopic).
Avoid contact with water, like bathing, showering, or swimming, soon after applying tacrolimus (Protopic) to prevent washing off the ointment.
Don't cover medicated area(s) with bandages, dressings, or wraps. This can cause more tacrolimus (Protopic) to get absorbed into your body, which raises your risk for side effects. But it's okay to wear normal clothing over the affected area.
Use moisturizers to keep your skin hydrated since it can help relieve your symptoms. Be sure to apply it after tacrolimus (Protopic).
Stop using tacrolimus (Protopic) when your eczema symptoms, such as itching, rash, and redness, go away. If your symptoms don’t improve after 6 weeks, tell your prescriber. They might need to check whether you should continue the medication or not.
Tacrolimus (Protopic) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: Weakened immune system | Taking tacrolimus (Protopic) for a long time
Rarely, some people using tacrolimus (Protopic) have reported skin and lymphoma cancer. That's why it's important to only apply the ointment as directed and not for longer than prescribed. Try to keep the medication only on the treatment areas and away from healthy skin. If eczema symptoms don't get better within 6 weeks, schedule a follow-up visit with your prescriber since they might have to reassess.
Tacrolimus (Protopic) can raise your risk of chickenpox, shingles, and other herpes infections. Don't apply it to areas of the skin where there's an active infection. If an infection develops while you're using this medication, stop using it and let your prescriber know. The infection will need to be treated before you can continue to use tacrolimus (Protopic).
Let your prescriber know if you notice swollen lymph nodes after starting tacrolimus (Protopic). This could be a sign of an infection or another serious medical problem. Depending on the cause of your swollen lymph nodes, you might have to stop using tacrolimus (Protopic).
Tacrolimus (Protopic) might affect how your body responds to sunlight. To prevent sunburns, make sure you use sunscreen or wear protective clothing. Stay away from tanning beds and direct sun exposure while applying this medication.
Risk factors: Kidney problems | Problems in the skin's protective layer | Applying tacrolimus (Protopic) to a large area
In some rare cases, tacrolimus (Protopic) can cause sudden kidney failure. This was reported in people who have problems in the skin’s protective layer and also applied the medication to a large area of skin. Speak with your prescriber if you're concerned about this potential side effect.
Tacrolimus (Protopic) comes in two strengths: 0.03% and 0.01%. Both the 0.03% and 0.01% strengths are FDA approved for adults, while the 0.03% strength is only approved for children ages 2 to 15.
Adults and children: Apply a thin layer to the affected skin twice daily.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Accord Healthcare Inc. (2024). Tacrolimus ointment [package insert]. DailyMed.
Creamer, T. P. (2020). Calcineurin. Cell Communication and Signaling.
National Eczema Society. (n.d.). Topical calcineurin inhibitors (TCIs).
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