Tacrolimus (Topical Route) Side Effects

Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

Protopic

Descriptions

Tacrolimus topical is used on the skin to treat moderate to severe atopic dermatitis in patients who have received other medicines that have not worked well. Atopic dermatitis is a skin condition where there is itching, redness, and inflammation, much like an allergic reaction. Tacrolimus helps to suppress these symptoms which are reactions caused by the body's immune system.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

Ointment

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of tacrolimus topical in children 2 years of age and older. However, this medicine is not recommended in children younger than 2 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tacrolimus topical in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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.

Bepridil
Cisapride
Dronedarone
Fluconazole
Lefamulin
Mesoridazine
Mifepristone
Nelfinavir
Pimozide
Piperaquine
Posaconazole
Ritonavir
Saquinavir
Sparfloxacin
Terfenadine
Thioridazine
Ziprasidone

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.

Abacavir
Abametapir
Abrocitinib
Aceclofenac
Acemetacin
Adagrasib
Adenovirus Vaccine, Live
Alefacept
Alfuzosin
Amikacin
Amiloride
Amiodarone
Amisulpride
Amitriptyline
Amlodipine
Amphotericin B
Amprenavir
Amtolmetin Guacil
Anagrelide
Apalutamide
Apomorphine
Aprepitant
Aranidipine
Aripiprazole
Aripiprazole Lauroxil
Armodafinil
Arsenic Trioxide
Asciminib
Asenapine
Aspirin
Astemizole
Atazanavir
Avacopan
Azilsartan
Azilsartan Medoxomil
Azithromycin
Bacillus of Calmette and Guerin Vaccine, Live
Bedaquiline
Benazepril
Berotralstat
Boceprevir
Bosentan
Bromfenac
Bufexamac
Buprenorphine
Buserelin
Candesartan
Cannabidiol
Cannabis
Canrenoate
Canrenone
Capreomycin
Captopril
Carbamazepine
Caspofungin
Celecoxib
Cenobamate
Ceritinib
Chloramphenicol
Chloroquine
Chlorpromazine
Cholera Vaccine, Live
Choline Salicylate
Cilnidipine
Cimetidine
Ciprofloxacin
Cisplatin
Citalopram
Clarithromycin
Clevidipine
Clofazimine
Clomipramine
Clonixin
Clothiapine
Clotrimazole
Clozapine
Cobicistat
Colchicine
Conivaptan
Crizotinib
Cyclobenzaprine
Cyclosporine
Dabrafenib
Dalfopristin
Danazol
Daridorexant
Darunavir
Dasabuvir
Dasatinib
Degarelix
Delamanid
Delavirdine
Dengue Tetravalent Vaccine, Live
Desipramine
Deslorelin
Deutetrabenazine
Dexamethasone
Dexibuprofen
Dexketoprofen
Dexmedetomidine
Diclofenac
Didanosine
Diflunisal
Diltiazem
Dipyrone
Disopyramide
Dofetilide
Dolasetron
Domperidone
Donepezil
Doxepin
Droperidol
Droxicam
Duvelisib
Ebastine
Ebola Zaire Vaccine, Live
Echinacea
Efavirenz
Elacestrant
Elagolix
Elbasvir
Eliglustat
Emtricitabine
Enalapril
Enalaprilat
Enasidenib
Encorafenib
Entrectinib
Enzalutamide
Eplerenone
Eprosartan
Erdafitinib
Eribulin
Erythromycin
Escitalopram
Eslicarbazepine Acetate
Esomeprazole
Ethinyl Estradiol
Etodolac
Etofenamate
Etoricoxib
Etrasimod
Etravirine
Famotidine
Fedratinib
Felbamate
Felbinac
Felodipine
Fenoprofen
Fentanyl
Fepradinol
Feprazone
Fexinidazole
Fingolimod
Flecainide
Floctafenine
Flufenamic Acid
Fluoxetine
Flurbiprofen
Fluvoxamine
Formoterol
Fosamprenavir
Fosaprepitant
Foscarnet
Fosinopril
Fosnetupitant
Fosphenytoin
Fostemsavir
Galantamine
Gatifloxacin
Gemifloxacin
Gentamicin
Gepirone
Gilteritinib
Glasdegib
Glecaprevir
Gonadorelin
Goserelin
