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Tacrolimus

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 as soon as possible if any of the following side effects occur:

Incidence not known

  • Agitation
  • Black, tarry stools
  • Bloody urine
  • Burning or stinging sensation of face
  • Change in size, shape, or color of existing mole
  • Coma
  • Confusion
  • Convulsions
  • Decreased frequency/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/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 face
  • Seizures
  • Small, red skin lesion, growth, or bump usually on 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 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 eye
  • Pain or tenderness around eyes and cheekbones
  • Pus at root of hair
  • Rash
  • Redness in eye
  • Runny nose
  • Severe skin rash or hives
  • Skin blisters—in children
  • Skin tingling
  • Stomach discomfort, upset, or pain
  • Stuffy nose
  • Swelling of eye, eyelid, or inner lining of eyelid
  • Swollen glands
  • Tightness of 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.

Precautions

It is very important that your doctor check your progress at regular visits. Your doctor will want to make sure the tacrolimus ointment is working properly and to check for unwanted effects. If your condition has not improved after 6 weeks, your doctor will want to reexamine you.

Report any adverse reactions or side effects to your doctor.

Use this medicine only for the condition for which it was prescribed by your doctor.

You should not use this medicine beyond a year.

Tacrolimus ointment may increase the risk of skin tumors, when patients are also exposed to sunlight. The association between topical tacrolimus and the incidence of skin tumors has not been proven. When you begin taking this medicine:

  • Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
  • Wear protective clothing, including a hat. Also, wear sunglasses.
  • Apply a sun block 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 health care professional.
  • Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
  • Do not use a sunlamp or tanning bed or booth.

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

Proper Use

Infections in the affected areas should be treated before starting treatment with tacrolimus ointment.

Dry skin completely before applying tacrolimus ointment.

Apply a thin layer of tacrolimus ointment and rub it in well to cover the affected areas

Do not swallow this medicine.

Wash hand thoroughly after applying tacrolimus ointment, if hands are not any area for treatment.

Use of this medicine may cause reactions at the site of application such as a mild to moderate feeling of warmth and/or sensation of burning. You should contact your doctor if this reaction is severe or persists for more than 1 week.

While using tacrolimus, if symptoms of your skin condition go away, consult your doctor.

Do not use any occlusive dressings (a dressing that seals the are that is being treated such as a plastic exercise suit or plastic wraps used to store foods).

Do not bathe, shower or swim right after applying this medicine. This could wash off the ointment.

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 ointment dosage form
    • For atopic dermatitis:
      • Adults—Gently apply 0.03% or 0.1% ointment to skin that is clean and dry two times a day. Do not cover the area with a bandage that sticks to the skin. Stop using when the signs and symptoms of eczema, such as itching, rash, and redness go away, as directed by your doctor.
      • Children 2 to 15 years old—Gently apply 0.03% ointment to skin that is clean and dry two times a day. Do not cover the area with a bandage that sticks to the skin. Stop using when the signs and symptoms of eczema, such as itching, rash, and redness go away, as directed by your doctor.
      • Children under 2 years of age—Use and dose must be determined by your doctor.

Storage

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

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.

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

Some side effects may occur more or less often in children than they do in adult patients. This medicine has not been tested and should not be used in children under 2 years of age. Only the lower concentration of 0.03% tacrolimus ointment should be used in children 2 to 15 years of age.

Geriatric

Tacrolimus ointment has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

  • 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.

  • Aceclofenac
  • Acemetacin
  • Alclofenac
  • Amikacin
  • Amiloride
  • Amiodarone
  • Apazone
  • Atazanavir
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Basiliximab
  • Benoxaprofen
  • Bromfenac
  • Bufexamac
  • Carbamazepine
  • Carprofen
  • Caspofungin
  • Cisplatin
  • Clometacin
  • Clonixin
  • Colchicine
  • Crizotinib
  • Cyclosporine
  • Darunavir
  • Dexketoprofen
  • Dibekacin
  • Diclofenac
  • Diflunisal
  • Dipyrone
  • Droxicam
  • Efavirenz
  • Etodolac
  • Etofenamate
  • Etravirine
  • Felbinac
  • Fenbufen
  • Fenoprofen
  • Fentiazac
  • Floctafenine
  • Flufenamic Acid
  • Flurbiprofen
  • Gentamicin
  • Ibuprofen
  • Indomethacin
  • Indoprofen
  • Infliximab
  • Isoxicam
  • Itraconazole
  • Kanamycin
  • Ketoprofen
  • Ketorolac
  • Lornoxicam
  • Measles Virus Vaccine, Live
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Mumps Virus Vaccine, Live
  • Nabumetone
  • Naproxen
  • Nefazodone
  • Nelfinavir
  • Neomycin
  • Netilmicin
  • Niflumic Acid
  • Nimesulide
  • Oxaprozin
  • Oxyphenbutazone
  • Pazopanib
  • Phenobarbital
  • Phenylbutazone
  • Phenytoin
  • Pirazolac
  • Piroxicam
  • Pirprofen
  • Poliovirus Vaccine, Live
  • Posaconazole
  • Propyphenazone
  • Proquazone
  • Rifabutin
  • Rifampin
  • Rotavirus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Sirolimus
  • Smallpox Vaccine
  • Spironolactone
  • St John’s Wort
  • Streptomycin
  • Sulindac
  • Suprofen
  • Telaprevir
  • Tenidap
  • Tenofovir
  • Tenoxicam
  • Tiaprofenic Acid
  • Tobramycin
  • Tolmetin
  • Triamterene
  • Typhoid Vaccine
  • Varicella Virus Vaccine
  • Vemurafenib
  • Voriconazole
  • Yellow Fever Vaccine
  • Zomepirac

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.

  • Amprenavir
  • Chloramphenicol
  • Clarithromycin
  • Clotrimazole
  • Dalfopristin
  • Danazol
  • Diltiazem
  • Erythromycin
  • Fluconazole
  • Fosphenytoin
  • Ketoconazole
  • Metoclopramide
  • Metronidazole
  • Mibefradil
  • Nevirapine
  • Nifedipine
  • Quinupristin
  • Rifapentine
  • Ritonavir
  • Saquinavir
  • Schisandra sphenanthera
  • Theophylline

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Chickenpox, existing or recent (including recent exposure) or
  • Herpes simplex virus infections (skin blisters) or
  • Varicella zoster virus infection (shingles)—Increased risk may be associated with these conditions.
  • Immunocompromised patients (weakened immune system)—May cause serious problems; this medicine should not be used by these patients
  • Kidney problems or
  • Tendency to develop kidney problems—You should use this medicine with caution. It may cause your kidney problems to become worse.
  • Precancerous condition of the skin or
  • Skin cancer—You should not use this medicine.
  • Skin infections, other—Safety is unknown
  • Cancer of the lymph system—May increase risk in transplant patients receiving oral or injected immunosuppressant therapy and topical tacrolimus
  • Netherton’s syndrome—May cause too much of the tacrolimus to be absorbed into the body

Description

Tacrolimus ointment is used for moderate to severe atopic dermatitis. This is a skin condition where there is itching, redness and inflammation, much like an allergic reaction. Tacrolimus helps to suppress these symptoms which are a reaction caused by the body’s immune system. It can be used for short-term or long-term intermittent treatment. It is often used when other types of treatment are not working or not tolerated by the patient.

Tacrolimus is available only with your doctor’s prescription.