Granisetron
Grazoprevir
Halofantrine
Haloperidol
Histrelin
Hydroquinidine
Hydroxychloroquine
Hydroxyzine
Ibuprofen
Ibuprofen Lysine
Ibutilide
Idelalisib
Iloperidone
Imatinib
Imipramine
Indinavir
Indomethacin
Infliximab
Influenza Virus Vaccine, Live
Inotuzumab Ozogamicin
Irbesartan
Isavuconazonium Sulfate
Isradipine
Itraconazole
Ivabradine
Ivacaftor
Ivosidenib
Kanamycin
Ketoconazole
Ketoprofen
Ketorolac
Lamivudine
Lanreotide
Lansoprazole
Lapatinib
Larotrectinib
Lasmiditan
Lenacapavir
Lenvatinib
Lercanidipine
Lesinurad
Letermovir
Leuprolide
Levamlodipine
Levofloxacin
Lisinopril
Lofexidine
Lomitapide
Lonafarnib
Lopinavir
Lorlatinib
Lornoxicam
Losartan
Loxoprofen
Lumacaftor
Lumefantrine
Lumiracoxib
Macimorelin
Manidipine
Mavacamten
Measles Virus Vaccine, Live
Meclofenamate
Mefenamic Acid
Mefloquine
Meloxicam
Methadone
Methotrimeprazine
Methylprednisolone
Metoclopramide
Metronidazole
Mirtazapine
Mitapivat
Mitotane
Mizolastine
Mobocertinib
Modafinil
Moexipril
Moricizine
Morniflumate
Moxifloxacin
Mumps Virus Vaccine, Live
Mycophenolic Acid
Nabumetone
Nafarelin
Nafcillin
Naproxen
Nefazodone
Neomycin
Nepafenac
Neratinib
Netilmicin
Netupitant
Nevirapine
Nicardipine
Nifedipine
Niflumic Acid
Nilotinib
Nimesulide
Nimesulide Beta Cyclodextrin
Nimodipine
Nirmatrelvir
Nirogacestat
Nisoldipine
Nitrendipine
Norfloxacin
Octreotide
Ofloxacin
Olanzapine
Olmesartan
Omaveloxolone
Ombitasvir
Omeprazole
Ondansetron
Osilodrostat
Osimertinib
Oxaliplatin
Oxaprozin
Oxcarbazepine
Oxyphenbutazone
Ozanimod
Pacritinib
Palbociclib
Paliperidone
Panobinostat
Papaverine
Parecoxib
Paritaprevir
Paromomycin
Paroxetine
Pasireotide
Pazopanib
Pentamidine
Perindopril
Perphenazine
Phenobarbital
Phenylbutazone
Phenytoin
Piketoprofen
Pimavanserin
Pipamperone
Piroxicam
Pirtobrutinib
Pitolisant
Pixantrone
Plazomicin
Poliovirus Vaccine, Live
Ponesimod
Potassium Phosphate
Prednisone
Primidone
Probucol
Procainamide
Prochlorperazine
Proglumetacin
Promethazine
Propafenone
Propionic Acid
Propyphenazone
Proquazone
Protriptyline
Quetiapine
Quinapril
Quinidine
Quinine
Quinupristin
Quizartinib
Ramipril
Ranitidine
Ranolazine
Relugolix
Remdesivir
Repotrectinib
Ribociclib
Rifabutin
Rifampin
Rifapentine
Risperidone
Ritlecitinib
Rofecoxib
Rotavirus Vaccine, Live
Rubella Virus Vaccine, Live
Salicylic Acid
Salsalate
Schisandra sphenanthera
Selpercatinib
Sertindole
Sertraline
Sevoflurane
Simeprevir
Siponimod
Sirolimus
Smallpox Monkeypox Vaccine, Live Non-Replicating
Smallpox Vaccine
Sodium Phosphate
Sodium Phosphate, Dibasic
Sodium Phosphate, Monobasic
Sodium Salicylate
Solifenacin
Sorafenib
Sotalol
Sotorasib
Sparsentan
Spectinomycin
Spirapril
Spironolactone
Stavudine
St John's Wort
Streptomycin
Sulindac
Sulpiride
Sultopride
Sunitinib
Tamoxifen
Taurursodiol
Telaprevir
Telavancin
Telithromycin
Telmisartan
Telotristat Ethyl
Tenofovir
Tenoxicam
Tepotinib
Tetrabenazine
Tiaprofenic Acid
Tipranavir
Tobramycin
Tocilizumab
Tofacitinib
Tolfenamic Acid
Tolmetin
Tolterodine
Toremifene
Trandolapril
Trazodone
Triamterene
Triclabendazole
Trimipramine
Triptorelin
Trofinetide
Troleandomycin
Tucatinib
Typhoid Vaccine, Live
Valdecoxib
Valsartan
Vandetanib
Vardenafil
Varicella Virus Vaccine, Live
Vemurafenib
Venlafaxine
Verapamil
Vilanterol
Vilazodone
Vinflunine
Voclosporin
Vonoprazan
Voriconazole
Vorinostat
Voxilaprevir
Yellow Fever Vaccine
Zidovudine
Zoster Vaccine, Live
Zotepine
Zuclopenthixol

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.

Ertapenem
Tigecycline

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol
Grapefruit Juice

Proper Use

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should not be the first medicine you use to treat your condition. It is meant to be used only after you have tried other medicines that have not worked or have caused unwanted side effects.

This medicine may be associated with an increased risk for developing chicken pox, eczema herpeticum, herpes simplex virus infections (skin blisters), or varicella zoster virus infection (shingles). Ask your doctor if you have questions about this and report any signs or symptoms of these conditions to your doctor.

This medicine should not be used continuously for a long time. If needed, treatment may be repeated with breaks in between.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine is for use on the skin only. Do not get it in your eyes, nose, or mouth. Do not use on skin areas that have cuts or scrapes. If it does get on these areas, rinse it off right away.

To use:

Wash your hands with soap and water before and after using this medicine. If you are treating a rash on your hands, do not wash your hands after using the medicine.
Dry skin completely before applying the ointment.
Apply a thin layer of ointment (use a small amount just enough to cover area) and rub it in well to cover the affected areas.
Do not cover the treated skin with occlusive dressings, bandages, or wraps.
Do not bathe, shower, or swim right after applying this medicine. This could wash off the ointment.
If your doctor recommends a moisturizer, apply it after applying this medicine.

Do not use cosmetics or other skin care products on the treated skin areas.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For topical dosage form (ointment):
- For atopic dermatitis:
  - Adults and teenagers 16 years of age and older—Apply 0.03% or 0.1% ointment to a clean, dry, and intact skin two times a day.
  - Children 2 to 15 years old—Apply 0.03% ointment to a clean, dry, and intact skin two times a day.
  - Children younger than 2 years of age—Use is not recommended.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not leave the ointment in the car in cold or hot weather. Make sure that the tube is tightly closed.

Precautions

It is very important that your doctor check your or your child's progress at regular visits. This is to make sure the medicine is working properly and to check for unwanted effects. If your condition has not improved after 6 weeks or if they get worse, call your doctor.

This medicine may increase your risk of getting skin cancer or cancer of the lymph system (lymphoma). Talk to your doctor if you have concerns about this.

Stop using this medicine if signs and symptoms of eczema, such as itching, burning, stinging, rash, and redness go away, or as directed by your doctor.

This medicine may increase your risk of getting skin tumors, especially when exposed to sunlight. When you begin using this medicine:

Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible. Stay out of the sun even when the medicine is not on your skin.
Wear protective clothing, including a hat. Also, wear sunglasses.
Apply a sunblock product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your doctor.
Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
Make sure your doctor knows if you are receiving any type of UV light treatment or "phototherapy".
Do not use a sunlamp or a tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

This medicine may cause you to be very sick if it is not used correctly. Call a doctor or poison control center right away if you accidentally swallow this medicine.

Do not use this medicine for a skin problem that has not been checked by your doctor.

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.

Side Effects

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
depression
fever
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
nausea
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
weight gain
weight loss
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

Cough
fever
general aches and pains
headache
itching skin—in children
loss of appetite
skin burning
skin flushing in areas of ointment application when drinking alcohol
sneezing
weakness

Less common

Acid or sour stomach
acne
back pain
belching
burning, itching, or pain in hairy areas
chills
cyst
flushing
heartburn
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
runny nose
severe skin rash or hives
skin blisters—in children
skin tingling
stomach discomfort, upset, or pain
stuffy nose
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.

Portions of this document last updated: April 01, 2024

Original article: https://www.mayoclinic.org/drugs-supplements/tacrolimus-topical-route/side-effects/drg-20068159

Tacrolimus (Topical Route)